(91 days)
No
The device description and performance studies focus on the material properties and biological function of a wound matrix, with no mention of AI or ML.
Yes
The device is indicated for the management of various types of wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, and diabetic ulcers, which classifies it as a therapeutic device.
No
The device is a wound matrix intended for the management of various 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 physical wound matrix made of atelocollagen sponge, which is a hardware component. The performance studies also focus on physical and biological properties of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of wounds." This involves direct application to the patient's body to aid in wound healing.
- Device Description: The description details a "single layer wound matrix" applied "directly to the wound surface" to provide a "scaffold for cellular invasion and capillary growth." This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, packaging, shelf life, and physical properties of the matrix, which are relevant to a therapeutic device applied to the body. There are no studies related to diagnostic accuracy or performance.
In vitro diagnostic devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is applied to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
PELNAC® Wound Matrix is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- trauma wounds (abrasions, lacerations, partial thickness 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® Wound Matrix is a single layer wound matrix of 100% atelocollagen sponge derived from porcine Achiles tendon that is applied directly to the wound surface. When applied to full-thickness skin defects, PELNAC® Wound Matrix provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and in two levels of thickness and is provided terminally sterilized by ethylene oxide. PELNAC® Wound Matrix 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)
Non-Clinical Performance Data: The following non-clinical performance testing conducted on PELNAC™ Bilayer Wound Matrix (K191992) is being leveraged for PELNAC® 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 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:
- 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
- ■Implantation
- ■Cytotoxicity
- ▪Skin Sensitization
- ■Intracutaneous Reactivity
- ■Material Mediated Pyrogenicity
- ▪Chemical Characterization
- ■Toxicological Risk Assessment
- Sterilization, Packaging and Shelf Life: .
- O ISO 11135
- O ISO 11607-1
- O ASTM F1886
- USP Bacterial Endotoxin Test o
- Performance Testing:
- o Pore Size
- O Degree of Cross-Linking
- O Drapeability
- o Heavy Metal Content
- . Risk Analysis:
- o ISO 14971
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2022
Gunze Limited % Stuart Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K213573
Trade/Device Name: PELNAC Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: October 26, 2021 Received: November 10, 2021
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 For Acting 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) K213573
Device Name PELNAC® Wound Matrix
Indications for Use (Describe) PELNAC® Wound Matrix is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound deliscence),
- · trauma wounds (abrasions, lacerations, partial thickness burns and skin tears), and
- · draining wounds.
The device is intended for one-time use.
Type of Use (Select one or both, as applicable)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® Wound Matrix
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
February 7, 2022
4. Device Identification
| Type of 510(k): | Traditional 510(k) |
|---|---|
| Trade Name: | PELNAC® 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: | AVAGEN Wound Dressing |
|---|---|
| ------------- | ----------------------- |
4
| 510(k) No.: | K022127 |
|---|---|
| Manufacturer: | Integra Life Sciences |
| The following reference devices have also been included in this submission. | |
| Trade Name: | PELNACTM Bilayer Wound Matrix |
| 510(k) No.: | K191992 |
| Manufacturer: | GUNZE LIMITED |
| Trade Name: | Integra® Wound Matrix (Thin) |
| 510(k) No.: | K113104 |
Integra Life Sciences
6. Indications for Use
PELNAC® Wound Matrix is indicated for the management of wounds including:
- partial and full-thickness wounds,
- · pressure ulcers,
- venous ulcers,
Manufacturer:
- · diabetic ulcers,
- chronic vascular ulcers,
- · tunneled/undermined wounds,
- 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 is intended for one-time use.
7. Device Description
PELNAC® Wound Matrix is a single layer wound matrix of 100% atelocollagen sponge derived from porcine Achiles tendon that is applied directly to the wound surface. When applied to full-thickness skin defects, PELNAC® Wound Matrix provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and in two levels of thickness and is provided terminally sterilized by ethylene oxide. PELNAC® Wound Matrix 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® Wound Matrix has the same indications for use as the predicate device AVAGEN Wound Dressing (K022127). The subject and predicate device employ the same mode of action in that both devices contain a single layer 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® 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 devices are also included in Table 5-1.
5
Attributes Subject Device Predicate Device Similarities / Reference Reference Differences Device #1 Device #2 PELNAC™ Bilayer Wound Device Name PELNAC® Wound Matrix AVAGEN Wound Dressing Integra® Wound Matrix Matrix (Thin) Manufacturer GUNZE LIMITED Integra Life Sciences GUNZE LIMITED Integra Life Sciences -510(k) # K213573 K022127 K191992 K113104 KGN KGN Product Code KGN KGN Same AVAGEN Wound Dressing is PELNAC™ Bilayer Wound Indications PELNAC® Wound Matrix is Same Integra® Wound Matrix for Use indicated for the indicated for the Matrix is indicated for (Thin) is indicated for the management of wounds management of wounds the management of management of wounds including: partial and fullincluding: partial and fullwounds including: including: partial and fullthickness wounds, pressure thickness wounds, pressure partial and full-thickness thickness wounds, ulcers, venous ulcers, ulcers, venous ulcers, wounds, pressure ulcers, pressure ulcers, venous diabetic ulcers, chronic diabetic ulcers, chronic venous ulcers, diabetic ulcers, diabetic ulcers, vascular ulcers, vascular ulcers, ulcers, chronic vascular chronic vascular ulcers, tunneled/undermined tunneled/undermined ulcers, surgical wounds tunneled/undermined wounds, surgical wounds wounds, surgical wounds (donor sites/grafts, postwounds, surgical wounds (donor sites/grafts, post-(donor sites/grafts, post-(donor sites/grafts, post-Moh's surgery, post-Moh's surgery, post-laser Moh's surgery, post-laser laser surgery, podiatric, Moh's surgery, post-laser surgery, podiatric, wound surgery, podiatric, wound wound dehiscence), surgery, podiatric, wound dehiscence), trauma dehiscence), trauma wounds dehiscence), trauma wounds trauma wounds (abrasions, lacerations, (abrasions, lacerations, wounds (abrasions, (abrasions, lacerations, partial thickness burns, and second-degree bums, and second-degree burns, lacerations, second-degree skin tears), and draining skin tears) and draining and skin tears), and bums, and skin tears) and wounds. The device is wounds. The device is draining wounds. The draining wounds. The intended for one-time use. intended for one-time use. device is intended for device is intended for oneone-time use. time use.
