← Product Code [NQB](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NQB) · K032104 # AMNIOLENS (K032104) _Bio-Tissue, Inc. · NQB · Dec 12, 2003 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NQB/K032104 ## Device Facts - **Applicant:** Bio-Tissue, Inc. - **Product Code:** [NQB](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NQB.md) - **Decision Date:** Dec 12, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.3130 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred. The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures. ## Device Story ProKera™ is a corneal-epithelial insert comprising an ophthalmic conformer and cryopreserved amniotic membrane. Inserted between eyeball and eyelid by a clinician; maintains orbital cavity space; prevents adhesions; enables sutureless application of amniotic membrane to ocular surface. Device functions as a physical barrier and therapeutic scaffold. Benefits include reduced surgical complexity and promotion of ocular surface healing. Operational context involves cryopreservation storage at -80°C. ## Clinical Evidence Bench testing only. Testing confirmed fastening strength of the amniotic membrane using impact testing (dropping stainless steel balls). Cryopreservation stability testing at -80°C for three weeks showed no change in fastening strength, no loss of integrity, and no microscopic cracks or chipping. ## Technological Characteristics Ophthalmic conformer with integrated cryopreserved amniotic membrane. Conforms to 21 C.F.R. § 1270/1271 (human tissue), AATB standards, ISO 11737.1, EN 11743-3, USP XXV <1227>, USP XXIV <61>, USP XXIV <71>, and PDA Technical Report No. 21. Mechanical fastening mechanism. ## Regulatory Identification An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. ## Predicate Devices - Symblepharon Ring ([K921221](/device/K921221.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) SUMMARY ProKera™ Bio-Tissue, Inc. This 510(k) summary of safety and effectiveness for the ProKera™ is submitted in accordance with the requirements of the SMDA and follows Office of Device In accordance with the requirement of a station and content of a 510(k) summary. | Applicant: | Bio-Tissue, Inc. | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 7000 SW 97 Avenue
Suite 211
Miami, FL 33173 | | Contact Person: | David J. Bloch
Regulatory Counsel | | Telephone: | (202) 414-9209 (telephone)
(202) 414-9209 (fax) | | Preparation Date: | July 2, 2003 | | Device Trade Name: | ProKera™ | | Common Name: | Ophthalmic Conformer, with Amniotic Membrane | | Classification Name: | Ophthalmic Conformer, 21 CFR §886.3130 | | Product Code: | NQB | | Predicate Device: | Symblepharon Ring, 510(k) # K921221 | | Device Description: | The ProKera™ is a corneal-epithelial insert, consisting of an
ophthalmic conformer that incorporates amniotic membrane.
The device is intended for use in eyes in which the ocular
surface cells have been damaged, or underlying stroma is
inflamed and scarred.

The device is inserted between the eyeball and the eyelid to
maintain space in the orbital cavity and to prevent closure on
adhesions. Insertion of the conformer also enables
application of the amniotic membrane to the ocular surface
without the need for sutures. | {1}------------------------------------------------ | Performance Data: | Bio-Tissue has performed testing to confirm that the
conformers hold the amniotic membrane in place firmly, and
that the device does not pose a risk of coming loose. The
strength of the fastening of amniotic membrane by these two
rings was tested by dropping stainless steel balls weighing
either 12.138 g or 16.567 g onto the attached membrane. | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | In addition, because the amniotic membrane is preserved
through cryopreservation prior to use, the ProKera™ would
be stored at freezing temperatures once the membrane is in
place. Bio-Tissue has performed testing to confirm that
cryopreservation does not negatively affect the rings or the
amniotic membrane. The conformer ring was placed in the –
80°C temperatures at which the membrane is stored for up
to three weeks, and has shown no change in the fastening
strength or in the integrity of the skirt or the inner ring.
Microscopic evaluation has revealed no cracks or chipping. | | Statement of
Conformance: | Bio-Tissue conforms to the requirements of 21 C.F.R. §
1270 and 1271 for establishments that process human
tissue, as well as the standards of the American Association
of Tissue Banks (AATB), ISO 11737.1 and EN 11743-3, the
United States Pharmacopeia standards USP XXV <1227>
Validation of Microbial Recovery from Pharmacopeial
Articles, USP XXIV <61> Microbial Limits Tests, USP XXIV
<71> Sterility Tests, and PDA Technical Report No. 21,
Bioburden Recovery Validation. | | CONCLUSIONS: | Based on the foregoing and other information in this
application, Bio-Tissue, Inc. believes that the ProKera™ is
substantially equivalent to its claimed predicates under
conditions of intended use. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 2 2003 Bio-Tissue Inc., c/o David J. Bloch 1301 K Street, N.W. Suite 1100 - East Tower Washington, D.C. 20005 Re: K032104 Trade/Device Name: ProKera™ Ophthalmic Conformer Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: NQB Dated: November 10, 2003 Received: November 15/2003 Dear Mr. Bloch: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Alegi Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K032104 Device Name: ProKera™ Indications For Use: The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred. The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures. Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K032104 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NQB/K032104](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NQB/K032104) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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