(84 days)
Not Found
No
The device description focuses on the material composition and function as a wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing designed to encourage healing, which aligns with the definition of a therapeutic device.
No
The device description and intended use indicate that Collatek Hydrogel is a wound dressing designed to encourage healing by maintaining a moist environment. It is used for treating various types of wounds, not for diagnosing conditions.
No
The device description clearly states it is a "sterile wound-dressing from polyacrylic acid and collagen," which is a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that Collatek Hydrogel is a wound dressing applied directly to the wound site on the body. It does not involve the analysis of biological samples like blood, urine, or tissue in a laboratory setting.
- The function is wound healing support. The device's purpose is to maintain a moist environment to encourage wound healing, not to diagnose a condition or provide information about a patient's health status based on in vitro analysis.
The information provided aligns with a medical device intended for topical application and wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
- First and second degree burns
- · Severe sunburns ■
- · Superficial injuries, cuts, abrasions and surgical wounds
Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:
- 1 Pressure (stage I-IV) and venous stasis ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Donor sites and grafts lik
Precautions:
- Collatek Hydrogel is not recommended for persons sensitive to bovine products I
- Collatek is not recommended for third degree burns
Product codes
MGQ
Device Description
Collatek Hydrogel is a sterile wound-dressing from polyacrylic acid and collagen. The dressing encourages healing by maintaining a moist environment at the wound site in the case of dry of lightly exudating wounds. The collagen used in the dressing is from animals born, raised and slaughtered in the USA.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summary
Submitter's Name and Address:
BioCore Medical Technologies, Inc. 11800 Tech Rd. Suite 240 Silver Spring, MD 20904
Contact Person, Telephone and Fax Number:
Ajay Kumar Phone: (301) 625-6818 Fax: (301) 625-6819
Date Summary was Prepared:
September 6, 2002
Device Names:
| Proprietary Name: | Collatek Hydrogel |
|---|---|
| Common Name: | Wound dressing |
| Classification Name: | Wound and burn dressing |
Predicate Device:
| Trade name: | Woun'Dres Collagen Hydrogel Wound Dressing |
|---|---|
| Company: | Coloplast Corporation |
| 510(k) number: | K991202 |
| Date Approved: | June 4, 1999 |
| Trade name: | Nu-Gel Wound Dressing |
|---|---|
| Company: | Johnson and Johnson Medical Inc. |
| 510(k) number: | K983362 |
| Date Approved: | December 16, 1998 |
Device Description:
Collatek Hydrogel is a sterile wound-dressing from polyacrylic acid and collagen. The dressing encourages healing by maintaining a moist environment at the wound site in the case of dry of lightly exudating wounds. The collagen used in the dressing is from animals born, raised and slaughtered in the USA.
Basis for Substantial Equivalence:
1. Indications for Use
Collatek Hydrogel will be used to manage full thickness wounds with moderate to heavy exudate. Collatek Hydrogel is intended for use on dry, light and moderately exudating of the following types: first and second degree burns, severe sunburns, superficial injuries, abrasions, cuts, surgical wounds, pressure ulcers, venous stasis ulcers, ulcers caused by mixed etiologies, diabetic ulcers, donor sites and grafts.
Woun'Dres is indicated for partial and full thickness wounds including pressure ulcers, dower extremity ulcers including venous arterial and mixed etiology, surgical wounds, first and second degree burns and abrasions. Nu-Gel is indicated for first and second degree burns, superficial injuries, radiation
DEC 0 2 2002
1
burns, pressure ulcers stage I-IV, lower extremity ulcers, arterial ulcers, ulcers of mixed etiology, diabetic ulcers, donor sites and grafts. Therefore, Collatek Hydrogel 's indications for use are comparable to the predicate devices (Woun'Dres and Nu-Gel Wound Dressing).
2. Technological Characteristics
Collatek Hydrogel is designed to create a favorable environment at the wound site by providing a moist environment in the case of dry or light to moderately exudating wounds. Nu-Gel provides a moist environment by protecting against dehydration and absorbing excess exudates. Woun'Dres is a hydrogel dressing for providing a moist environment. Therefore, Collatek Hydrogel is similar in technological characteristics to the predicate devices (Woun'Dres and Nu-Gel Wound Dressing).
3. Materials
Collatek Hydrogel contains polyacrylic acid (Trade name: Carbomer) and collagen as primary components. Woun'Dres is made from collagen and Allantoin. Nu-Gel consists of polyvinyl pyrrolidone. The polymers in these dressings are to provide a hydrogel for maintaining a moist environment. Therefore, Collatek Hydrogel is similar to the predicate devices (Woun'Dres and Nu-Gel Wound Dressing) with respect to materials of construction.
4. Safety
Biocompatibility testing has confirmed that Collatek Hydrogel meets requirements as stated by the FDA regulations in Blue Book Memorandum G95-1. Biocompatibility tests were in accordance with GLP. Woun'Dres and Nu-Gel Wound Dressing both passed biocompatibility tests.
5. Sterility and Packaging
Collatek will be packaged as a sterile dressing.
Conclusion
Collatek Hydrogel is similar in design, function, materials and intended use and is therefore substantially equivalent to the commercially available predicate devices: Woun'Dres and Nu-Gel Wound Dressing
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioCore Medical Technologies, Inc. Ajav Kumar VP of Operations 11800 Tech Road, Suite 240 Silver Spring, Maryland 20904
Re: K022995
Trade/Device Name: Collatek Hydrogel Regulation Name: Wound and burn dressing, hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: September 6, 2002 Received: September 9, 2002
Dear Mr. Kumar:
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. 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 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); good manufacturing practice requirements as set forth in the
DFC 0 2 2002
3
Page 2 - Mr. Ajay Kumar
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. 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
(or Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
11022995 510(k) Number (if known):
Device Name: Collatek Hydrogel
Indications for Use:
Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
- First and second degree burns
- · Severe sunburns ■
- · Superficial injuries, cuts, abrasions and surgical wounds
Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:
- 1 Pressure (stage I-IV) and venous stasis ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Donor sites and grafts lik
Precautions:
- Collatek Hydrogel is not recommended for persons sensitive to bovine products I
- Collatek is not recommended for third degree burns
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
Division Sign~Off) Division of General, Restorative and Neurological Devices
10(k) N K022995
OR Over-The-Counter-Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)