K Number
K032104
Device Name
AMNIOLENS
Manufacturer
Date Cleared
2003-12-12

(157 days)

Product Code
Regulation Number
886.3130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The description focuses on the physical components and biological material of the device, with no mention of software, algorithms, or data processing related to AI/ML.

Yes
The device is described as an ophthalmic conformer with amniotic membrane intended for use in eyes with damaged ocular surface cells or inflamed/scarred stroma, and its purpose is to maintain space, prevent closure/adhesions, and apply amniotic membrane for healing, which are therapeutic actions.

No

The device is described as a "corneal-epithelial insert" intended to maintain space and apply amniotic membrane for therapeutic purposes, rather than to diagnose a condition.

No

The device description clearly states it is a "corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane," which are physical components, not software.

Based on the provided information, the ProKera™ device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • ProKera™ Function: The description clearly states that the ProKera™ is a "corneal-epithelial insert" that is "inserted between the eyeball and the eyelid." Its purpose is to physically support the ocular surface and deliver amniotic membrane. It is a therapeutic device applied directly to the body, not a test performed on a sample taken from the body.

The information provided describes a medical device used for treatment and support of the eye, not a diagnostic test.

N/A

Intended Use / 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.

Product codes

NQB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ocular surface, eyeball, eyelid, orbital cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K921221

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 886.3130 Ophthalmic conformer.

(a)
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. ](b)
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.

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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
Validation of Microbial Recovery from Pharmacopeial
Articles, USP XXIV Microbial Limits Tests, USP XXIV
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. |

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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.

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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

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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