(164 days)
Wound Matrix PLUS is intended for the management of wounds including:
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Chronic vascular ulcers
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
- Trauma wounds (abrasions, lacerations,second-degree burns, and skin tears)
- Draining wounds
- Tunneled/undermined wounds
The device is intended for one-time use.
Geistlich Wound Matrix PLUS is an animal-sourced, acellular extracellular matrix (ECM) wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. Wound Matrix PLUS is terminally sterilized using gamma irradiation in its packaging.
The device is offered in various sizes and can be shaped to the required dimension using standard sterile instruments (scissors or scalpel).
The device is intended to be used by licensed healthcare practitioners and will be supplied sterile for single one-time use.
This appears to be an FDA 510(k) summary for a medical device called Geistlich Wound Matrix PLUS. It demonstrates substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria.
Therefore, the requested information cannot be fully extracted as such a study is not provided in this document. The document primarily focuses on demonstrating that the new device (Geistlich Wound Matrix PLUS) is as safe and effective as a legally marketed predicate device (ACell Inc.'s Cytal Wound Matrix) and a reference device (Geistlich Fibro-Gide) based on similar technological characteristics and performance data leveraged from the reference device.
However, I can extract information related to the performance data presented, which are mainly biocompatibility and viral inactivation studies, and explain why the other requested information is not applicable here.
Summary of Device Acceptance Information (Based on 510(k) Submission for Substantial Equivalence)
The provided document describes the Geistlich Wound Matrix PLUS seeking 510(k) clearance for substantial equivalence to a predicate device, ACell Inc.'s Cytal Wound Matrix (K152721), and referencing Geistlich Fibro-Gide (K171050) for performance data. This type of submission relies on demonstrating that the new device has similar technological characteristics and safety/effectiveness profiles to already cleared devices, rather than presenting a de novo study with explicit acceptance criteria for performance metrics like sensitivity or specificity.
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for substantial equivalence based on biocompatibility and viral inactivation leveraged from a reference device, there are no explicit "acceptance criteria" presented in the sense of performance thresholds for a diagnostic or AI device (e.g., minimum sensitivity, specificity, or AUC). Instead, the performance criteria are that the device demonstrates biocompatibility and viral safety.
| Test (Standard) | Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Result for Wound Matrix PLUS / Fibro-Gide) |
|---|---|---|
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Not irritant | Not irritant |
| Sensitization (ISO 10993-10) | Not sensitizing | Not sensitizing |
| Acute systemic toxicity (ISO 10993-11) | No acute systemic toxicity | No acute systemic toxicity |
| Pyrogenicity (USP <151>) | Non-pyrogenic | Non-pyrogenic |
| Genotoxicity (ISO 10993-3) | Non-mutagenic, Not genotoxic | Non-mutagenic, Not genotoxic |
| Local tissue response (ISO 10993-6) | Acceptable local tissue response; No systemic toxicity | Local tissue effects: slight irritant. Systemic toxicity: No evidence of systemic toxicity |
| Subchronic systemic toxicity (ISO 10993-11) | No subchronic toxicity | No subchronic toxicity |
| Chronic systemic toxicity (ISO 10993-11) | No chronic toxicity | No chronic toxicity |
| Chemical Characterization (ISO 10993-18) | No product-related semi-volatile organic compounds detected | No product-related semi-volatile organic compounds were detected |
| Viral Inactivation (ISO 22442-3, ICH Q5A) | Support viral safety | Results support the viral safety of the device |
| Expiration Dating / Shelf Life (ISO 11607) | Support intended shelf life | Product shelf life of three years supported |
| Sterility Assurance Level (SAL) | SAL of 10-6 | SAL of 10-6 |
2. Sample size used for the test set and the data provenance:
- Sample size for Biocompatibility Tests: The specific number of animals or cell cultures used for each biocompatibility test (e.g., number of rabbits for irritation, guinea pigs for sensitization, mice for systemic toxicity, rats for implantation) is not explicitly stated in this summary. These are standard in vitro/in vivo biological tests.
- Data Provenance: The biocompatibility and viral inactivation testing "was leveraged from the previously reviewed and cleared reference device (Geistlich Fibro-Gide (K171050) that is identical in composition and technology to the subject device." This implies the tests were conducted with the Fibro-Gide device. The location or specific laboratory where these tests were performed is not mentioned, nor is whether the data was retrospective or prospective relative to the Fibro-Gide submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the studies are focused on material properties (biocompatibility, viral safety, shelf life) and not on diagnostic accuracy requiring expert consensus or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for biocompatibility and material property testing, which are lab-based assessments not requiring adjudication by experts.
