(457 days)
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.
G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.
G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.
G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.
The provided text describes the G4Derm / G4Derm Plus Synthetic Wound Matrix and its substantial equivalence to a predicate device, Woun'Dres® Collagen Hydrogel (K991202), and two reference devices, PuraDERM (K193085/K143058) and Excellagen (K110318). However, the document does not include a specific table of acceptance criteria or detailed reported device performance in a quantitative manner that would allow for a direct comparison with specific numerical targets.
Based on the information provided, here's a breakdown of the available data:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "Gel4Med / G4Derm Plus Synthetic Wound Matrix is substantially equivalent in intended use, indications for use, device design, function, physical properties, principles of operation, instructions for use, biocompatibility, safety, and performance to the predicate device." It also mentions that "Any differences in the technological characteristics of the subject device when compared to the predicate have been successfully evaluated using appropriate scientific methods."
The general performance attributes assessed are:
- Safety: Demonstrated through biocompatibility testing (ISO 10993-1) and human skin irritation testing.
- Effectiveness: Demonstrated through in vivo performance testing in a wound healing animal model.
- Sterility: Achieved a minimum sterility assurance level of 10^-6 in accordance with ISO 17665.
- Antibacterial barrier effectiveness: Tested in vitro.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The document mentions "a large animal wound healing model" for performance testing. However, it does not specify the exact number of animals or wounds used in this in vivo study. It also mentions "Human Skin Irritation Test" and "antibacterial barrier effectiveness testing (in vitro)" but does not provide sample sizes for these tests.
- Data Provenance: The animal model is described as a "GLP pre-clinical performance testing in wound healing animal model". The location or country of origin of this study is not specified. The human skin irritation test is described as "clinical (human skin irritation) testing," but no further details on the population or location are provided. The in-vitro antibacterial barrier effectiveness testing, by its nature, is laboratory-based and not tied to patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document. The studies mentioned (animal wound healing, human skin irritation, in vitro antibacterial testing) do not typically involve experts establishing "ground truth" in the same way, for example, diagnostic imaging studies do. Instead, their endpoints are measured objectively (e.g., wound closure rates, irritation scores, bacterial counts).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided, as the studies described are not subjective assessments requiring adjudication like in diagnostic image interpretation.
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 information is not applicable and therefore not provided. The device described is a synthetic wound matrix, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided, as the device is a physical wound dressing and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of the wound matrix would be based on objective biological and physical measurements from the studies conducted:
- Animal performance testing: Likely measured outcomes related to wound healing, such as wound closure rates, reduction in wound size, tissue regeneration, and histological assessments. These are direct biological outcomes.
- Biocompatibility testing: Assesses the device's interaction with biological systems using standardized tests, leading to objective safety profiles.
- Human skin irritation testing: Measures physiological responses of the skin to the device.
- Antibacterial barrier effectiveness: Measures the device's ability to prevent bacterial penetration in an in vitro setup.
8. The sample size for the training set:
This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
This information is not applicable and therefore not provided, 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 logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 9, 2024
Gel4Med, Inc. Ana Tellechea Senior Product Development Manager 1660 Soldiers Field Rd STE 7 #1063 Brighton, Massachusetts 02135
Re: K222025
Trade/Device Name: G4Derm / G4Derm Plus Synthetic Wound Matrix Regulatory Class: Unclassified Product Code: FRO
Dear Ana Tellechea:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on October 11, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, Yu-Chieh Chiu, yuchieh.chiu@fda.hhs.gov.
Sincerely.
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director for Wound Devices DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2024
Gel4Med, Inc. Ana Tellechea Senior Product Development Manager 1660 Soldiers Field Rd STE 7 #1063 Brighton, Massachusetts 02135
Re: K222025
Trade/Device Name: G4Derm / G4Derm Plus Synthetic Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: June 16, 2023 Received: June 16, 2023
Dear Ana Tellechea:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on October 11, 2023.
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about medical devices and radiation-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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director for Wound Devices DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222025
Device Name G4Derm / G4Derm Plus Synthetic Wound Matrix
Indications for Use (Describe)
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.
| 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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510(k) Summary- K222025 (As required by 21 CFR 807.92)
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510(k) Summary
-
- Submitter Information
| Submitter: | Gel4Med, Inc.1660 Soldiers Field Rd STE 7 #1063Brighton, MA 02135 |
|---|---|
| Contact: | Ana Tellechea, Pharm.D., Ph.D.Senior Product Development ManagerEmail: ana@gelformed.comPhone: (617) 642-2599 |
| Date Prepared: | October 6, 2023 |
-
- Subject Device
| Name of Device: | G4Derm / G4Derm Plus Synthetic Wound Matrix |
|---|---|
| Common Name: | Wound Dressing |
| Classification Regulation/Class: | Unclassified |
| Product Code: | FRO |
| Panel: | General and Plastic Surgery |
3. Predicate and Reference Devices
Predicate Device:
- . Woun'Dres® Collagen Hydrogel (Coloplast Corporation); K991202
Reference Devices:
4. Device Description
G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.
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G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.
G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.
