(140 days)
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.
lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound. 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.
The provided document is a 510(k) summary for the Iamin-2 Hydrating Gel, a medical device intended to serve as a hydrogel dressing for various wound types. The device is being submitted for substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and specific performance metrics in the way one might expect for a diagnostic or AI-powered device are not explicitly stated in this 510(k) summary. For a Class II (or unclassified) device like a wound dressing seeking substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the device has the same technological characteristics and intended use as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the table would look something like this, focusing on the comparison to predicate devices:
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence for Wound Dressings) | Reported Device Performance (Iamin®-2 Hydrating Gel) |
|---|---|
| Intended Use: Device provides a moist wound environment and protects the wound. | "Iamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound." (Directly stated, identical to predicates). |
| Technological Characteristics (e.g., form, absorptive ability, occlusion, conformability, sterility, moist wound healing, appearance): Comparable to predicate devices. | "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." (Directly stated). |
| Material Composition: Similar to predicate devices, providing a soothing, moist environment. | "Iamin®-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." (Implied to be functionally similar to predicates as it's designed to provide a "soothing, moist environment"). |
| Safety: No new safety concerns raised compared to predicate devices. | Implied by the FDA's substantial equivalence determination for general controls. Restrictions on labeling (e.g., no third-degree burns, no claims of accelerating healing) further define safe use. |
| Effectiveness: Provides a moist environment and protection, not claiming accelerated healing. | "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." (Consistent with predicate claims). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a specific "test set" or clinical study with patient samples in the traditional sense for evaluating the performance of the Iamin®-2 Hydrating Gel itself. This typically means that for devices like simple wound dressings established through precedent, the demonstration of substantial equivalence relies heavily on:
- Comparison of device characteristics: Chemical composition, physical properties, intended use, and technological characteristics are compared against legally marketed predicate devices.
- Existing knowledge and scientific principles: The understanding that hydrogels create a moist wound environment is well-established.
Therefore, there is no information provided on sample size, data provenance (e.g., country of origin), or whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. "Ground truth" as it's typically understood for diagnostic or AI systems (e.g., pathology reports for image analysis) is not relevant for demonstrating substantial equivalence for a wound dressing based on its physical and chemical properties matching predicates.
The "experts" involved are primarily the FDA reviewers who assess the submission based on regulatory guidelines and existing scientific understanding of wound care products.
4. Adjudication Method
This information is not applicable or provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical trials or performance studies where expert reviewers evaluate patient cases against a reference standard. Since no such study is described for the Iamin®-2 Hydrating Gel, there's no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or relevant for this type of device submission. MRMC studies are used to compare the diagnostic accuracy or effectiveness of different diagnostic methods or technologies, often involving human readers with and without AI assistance. The Iamin®-2 Hydrating Gel is a physical wound dressing, not a diagnostic tool or an AI-assisted system.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This is not applicable. The device is a physical hydrogel dressing, not an algorithm or an AI system. Therefore, no standalone algorithm performance study was conducted or reported.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy is not applicable to this 510(k) submission.
For this device, the "truth" is established by:
- Scientific principles: The known benefits of a moist wound environment for healing.
- Regulatory precedent: The characteristics of legally marketed predicate devices that have already been deemed safe and effective for similar indications.
- Material science: The properties of the ingredients to form a hydrogel.
8. Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set mentioned for an AI algorithm.
In summary, the provided 510(k) summary for the Iamin®-2 Hydrating Gel focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than on detailed clinical study data or performance metrics for a novel technology. This is a common approach for unclassified or Class II medical devices that fit well within existing product categories with established safety and effectiveness profiles. The "study" here is primarily the comparison of the device's characteristics and intended use to those of the predicate devices.
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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.
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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.
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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.
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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
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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) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
N/A