Premvia is indicated for the management of wounds including: partial thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, postlaser surgery, podiatric wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.

Device Description

Premvia™ is a wound matrix supplied in a package containing sterile 3 lyophilized vials and 1 vial of sterile reconstitution solution. Premvia™ is a resorbable, viscoelastic hydrogel matrix that consists of modified glycosaminoglycan and collagen molecules that crosslink upon reconstitution and combination of the three sterile, lyophilized components: thiolmodified hyaluronan, thiol-modified gelatin, and polyethylene glycol diacrylate (Extralink). To create the hydrogel, each component is reconstituted with sterile saline solution (pH 6.8-7.2) and then mixed together.

AI/ML Overview

The provided text describes the BioTime Premvia, a wound matrix device (K134037) and its substantial equivalence to a predicate device, INTEGRATM Flowable Wound Matrix (K072113). However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in terms of numerical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence based on:

Identical Indications for Use
Similar Class of materials (collagen and glycosaminoglycan)
Similar Delivery method (syringe)
Biocompatibility and similar physical properties (dispersion, absorbance, hydrating properties)
Capability of providing a matrix for cells and vascular integration

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, ground truth establishment for test/training sets, adjudication methods, or MRMC studies, as this information is not present in the document.

The document states that "Product testing has been done to assess the following characteristics," and then lists types of tests like ISO 10993 Biocompatibility, EN 13726-1 for primary wound dressings (e.g., Free Swell Absorptive Capacity, Fluid Affinity of Amorphous Hydrogel Dressings, Dispersion/Solubility of Hydrogel Dressings), and Cytocompatibility with human skin cells. These are categories of tests, not specific acceptance criteria with numerical targets or results.

Summary of available information:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document lists types of tests performed (e.g., ISO 10993 Biocompatibility, EN 13726-1) but does not state specific acceptance criteria or performance metrics for these tests.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set with ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (no algorithm training described).
9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, one behind the other. The faces are oriented to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2014

BioTime Incorporated Mr. David C. Furr Principal Consultant 8708 Capehart Cove Austin, Texas 78733

Re: K134037

Trade/Device Name: BioTime Premvia Regulatory Class: Unclassified Product Code: KGN Dated: July 7, 2014 Received: July 8, 2014

Dear Mr. Furr:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K134037

Device Name BioTime Premvia

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Jiyoung Dang -S

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510(k) Summary Pursuant to 21 CFR 807.92

K134037

Date: July 2, 2014

1. Submitted By:	BioTime, Inc.1301 Harbor Bay ParkwayAlameda, CA 94502510-521-3390
2. Contact:	David C. FurrFDC Services, LLC8708 Capehart CoveAustin, Texas 78733512-906-9654
3. Product:	BioTime Premvia™Regulation - N/AClassification – UnclassifiedProduct Code: KGN
4. Common/Trade Name:	Dressing, Wound, CollagenPremvia™

Description:

Intended Use:

Premvia™ is indicated for the management of wounds including: partial-thickness, fullthickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skins tears and draining wounds.

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Technological Characteristics:

The product is a single use kit consisting of 4 components: Glycosil® (thiol-modified hyaluronan), Gelin® (thiol-modified gelatin), Extralink® (polyethylene glycol diacrylate, PEGDA), and a saline reconstitution solution (pH-adjusted Lactated Ringer's solution). The first three components are supplied in vials as pre-measured, sterile, and lyophilized solids that, when dissolved in the saline reconstitution solution (the 4th component) and mixed together, form a clear, transparent, and viscoelastic hydrogel matrix which can be used as a flowable wound dressing. The three lyophilized components, when reconstituted and combined will yield about 5cc of hydrogel.

Product testing has been done to assess the following characteristics:

ISO 10993 Biocompatibility, including the following -●
- Ames Mutagenicity
- Genotoxicity
- Cytotoxicity
- I Implantation
- Sensitization
- Irritation
- Systemic Toxicity
EN 13726-1 Tests for primary wound dressings including the following-●
- Free Swell Absorptive Capacity ■
- . Fluid Affinity of Amorphous Hydrogel Dressings
- 트 Dispersion/Solubility of Hydrogel Dressings
Cytocompatibility with human skin cells ●

Substantial Equivalence:

Premvia™ is substantially equivalent to the following cleared device:

INTEGRATM Flowable Wound Matrix (K072113) - Integra LifeSciences Corporation

Premvia™ wound dressing is substantially equivalent to the INTEGRA Flowable Wound Matrix (K072113) since they have essentially the same:

Indications for use There are no significant differences in indications. ●
. Class of materials that compose each device - Both Premvia™ and Integra wound matrices are composed of collagen and glycosaminoglycan. Premvia™ is composed of porcine denatured collagen and hyaluronic acid (a glycosaminoglycan) which is crosslinked in situ. Integra is composed of crosslinked chondroitin sulfate (a glycosaminoglycan) and bovine collagen. Collagen or denatured collagen, glycosaminoglycan, or a combination of the two has also been used in a variety of other wound healing devices with the same classification (KGN).

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. Delivery method (syringe) - Premvia™ and Integra Flowable Wound matrix are both rehydrated or reconstituted before use and mixed within a syringe before application. For both products the application syringe is used to apply directly within tunneled or undermined wounds or onto the surface of other more superficial as prescribed.
Biocompatibilty and Properties Both Premvia™ and Integra Flowable Wound ● matrix have been extensively tested and determined to be biocompatible. In addition, comparison testing was done to assess physical characteristics of hydrogel wound dressings. These properties include the dispersion, absorbance, and hydrating properties of gel or gel-like wound products. Premvia™ and Integra Flowable Wound matrices both act by providing moisture to the wound environment, providing important hydration for dry wounds that may accelerate healing, and both products are dispersible, meaning that unincorporated or unintegrated material may be removed when desired with irrigation or debridement. They also swell slightly in more moist environments, indicating a similar level of ability to absorb wound exudate.
Both products are capable of providing a matrix for cells and vascular integration. ●

Conclusion:

Our concusion is that Premvia™ and Integra Flowable Wound matrix are substantially equivalent since they have equivalent indications, presentation, chemistry, and function. No significant differences exist that would affect equivalence.

Regulation Number and Section

N/A