(255 days)
PELNAC® Meshed 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, partial thickness burns, and skin tears), and
- · draining wounds.
The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
PELNAC® Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine derived sponge layer and a silicone film layer. Slits are added to the silicone and collagen layers to aid in the drainage of exudate. When applied to full-thickness skin defects, PELNAC® provides a scaffold for cellular invasion and capillary growth. The device 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.
The provided document is a 510(k) Premarket Notification for the PELNAC® Meshed Bilayer Wound Matrix. It demonstrates substantial equivalence to a predicate device, INTEGRA™ Meshed Bilayer Wound Matrix (K081635), and a reference device, PELNAC™ Bilayer Wound Matrix (K191992).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with "reported device performance" in the format typically seen with quantitative thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it relies on comparative testing to the predicate device and established standards for safety and performance for medical devices.
The acceptance criteria are implicitly met by demonstrating conformance to recognized standards and by showing similar performance characteristics to the predicate and reference devices in non-clinical tests.
However, based on the Non-Clinical Performance Data section, we can infer the following performance characteristics and the fact that they were met:
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (Implied "Conforms" or "Met" based on submission for clearance) |
|---|---|
| Animal Tissue Sourcing (FDA Guidance 2019) | Conforms to FDA guidance |
| Viral Inactivation (FDA Guidance 1998) | Conforms to FDA guidance; new viral inactivation studies performed |
| Biocompatibility (ISO 10993-1, FDA Guidance) | Conforms to ISO 10993-1 and FDA guidance (including Implantation, Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity, Chemical Characterization, Toxicological Risk Assessment) |
| Sterilization (ISO 11135, SAL 10-6) | Conforms to ISO 11135 and achieves SAL 10-6 |
| Packaging (ISO 11607-1, ASTM F1886) | Conforms to ISO 11607-1 and ASTM F1886 |
| Shelf Life (USP <85> Bacterial Endotoxin Test) | 36 months; Conforms to USP <85> |
| Performance Testing: Pore Size | Conforms to product specification |
| Performance Testing: Degree of Cross-Linking | Conforms to product specification |
| Performance Testing: Water Vapor Transmission | Conforms to product specification |
| Performance Testing: Drapeability | Conforms to product specification |
| Performance Testing: Heavy Metal Content | Conforms to product specification |
| Performance Testing: Suture Retention | Conforms to product specification |
| Performance Testing: Tensile Strength | Conforms to product specification |
| NPWT Compatibility (Pressure Stability) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| NPWT Compatibility (Fluid Removal) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| NPWT Compatibility (Long-Termance) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| NPWT Compatibility (Alarm Function) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| Risk Analysis (ISO 14971) | Conforms to ISO 14971 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical performance testing. For these tests, specific sample sizes are not explicitly stated. For example, how many samples of the device were tested for "tensile strength" or "pore size" is not provided. The data provenance is also not specified in terms of country of origin or whether it's retrospective or prospective for these non-clinical tests. However, the tests are laboratory-based, performed according to recognized standards (e.g., ISO, ASTM, USP, FDA guidance).
The document states: "Except for new viral inactivation studies performed on the subject device, all other animal tissue testing was leveraged from the reference device (K191992)." and "All biocompatibility testing of the subject device was leveraged from the reference device (K191992)." and "All sterilization, packaging and shelf life testing of the subject device was leveraged from the reference device (K191992)." This implies that many of the non-clinical tests were not repeated for the subject device but relied on data from the previously cleared reference device.
