(117 days)
Not Found
No
The device description focuses on the physical properties and mechanism of action of a hydrogel wound dressing. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The product is intended to manage and relieve pain associated with various dermal wounds and skin conditions, and its function involves creating a protective barrier and maintaining a moist wound environment for optimal healing, which are therapeutic actions.
No
Explanation: The device is described as a wound dressing gel that manages and relieves pain, creates a protective barrier, and maintains a moist wound environment for healing. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a "clear, viscous hydrogel wound dressing composed entirely of all-natural, food-grade, safe ingredients". This describes a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description and Intended Use: The description and intended use of Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel clearly indicate it is a topical wound dressing applied directly to the skin. Its purpose is to manage and relieve pain associated with dermal wounds by forming a protective barrier and maintaining a moist wound environment. It does not involve the examination of specimens from the human body in vitro.
Therefore, this device falls under the category of a wound dressing or topical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel are the same as those for the predicate devices. This product provides management of and relief of the pain associated with all types of wounds, sores, injuries and ulcers of the dermal tissue. Examples of dermal lesions include burn wounds (First & Second degree), diabetic ulcers, pressure ulcers (stages 1 - IV), venous stasis ulcers, radiation dermatitis, partial thickness wounds, irritation of the skin, itching, foot ulcers, post-surgical incision, surgical sites (including soft tissue graft sites), cuts and abrasions, sunburn, skin conditions associated with periostomy care, irritation and pain following laser resurfacing treatment and dermabrasion therapy, chemical peel, and tattooing procedures.
This product is appropriate for all patient populations.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel is a clear, viscous hydrogel wound dressing composed entirely of all-natural, food-grade, safe ingredients, including an all-natural preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissues of the skin, and will manage the pain associated with all types of injuries to the skin.
The gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a profective barrier that is similar to dermal tissues. It also creates and maintains a moist wound environment, which is necessary for optimal healing. Socklt.10 Dermal Wound Gel/McMerlin® Dermal Wound Gel has been designed to be physiologically compatible with both intact and compromised tissues of the skin: the pH and osmotic pressure of the gel have been adjusted to be compatible with injured tissues.
Socklt!® Dermal Wound Gel and McMerlin® Dermal Wound Get are exactly the same in every aspect, the same device has two different trade names.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dermal tissue / skin
Indicated Patient Age Range
all patient populations
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)
No performance standards are established for this product under Section 514 of the Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K902345, K915002, K944427, K951417, K961758
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K090092 page 1/3
14 of 54
510(k) Summary
DATE PREPARED
Thursday, April 30, 2009
SUBMITTER
Aaron Hendershott, RAC Director of Regulatory Affairs McMerlin Dental Products, LP 1610 W. Polo Road Grand Prairie, TX 75052 Telephone: 972.602.3746
Device Name
Common name: Hydrogel Wound Dressing
Trade names: Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel
Classification name: This device is unclassified under 21CFR Parts 862-892.
Predicate Devices
| Table 2: Predicate Device General Information | ||||
|---|---|---|---|---|
| 510(k) | ||||
| Number | Proprietary | |||
| Name | Product | |||
| Code | Manufacturer | Classification | ||
| Panel | ||||
| K902345 | Carrington | |||
| Wound | ||||
| Dressing | FRO | Carrington | ||
| Laboratories. | ||||
| Inc. | General & | |||
| Plastic | ||||
| Surgery | ||||
| K915002 | Carrasyn | |||
| Hydrogel | ||||
| Wound | ||||
| Dressing | ||||
| [Carragauze | ||||
| PADS] | MGQ | Carrington | ||
| Laboratories, | ||||
| Inc. | General & | |||
| Plastic | ||||
| Surgery | ||||
| K944427 | Carrasyn FDG | MGQ | Carrington | |
| Laboratories | General & | |||
| Plastic | ||||
| Surgery | ||||
| K951417 | Carrasyn | |||
| Hydrogel | ||||
| Wound | ||||
| Dressing | ||||
| [Carragauze | ||||
| FDG Pads] | MGQ | Carrington | ||
| Laboratories | General & | |||
| Plastic | ||||
| Surgery | ||||
| K961758 | Carrasyn | |||
| Hydrogel | ||||
| Wound | ||||
| Dressing, et al | MGQ | Carrington | ||
| Laboratories | General & | |||
| Plastic | ||||
| Surgery |
Device Description
Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel is a clear, viscous hydrogel wound dressing composed entirely of all-natural, food-grade, safe ingredients, including an all-natural preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissues of the skin, and will manage the pain associated with all types of injuries to the skin.
