(93 days)
This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing. Examples of oral lesions include canker sores (aphthous ulcers), tooth extraction sites, oral mucositis, oral stomatic ulcers such is caused by braces and dentures, and irritation and pain following deep tooth scaling.
"Sock It!" Oral Pain Gel is a clear, viscous hydrogel wound dressing composed entirely of foodgrade ingredients including a food-grade preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and will manage the pain associated with all types of injuries to the mouth. 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 protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process. The pH and osmotic pressure of the gel are adjusted to be compatible with saliva.
The provided 510(k) summary for "Sock It!" Oral Pain Gel does not present explicit acceptance criteria or a dedicated study demonstrating the device's performance against such criteria in the manner typically seen in AI/ML device submissions. This document is a premarket notification for a medical device that was submitted in 2006, prior to the widespread adoption of AI/ML in medical devices and the associated regulatory expectations for performance studies.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary assertion is that "Sock It!" Oral Pain Gel is substantially equivalent to existing legally marketed hydrogel oral wound dressings based on its intended use, technological characteristics, and safety profile.
Here's an analysis based on the information provided, formatted to address your questions where possible, and noting where information is not available due to the nature of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as implied by substantial equivalence) |
|---|---|
| No explicit, quantitative acceptance criteria related to specific performance metrics (e.g., sensitivity, specificity, pain reduction score thresholds) are stated. | The device manages pain in various oral wounds, adheres to oral tissue, forms a protective barrier, and provides a moist wound environment. |
| Safe if swallowed (composed of food-grade ingredients). | |
| Physiologically compatible with intact and compromised tissue. | |
| pH and osmotic pressure adjusted to be compatible with saliva. | |
| Substantially equivalent in design and intended use to predicate devices: K933741, K953423, K964852, K983182, K012126. |
Explanation: The document does not define specific, measurable acceptance criteria in terms of clinical efficacy or quantitative performance metrics. Its acceptance by the FDA is based on demonstrating that it is substantially equivalent to predicate devices that are already on the market. This framework implies that if the new device has the same intended use and similar technological characteristics to a legally marketed device, and does not raise new questions of safety or effectiveness, it can be marketed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not provided. This submission does not describe a clinical performance study with a distinct "test set" as understood in AI/ML evaluations. The equivalency claim is based on the device's formulation and mechanism of action being similar to predicate devices.
- Data Provenance: Not applicable. There is no specific data provenance described for a performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There was no explicit "ground truth" establishment for a test set in the context of a performance study described in this 510(k) summary. The "ground truth" for the predicate devices' effectiveness would have been established through their initial regulatory pathways and clinical use.
4. Adjudication Method for the Test Set
- Not applicable. No performance study with adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Not applicable. This is not an AI/ML device, and no MRMC study is mentioned. The submission focuses on substantial equivalence, not on comparative effectiveness with human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a physical hydrogel product, not an algorithm.
7. The Type of Ground Truth Used
- Type of "Ground Truth" (Implicit): The "ground truth" here is implicitly derived from the established safety and effectiveness of the existing predicate devices through their prior regulatory clearances and clinical experience. The claim is that "Sock It!" offers the same performance (pain management, protective barrier, moist environment) as these already approved devices due to its similar mechanism and composition.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The development likely involved formulation and in-vitro testing to ensure physical properties and safety, but not an AI-specific training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no AI/ML training set, there's no ground truth establishment for it.
Summary of the Study (or lack thereof) Proving Acceptance:
The submission for "Sock It!" Oral Pain Gel does not outline a specific study designed to meet quantitative acceptance criteria. Instead, the "proof" the device meets acceptance criteria ("intended use" and "technological characteristics") is established through the argument of substantial equivalence to already approved predicate devices.
The submission highlights:
- Intended Use: The indications for use are "the same as these for the predicate devices."
- Technological Characteristics: The device is a hydrogel wound dressing, similar to predicate devices, and its primary mode of action (adhering, forming a protective barrier, creating a moist environment) is the same. The only difference noted is the method of hydration (factory-hydrated vs. user-hydrated or saliva-hydrated). The submission argues this difference is "non-substantial" and does not alter the fundamental safety or effectiveness.
Therefore, the "study" demonstrating acceptance is essentially the comparison to predicate devices and the argument that the differences do not introduce new questions of safety or effectiveness. The FDA's issuance of the 510(k) clearance confirms their agreement that substantial equivalence was demonstrated.