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:
- This is not applicable. Geistlich Wound Matrix PLUS is a wound dressing (a physical matrix), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or human reader assistance analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a wound dressing, not an algorithm or software. The performance data relates to its physical and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility tests, the "ground truth" is established by standard biological and chemical assays measuring specific toxicological endpoints (e.g., cell viability for cytotoxicity, inflammatory response for irritation, DNA damage for genotoxicity, systemic effects for toxicity tests).
- For viral inactivation, the ground truth relates to the measured reduction in viral titers.
- For shelf life, the ground truth is stability over time based on physical and functional properties.
8. The sample size for the training set:
- This is not applicable. There is no AI component or machine learning model that would require a "training set."
9. How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a larger, bolder font than the full name.
May 5, 2022
Geistlich Pharma AG % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Dr Chevy Chase, Maryland 20815
Re: K213607
Trade/Device Name: Geistlich Wound Matrix PLUS Regulatory Class: Unclassified Product Code: KGN
Dear Stephen Rhodes:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 28, 2022. Specifically, FDA is updating this SE Letter to correct the indications for use due to an administrative error.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
April 28, 2022
Geistlich Pharma AG % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Dr Chevy Chase, Maryland 20815
Re: K213607
Trade/Device Name: Geistlich Wound Matrix PLUS Regulatory Class: Unclassified Product Code: KGN Dated: December 17, 2021 Received: December 20, 2021
Dear Stephen Rhodes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213607
Device Name
Wound Matrix PLUS
Indications for Use (Describe)
Wound Matrix PLUS is intended for the management of wounds including:
- · Partial and full-thickness wounds
- · Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- Chronic vascular ulcers
- · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations,second-degree burns, and skin tears)
- · Draining wounds
- · Tunneled/undermined wounds
The device is intended for one-time use.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for Wound Matrix PLUS is provided below.
SUBMITTER 1.
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
Contact Person: Erik Wirth Phone: +41 41 492 69 28 Email: Erik.Wirth@geistlich.ch
Prepared By: Stephen P. Rhodes, Streamline Regulatory stephen.rhodes@streamlineregulatory.com Date Prepared: April 12, 2022
2. DEVICE
Name of Device: Wound Matrix PLUS Common Name: Collagen Wound Dressing Classification Regulation: Unclassified Regulatory Class: Unclassified Product Code: KGN Panel: General and Plastic Surgery
PREDICATE DEVICE 3.
Predicate Device: ACell Inc.'s Cytal Wound Matrix (K152721)
Reference Device: Geistlich Fibro-Gide (K171050)
4. DEVICE DESCRIPTION
Geistlich Wound Matrix PLUS is an animal-sourced, acellular extracellular matrix (ECM) wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. Wound Matrix PLUS is terminally sterilized using gamma irradiation in its packaging.
The device is offered in various sizes and can be shaped to the required dimension using standard sterile instruments (scissors or scalpel).
The device is intended to be used by licensed healthcare practitioners and will be supplied sterile for single one-time use.
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ട്. INDICATIONS FOR USE
Wound Matrix PLUS is intended for the management of wounds including:
- Partial and full-thickness wounds 0
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers ●
- Chronic vascular ulcers ●
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, ● wound dehiscence)
- o Trauma wounds (abrasions, lacerations, superficial second-degree burns, and skin tears)
- Draining wounds ●
- o Tunneled/undermined wounds
The device is intended for one-time use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The similarities and differences in technological characteristics between the subject device (Wound Matrix PLUS), predicate device (Cytal Wound Matrix - K152721), and the reference device (Geistlich Fibro-Gide - K171050) are summarized below.
Wound Matrix PLUS and Cytal Wound Matrix (K152721) are both porcine-derived matrices intended for wound management. The wound dressings provide a moist environment that is conducive to wound healing.