Intended Use and Indications for Use 5.
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partialand full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partialthickness burns including the management of abrasions and burns associated with dermabrasions and laser resurfacing.
6. Comparison With the Predicate Devices
G4Derm / G4Derm Plus is similar in design, function, mechanism of action, physical properties, and presentation to other wound dressings, including collagen-based devices such as Woun'Dres® Collagen Hydrogel (predicate, K991202) and Excellagen (reference device, K110318), as well as synthetic peptide-based hydrogel materials such as PuraDERM (reference device, K193085).
The intended use of G4Derm / G4Derm Plus and its predicate device is the same. They are intended for local wound management, i.e., to protect the wound and provide a moist wound environment conducive to wound healing. The devices are hydrogels that serve as primary contact wound dressings [via direct topical application] for the management of a variety of wounds, including partial and full thickness wounds, and are intended to be used with a secondary wound dressing.
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The indications for use for the proposed device are identical to the language from its predicate device. No new indications are proposed.
G4Derm / G4Derm Plus forms a porous hydrogel scaffold that resembles the microarchitecture of endogenous extracellular matrix ("ECM"). G4Derm / G4Derm Plus and its predicate/reference devices form a matrix barrier that fills and conforms to the wound, maintains a moist environment conducive to healing, and covers and protects the wound. The subject device also serves as an antibacterial barrier (based on in vitro testing).
G4Derm / G4Derm Plus is composed of a peptide-based agueous solution, with water being the major component. Woun'Dres is composed of water and collagen, along with skin protectants and a mild preservative, and is also presented as a hydrogel. The minor differences in technological characteristics between G4Derm / G4Derm Plus and its predicates do not present any new questions regarding its safety and effectiveness. The safety and effectiveness of G4Derm / G4Derm Plus is supported by sterility testing, biocompatibility testing, human skin irritation testing, and performance testing including a large animal wound healing model, as well as by additional verification and validation activities.
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| Table 1: Substantial Equivalence Comparison G4Derm Plus vs Predicate Device | |||
|---|---|---|---|
| SUBJECT DEVICE | PREDICATE DEVICE | SUBJECT VSPREDICATECOMPARISON | REFERENCE DEVICE 1 | REFERENCE DEVICE 2 | |
|---|---|---|---|---|---|
| Regulatory Information | |||||
| Trade Name | G4Derm/G4Derm PlusSynthetic Wound Matrix | Woun'Dres® CollagenHydrogel WoundDressing | Excellagen | PuraDERM Gel | |
| Applicant | Gel4Med | Coloplast | Tissue Repair Company | 3D Matrix | |
| 510(k)Number(s) | K222025 | K991202 | K110318 | K193085; K143058 | |
| OTC or Prescription(per 21 CFR801.109) | OTC and Prescription | OTC and Prescription | Same as predicatedevice. | Prescription | OTC and Prescription |
| Intended Use | Local management ofwounds.Direct topical application todermal wounds. | Local management ofwounds. Direct topicalapplication to dermal wounds. | Same as predicatedevice. | Local management ofwounds.Direct topical application todermal wounds. | Local management ofwounds.Direct topical applicationto dermal wounds. |
| Indications for Use | OTC: May be used forsuperficial wounds andabrasions and minor burns.Rx: Under the supervision ofhealth care professionals forthe local management ofpartial- and full- thicknesswounds including pressure,and diabetic ulcers; lowerextremity ulcers includingthose of venous, arterial, andmixed etiology; surgicalwounds; first- degree andpartial- thickness burnsincluding management ofabrasions and burnsassociated withdermabrasions and laserresurfacing. | OTC: May be used forsuperficial wounds andabrasions and minor burns.Rx: Under the supervision ofhealth care professionals forthe local management ofpartial- and full- thicknesswounds including pressure,and diabetic ulcers; lowerextremity ulcers includingthose of venous, arterial,and mixed etiology; surgicalwounds; first- and second-degree burns includingmanagement of abrasionsand burns associated withdermabrasions and laserresurfacing. | Same as predicatedevice. | OTC: N/ARx: Excellagen is indicatedfor the management ofwounds including partialand full thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgical wounds(donor sites/grafts, post-Moh's surgery, post- lasersurgery, podiatric, wounddehiscence), traumawounds (abrasions,lacerations, second- degreeburns, and skin tears) anddraining wounds. | OTC: PuraDERM is usedfor the management ofminor cuts, minorabrasions, minor wounds,and minor burns (1stdegree burns).Rx: PuraDERM Gel isindicated for the hydrationand management of partialand full-thickness wounds,such as pressure sores,leg ulcers, diabetic ulcers,and surgical wounds, andabrasions and burnsassociated withdermabrasion and laserresurfacing. |
| SUBJECT DEVICE | PREDICATE DEVICE | SUBJECT VSPREDICATECOMPARISON | REFERENCE DEVICE 1 | REFERENCE DEVICE 2 | |
| Technological Characteristics | |||||
| Form | Hydrogel | Hydrogel | Same as predicatedevice. | Hydrogel | Hydrogel |
