(262 days)
Not Found
No
The 510(k) summary describes a collagen-glycosaminoglycan wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the management of various wounds, including acute and chronic types, and supports a healing environment, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a wound dressing for managing and supporting a healing environment for wounds, which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a collagen-glycosaminoglycan wound dressing, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves applying the device directly to a wound on a patient's body to aid in healing.
- Device Description: The description details a "collagen-glycosaminoglycan wound dressing" that "maintains and supports a healing environment for wound management." This is a therapeutic device applied externally.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, the INTEGRA® Wound Matrix (Macro-Channels) is a therapeutic medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, partial thickness burns, 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
INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 proposed device is tested to ensure the following performance specifications are met: pore size, collagen nativity-FTIR test of denaturing, chondroitin-6-sulfate content, permeability, drapeability, degree of cross-linking, and bacterial endotoxin. In addition to bench performance tests, the in vivo safety and effectiveness of the INTEGRA® Wound Matrix (Macro-Channels) was assessed in a porcine wound healing model. The results of the study demonstrate that there are no significant differences in healing between the predicate and modified 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.
Not Found
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Integra LifeSciences Corporation Nicole Kotter Manager, Regulatory Affairs 1100 Campus Road Princeton, New Jersey 08540
Re: K210128
Trade/Device Name: INTEGRA Wound Matrix (Macro-Channels) Regulatory Class: Unclassified Product Code: KGN Dated: January 15, 2021 Received: January 19, 2021
Dear Nicole Kotter:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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,
Lixin Liu. Ph.D. 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
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Indications for Use
510(k) Number (if known)
Device Name
INTEGRA® Wound Matrix (Macro-Channels)
Indications for Use (Describe)
INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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510(K) SUMMARY
INTEGRA® Wound Matrix (Macro-Channels)
I. SUBMITTER
Submitter's name and address: Integra LifeSciences Corporation 1100 Campus Rd, Princeton, NJ 08540 USA
Contact person and telephone number: Saakshi Arora-Tice Specialist. Regulatory Affairs Telephone: 609.325.7374
Date Summary was prepared: January 14, 2021
II. DEVICE
| Name of the device: | INTEGRA® Wound Matrix (Macro-Channels) |
|---|---|
| Common Name: | Collagen Wound Dressing |
| Classification Name: | Not Classified |
| Regulatory Class: | Unclassified |
| Product Code: | KGN |
III. PREDICATE DEVICE
INTEGRA® Wound Matrix (Macro-Channels) is substantially equivalent in technological characteristics and intended use to the predicate device detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K022127 | KGN | INTEGRA® Wound | |
| Matrix (also known as | |||
| Integra Matrix Wound | |||
| Dressing) | Integra LifeSciences | ||
| Corporation |
The specific trade name AVAGEN Wound Dressing was cleared through 510(k) K022127 on September 10, 2002. Prior to official market release of AVAGEN Wound Dressing (K022127), Integra changed the product name from AVAGEN Wound Dressing to INTEGRA Matrix Wound Dressing in an effort to market a more uniform product family to consumers. The product name change from INTEGRA Matrix Wound Dressing to INTEGRA Wound Matrix was reflected in our INTEGRA Wound Matrix (Thin) 510(k) K113104 on February 9, 2012.
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IV. DEVICE DESCRIPTION
INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.
V. INDICATIONS FOR USE
INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Substantial Equivalence Comparison:
INTEGRA® Wound Matrix (Macro-Channels) is substantially equivalent in technological characteristics and intended use to the predicate device, which has been cleared under Premarket Notification 510(k) K022127. The modified device, INTEGRA® Wound Matrix (Macro-Channels), utilizes identical manufacturing processes, packaging, and sterilization as the predicate device (K022127) except for an additional process step to introduce the presence of macro-channels (small holes) in the proposed device to facilitate fluid drainage through the device post-application. Further, the following technological characteristics, e.g., pore size, collagennativity, extent of collagen cross-linking, and glycosaminoglycan content, are identical between INTEGRA® Wound Matrix (Macro-Channels) and the predicate device INTEGRA® Wound Matrix (K022127). The table below provides a comparison between the predicate and subject device.
| Product Name | INTEGRA® Wound Matrix
(predicate device) | INTEGRA® Wound Matrix
(Macro-Channels)
(subject device) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K022127 | K210128 |
| Product Code | KGN | KGN |
| Indications for Use | INTEGRA® 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 | INTEGRA® Wound Matrix
(Macro-Channels) 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,
second-degree burns, skin
tears) and draining wounds.