MAY 11 2009
1
K090092
K090092 Page 2/3
15 of 54
The gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a profective barrier that is similar to dermal tissues. It also creates and maintains a moist wound environment, which is necessary for optimal healing. Socklt.10 Dermal Wound Gel/McMerlin® Dermal Wound Gel has been designed to be physiologically compatible with both intact and compromised tissues of the skin: the pH and osmotic pressure of the gel have been adjusted to be compatible with injured tissues.
Socklt!® Dermal Wound Gel and McMerlin® Dermal Wound Get are exactly the same in every aspect, the same device has two different trade names.
Intended Use
The indications for Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel are the same as those for the predicate devices. This product provides management of and relief of the pain associated with all types of wounds, sores, injuries and ulcers of the dermal tissue. Examples of dermal lesions include burn wounds (First & Second degree), diabetic ulcers, pressure ulcers (stages 1 - IV), venous stasis ulcers, radiation dermatitis, partial thickness wounds, irritation of the skin, itching, foot ulcers, post-surgical incision, surgical sites (including soft tissue graft sites), cuts and abrasions, sunburn, skin conditions associated with periostomy care, irritation and pain following laser resurfacing treatment and dermabrasion therapy, chemical peel, and tattooing procedures.
This product is appropriate for all patient populations.
Technological Characteristics
Two of the predicate devices are hydrogel wound dressings that have been freeze-dried to produce a fibrous-like material similar to a roll of cotton. This "bandage" material is placed on a dermal wound, where it re-hydrates. Two of the predicate devices are hydrogels that are hydrated at the time of manufacture. All five of these predicate hydrogels provide pain relief by coating damaged tissues and protecting them from further contamination and irritation. [Note: All five predicate devices are predicated upon Carrington Laboratories' hydrogel wound dressing (K902345) that, like Socklt.18 Dermal Wound Gel/McMerlin® Dermal Wound Gel, is hydrated at the factory and sold in a tube as a hydrated gel |
Rather than have the consumer re-hydrate the hydrogel "bandage" at the time of use (i.e. contact with the lesion). Sockly!® Dermal Wound Gel/McMerlin® Dermal Wound Gel is hydrated during manufacture and sold in a tube or bottle in the traditional hydrated gel form.
Regardless of which method is used for hydration, all of these hydrogels adhere to the wound surface, conform to the contours of the wound, and manage pain by forming a protective hydrogel barrier over the wound, similar to undamaged dermal tissue. All these hydrogel barriers manage pain by protecting the wound from contamination and irritation.
Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel is substantially equivalent in design to the five predicate devices.
Performance Standards
No performance standards are established for this product under Section 514 of the Act.
2
Executive Summary
Device Description
Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel (SI/MC) is a clear, viscous hydrogel wound dressing composed entirely of all-natural. safe ingredients, including an all-natural, food-grade preservative system. It is designed to be physiologically compatible with both intact and compromised tissues of the skin: the pH and osmotic pressure of the gel have been adjusted to be compatible with the injured tissues, e.g. blood and other bodily fluids normally found at the wound and/or lesion site. The gel is nontoxic and is safe if swallowed.
