← Product Code MGQ · K970153 # LAMIN-2 HYDRATING GEL (K970153) _Procyte Corp. · MGQ · Jun 5, 1997 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K970153 ## Device Facts - **Applicant:** Procyte Corp. - **Product Code:** MGQ - **Decision Date:** Jun 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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. ## Device Story Iamin®-2 Hydrating Gel is a hydrogel wound dressing; provides moist environment to protect wounds from abrasion, friction, desiccation, and contamination. Composed of water, glycerin, carbopol (carbomer), prezatide copper acetate, and parabens. Applied topically to wound/burn sites; intended for clinical or home use. Protects skin integrity; facilitates management of various ulcer types and minor burns. Does not accelerate healing; not for long-term/permanent use or as synthetic skin. ## Clinical Evidence No clinical data provided. Substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices. ## Technological Characteristics Hydrogel dressing; low bioburden, preserved preparation. Ingredients: water, glycerin, carbopol (carbomer), prezatide copper acetate, parabens. Form: gel. Properties: absorptive, occlusive, conformable. Sterility: sterile. ## Predicate Devices - lamin Hydrating Gel - Dermagran (Zinc-Saline) Hydrogel Wound Dressing - SteriCare Wound Care Gel - Carrington Gel Wound Dressing (Carrasyn Gel) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 6970153 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. 24 {1} ProCyte Corporation 510(k) Summary - lamin®-2 Hydrating Gel January 15, 1997 Page 2 of 2 R97C/53 **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. 25 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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: 1. This device may not be labeled for use on third degree burns. 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. 4. This device may not be labeled as a treatment or a cure for any type of 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 your 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 yours, ![img-0.jpeg](img-0.jpeg) 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 1 510(k) Number: K970153 Device Name: lamin®-2 Hydrating Gel ## 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. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-1.jpeg](img-1.jpeg) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/device/K970153](https://fda.innolitics.com/device/K970153) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com