(279 days)
No
The device description and performance studies focus on the material properties and clinical outcomes of a collagen-based wound matrix, with no mention of AI or ML technology.
Yes
The device is described as a 'Bilayer Wound Matrix' indicated for the management of various wounds, providing a scaffold for cellular invasion and capillary growth, which are therapeutic actions.
No
The device, PELNAC™ Bilayer Wound Matrix, is described as a collagen-based wound matrix intended for the management of various types of wounds, providing a scaffold for cellular invasion and capillary growth. Its function is to treat and manage wounds, not to diagnose medical conditions or identify the nature of a disease.
No
The device description clearly states it is a collagen-based wound matrix consisting of physical layers (collagen sponge, silicone film, synthetic gauze) and is provided in sheet form, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description of PELNAC™ Bilayer Wound Matrix clearly states it is a collagen-based wound matrix applied directly to the wound surface for the management of various types of wounds. It acts as a scaffold for cellular invasion and capillary growth. This is a therapeutic device applied in vivo (on the body), not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's condition. Its function is to aid in wound healing.
Therefore, PELNAC™ Bilayer Wound Matrix is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified doctor in a professional setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Human Repeat Insult Patch Test (HRIPT): Conducted on 56 subjects. PELNAC Bilayer Wound Matrix was applied 9 times during the induction phase, with evaluations at each visit. After a 2-3 week rest, subjects were challenged with the device at the same area, and evaluated at 24, 48, 72 & 96 hours for irritation and Type IV allergic response.
- Key results: None of the 56 subjects developed irritation or sensitization. No adverse events related to the product, demonstrating it is neither an irritant nor a sensitizer.
- Clinical Use Cohort Study: PELNAC Bilayer Wound Matrix was used on a cohort of 18 subjects who sustained finger degloving injuries. Subjects ranged in age from 19 to 66 years, with a mean age of 42 years. The device was placed within 2 days of injury and remained for 21 days. Patients were followed weekly until day 21, and then at 3, 6, 9, and 12 months. Assessments included biopsy samples and histological analysis at the 12-month follow-up.
- Key results: No reports of expanding erythema, edema, pain, vesicles, or other immune response that would signal removal of the dressing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/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
1
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
2
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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3
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.
4
- . 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
5
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.
6
| 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™ 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. | AVAGEN Wound | |||||
| Dressing is indicated | ||||||
| for the | ||||||
| management of | ||||||
| wounds including: | ||||||
| partial and full- | ||||||
| thickness wounds, | ||||||
| pressure ulcers, | ||||||
| venous ulcers, | ||||||
| diabetic ulcers, | ||||||
| chronic vascular | ||||||
| ulcers, | ||||||
| tunneled/undermin | ||||||
| ed wounds, 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. | Bilayer Matrix | |||||
| Wound Dressing 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. | INTEGRA™ 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, second | ||||||
| degree burns, and | ||||||
| skin tears) and | ||||||
| draining wounds. | ||||||
| May be used in | ||||||
| conjunction with | ||||||
| negative pressure | ||||||
| wound therapy. The | ||||||
| device is intended | ||||||
| for one-time use. | Wound Matrix TF is | |||||
| intended for the | ||||||
| management of | ||||||
| wounds including: | ||||||
| Partial and full | ||||||
| thickness wounds; | ||||||
| Pressure ulcers; | ||||||
| Venous ulcers; | ||||||
| Diabetic ulcers; | ||||||
| Chronic vascular | ||||||
| ulcers; Tunneled, | ||||||
| undermined | ||||||
| wounds; 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. | ||||||
| The device is | ||||||
| supplied sterile and | ||||||
| is intended for one- | ||||||
| time use. | Same. Except for | |||||
| those indications | ||||||
| related to tunneled | ||||||
| /undermined | ||||||
| wounds found in the | ||||||
| predicate device | ||||||
| which are not found | ||||||