For the NPWT compatibility testing, it mentions "Side-by-side testing was conducted between the subject device in conjunction with NPWT, the predicate device in conjunction with NPWT, and NPWT without a wound matrix group." This implies a comparative test setup, but the number of test units or replicates used in this "simulated wound model" is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported studies are non-clinical performance tests evaluating physical, chemical, and biological properties, as well as compatibility with another medical device (NPWT). These types of studies do not typically involve human expert adjudication to establish ground truth in the way clinical studies for diagnostic devices do. Conformance to specifications and standards is assessed by laboratory testing and technical evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is non-clinical performance and safety testing, there is no "adjudication" of results in the context of clinical expert agreement for a ground truth. Test results are compared against defined specifications and regulatory standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a "wound matrix," not an AI-powered diagnostic tool, and the studies described are non-clinical. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software requiring standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" is defined by:
- Established industry standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization, ASTM F1886 for packaging integrity).
- FDA guidance documents (e.g., regarding animal derived materials, viral safety).
- Product specifications for features like pore size, cross-linking, tensile strength, etc.
- Performance metrics of predicate/reference devices for comparative testing, particularly for NPWT compatibility.
There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus required for this type of 510(k) submission focused on non-clinical substantial equivalence.
8. The sample size for the training set
Not applicable. This is a medical device for wound management, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence/machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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July 14, 2022
Gunze Limited % Stuart Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K213498
Trade/Device Name: PELNAC® Meshed Bilayer Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 1, 2022 Received: June 7, 2022
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/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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K213498
Device Name PELNAC® Meshed Bilayer Wound Matrix
Indications for Use (Describe) PELNAC® Meshed 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, partial thickness burns, and skin tears), and
- · draining wounds.
The device may be used in conjunction with negative pressure wound therapy. 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® Meshed Bilayer Wound Matrix K213498
1. Submission Sponsor
GUNZE LIMITED Medical Division 46 Natsumegaichi, Aono Ayabe, Kyoto Japan 623-8513 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 Contact: Mr. Stuart R. Goldman Title: Sr. Consultant RA/QA
3. Date Prepared
July 12, 2022
4. Device Identification
| Type of 510(k): | Traditional 510(k) |
|---|---|
| Trade Name: | PELNAC® Meshed Bilayer Wound Matrix |
| Product Code: | KGN |
| Classification Name: | Dressing, Wound, Collagen |
| Regulation Number: | Pre-Amendment |
| Regulation Description: | Pre-Amendment |
| Device Class: | Unclassified |
| Review Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate Device
| Trade Name: | INTEGRA™ Meshed Bilayer Wound Matrix |
|---|---|
| 510(k) No.: | K081635 |
| Manufacturer: | Integra Life Sciences |
The predicate device has not been subject to a design related recall.
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The following reference device is also included in this submission.
| Trade Name: | PELNACTM Bilayer Wound Matrix |
|---|---|
| 510(k) No.: | K191992 |
| Manufacturer: | GUNZE LIMITED |
6. Indications for Use
PELNAC® Meshed 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, partial thickness burns, and skin tears), and
- draining wounds.
PELNAC® Meshed Bilayer Wound Matrix may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
7. Device Description
PELNAC® Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine derived sponge layer and a silicone film layer. Slits are added to the silicone and collagen layers to aid in the drainage of exudate. When applied to full-thickness skin defects, PELNAC® provides a scaffold for cellular invasion and capillary growth. The device 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® Meshed Bilayer Wound Matrix has the same intended use and indications for use as the predicate device INTEGRA™ Meshed Bilayer Wound Matrix (K081635). The subject and predicate device employ the same mode of action in that both devices contain a wound matrix of porous sponge-like material of animal derived collagen that serves as a scaffold for cellular invasion and capillary growth.
Table 5-1 compares PELNAC® Meshed Bilayer Wound Matrix to the predicate device with respect to their indications for use and technological characteristics 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 device are also included in Table 5-1.