The subject device is offered in one thickness (6mm) and the following sizes: 10 x 10 mm, 10 x 20 mm, 10 x 40 mm, 10 x 80 mm, 15 x 20 mm, 20 x 20 mm, 20 x 40 mm, and 25 x 25 mm. The predicate's largest size is 100 x 150 mm and is provided in a range of thicknesses (one to eight layers) up to 3-4 mm. The difference in size and number of layers between Wound Matrix PLUS and Cytal Wound Matrix does not raise different questions of safety or effectiveness in the subject device. Both the subject and predicate device can be shaped to the desired dimensions or multiple devices can be used. Additionally, the predicate device is sterilized with electron beam irradiation and the subject device is gamma-sterilized. Both devices are provided sterile with an SAL of 10-6.
| Wound Matrix PLUSK213607 | Cytal Wound MatrixK152721 | |
|---|---|---|
| Material Origin | Porcine derived collagen | Porcine derived collagen |
| Sizes/ Form | 10 x 10 mm, 10 x 20 mm, 10 x 40 mm,10 x 80 mm, 15 x 15 mm, 15 x 20 mm,20 x 20 mm, 25 x 25 mm, 20 x 40 mm | Up to 100 x 150 mm |
| Thickness | 6 mm | 3 – 4 mm |
| Sterilization | Irradiation (gamma) | Irradiation (electron beam) |
| Sterility Level | SAL of 10-6 | SAL of 10-6 |
Technological Characteristics
Overall, the differences in technological characteristics of the subject and predicate devices do not raise any different questions of safety and effectiveness.
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Lastly, the subject Wound Matrix PLUS has the same technological characteristics as the cleared Geistlich Fibro-Gide reference device (K171050) although with different indications.
PERFORMANCE DATA 7.
For all performance testing, the testing was leveraged from the previously reviewed and cleared reference device (Geistlich Fibro-Gide (K171050) that is identical in composition and technology to the subject device. The substantial equivalence evaluation of Wound Matrix PLUS and Cytal Wound Matrix was supported by non-clinical performance including GLP biocompatibility testing, as per ISO 10993-1 and consistent with FDA Guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and laboratory testing.
Wound Matrix PLUS is classified as a permanent contact device. Biocompatibility information is summarized in the table below:
| Test (Standard) | Test method | Results |
|---|---|---|
| Cytotoxicity (ISO 10993-5) | In vitro mouse L929 fibroblast cellculture assay | Non-cytotoxic |
| Irritation (ISO 10993-10) | Intracutaneous reactivity in therabbit | Not irritant |
| Sensitization (ISO 10993-10) | Guinea pig maximization test | Not sensitizing |
| Acute systemic toxicity(ISO 10993-11) | Acute systemic toxicity test in themouse | No acute systemic toxicity |
| Pyrogenicity (USP <151>) | Rabbit pyrogen test | Non-pyrogenic |
| Genotoxicity (ISO 10993-3) | Bacterial reverse mutagenicityassay in Salmonella typhimuriumand Escherichia coli (Ames test)In vitro chromosomal aberrationstudy in human lymphocytesMouse peripheral bloodmicronucleus study | Non-mutagenicNot genotoxicNot genotoxic |
| Local tissue response afterimplantation (ISO 10993-6) | 4-week, 12-week and 26 weeksubcutaneous implantation in rats | Local tissue effects: slight irritant.Systemic toxicity: No evidence ofsystemic toxicity |
| Subchronic systemictoxicity (ISO 10993-11) | 4-week subcutaneous implantationin rats, with systemic toxicityendpoint | No subchronic toxicity |
| Chronic systemic toxicity(ISO 10993-11) | 26-week subcutaneousimplantation in rats, with systemictoxicity endpoint | No chronic toxicity |
| Chemical CharacterizationExtractable Substances (ISO10993-18) | GC/Headspace and ICP | No product-related semi-volatileorganic compounds were detected inthe GC/MS fingerprintchromatograms of the test material |
Leachables and Biocompatibility Test Results
The results indicate that Wound Matrix PLUS is biocompatible.
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Per FDA guidance on shelf life, sterilization, and devices containing animal-derived material, the following laboratory studies were also conducted:
Laboratory Testing
- Viral Inactivation: Viral validation studies per ISO 22442-3 Medical devices utilizing ● animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents and requirements of ICH Q5A Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
- Expiration Dating / Shelf Life for Three Year Shelf Life. Packaging stability was . confirmed by ISO 11607 Packaging for terminally sterilized medical devices, and realtime shelf life testing was conducted on device properties
The results support the viral safety of the device and the product shelf life of three years.
CONCLUSIONS 8.
The subject Wound Matrix PLUS has the same intended use and indications as the predicate Cytal Wound Matrix (K152721).
There are similar technological characteristics between the subject Wound Matrix PLUS and the predicate Cytal Wound Matrix. The differences in technological characteristics do not raise any different questions of safety or effectiveness.
Wound Matrix PLUS has the same design, material, manufacturing, packaging and sterilization to the reference device, Fibro-Gide (K171050).
N/A