(219 days)
Not Found
No
The 510(k) summary describes a wound matrix composed of specific chemical components that form a hydrogel. There is no mention of any software, algorithms, image processing, or data analysis that would indicate the use of AI or ML. The performance studies focus on material properties and biocompatibility.
Yes
Premvia is indicated for the management of wounds and promotes healing by providing a moist environment, which are therapeutic actions.
No
The device is described as a wound matrix for the management of wounds, providing moisture and absorption of exudate to accelerate healing. It does not perform any diagnostic function.
No
The device description clearly states that Premvia is a wound matrix supplied in lyophilized vials and reconstitution solution, which are physical components, not software. The performance studies also focus on biocompatibility and physical characteristics of the hydrogel, further indicating it is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Premvia is indicated for the management of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound matrix that is applied to the wound itself. It's a resorbable, viscoelastic hydrogel. This is consistent with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and physical characteristics relevant to wound dressings (absorptive capacity, fluid affinity, dispersion, cytocompatibility). These are not the types of studies typically performed for IVDs, which would involve evaluating analytical and clinical performance related to a diagnostic claim.
In summary, Premvia is a wound care product intended for the treatment and management of wounds, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Product testing has been done to assess the following characteristics:
- ISO 10993 Biocompatibility, including the following: Ames Mutagenicity, Genotoxicity, Cytotoxicity, 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, Dispersion/Solubility of Hydrogel Dressings
- Cytocompatibility with human skin cells
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
INTEGRA Flowable Wound Matrix (K072113)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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)
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.
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 Parkway
Alameda, CA 94502
510-521-3390 |
|-----------------------|-------------------------------------------------------------------------------------------------|
| 2. Contact: | David C. Furr
FDC Services, LLC
8708 Capehart Cove
Austin, Texas 78733
512-906-9654 |
| 3. Product: | BioTime Premvia™
Regulation - N/A
Classification – Unclassified
Product Code: KGN |
| 4. Common/Trade Name: | Dressing, Wound, Collagen
Premvia™ |
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.
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.
4
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.