(279 days)
PELNAC™ Bilayer Wound Matrix is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
- · draining wounds.
The device is intended for one-time use.
PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
This document is a 510(k) premarket notification for the PELNAC™ Bilayer Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that an AI/software device meets specific performance acceptance criteria for diagnostic tasks.
Therefore, most of the requested information regarding acceptance criteria for AI/software, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission is for a material device (wound matrix) and the "study" mentioned is a human repeat insult patch test (HRIPT) and a clinical follow-up for a tissue-based medical device.
However, I can extract information related to the device's safety and performance testing as presented in the document, which serves a similar role to "acceptance criteria" for a physical medical device.
Acceptance Criteria and Study for PELNAC™ Bilayer Wound Matrix
The "acceptance criteria" for this device are established through demonstrating its substantial equivalence to a legally marketed predicate device (AVAGEN Wound Dressing) and conformity to recognized standards and guidance. The "study" refers to non-clinical and clinical testing performed to support this claim.
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a physical medical device and not an AI/software, the "acceptance criteria" are not reported as diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to biocompatibility, sterility, physical/chemical properties, and clinical safety/tolerance. The "reported device performance" indicates whether the device met these established safety and performance benchmarks.
| Acceptance Criteria Category (Derived from Testing Standards/Guidance) | Reported Device Performance / Evaluation Outcome |
|---|---|
| Material Safety (Biocompatibility) | |
| - Cytotoxicity (ISO 10993-5) | Performed; Results confirm design inputs met. |
| - Skin Sensitization (ISO 10993-10) | Performed; Results confirm design inputs met. |
| - Intracutaneous Reactivity (ISO 10993-10) | Performed; Results confirm design inputs met. |
| - Implantation (ISO 10993-6) | Performed; Results confirm design inputs met. |
| - Material-mediated Pyrogenicity (USP <85>) | Performed; Results confirm design inputs met. This is not explicitly listed under ISO 10993-1 in the table, but USP <85> is listed separately under Sterilization, Packaging and Shelf Life. It is inferred to be part of the biological evaluation. |
| - Chemical Characterization (ISO 10993-18) | Performed; Results confirm design inputs met. |
| - Toxicological Risk Assessment (ISO 10993-17) | Performed; Results confirm design inputs met. |
| Viral Inactivation (for animal-derived materials) | Performed; Results confirm design inputs met. |
| Physical and Chemical Properties | Performed; Results confirm design inputs met. |
| Sterility (ISO 11135) | Performed; Results confirm design inputs met. |
| Packaging Integrity (ISO 11607-1, ASTM F1886) | Performed; Results confirm design inputs met. |
| Shelf Life (Stability over time) | 36 months; Deemed "Similar" to predicate (24 months). This difference was likely supported by stability data. |
| Usability (IEC 62366-1) | Performed; Results confirm design inputs met. |
| Risk Analysis (ISO 14971) | Performed; Results confirm design inputs met. |
| Immunogenicity/Irritation (Clinical) | None of 56 subjects developed irritation or sensitization; No adverse events related to the product demonstrated irritant or sensitizer activity. |
| Local Inflammatory Tissue Response (Clinical) | No reports of expanding erythema, edema, pain, vesicles, or other immune response, signaling removal of the dressing in 18 subjects with finger degloving injuries. Biopsy samples and histological analysis at 12 months showed no immune response. |
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical (In vitro/Bench/Animal Studies): The document states "final finished samples of PELNAC™ Bilayer Wound Matrix" were tested, but specific sample sizes for these tests (biocompatibility, physical/chemical, sterility, packaging) are not provided.
- Clinical Data:
- Human Repeat Insult Patch Test (HRIPT): 56 subjects.
- Finger Degloving Injuries Pilot Study: 18 subjects.
- Data Provenance: Not explicitly stated for all non-clinical tests. For the clinical studies:
- The HRIPT and the finger degloving study were likely conducted by or sponsored by the manufacturer (Gunze Limited), which is based in Japan. The document does not specify the country of origin for the clinical data points, nor whether they were retrospective or prospective studies, though the nature of HRIPT and follow-up studies typically implies a prospective design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This device is a material device, not an AI/software. There is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for the clinical study would be observed physiological responses to the device (irritation, sensitization, healing, lack of adverse immune response), assessed by qualified medical professionals involved in the study (e.g., dermatologists for HRIPT, surgeons for the finger injury study). The number and qualifications of these medical professionals are not specified in the provided text.