The device is intended for
one-time use. | Moh's surgery, post-laser
surgery, podiatric, wound
dehiscence), trauma wounds
(abrasions, lacerations, partial
thickness burns, skin tears)
and draining wounds. The
device is intended for one-
time use. |
| Design | | |
| Physical Structure/Materials | Type I Bovine Collagen -
glycosaminoglycan matrix | Type I Bovine Collagen -
glycosaminoglycan matrix |
| Form | Sheet | Sheet |
| Perforations | No | Yes |
| Characteristics | | |
| Dimensions | 2"x2" (5 cm x 5cm)
4"x5" (10 cm x 12.5 cm)
4"x10" (10 cm x 25 cm)
8"x10" (20 cm x 25 cm) | 2"x2" (5 cm x 5cm)
4"x5" (10 cm x 12.5 cm)
4"x10" (10 cm x 25 cm)
8"x10" (20 cm x 25 cm) |
| Resistance to collagenase
Digestion | Optical Density Less than
0.800 absorbance unit | Optical Density Less than
0.800 absorbance unit |
| Endotoxin | Must be Less than 20
EU/device | Must be Less than 20
EU/device |
| Biocompatibility | Passes panel of ISO 10993
tests: Cytotoxicity, Dermal
Irritation, Dermal
Sensitization, Acute Systemic
Toxicity, Hemolysis, Sub-
chronic (sub-acute) Toxicity,
Genotoxicity | Biocompatibility testing
completed on INTEGRA®
Wound Matrix was leveraged
to support INTEGRA®
Wound Matrix (Macro-
Channels). Passes ISO 10993
tests for cytotoxicity. |
| Anatomical Location | Wounds | Wounds |
| Thickness | Approximately 0.8mm | Approximately 0.8mm |
| Sterility | e-beam irradiation, 10-6 SAL,
single-use only | e-beam irradiation, 10-6 SAL,
single-use only |
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VII. PERFORMANCE DATA:
INTEGRA® Wound Matrix (Macro-Channels) and INTEGRA® Wound Matrix (K022127) are comprised of identical materials and are processed and sterilized by similar methods.
Biocompatibility testing, including Cytotoxicity, Dermal Sensitization, Irritation, Acute Systemic Toxicity, Subchronic toxicity, Implantation, Genotoxicity, and Hemocompatibility tests, were conducted for the predicate device INTEGRA® Wound Matrix (K022127). All test results were acceptable. Due to the equivalent nature of the device composition, the biocompatibility testing completed on the INTEGRA® Wound Matrix (K022127) was leveraged to support the proposed device INTEGRA® Wound Matrix (Macro-Channels). In addition, the added manufacturing
6
process step was considered during the risk assessment for biocompatibility evaluations of the subject device, and the knowledge gaps were addressed through chemical analysis of manufacturing aids used during the process.
The proposed device is tested to ensure the following performance specifications are met: pore size, collagen nativity-FTIR test of denaturing, chondroitin-6-sulfate content, permeability, drapeability, degree of cross-linking, and bacterial endotoxin. In addition to bench performance tests, the in vivo safety and effectiveness of the INTEGRA® Wound Matrix (Macro-Channels) was assessed in a porcine wound healing model. The results of the study demonstrate that there are no significant differences in healing between the predicate and modified devices. Furthermore, the safe history of clinical use of similar collagen products, including the predicate device, manufactured, and marketed by Integra LifeSciences Corporation has been cited in this 510(k) Premarket Notification.
Conclusion:
The proposed INTEGRA® Wound Matrix (Macro-Channels) is substantially equivalent to the commercially marketed device, INTEGRA® Wound Matrix (K022127).
The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device and do not raise different questions of safety or effectiveness.