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063148
510(k) SUMMARY
DATE PREPARED
13 October 2006
SUBMITTER
JAN 1 7 2007
Eileen Vennum, RAC President McMerlin Dental Company 1610 W. Polo Road, Suite A Grand Prairie, TX 75052 Telephone: 972.602.3746
DEVICE NAME
| Common name: | Hydrogel Oral Wound Dressing |
|---|---|
| Trade name: | "Sock It!" Oral Pain Gel |
| Classification name: | This device is unclassified under 21CFR Parts 862-892. |
PREDICATE DEVICES
K933741 Carrasyn Oral Wound Dressing (marketed as "OraPatch") K953423 Carrasyn Oral Wound Dressing (inarketed as "OraPatch"" and OraBan"Mr") K964852 RadiaCare Oral Wound Rinse (marketed as "SaliCept™ Oral Stomatitis Rinse" ) K983182 Caraloe Oral Rinse (marketed as "Carrington Oral Wound Rinse"May K012126 Salicept Oral Patch (marketed as SaliCept™ Freeze Dried Gel [FDG])
DEVICE DESCRIPTION
"Sock It!" Oral Pain Gel is a clear, viscous hydrogel wound dressing composed entirely of foodgrade ingredients including a food-grade preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and will manage the pain associated with all types of injuries to the mouth.
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 protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process. The pH and osmotic pressure of the gel are adjusted to be compatible with saliva.
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INTENDED USE
The indications for "Sock It!" Gel are the same as these for the predicate devices. This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing. Examples of oral lesions include canker sores (aphthous ulcers), tooth extraction sites, oral mucositis, oral stomatic ulcers such is caused by braces and dentures, and irritation and pain following deep tooth scaling.
This product is appropriate for all patient populations.
TECHNOLOGICAL CHARACTERISTICS
Three 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 an oral wound, where it re-hydrates to a hydrogel the ough contact with saliva. Two of the predicate devices are hydrogel wound dressings that have been freeze-dried to produce a powder, These are re-hydrated by the consumer who adds water at the time of use. The resulting thin hydrogel is swished around inside the mouth to coat the oral mucosa. All five of these predicate hydrogels provide pain relief by coating damaged mucosa and protecting it from further contamination and irritation. [Note: All five predicate devices are predicated upon Carrington Laboratories' hydrogel wound dressing (K902345) that, like "Sock It!" Gel, is hydrated at the factory and sold in a tube as a hydrated gel.]
Rather than use saliva to re-hydroge! "handage" in the mouth or rely on the consumer to add the correct amount of water to re-hydrate the powdered hydrogel immediately prior to use. "Sock It!" hydrogel is hydrated during manufacture and sold in a tube in the traditional hydrated gel form.
The non-substantial difference in design between "Sock It!" gel and the five predicate devices is the time and manner in which water is incorporated into the hydrogel- I) in the mouth with saliva, 2) by the consumer in the container immediately prior to use, or 3) at the factory prior to filling the tube. 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 natural mucosa. All these hydrogel barriers manage pain by protecting the wound from contamination and irritation. They all slowly dissolve in the mouth, and all are safe if swallowed.
"Sock It!" Oral Pain 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.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 17 2007
Ms. Eileen Vennum President Merlin Group DBA McMerlin Dental Company 1610 West Polo Road, Suite A Grand Prairie, Texas 75052
Re: K063148
Trade/Device Name: "Sock It!"™ Oral Pain Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: January 5, 2007 Received: January 8, 2007
Dear Ms. Vennum:
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.
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Page 2 - Ms. Vennum
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 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.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snotte y. Michain Omd.
Chiu Lin, Ph.D. Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE (PROFESSIONAL)
510(k) Number (if known): K063148 Device Name: "Sock It!" Oral Pain Gel (hydrogel oral wound dressing) This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing.
Manages pain of, for example;
- All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa -
- -Canker sores and cold sores
- Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
- Soft tissue pain from orthodontics -
- ~ Aphthous ulcers
- -Extraction site pain
- Oral mucositis and stomatitis -
- Irritation and pain following tooth scaling and prophylaxis -
AND/OR Over-The-Counter Use Prescription Use x (21 CFR 801 Subpart C) (21 CFR 801 Subpart D)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Susan Chase
Jun-Dir) on of Anesthesiology, General Hospitzl, ion Control. Dental Device
xx63148
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INDICATIONS FOR USE (OTC)
K063148 510(k) Number (if known): 510(K) Name: "Sock It!"M" Oral Pain Gel (hydrogel oral wound dressing) Dovice Name. " Book It. " Olar Pull. Os of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing.
Manages pain of, for example:
- All types of oral wounds, mouth sores, injuries and ulcers of the mouth a
- Canker sores and cold sores -
- Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
- -Aphthous ulcers
- Irritation and discomfort from ill-fitting demures -
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ メ (21 CFR 801 Subpart C) (21 CFR 801 Subpart D)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 2
N/A