4. Adjudication Method for the Test Set:
- Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human reader studies or expert consensus for ground truth establishment in AI/software evaluations. Clinical observations for this device would be direct assessments by the treating/evaluating clinicians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, not for a wound matrix medical device. The "clinical studies" described (HRIPT, finger degloving) are safety and performance studies for a material device, not diagnostic effectiveness studies comparing human readers with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- For Biocompatibility and Physical/Chemical Testing: The "ground truth" is adherence to established international standards (e.g., ISO 10993 series) and internal specifications, derived from scientific understanding of material safety and performance.
- For Clinical Studies (HRIPT, Finger Degloving): The "ground truth" is direct clinical observation and objective measurement of patient responses (e.g., absence of skin irritation/sensitization, absence of specific immune responses, healing progression, histological analysis reports). This is based on outcomes data and clinical assessment by medical professionals.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
April 29, 2020
Gunze Limited % Stuart Goldman Senior Consult Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K191992
Trade/Device Name: PELNAC Bilayer Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: March 24, 2020 Received: March 26, 2020
Dear Stuart Goldman:
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/cfpmp/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 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
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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 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,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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) K191992
Device Name PELNACTM Bilayer Wound Matrix
Indications for Use (Describe) PELNACTM Bilayer Wound Matrix is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
- · draining wounds.
The device is intended for one-time use.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
PELNAC™ Bilayer Wound Matrix
1. Submission Sponsor
GUNZE LIMITED Medical Division 46 Natsumegaichi, Aono Ayabe, Kyoto 623-8513 Japan Contact: Mr. Hidenori Nishioka Title: Regulatory Affairs
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA
3. Date Prepared
April 29, 2020
4. Device Identification
Trade/Proprietary Name: PELNAC™ Bilayer Wound Matrix Common/Usual Name: Wound Dressing Classification Name: Dressing, Wound, Collagen Regulation Number: Pre-Amendment Device Product Code: KGN Class: Unclassified (Pre-Amendment Device) Review Panel: General & Plastic Surgery
5. Legally Marketed Predicate and Reference Devices
- . Predicate Device (AVAGEN):
- Integra Life Sciences Corp. AVAGEN Wound Dressing (K022127 / KGN) O
The predicate device has not been subject to a design related recall.
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- . Reference Device #1 (BMWD):
- Integra Life Sciences Corp. Bilayer Matrix Wound Dressing (K021792 / FRO) o
- Reference Device #2 (IMBWM):
- Integra Life Sciences Corp. INTEGRA™ Meshed Bilayer Wound Matrix (K081635 / FRO) o
- . Reference Device #3 (WMTF):
- o Miromatrix Medical, Inc. – Wound Matrix TF (K143426 / KGN)
6. Indications for Use
PELNAC™ Bilayer Wound Matrix is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
- draining wounds.
The device is intended for one-time use.
7. Device Description
PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
8. Substantial Equivalence Discussion
PELNAC™ Bilayer Wound Matrix has the same indications for use as the predicate device AVAGEN Wound Dressing (K022127), except for those indications related to tunneled / undermined wounds found in the predicate device which are not included in the indications for the subject and predicate devices employ the same mode of action in that both devices contain a porous sponge-like matrix of animalderived collagen that serves as a scaffold for cellular invasion and capillary growth.
Table 5-1 compares PELNAC™ Bilayer Wound Matrix to the predicate device AVAGEN (K022127) with respect to regulatory information, intended use, indications for use, technological characteristics, and safety and
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K191992
performance testing and provides detailed information regarding the basis for the determination of substantial equivalence between the subject and predicate device. Similar and relevant information on the reference devices is also included in Table 5-1.
