(236 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a collagen wound dressing, with no mention of AI or ML technologies.
Yes
The device is a wound dressing designed for the management of wounds and control of bleeding, which constitutes a therapeutic purpose.
No
This device is a wound dressing designed for the management of moderately to heavily exudating wounds and to control minor bleeding. It is a therapeutic device, not one used to diagnose conditions or determine the nature of a disease.
No
The device description clearly states it is a "Fibrillar Collagen Wound Dressing," which is a physical, absorbent matrix. It is a tangible product applied directly to wounds, not a software program.
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: The Fibrillar Collagen Wound Dressing is a physical dressing applied directly to a wound. It interacts with wound exudate and has hemostatic properties. It does not perform any diagnostic testing on a sample taken from the body.
- Intended Use: The intended use is for the management of wounds and control of minor bleeding, which are therapeutic and wound care functions, not diagnostic ones.
Therefore, this device falls under the category of a wound dressing or topical hemostatic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as:
- Pressure ulcers
- Venous stasis ulcers
- Diabetic ulcers
- Acute wounds, for example trauma and surgical wounds
- Partial-thickness burns
Product codes
KGN
Device Description
The Fibrillar Collagen Wound Dressing is an absorbent microfibrillar collagen matrix intended for the management of moderately to heavily exudating wounds and the control of minor bleeding. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The Fibrillar Collagen Wound Dressing is applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the product, being comprised of microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding. The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
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
Prescription Use
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
Nonclinical tests submitted
The submission included summary-level information demonstrating compliance with design controls, including risk analysis method and Declaration of Conformity with Design Controls. Design validation included performance data to demonstrate conformance with the special controls and to ensure that the modified device would meet user requirements. Safety and performance testing completed on the subject device are shown in the table below:
Test: Cytotoxicity, Test Method / Model: L929 MEM Elution, ISO 10993-5
Test: Sensitization, Test Method / Model: Guinea Pig Maximization, ISO 10993-10
Test: Intracutaneous Reactivity, Test Method / Model: Intracutaneous Reactivity in Rabbits, ISO 10993-10
Test: Acute Systemic Toxicity, Test Method / Model: Acute Systemic Toxicity in Mice, ISO 10993-11
Test: Pyrogenicity, Test Method / Model: Rabbit Pyrogen Study, USP
Additional implantation and subchronic toxicity testing of the predicate device was leveraged to support the safety and performance of the subject device.
Conclusions Drawn from Non-Clinical Studies
The conclusions drawn from the design control process demonstrate that the device is substantially equivalent to its legally marketed predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
May 31, 2022
Collagen Matrix, Inc. Peggy Hansen Senior Vice President 15 Thornton Road Oakland, New Jersey 07436
Re: K213341
Trade/Device Name: Fibrillar Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: October 5, 2021 Received: October 7, 2021
Dear Peggy Hansen:
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) K213341
Device Name
Fibrillar Collagen Wound Dressing
Indications for Use (Describe)
Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as:
- Pressure ulcers
- Venous stasis ulcers
- Diabetic ulcers
- Acute wounds, for example trauma and surgical wounds
- Partial-thickness burns
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Collagen Matrix. The logo consists of a grid of horizontal lines with arrows pointing to the right on the left side, followed by the words "COLLAGEN MATRIX" in large, bold, blue letters. Below the company name, the words "SCIENCE • TECHNOLOGY • INNOVATION" are written in smaller, blue letters.
510(k) Summary
510(k) Number: K213341
1. Applicant Information
| Applicant Name: | Collagen Matrix, Inc. |
|---|---|
| Address: | 15 Thornton Road |
| Oakland, New Jersey 07436 | |
| Telephone: | (201) 405-1477, ext. 304 |
| Fax: | (201) 405-1355 |
| Contact Person: | Peggy Hansen |
| GM, Contract Development & Manufacturing | |
| SVP, Regulatory & Clinical Affairs | |
| phansen@collagenmatrix.com |
Date Prepared: May 31, 2022
2. Name of the Device
| Device Trade Name: | Fibrillar Collagen Wound Dressing |
|---|---|
| Device Common Name(s): | Topical Wound Dressing |
| Device Classification Name: | Dressing, Wound, Collagen |
| KGN | |
| Unclassified |
3. Legally Marketed Devices to Which Substantial Equivalence is Claimed
Primary Predicate Device: Collagen Topical Wound Dressing Collagen Matrix, Inc. K030921
4. Description of the Device
The Fibrillar Collagen Wound Dressing is an absorbent microfibrillar collagen matrix intended for the management of moderately to heavily exudating wounds and the control of minor bleeding. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The Fibrillar Collagen Wound Dressing is applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the product, being comprised of microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding.
4
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
5. Intended Use
Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds, for example trauma and surgical wounds, and partial-thickness burns.
6. Summary/Comparison of Technical Characteristics
The subject device has substantially equivalent technological characteristics as the cited legally marketed predicate devices.
| Parameter | Fibrillar Collagen Wound Dressing
(Subject Device) | Collagen Topical Wound Dressing
K030921
(Predicate Device) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Fibrillar Collagen Wound Dressing is
indicated for the management of
moderately to heavily exudating
wounds and to control minor
bleeding.
Fibrillar Collagen Wound Dressing
may be used for the management of
exudating wounds such as pressure
ulcers, venous stasis ulcers, diabetic
ulcers, acute wounds, for example
trauma and surgical wounds, and
partial-thickness burns. | Collagen Topical Wound Dressing is
indicated for the management of
moderately to heavily exudating
wounds and to control minor
bleeding.
Collagen Topical Wound Dressing
may be used for the management of
exudating wounds such as pressure
ulcers, venous stasis ulcers, diabetic
ulcers, acute wounds, for example
trauma and surgical wounds, and
partial-thickness burns. |
| Material | Collagen | Collagen |
| Biocompatibility | Biocompatible | Biocompatible |
| Sterility | Sterile | Sterile |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic |
| Single Use/Reuse | Single use only | Single use only |
Nonclinical tests submitted
The submission included summary-level information demonstrating compliance with design controls, including risk analysis method and Declaration of Conformity with Design Controls. Design validation included performance data to demonstrate conformance with the special controls and to ensure that the modified device would meet user requirements. Safety and performance testing completed on the subject device are shown in the table below:
| Test | Test Method / Model |
|---|---|
| Cytotoxicity | L929 MEM Elution, ISO 10993-5 |
5
| Test | Test Method / Model |
|---|---|
| Sensitization | Guinea Pig Maximization, ISO 10993-10 |
| Intracutaneous Reactivity | Intracutaneous Reactivity in Rabbits, ISO 10993-10 |
| Acute Systemic Toxicity | Acute Systemic Toxicity in Mice, ISO 10993-11 |
| Pyrogenicity | Rabbit Pyrogen Study, USP |
Additional implantation and subchronic toxicity testing of the predicate device was leveraged to support the safety and performance of the subject device.
Conclusions Drawn from Non-Clinical Studies
The conclusions drawn from the design control process demonstrate that the device is substantially equivalent to its legally marketed predicate.