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| Attributes | Subject Device | Predicate Device | Similarities /Differences | Reference Device |
|---|---|---|---|---|
| Device Name | PELNAC® Meshed Bilayer WoundMatrix | INTEGRA™ Meshed Bilayer WoundMatrix | - | PELNAC™ Bilayer Wound Matrix |
| Manufacturer | GUNZE LIMITED | Integra Life Sciences | - | GUNZE LIMITED |
| 510(k) # | K213498 | K081635 | - | K191992 |
| Product Code | KGN | KGN | Same | KGN |
| Indications for Use | PELNAC® Meshed Bilayer WoundMatrix is indicated for themanagement of wounds including:partial and full-thickness wounds,pressure ulcers, venous ulcers,diabetic ulcers, chronic vascularulcers, surgical wounds (donorsites/grafts, post-Moh's surgery,post-laser surgery, podiatric, wounddehiscence), trauma wounds(abrasions, lacerations, partialthickness burns, and skin tears), anddraining wounds. PELNAC® MeshedBilayer Wound Matrix may be usedin conjunction with negativepressure wound therapy. The deviceis intended for one-time use. | INTEGRA™ Meshed Bilayer WoundMatrix is indicated for the managementof wounds including: partial and full-thickness wounds, pressure ulcers,venous ulcers, diabetic ulcers, chronicvascular ulcers, surgical wounds (donorsites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wounddehiscence), trauma wounds (abrasions,lacerations, second-degree bums, andskin tears) and draining wounds. Thedevice may be used in conjunction withnegative pressure wound therapy. Thedevice is intended for one-time use. | Same | PELNAC™ Bilayer Wound Matrixis indicated for the managementof wounds including: partial andfull-thickness wounds, pressureulcers, venous ulcers, diabeticulcers, chronic vascular ulcers,surgical wounds (donorsites/grafts, post-Moh's surgery,post-laser surgery, podiatric,wound dehiscence), traumawounds (abrasions, lacerations,second-degree burns, and skintears), and draining wounds. Thedevice is intended for one-timeuse. |
| Attributes | Subject Device | Predicate Device | Similarities /Differences | Reference Device |
| Construction | Bilayer | Bilayer | Same | Bilayer |
| Form | Sheet | Sheet | Same | Sheet |
| Materials | Top layer: silicone film.Bottom layer: porcine derivedcollagen sponge. | Top layer: polysiloxane (silicone).Bottom layer: porous matrix of cross-linked bovine tendon collagen andglycosaminoglycan. | Different.Therefore, thereference devicewas added. | Top layer: silicone film.Bottom layer: porcine derivedcollagen sponge. |
| Meshed(fenestrated)Structure | Yes | Yes | Same | Available with or without. |
| Mode of Action | Collagen sponge is applied to thewound surface and acts as a scaffoldfor cellular invasion and capillarygrowth to occur. The scaffold iseventually remodeled as thepatient's cells rebuild the damagedsite. | Collagen sponge is applied to the woundsurface and acts as a scaffold for cellularinvasion and capillary growth to occur.The scaffold is eventually remodeled asthe patient's cells rebuild the damagedsite. | Same | Collagen sponge layer is appliedto the wound surface and acts asa scaffold for cellular invasionand capillary growth to occur.The scaffold is eventuallyremodeled as the patient's cellsrebuild the damaged site. |
| Single Use | Yes | Yes | Same | Yes |
| Supplied Sterile | Yes (EO)SAL 10-6 | Yes (radiation)SAL 10-6 | Similar | Yes (EO)SAL 10-6 |
| Shelf Life | 36 months | 24 months | Similar | 36 months |
Table 5-1 – Substantial Equivalence Comparison of PELNAC® Meshed Bilayer Wound Matrix to the Predicate Device
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| Attributes | Subject Device | Predicate Device | Similarities /Differences | Reference Device |
|---|---|---|---|---|
| Sizes | 20 × 30 mm | 50 x 50 mm | Similar. The sizesof the subjectdevice fall withinthe size range ofthe predicatedevice and are thesame as thereference device. | 20 × 30 mm |
| 40 × 30 mm | 100 × 125 mm | 40 × 30 mm | ||
| 40 × 60 mm | 100 × 250 mm | 40 × 60 mm | ||
| 82 × 60 mm | 200 × 250 mm | 82 × 60 mm | ||
| 82 × 90 mm | 82 × 90 mm | |||
| 82 × 120 mm | 82 × 120 mm | |||
| 120 × 240 mm | 120 × 240 mm | |||
| 200 × 240 mm | 200 × 240 mm | |||
| BiologicalEvaluation | Conforms with ISO 10993-1 and FDAguidance. | Performed | Similar | Performed. Conforms with ISO10993-1 and FDA guidance. |
| Collagen ViralInactivation | Conforms with FDA guidance. | Performed | Similar | Performed. Conforms with FDAguidance. |
| Physical andChemicalProperties Testing | Conforms with product specification. | Performed | Similar | Performed. Conforms withproduct specification. |
| Non-ClinicalPerformanceTesting | Conforms with product performancerequirements including for new usein conjunction with negativepressure wound therapy. | Performed | Similar | Performed. Conforms withproduct performancerequirements. |
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9. Non-Clinical Performance Data
The following non-clinical performance testing was conducted on PELNAC® Meshed Bilayer Wound Matrix. Results confirm that the product specifications for the subject device have been met.