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| Attributes | Subject Device | Predicate Device (AVAGEN) | Reference Device #1 (BMWD) | Reference Device #2 (IMBWM) | Reference Device #3 (WMTF) | Similarities / Differences |
|---|---|---|---|---|---|---|
| Regulatory Information | ||||||
| Device Name | PELNAC™ Bilayer Wound Matrix (Non-Meshed Type and Meshed Type) | AVAGEN Wound Dressing | Bilayer Matrix Wound Dressing | Integra Meshed Bilayer Wound Matrix | Wound Matrix TF | - |
| Manufacturer | GUNZE LIMITED | Integra Life Sciences | Integra Life Sciences | Integra Life Sciences | Miromatrix Medical | - |
| 510(k) # | Pending | K022127 | K021792 | K081635 | K143426 | - |
| Product Code | KGN | KGN | FRO | FRO | KGN | Same for the subject and predicate device. |
| Regulation | Pre-Amendment | Pre-Amendment | Pre-Amendment | Pre-Amendment | Pre-Amendment | Same for the subject and predicate device. |
| Class | Unclassified | Unclassified | Unclassified | Unclassified | Unclassified | Same for the subject and predicate device. |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Same for the subject and predicate device. |
| Indications for Use | PELNAC™ BilayerWound Matrix isindicated for themanagement ofwounds including:partial and full-thickness wounds,pressure ulcers,venous ulcers,diabetic ulcers,chronic vascularulcers, surgicalwounds (donorsites/grafts, post-Moh's surgery, post-laser surgery,podiatric, wounddehiscence), traumawounds (abrasions,lacerations, second-degree burns, andskin tears), anddraining wounds.The device isintended for one-time use. | AVAGEN WoundDressing is indicatedfor themanagement ofwounds including:partial and full-thickness wounds,pressure ulcers,venous ulcers,diabetic ulcers,chronic vascularulcers,tunneled/undermined wounds, surgicalwounds (donorsites/grafts, post-Moh's surgery, post-laser surgery,podiatric, wounddehiscence), traumawounds (abrasions,lacerations, second-degree burns, andskin tears) anddraining wounds.The device isintended for one-time use. | Bilayer MatrixWound Dressing isindicated for themanagement ofwounds including:partial and full-thickness wounds,pressure ulcers,venous ulcers,diabetic ulcers,chronic vascularulcers, surgicalwounds (donorsites/grafts, post-Moh's surgery, post-laser surgery,podiatric, wounddehiscence), traumawounds (abrasions,lacerations, second-degree burns, andskin tears) anddraining wounds.The device isintended for one-time use. | INTEGRA™ MeshedBilayer WoundMatrix is indicatedfor themanagement ofwounds including:partial and full-thickness wounds,pressure ulcers,venous ulcers,diabetic ulcers,chronic vascularulcers, surgicalwounds (donorsites/grafts, post-Moh's surgery, post-laser surgery,podiatric, wounddehiscence), traumawounds (abrasions,lacerations, seconddegree burns, andskin tears) anddraining wounds.May be used inconjunction withnegative pressurewound therapy. Thedevice is intendedfor one-time use. | Wound Matrix TF isintended for themanagement ofwounds including:Partial and fullthickness wounds;Pressure ulcers;Venous ulcers;Diabetic ulcers;Chronic vascularulcers; Tunneled,underminedwounds; Surgicalwounds (donorsites/grafts, post-Mohs' surgery, post-laser surgery,podiatric, wounddehiscence);Trauma wounds(abrasions,lacerations, second-degree burns, andskin tears); Drainingwounds.The device issupplied sterile andis intended for one-time use. | Same. Except forthose indicationsrelated to tunneled/underminedwounds found in thepredicate devicewhich are not foundin the subjectdevice, the subjectand predicatedevice have thesame indications foruse. |
| Attributes | Subject Device | Predicate Device(AVAGEN) | ReferenceDevice #1(BMWD) | ReferenceDevice #2(IMBWM) | ReferenceDevice #3(WMTF) | Similarities /Differences |
| Technological Characteristics | ||||||
| Construction | Bilayer | Single layer | Bilayer | Bilayer | Single layer | Different.Therefore,Reference Devices1/2 were added tothe substantialequivalencediscussion. |
| Form | Sheet | Sheet | Sheet | Sheet | Sheet | Same |
