(14 days)
No
The summary describes a topical wound dressing and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding, which are therapeutic actions.
No
The device is a wound dressing used for managing exudating wounds and controlling minor bleeding, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a physical "opaque, absorbent, collagen membrane matrix" intended for topical use, indicating it is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "management of moderately to heavily exudating wounds and to control minor bleeding." This is a therapeutic application, not a diagnostic one.
- Device Description: The description of the device as an "opaque, absorbent, collagen membrane matrix intended for topical use" aligns with a wound dressing, not a device used to perform tests on samples from the body.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on safety, biocompatibility, and equivalence to predicate wound dressings, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with a wound for healing and management, which is a therapeutic function.
N/A
Intended Use / Indications for Use
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 .
- Acutc wounds, for example trauma and surgical wounds .
- . Partial-thickness burns
Product codes
KGN
Device Description
Collagen Topical Wound Drcssing is an opaque, absorbent, collagen membrane matrix intended for topical use. The product is supplied sterile 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
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
The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.
Key Metrics
Not Found
Predicate Device(s)
Collagen Topical Wound Dressing, K030921, Collagen Topical Wound Dressing, K040211
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAR 1 7 2004
K040558
page 1/2
510(k) Summary of Safety and Effectiveness
| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Director, Clinical, Regulatory, and Quality Assurance
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | March 2, 2004 |
| Device Common Name: | Collagen Topical Wound Dressing |
| Device Trade Name: | To be determined |
| Device Classification Name: | Dressing, Wound, Collagen
Unclassified
KGN |
| Predicate Device(s): | Collagen Topical Wound Dressing, K030921
Collagen Topical Wound Dressing, K040211 |
Description of the Device
Collagen Topical Wound Drcssing is an opaque, absorbent, collagen membrane matrix intended for topical use. The product is supplied sterile and for single use only.
Indications for Use
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 .
- Acutc wounds, for example trauma and surgical wounds .
- . Partial-thickness burns
1
K040558
page 2/2
Summary/Comparison of Technical Characteristics
Collagen Topical Wound Dressing has the same fundamental scientific technology and intended use as the predicate device. In particular, the Collagen Topical Wound Dressing and its predicate are the same with respect to intended use, material, source, sterilization, etc.
Safety
Collagen Topical Wound Dressing has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.
Conclusion
The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey ()7417
Re: K040558
Trade/Device Name: Collagen Topical Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 2, 2004 Received: March 5, 2004
Dear Ms. 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 Fedcral 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he 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 docs 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Peggy Hanson, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KO40559 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ Collagen Topical Wound Dressing
Indications for Use:
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 .
- Partial-thickness burns .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE EIELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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510(k) Number K040558