| in the subject | ||||||
| device, the subject | ||||||
| and predicate | ||||||
| device have the | ||||||
| same indications for | ||||||
| use. | ||||||
| Attributes | Subject Device | Predicate Device | ||||
| (AVAGEN) | Reference | |||||
| Device #1 | ||||||
| (BMWD) | Reference | |||||
| Device #2 | ||||||
| (IMBWM) | Reference | |||||
| Device #3 | ||||||
| (WMTF) | Similarities / | |||||
| Differences | ||||||
| Technological Characteristics | ||||||
| Construction | Bilayer | Single layer | Bilayer | Bilayer | Single layer | Different. |
| Therefore, | ||||||
| Reference Devices | ||||||
| 1/2 were added to | ||||||
| the substantial | ||||||
| equivalence | ||||||
| discussion. | ||||||
| Form | Sheet | Sheet | Sheet | Sheet | Sheet | Same |
| Materials | Silicone film, | |||||
| synthetic gauze, and | ||||||
| collagen sponge | ||||||
| porous matrix of | ||||||
| porcine (Achilles) | ||||||
| tendon. | Collagen sponge | |||||
| porous matrix of | ||||||
| bovine tendon + | ||||||
| glycosaminoglyca. | Silicone film and | |||||
| collagen sponge | ||||||
| porous matrix of | ||||||
| bovine tendon + | ||||||
| glycosaminoglyca. | Silicone film and | |||||
| collagen sponge | ||||||
| porous matrix of | ||||||
| bovine tendon + | ||||||
| glycosaminoglyca. | Porous matrix of | |||||
| porcine derived | ||||||
| (liver tissue) | ||||||
| collagen matrix. | Different. | |||||
| Therefore, | ||||||
| Reference Device 3 | ||||||
| was added to the | ||||||
| substantial | ||||||
| equivalence | ||||||
| discussion. | ||||||
| Meshed | ||||||
| (fenestrated) | ||||||
| Structure | No / Yes | No | No | Yes | No | Different. |
| Therefore, | ||||||
| Reference Devices | ||||||
| 2/3 were added to | ||||||
| the substantial | ||||||
| equivalence | ||||||
| discussion. | ||||||
| Mode of Action | Collagen sponge | |||||
| layer is applied to | ||||||
| the wound surface | ||||||
| and acts as a | ||||||
| scaffold for cellular | ||||||
| invasion and | ||||||
| capillary growth. | Collagen sponge | |||||
| layer is applied to | ||||||
| the wound surface | ||||||
| and acts as a | ||||||
| scaffold for cellular | ||||||
| invasion and | ||||||
| capillary growth. | Collagen sponge | |||||
| layer is applied to | ||||||
| the wound surface | ||||||
| and acts as a | ||||||
| scaffold for cellular | ||||||
| invasion and | ||||||
| capillary growth. | Collagen sponge | |||||
| layer is applied to | ||||||
| the wound surface | ||||||
| and acts as a | ||||||
| scaffold for cellular | ||||||
| invasion and | ||||||
| capillary growth. | Collagen sponge | |||||
| layer is applied to | ||||||
| the wound surface | ||||||
| and acts as a | ||||||
| scaffold for cellular | ||||||
| invasion and | ||||||
| capillary growth. | Same | |||||
| Attributes | Subject Device | Predicate Device | ||||
| (AVAGEN) | Reference | |||||
| Device #1 | ||||||
| (BMWD) | Reference | |||||
| Device #2 | ||||||
| (IMBWM) | Reference | |||||
| Device #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 | ||||||
| Biological | ||||||
| Evaluation | ISO 10993-1: |
- Cytotoxicity,
- Skin Sensitization,
- Intracutaneous
Reactivity, - Implantation,
- Material-mediated
Pyrogenicity, - Chemical
Characterization, - Toxicological Risk
Assessment | ISO 10993-1: - Cytotoxicity,
- Dermal
Sensitization, - Irritation,
- Acute Systemic
Toxicity, - Hemolysis,
- Pyrogenicity | ISO 10993-1:
- Cytotoxicity,
- Dermal
Sensitization, - Irritation,
- Acute Systemic
Toxicity, - Hemolysis,
- Pyrogenicity | ISO 10993-1:
- Cytotoxicity,
- Dermal
Sensitization, - Irritation,
- Acute Systemic
Toxicity, - Hemolysis,
- Pyrogenicity | ISO 10993-1:
- Cytotoxicity,
- Skin Sensitization,
- Intracutaneous
Reactivity, - Acute Systemic
Toxicity, - In Vitro Bacterial
Reverse Mutation, - In Vitro
Chromosome
Aberration, - In Vitro
Mammalian Cell
Gene Mutation, - Pyrogenicity. | Similar |
| Attributes | Subject Device | Predicate Device
(AVAGEN) | Reference
Device #1
(BMWD) | Reference
Device #2
(IMBWM) | Reference
Device #3
(WMTF) | Similarities /
Differences |
| | | | | | - Sub-Chronic
Systemic Toxicity | |
| Collagen Viral
Inactivation | Performed | Performed | Performed | Performed | Performed | Similar |
| Physical and
Chemical Properties
Testing | Performed | Performed | Performed | Performed | Performed | Similar |
| Non-Clinical
Performance
Testing | Performed | Unknown | Performed | Performed | Performed | Similar |
Table 5-1 – Substantial Equivalence Comparison of PELNAC™ Bilayer Wound Matrix vs. Predicate and Reference Devices
7
8
9
10
11
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 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.
12
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.