(140 days)
Not Found
Not Found
No
The summary describes a hydrogel wound dressing and its intended use, with no mention of AI or ML technology.
Yes.
The device is intended for the dressing and management of various types of wounds and skin conditions, providing a moist wound environment and protection, which qualifies it as a therapeutic device.
No
The device, lamin®-2 Hydrating Gel, is described as a wound dressing that provides a moist environment and protection for various skin wounds. Its intended use and device description do not mention any diagnostic capabilities, such as detecting, identifying, or monitoring a disease or condition. It is purely for treatment and management of existing wounds.
No
The device description clearly states it is a hydrogel dressing composed of various chemical ingredients, indicating it is a physical product, 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 a wound dressing for managing various types of ulcers, burns, cuts, and skin irritations. It's applied to the skin to provide a moist environment and protection.
- Device Description: The description details the composition of the gel and its function in providing a moist wound environment.
- Lack of Diagnostic Activity: 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. IVDs are specifically designed for these types of in vitro tests.
The device is a therapeutic wound care product, not a diagnostic tool.
N/A
Intended Use / Indications for Use
lamin®-2 Hydrating Gel is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and external contamination.
Product codes
MGQ
Device Description
lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound. ProCyte Corporation lamin®-2 Hydrating Gel was designed to provide a soothing, moist environment for each application to various types of wounds. lamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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)
lamin Hydrating Gel, Dermagran (Zinc-Saline) Hydrogel Wound Dressing, SteriCare Wound Care Gel, Carrington Gel Wound Dressing: (also known as Carrasyn Gel)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
11.5 510(k) Summary
JUN - 5 1997
Submitter's Name and Address: ProCyte Corporation 12040 115th Ave NE #210 Kirkland, Washington 98034
Contact person and telephone number: Paul Ketteridge Regulatory Affairs Officer Telephone: (206) 820-4548 Fax: (206) 820-7611 Date summary was prepared: January 14, 1997
Name of the Device:
| Proprietary name: | lamin®-2 Hydrating Gel |
|---|---|
| Common name: | Hydrogel Dressing |
| Classification name: | Hydrogel and Burn Dressing |
Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:
lamin®-2 Hydrating Gel is substantially equivalent in function and intended use to the following non-classified commercially available non-interactive wound and burn dressings: lamin Hydrating Gel Dermagran (Zinc-Saline) Hydrogel Wound Dressing
SteriCare Wound Care Gel
Carrington Gel Wound Dressing: (also known as Carrasyn Gel)
Device Description:
Explanation of how the device functions: lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound.
1
K970/53
ummary - lamin®-2 Hydrating Gel
Basic scientific concepts that form the basis for the device: lamin®-2 Hydrating Gel was designed to provide a soothing, moist environment for each application to various types of wounds.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: lamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing.
Statement of the Intended Use of the Device, Including General Description of the Conditions the Device Will Mitigate and the Patient Population for which the Device Is Intended: An hydrogel for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.
These indication statements are not different from the predicate devices identified above.
Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device: The technological characteristics of the device such as form, absorptive ability, occlusion, conformability, sterility, moist wound healing and appearance are not different from the predicate devices cited.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three wavy lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Ketteridge, R.Ph. Regulatory Affairs Officer Procyte Corporation . . . . . . . . . . . . . . . 12040 115th Avenue N.E., Suite 210 Kirkland, Washington 98034-6900
JUN - 5 1997
" Re:
K970153 Iamin® 2-Hydrating Gel Regulatory Class: Unclassified Product Code: MGQ Dated: April 28, 1997 Received: April 29, 1997
Dear Mr. Ketteridge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of 4. wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
3
Page 2 - Mr. Paul Ketteridge, R.Ph.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
tocella
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ProCyte Corporation K970153 - lamin@-2 Hydrating Gel April 28, 1997 Page 4 of 9
Attachment 2
Page 1 of
510(k) Number :
Device Name:
Indications For Use:
lamin@-2 Hydrating Gel is intended to be used for the dressing and management of pressure ්යාක (stage Hydraing Gel (rie alessing pressure sores, cuts, abrasions, intraded to cover a wound or burn on a patient's skin, provide a peristomal care. The dressing is intensed to over a nother friction, desiccation, and external contamination.
(Please Do Not Write Below This Line-Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K970153 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|