SI/MC's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier (i.e. wound dressing) similar to the uncompromised dermal tissue. This protective barrier provides an undisturbed, moist wound environment, which is necessary for optimal healing. The gel provides a safe, nourishing environment for the delicate cells involved in the wound healing process.
Indications for Use
SI/MC is intended to manage the pain of all types of 1st of 2nd degree dermal wounds, skin sores, injuries and ulcers of the dermal tissue. Examples of dermal lesions include burn wounds (First & Second degree), diabetic ulcers, pressure ulcers (stages I - IV), venous stasis ulcers, radiation dermatitis, partial thickness wounds, irritation of the skin, itching, sunburn, foot ulcers, post-surgical incision, surgical sites (including soft tissue graft sites), cuts and abrasions, skin condition associated periostomy care, irritation and pain following laser resurfacing treatment and dermabrasion therapy, chemical peels, and tattooing procedures.
This product is appropriate for all patient populations.
Components
Table 2: Ingredient List shows the ingredients in SI/MC and their functions in the formula. All or some of these ingredients are used. This information is confidential and proprietary.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 9 2009
McMerlin Dental Products, LP % Aaron Hendershott, RAC Director of Regulatory Affairs 1610 West Polo Road Grand Prairie, Texas 75052
Re: K090092
Trade/Device Name: Sockit!® Dermal Wound Gel (Hydrogel Wound Dressing) McMerlin® Dermal Wound Gel (Hydrogel Wound Dressing)
Regulatory Class: Unclassified Product Code: FRO Dated: May 11, 2009 Received: May 11, 2009
Dear Mr. Hendershott:
This letter corrects our substantially equivalent letter of May 11, 2009.
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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Aaron Hendershott, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Жилиий П. Саук
FOR Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known)
510(k) Number (if known): K010092
Device Names:
Socklt!® Dermal Wound Gel (Hydrogel Wound Dressing) McMerlin® Dermal Wound Gel (Hydrogel Wound Dressing)
Indications for Use:
This product provides for the management of and relieves the pain associated with all types of dermal wounds, skin sores, injuries and ulcers of the skin. Examples include:
- · All types of dermal wounds, skin sores, injuries and ulcers of the skin
- · First & Second degree burns
- · Pressure ulcers, stages I IV
- · Stasis ulcers
- · Diabetic ulcers
- · Radiation dermatitis
- Post-surgical incision
- · Surgical sites, including soft tissue graft sites
- · Foot ulcers
- Venous stasis ulcers
- Cuts & Abrasions
- · Partial thickness wounds
- · Irritation of the skin
- · Itching
- · Sunbum
- · Skin condition associated periostomy care
- · Chemical peel
- · Tattooing procedures
- · Irritation and pain following skin Laser resurfacing treatment
- · Irritation and pain following dermabrasion therapy
Prescription Use × (Part 21 CFR 801 Subpart D) And/Or Over-The-Counter-Use (21 CFR 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane la mxm
(Division Sign-C Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K090092
McMerlin® Dental Products, LP · 1610 West Polo Road · Grand Praine, TX 75052 Telephone: 972.602.3746 · Fax: 972.602.9185
6
Indications for Use
510(k) Number (if known): K090092
Device Names:
Socklt!® Dermal Wound Gel (Hydrogel Wound Dressing) McMerlin® Dermal Wound Gel (Hydrogel Wound Dressing)
Indications for Use:
This product provides for the management of and relieves the pain associated with all minor dermal wounds, minor skin sores, minor injuries and minor irritations of the skin. Examples include:
- Minor burns
- Minor Cuts & Abrasions
- · Superficial itching
- · Sunburn
- · Minor burns from a chemical peel treatment
- · Minor irritation and pain following tattooing procedures
- · Minor irritation and pain following skin laser resurfacing treatment
- · Minor irritation and pain following dermabrasion therapy
Prescription Use (Part 21 CFR 801 Subpart D) And/Or Over-The-Counter-Use × (21 CFR 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| David Kmore fer MXm | |
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices |
510(k) Number: K090092