Amnio‑Disc™ — Product Information

Dehydrated Human Amniotic Membrane Allograft
Regulatory Basis: 21 CFR 1271 — 361 HCT/P

1. Product Overview

Amnio‑Disc™ is a single‑use, devitalized, dehydrated human amniotic membrane allograft designed to provide temporary protection and structural support to compromised ocular surfaces. The controlled dehydration process preserves the native extracellular matrix, enabling a biologically supportive environment for epithelial repair.

Key attributes:

• Fully aseptic processing
• Terminal gamma sterilization to SAL 10⁻⁶
• Ambient storage (no refrigeration required)
• Six standardized diameters for precise clinical matching
• 361 HCT/P classification under 21 CFR 1271

2. Intended Use

Amnio‑Disc™ is indicated as a protective barrier and covering for the ocular surface in cases where the corneal epithelium is:

• Compromised
• Disrupted
• Delayed in healing
• Exposed following surgery or trauma

Clinical scenarios include:

• Persistent epithelial defects
• Post‑surgical epithelial support
• Chemical/thermal injuries
• Temporary coverage during active healing phases

3. Homologous Use Justification

Amnio‑Disc™ performs the same protective and structural function as native amniotic membrane in vivo.

• Native function: protective, moisture‑retaining, structural tissue layer
• Clinical function: identical protective and supportive role at the ocular surface

4. Product Specifications

Available Diameters

6 mm • 8 mm • 10 mm • 12 mm • 14 mm • 16 mm
Designed to accommodate the full spectrum of ocular surface presentations.

Sterility

• Gamma‑irradiated to SAL 10⁻⁶
• Validated terminal sterilization
• Single‑use, aseptically processed

Storage

• Ambient room temperature
• No cold chain required
• Supplied in sealed, sterile packaging

5. Processing & Minimal Manipulation

Amnio‑Disc™ is processed in compliance with 21 CFR 1271 minimal manipulation standards.

Key features:

• Dehydration preserves basement membrane, stromal structure, and biologically active proteins
• No chemical cross‑linking
• No exogenous drugs, biologics, or non‑permitted additives
• Structural integrity superior to conventional dehydrated AM products (as per document)

Quoted line:

“The dehydration protocol maintains the native extracellular matrix architecture… without chemical alteration or cross‑linking.”

A bandage contact lens may be applied separately by the clinician for retention.

6. Mechanism of Action

Amnio‑Disc™ supports ocular surface healing through:

a. Mechanical Protection

Acts as a physical barrier shielding the epithelium from mechanical and environmental insult.

b. Biological Repair Support

Preserved ECM components (collagen, laminin, fibronectin) provide cues for:

• Epithelial migration
• Adhesion
• Proliferation

c. Moist Microenvironment

Maintains hydration essential for epithelial wound closure.

d. Temporary Coverage

Provides stable coverage during the active healing phase.

7. Donor Eligibility & Safety

All tissue is recovered from healthy, consenting donors following live birth (C‑section).

Safety measures include:

• Medical & behavioral risk assessment
• Physical examination
• Medical record review
• Full infectious disease testing panel
• Medical Director–supervised eligibility determination

All processes comply with 21 CFR 1271 Subpart C and CGTP/CGMP requirements.

8. Clinical Handling & Application

• Ready‑to‑use; no hydration or reconstitution required
• Apply directly to the ocular surface
• Conforms immediately upon contact
• Optional bandage contact lens for retention

9. Regulatory Classification

Amnio‑Disc™ meets all six criteria for regulation solely as a 361 HCT/P under:

• Section 361 of the PHS Act
• 21 CFR Part 1271

Criteria satisfied:

1. Minimally manipulated
2. Homologous use
3. Not combined with non‑permitted articles
4. Does not rely on living cells
5. Locally acting
6. CGTP compliant

This classification eliminates the need for FDA premarket approval or 510(k).

10. Clinical & Procurement Summary

For Surgeons

• Native architecture preserved
• Immediate application
• Six diameters for precise matching
• Reliable handling and placement

For Procurement

• Ambient storage (no cold chain)
• Simplified regulatory pathway (361 HCT/P)
• Full donor‑to‑patient traceability
• CGTP/CGMP compliant manufacturing

Safety Profile

• Terminal gamma sterilization (SAL 10⁻⁶)
• Multi‑modal donor screening
• Aseptic processing
• No exogenous additives

11. Manufacturer

Akriti Ophthalmic Pvt. Ltd.
M34–M36, Medical Devices Park, Sultanpur Village
Patancheru Mandal, Hyderabad – 502319
Telangana, India
www.akritiophthalmic.com