| Single Use | Yes | No | Different but does notaffect safety andeffectiveness.Reference devices 1and 2 are included tosupport technologicalcharacteristics. | Yes | Yes |
| Product Application | Apply directly to the cleanwound and fill wound to thelevel of the surrounding skin. | Apply directly to the cleanwound and fill wound to thelevel of the surrounding skin. | Same as predicatedevice. | Apply directly to cleanwound and fill wound to thelevel of the surroundingskin. | Apply directly to cleanwound and fill wound to thelevel of the surroundingskin. |
| Frequency ofApplication | Change dressing and reapplyproduct as needed. | Change dressing and reapplyproduct as needed.Recommended minimumdressing changes 3 times perweek. | Similar to predicatedevice.Animal performancetesting data supports SEReference devices 1 and2 are included tosupport technologicalcharacteristics. | Change dressing asneeded and reapplyproduct at once per weekintervals. | Change dressing andreapply product as needed.Recommended maximumcontinuous wear of 7 days. |
| Labeled Sterile | Yes | No | Different but does notaffect safety andeffectiveness.Reference devices 1 and2 are included tosupport technologicalcharacteristics. | Yes | Yes |
| Presentation | Supplied sterile in single usesyringe for directadministration to the wound.Sterile applicator/ nozzle isalso provided and may beused if desired. | Supplied non-sterile inmultiple use tubes for directadministration to the wound. | Different. Differenceswere evaluated bybiocompatibility andperformance testing andsupport SE. Referencedevices 1 and 2 areincluded to supporttechnologicalcharacteristics. | Supplied sterile in singleuse syringe for directadministration to thewound. Sterile flexibleapplicator is also provided. | Supplied sterile in single-use syringe for directadministration to thewound. Provided applicatornozzle may be used ifdesired. |
| Shelf-Life | 12 months (1 year) | 2 years | Similar to predicatedevice. | 3 years | 3 years |
| SUBJECT DEVICE | PREDICATE DEVICE | SUBJECT VSPREDICATECOMPARISON | REFERENCE DEVICE 1 | REFERENCE DEVICE 2 | |
| Storage | Store at +2°C to +30°C(+36°F to +86°F)Do not freeze.Avoid excessive heat. | Not Specified (roomtemperature) | Similar to predicatedevice. | Store at 36°- 46°F / 2 -8°C.Avoid freezing. | Store in a refrigerator (+2°Cto +8°C / +35.6°Fto +46.4°F).Do not Freeze. |
| Safety and Performance Testing | |||||
| BiologicalEvaluation | Performed. BiocompatibilityTesting in accordance withISO 10993-1demonstrated safety of thedevice for its intended use[management of wounds].Clinical (human skinirritation) testing confirmedsafety. | Performed. BiocompatibilityTesting demonstrated safety ofthe device for its intended use[management of wounds]. | Similar. No new ordifferent questions ofsafety were raisedwhen compared to thepredicate device. | Performed. BiocompatibilityTesting in accordance withISO 10993-1 demonstratedsafety of the device for itsintended use [managementof wounds]. | Performed. BiocompatibilityTesting in accordance withISO 10993-1demonstrated safety of thedevice for its intended use[management of wounds]. |
| Animal PerformanceTesting | Performed. GLP pre- clinicalperformance testing inwound healing animal modeldemonstrated substantialequivalence regarding safetyand effectiveness whencompared to the predicatedevices. | Unknown | Similar. Animalperformance testingdemonstrated that thesubject device is safeand effective underthe proposedconditions of use forits intended use [localmanagement ofwounds] andsubstantialequivalence to itspredicate device. | Unknown | Performed. GLP pre-clinical performance testingin wound healing animalmodel demonstratedsubstantial equivalenceregarding safety andeffectiveness whencompared to the predicatedevices. |
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7. Safety and Performance Data
G4Derm / G4Derm Plus is terminally sterilized to achieve a minimum sterility assurance level of 10° in accordance with ISO 17665. G4Derm / G4Derm Plus safety and effectiveness is further supported by pre-clinical data including in vivo performance testing in an established porcine wound healing model; 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"; clinical data (Human Skin Irritation Test); antibacterial barrier effectiveness testing (in vitro); additional verification and validation activities.
8. Substantial Equivalence Discussion and Conclusion
G4Derm / G4Derm Plus Synthetic Wound Matrix is substantially equivalent in intended use, indications for use, device design, function, physical properties, principles of operation, instructions for use, biocompatibility, safety, and performance to the predicate device. The technological differences between G4Derm / G4DermPlus and the predicate are minor and do not raise any new or different questions regarding its safety and effectiveness. Any differences in the technological characteristics of the subject device when compared to the predicate have been successfully evaluated using appropriate scientific methods. Safety and performance evaluation including sterility testing, shelf-life testing, biocompatibility testing, animal performance testing, and additional verification and validation activities confirmed that the subject device is as safe, as effective, and performs as well as the predicate device for its intended use and indications for use.
In conclusion, the evaluation of G4Derm / G4Derm Plus Synthetic Wound Matrix has determined it to be substantially equivalent to the previously cleared predicate devices.
N/A