Table 5-1 – Substantial Equivalence Comparison of PELNAC® Wound Matrix to the Predicate Device
6
| Attributes | Subject Device | Predicate Device | Similarities /
Differences | Reference
Device #1 | Reference
Device #2 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Construction | Single layer | Single layer | Same | Bilayer | Single layer |
| Form | Sheet | Sheet | Same | Sheet | Sheet |
| Materials | Collagen sponge porous
matrix of porcine (Achilles)
tendon. | Collagen sponge porous
matrix of bovine tendon +
glycosaminoglycn. | Different.
Therefore,
Reference Device #1
was added to the
substantial
equivalence
discussion for the
different source of
animal tissue used. | Silicone film, synthetic
gauze, and collagen
sponge porous matrix of
porcine (Achilles)
tendon. | Collagen sponge porous
matrix of bovine tendon +
glycosaminoglyca. |
| Meshed
(fenestrated)
Structure | No | No | Same | Available with or
without. | No |
| Mode of
Action | Collagen sponge is applied to
the wound surface and acts
as a scaffold for cellular
invasion and capillary growth
to occur. | Collagen sponge is applied to
the wound surface and acts
as a scaffold for cellular
invasion and capillary growth
to occur. | Same | Collagen sponge layer is
applied to the wound
surface and acts as a
scaffold for cellular
invasion and capillary
growth to occur. | Collagen sponge is applied
to the wound surface and
acts as a scaffold for
cellular invasion and
capillary growth to occur. |
| Single Use | Yes | Yes | Same | Yes | Yes |
| Attributes | Subject Device | Predicate Device | Similarities /
Differences | Reference
Device #1 | Reference
Device #2 |
| Supplied
Sterile | Yes (EO) | Yes (radiation) | Similar | Yes (EO) | Yes (radiation) |
| Shelf Life | 36 months | 24 months | Similar | 36 months | 24 months |
| Sizes | 20 x 30 mm
40 x 30 mm
40 x 60 mm
82 x 60 mm
82 x 90 mm
82 x 120 mm
120 x 240 mm
200 x 240 mm | 50 x 50
100 x 125 mm
100 x 250 mm
200 x 250 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 x 30 mm
40 x 30 mm
40 x 60 mm
82 x 60 mm
82 x 90 mm
82 x 120 mm
120 x 240 mm
200 x 240 mm | 50 x 50 mm
100 x 125 mm
100 x 250 mm
200 x 250 mm |
| Thickness | 3 mm and
1.5 mm (thin) | 0.8 mm | Different.
Therefore,
Reference Device #2
was added to the
substantial
equivalence
discussion to add a
thin version of the
device. The
drapability of the
subject device has
been demonstrated
through
performance
testing. | 3 mm | 0.4 mm |
| Biological
Evaluation | Conforms with ISO 10993-1
and FDA guidance. | Performed | Similar | Performed. Conforms
with ISO 10993-1 and
FDA guidance. | Performed |
| Attributes | Subject Device | Predicate Device | Similarities /
Differences | Reference
Device #1 | Reference
Device #2 |
| Collagen Viral
Inactivation | Conforms with FDA guidance. | Unknown | Similar | Performed. Conforms
with FDA guidance. | Unknown |
| Physical and
Chemical
Properties
Testing | Conforms with product
specification. | Unknown | Similar | Performed. Conforms
with product
specification. | Unknown |
| Non-Clinical
Performance
Testing | Conforms with product
performance requirements.
New drapeability testing was
also performed for the
subject device and compared
to Reference Device #2.
Suture retention testing is
not required for the subject
device as it is not to be
sutured to the wound bed,
and instead is held in place
by way of appropriate
secondary dressings as
described in its instructions for
use. | Unknown | Similar | Performed. Conforms
with product
performance
requirements. | Performed |
7
8
9
9. Non-Clinical Performance Data
The following non-clinical performance testing conducted on PELNAC™ Bilayer Wound Matrix (K191992) is being leveraged for PELNAC® 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 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:
- 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
- ■Implantation
- ■Cytotoxicity
- ▪Skin Sensitization
- ■Intracutaneous Reactivity
- ■Material Mediated Pyrogenicity
- ▪Chemical Characterization
- ■Toxicological Risk Assessment
- Sterilization, Packaging and Shelf Life: .
- O ISO 11135
- O ISO 11607-1
- O ASTM F1886
- USP Bacterial Endotoxin Test o
- Performance Testing:
- o Pore Size
- O Degree of Cross-Linking
- O Drapeability
- o Heavy Metal Content
- . Risk Analysis:
- o ISO 14971
10. Clinical Performance Data
Not applicable to this submission.
10
11. Substantial Equivalence Conclusion
PELNAC® 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 non-clinical performance testing and other verification and validation activities. PELNAC® Wound Matrix as designed and manufactured by GUNZE LIMITED is substantially equivalent to the predicate device, AVAGEN Wound Dressing.