- . Animal Tissue Sourcing and Viral Inactivation:
- FDA Guidance Document Medical Devices Containing Materials Derived from Animal о Sources (Except for In Vitro Diagnostic Devices) – 2019
(The animal tissue sourcing of the subject device was evaluated following the recommendations of the above referenced FDA guidance document.)
- FDA Guidance Document Q5A Viral Safety Evaluation of Biotechnology Products Derived o from Cell Lines of Human or Animal Origin – 1998
(The viral safety evaluation of the subject device was evaluated following the recommendations of the above referenced FDA guidance document.)
Except for new viral inactivation studies performed on the subject device, all other animal tissue testing was leveraged from the reference device (K191992).
- Biocompatibility: ●
- o FDA Guidance Document – Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within o a Risk Management Process
(The biocompatibility of the subject device was evaluated following the recommendations of the above referenced FDA guidance document.)
- ■Implantation
- ■Cytotoxicity
- ■Skin Sensitization
- ■Intracutaneous Reactivity
- ■Material Mediated Pyrogenicity
- ■Chemical Characterization
- ■Toxicological Risk Assessment
All biocompatibility testing of the subject device was leveraged from the reference device (K191992).
- Sterilization, Packaging and Shelf Life:
- ISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the O development, validation and routine control of a sterilization process for medical devices
- O ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ASTM F1886, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by O Visual Inspection
- USP <85> Bacterial Endotoxin Test O
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All sterilization, packaging and shelf life testing of the subject device was leveraged from the reference device (K191992).
- Performance Testing: ●
- Pore Size O
- Degree of Cross-Linking o
- Water Vapor Transmission o
- Drapeability o
- o Heavy Metal Content
- o Suture Retention
- Tensile Strength o
PELNAC® Meshed Bilayer Wound Matrix has only been demonstrated for use in conjunction with the InfoV.A.C. NPWT Therapy System in continuous and intermittent mode. Side-by-side testing was conducted between the subject device in conjunction with NPWT, the predicate device in conjunction with NPWT, and NPWT without a wound matrix group. This testing used a simulated wound model in conjunction with a simulated wound fluid. The tests consisted of Pressure Stability, Fluid Removal, Long-Termance and Alarm Function (on the InfoV.A.C. NPWT Therapy System in continuous and intermittent mode).
- . Risk Analysis:
- o ISO 14971, Medical devices - Application of risk management to medical devices
10. Clinical Performance Data
Not applicable to this submission.
11. Substantial Equivalence Conclusion
PELNAC® Meshed Bilayer Wound Matrix has the same indications for use as INTEGRA™ Meshed Bilayer Wound Matrix. Any minor differences in the technological features of the subject device when compared to the predicate device have been evaluated through non-clinical performance testing and other verification and validation activities. PELNAC® Meshed Bilayer Wound Matrix is substantially equivalent to the predicate device.
N/A