(255 days)
No
The device description and performance studies focus on the physical and biological properties of a collagen-based wound matrix. There is no mention of AI or ML in the intended use, device description, or performance testing.
Yes
The device is used for the management of various types of wounds, including diabetic and pressure ulcers, which are conditions that require therapeutic intervention.
No
The device is a wound matrix intended for the management of wounds, providing a scaffold for cellular invasion and capillary growth. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a collagen-based wound matrix with a porcine derived sponge layer and a silicone film layer, which are physical components, not software.
Based on the provided text, 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® Meshed Bilayer Wound Matrix clearly states it is a collagen-based wound matrix applied directly to wounds on the body. Its intended use is for the management of wounds by providing a scaffold for cellular invasion and capillary growth.
- No Mention of Samples or Testing: There is no mention of the device being used to test samples from the body or to provide diagnostic information based on such testing.
Therefore, PELNAC® Meshed Bilayer Wound Matrix is a therapeutic device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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.
The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
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
"can only be applied to a patient by a 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)
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 Sources (Except for In Vitro Diagnostic Devices) – 2019, FDA Guidance Document Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin – 1998. Except for new viral inactivation studies performed on the subject device, all other animal tissue testing was leveraged from the reference device (K191992).
- Biocompatibility: 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 a Risk Management Process. Biocompatibility tests performed include 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 development, validation and routine control of a sterilization process for medical devices, 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 Visual Inspection, USP Bacterial Endotoxin Test. All sterilization, packaging and shelf life testing of the subject device was leveraged from the reference device (K191992).
- Performance Testing: Pore Size, Degree of Cross-Linking, Water Vapor Transmission, Drapeability, Heavy Metal Content, Suture Retention, Tensile Strength. 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: ISO 14971, Medical devices - Application of risk management to medical devices.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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
1
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
2
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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3
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.
4
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.
5
| Attributes | Subject Device | Predicate Device | Similarities /
Differences | Reference Device |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | PELNAC® Meshed Bilayer Wound
Matrix | INTEGRA™ Meshed Bilayer Wound
Matrix | - | 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 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. | 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 bums, 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. | Same | 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. |
| 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 derived
collagen sponge. | Top layer: polysiloxane (silicone).
Bottom layer: porous matrix of cross-
linked bovine tendon collagen and
glycosaminoglycan. | Different.
Therefore, the
reference device
was added. | Top layer: silicone film.
Bottom layer: porcine derived
collagen sponge. |
| Meshed
(fenestrated)
Structure | Yes | Yes | Same | Available with or without. |
| Mode of Action | Collagen sponge is applied to the
wound surface and acts as a scaffold
for cellular invasion and capillary
growth to occur. The scaffold is
eventually remodeled as the
patient's cells rebuild the damaged
site. | Collagen sponge is applied to the wound
surface and acts as a scaffold for cellular
invasion and capillary growth to occur.
The scaffold is eventually remodeled as
the patient's cells rebuild the damaged
site. | Same | Collagen sponge layer is applied
to the wound surface and acts as
a scaffold for cellular invasion
and capillary growth to occur.
The scaffold is eventually
remodeled as the patient's cells
rebuild 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
6
7
| Attributes | Subject Device | Predicate Device | Similarities /
Differences | Reference Device |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Sizes | 20 × 30 mm | 50 x 50 mm | Similar. The sizes
of the subject
device fall within
the size range of
the predicate
device and are the
same as the
reference 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 |
| Biological
Evaluation | Conforms with ISO 10993-1 and FDA
guidance. | Performed | Similar | Performed. Conforms with ISO
10993-1 and FDA guidance. |
| Collagen Viral
Inactivation | Conforms with FDA guidance. | Performed | Similar | Performed. Conforms with FDA
guidance. |
| Physical and
Chemical
Properties Testing | Conforms with product specification. | Performed | Similar | Performed. Conforms with
product specification. |
| Non-Clinical
Performance
Testing | Conforms with product performance
requirements including for new use
in conjunction with negative
pressure wound therapy. | Performed | Similar | Performed. Conforms with
product performance
requirements. |
8
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 Bacterial Endotoxin Test O
9
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.