| Materials | Silicone film,synthetic gauze, andcollagen spongeporous matrix ofporcine (Achilles)tendon. | Collagen spongeporous matrix ofbovine tendon +glycosaminoglyca. | Silicone film andcollagen spongeporous matrix ofbovine tendon +glycosaminoglyca. | Silicone film andcollagen spongeporous matrix ofbovine tendon +glycosaminoglyca. | Porous matrix ofporcine derived(liver tissue)collagen matrix. | Different.Therefore,Reference Device 3was added to thesubstantialequivalencediscussion. |
| Meshed(fenestrated)Structure | No / Yes | No | No | Yes | No | Different.Therefore,Reference Devices2/3 were added tothe substantialequivalencediscussion. |
| Mode of Action | Collagen spongelayer is applied tothe wound surfaceand acts as ascaffold for cellularinvasion andcapillary growth. | Collagen spongelayer is applied tothe wound surfaceand acts as ascaffold for cellularinvasion andcapillary growth. | Collagen spongelayer is applied tothe wound surfaceand acts as ascaffold for cellularinvasion andcapillary growth. | Collagen spongelayer is applied tothe wound surfaceand acts as ascaffold for cellularinvasion andcapillary growth. | Collagen spongelayer is applied tothe wound surfaceand acts as ascaffold for cellularinvasion andcapillary growth. | Same |
| Attributes | Subject Device | Predicate Device(AVAGEN) | ReferenceDevice #1(BMWD) | ReferenceDevice #2(IMBWM) | ReferenceDevice #3(WMTF) | Similarities /Differences |
| Single Use | Yes | Yes | Yes | Yes | Yes | Same |
| Supplied Sterile | Yes (EO) | Yes (radiation) | Yes (radiation) | Yes (radiation) | Yes (radiation) | Same |
| Shelf Life | 36 months | 24 months | 24 months | 24 months | Similar | |
| Sizes | 20 × 30 mm | 100 × 125 mm | 50 × 50 mm | 50 × 50 mm | 20 × 20 mm | Similar. The sizes of |
| 40 × 30 mm | 100 × 250 mm | 100 × 125 mm | 100 × 125 mm | 20 × 30 mm | the subject device | |
| 40 × 60 mm | 200 × 250 mm | 100 × 250 mm | 100 × 250 mm | 30 × 30 mm | fall within the size | |
| 82 × 60 mm | 200 × 250 mm | 200 × 250 mm | 30 × 70 mm | range of the | ||
| 82 × 90 mm | 40 × 40 mm | predicate device | ||||
| 82 × 120 mm | 50 × 50 mm | and Reference | ||||
| 120 × 240 mm | 80 × 80 mm | Device 3. | ||||
| 200 × 240 mm | 70 × 100 mm | |||||
| 80 × 150 mm | ||||||
| Safety and Performance Testing | ||||||
| BiologicalEvaluation | ISO 10993-1:- Cytotoxicity,- Skin Sensitization,- IntracutaneousReactivity,- Implantation,- Material-mediatedPyrogenicity,- ChemicalCharacterization,- Toxicological RiskAssessment | ISO 10993-1:- Cytotoxicity,- DermalSensitization,- Irritation,- Acute SystemicToxicity,- Hemolysis,- Pyrogenicity | ISO 10993-1:- Cytotoxicity,- DermalSensitization,- Irritation,- Acute SystemicToxicity,- Hemolysis,- Pyrogenicity | ISO 10993-1:- Cytotoxicity,- DermalSensitization,- Irritation,- Acute SystemicToxicity,- Hemolysis,- Pyrogenicity | ISO 10993-1:- Cytotoxicity,- Skin Sensitization,- IntracutaneousReactivity,- Acute SystemicToxicity,- In Vitro BacterialReverse Mutation,- In VitroChromosomeAberration,- In VitroMammalian CellGene Mutation,- Pyrogenicity. | Similar |
| Attributes | Subject Device | Predicate Device(AVAGEN) | ReferenceDevice #1(BMWD) | ReferenceDevice #2(IMBWM) | ReferenceDevice #3(WMTF) | Similarities /Differences |
| - Sub-ChronicSystemic Toxicity | ||||||
| Collagen ViralInactivation | Performed | Performed | Performed | Performed | Performed | Similar |
| Physical andChemical PropertiesTesting | Performed | Performed | Performed | Performed | Performed | Similar |
| Non-ClinicalPerformanceTesting | Performed | Unknown | Performed | Performed | Performed | Similar |
Table 5-1 – Substantial Equivalence Comparison of PELNAC™ Bilayer Wound Matrix vs. Predicate and Reference Devices
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9. Summary of Safety and Performance Testing
As part of demonstrating substantial equivalence of the predicate device to the predicate device, GUNZE LIMITED tested final finished samples of PELNAC™ Bilayer Wound Matrix for testing in accordance with the applicable parts of the following FDA guidance documents, voluntary FDA recognized consensus and other standards and to internal GUNZE test protocols and procedures referenced below. Results confirm that the design inputs and performance specifications for the subject device have been met.
- . Animal Tissue Sourcing and Viral Inactivation:
- FDA Guidance Document Medical Devices Containing Materials Derived from Animal o Sources (Except for In Vitro Diagnostic Devices) - 2019
- FDA Guidance Document Q5A Viral Safety Evaluation of Biotechnology Products Derived o from Cell Lines of Human or Animal Origin - 1998
- Biocompatibility:
- FDA Guidance Document Use of International Standard ISO 10993-1, Biological Evaluation o of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 10993-1: o
- . ISO 10993-5 (cytotoxicity)
- ISO 10993-6 (implantation)
- I ISO 10993-10 (skin sensitization and intracutaneous reactivity)
- I ISO 10993-11 (systemic toxicity)
- l ISO 10993-17 (toxicological risk assessment)
- 트 ISO 10993-18 (chemical characterization)
- Sterilization, Packaging and Shelf Life: ●
- O ISO 11135
- ISO 11607-1 o
- ASTM F1886 O
- USP <85> Bacterial Endotoxin Test O
- Usability: .
- o IEC 62366-1
- . Risk Analysis:
- o ISO 14971
- . Physical and Chemical Properties Testing
- Non-Clinical Performance Testing
10. Summary of Clinical Data
To address the subject product immunogenicity, a Human Repeat Insult Patch Test (HRIPT) was conducted on 56 subjects. PELNAC Bilayer Wound Matrix was placed on the subjects 9 (nine) times during the induction phase and the area was evaluated at each visit prior to the next patch placement. After 2-3 weeks rest period the subjects were challenged by placing the device at the same area and evaluated at 24, 48, 72 & 96 hours for irritation and Type IV allergic response. The results demonstrated that none of the 56 subjects developed irritation or sensitization. There were no adverse events related to the product demonstrating that PELNAC Bilayer Wound Matrix is neither an irritant nor a sensitizer.
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In lieu of the prick test to demonstrate that the subject device does not elicit immunogenic reaction (antibodymediated) and does not cause any local inflammatory tissue responses, PELNAC Bilayer Wound Matrix was used on a cohort of 18 subjects who sustained finger degloving injuries. The subjects ranged in age from 19 to 66 years, mean age 42 years. They received the subject device within 2 days of their injury, and it remained in place for 21 days. The patients remained in the hospital for at least 24 hours after the surgery in which the subject device was placed and then were evaluated weekly until day 21. There were no reports of expanding erythema, edema, pain, vesicles, or other immune response that would signal removal of the dressing. All subjects were followed at 3, 6, 9, and 12 months. Assessments were evaluated at the 12 month follow up including biopsy samples and histological analysis.
11. Statement of Substantial Equivalence
PELNAC™ Bilayer Wound Matrix has the same intended use and indications for use as AVAGEN Wound Dressing. Any minor differences in the technological features of the subject device when compared to the predicate device have been successfully evaluated through safety and other verification and validation activities. PELNAC™ Bilayer Wound Matrix, as designed and manufactured by GUNZE LIMITED has been determined to be substantially equivalent to the predicate device, AVAGEN Wound Dressing.
N/A