(114 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a wound dressing, with no mention of AI or ML technologies.
No.
A therapeutic device is one that treats a disease or condition. This device is a wound dressing for temporary management of wounds, which is a supportive, rather than therapeutic function.
No
The device is described as a wound dressing for temporary management of oral surgical wounds, not for diagnosing medical conditions.
No
The device description clearly states it is a physical wound dressing made from biocompatible regenerated cellulose, not software.
Based on the provided information, the SUNTOUCH® Dental Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a wound dressing for oral surgical wounds and extraction sites. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the material (dissolving, forming a barrier, adhering to the wound) and its function in protecting and managing the wound. It does not describe any process of analyzing a biological sample to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or any other biological sample to detect a disease, condition, or state.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and local reaction/absorption time, which are relevant to a wound dressing, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The SUNTOUCH® Dental Dressing's function is to physically protect and manage a wound, which falls under the category of a therapeutic or wound care device.
N/A
Intended Use / Indications for Use
SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative and traumatic injuries.
Product codes (comma separated list FDA assigned to the subject device)
MGO
Device Description
SUNTOUCH® Dental Dressing is made from biocompatible regenerated cellulose, chemically treated to become water-soluble, contains no chemical additives. Upon contact with moist oral wound, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation. SUNTOUCH® Dental Dressing dissolves in a few days and is safe if swallowed. Excess dressing material may be removed by rinsing with sterile water or saline solution.
The dressings are sterilized with Sterility Assurance Level (SAL) of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral surgical wounds
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)
The performance tests between proposed device and predicate device were conducted to evaluate the properties of the proposed and predicate device. The following parameters were monitored: Water absorbency, Gelation time, Weight per unit area, Content of sodium (USP Carboxymethylcellulose Sodium), Degree of polymerization (ASTM D 1795), Heavy metals (USP ), Chloride, pH value (USP ), Degree of etherification (ASTM D 1439) and Adhesion force. The results showed that the proposed and predicate device were substantially equivalent.
SUNTOUCH® Dental Dressing was evaluated in a porcine (minipig) model to evaluate the local reaction and absorption time as compared to predicate device. The results showed that the proposed and predicate device were substantially equivalent.
The biocompatibility testing was conducted to confirm the safe performance of SUNTOUCH® Dental Dressing. The biocompatibility tests (Table 5.2) were conducted following procedures outlined in the respective consensus standards, and the results met all relevant requirements in the test standards.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang Development Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, 516005 Cn
January 24, 2018
Re: K173196
Trade/Device Name: SUNTOUCH Dental Dressing Regulatory Class: Unclassified Product Code: MGO Dated: September 29, 2017 Received: October 2, 2017
Dear Junfeng Zhang:
We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173196
Device Name SUNTOUCH® Dental Dressing
Indications for Use (Describe)
SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative and traumatic injuries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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510(k) Summary
510(K) Number (if known): K173196
1. Submitter Identification:
Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China. Establishment Registration Number: 3007735241 Contact Person: Junfeng Zhang Position: Development Engineer Tel: +86-0752-5302186 Fax: +86-0752-5302020 Email: jfzhang@foryougroup.com Summary day: 01/24/2018
2. Subject Device Identification:
Type of 510(k) submission: Traditional Trade Name: SUNTOUCH® Dental Dressing Common Name: Dental Dressing Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Product Code: MGQ Regulation Number: Unclassified Review Panel: General & Plastic Surgery
3. Primary Predicate Device Identification
510(k) Number: K090612 Product Name: Benacel® Dental Dressing
4
Manufacturer: Unicare Biomedical, Inc.
4. Device Description
SUNTOUCH® Dental Dressing is made from biocompatible regenerated cellulose, chemically treated to become water-soluble, contains no chemical additives. Upon contact with moist oral wound, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation. SUNTOUCH® Dental Dressing dissolves in a few days and is safe if swallowed. Excess dressing material may be removed by rinsing with sterile water or saline solution.
The dressings are sterilized with Sterility Assurance Level (SAL) of 10-6.
5. Intended Use Statement
SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative and traumatic injuries.
6. Comparison to Predicate Device
SUNTOUCH® Dental Dressing is compared with the following Predicate Device in terms of intended use, design, material, size, structure, performance test, biocompatibility test and animal test.
510(k) Number: K090612 Product Name: Benacel® Dental Dressing Manufacturer: Unicare Biomedical, Inc
The following table (Table 5.1) shows similarities and differences of technology characteristics between proposed device and predicate device.
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| Item | Proposed Device | Predicate Device (K090612) |
|---|---|---|
| Indication | ||
| for Use | SUNTOUCH® Dental | |
| Dressing is intended for | ||
| use as a wound dressing | ||
| in extraction sites, and | ||
| may be used as a wound | ||
| dressing for the | ||
| temporary management | ||
| of oral surgical wounds, | ||
| such as operative, | ||
| postoperative and | ||
| traumatic injuries. | Benacel® Dental Dressing is | |
| intended for use as a wound | ||
| dressing in extraction sites | ||
| and the management of alveolar | ||
| osteitis (dry socket) and may be | ||
| used as a wound | ||
| dressing for the temporary | ||
| management of oral surgical | ||
| wounds, such as operative, | ||
| postoperative, donor sites, and | ||
| traumatic injuries. Benacel® Dental | ||
| Dressing may also be used as a | ||
| wound dressing for the | ||
| management and protection of oral | ||
| lesions, including sores, ulcers, and | ||
| injuries, such as cuts, lacerations | ||
| and abrasions of the oral mucosa. | ||
| Prescription/ | ||
| OTC | Prescription | Prescription |
| Mechanism | When contact with moist | |
| oral mucosa, the | ||
| material dissolves and | ||
| transforms into a | ||
| gelatinous material. By | ||
| applying gentle pressure | ||
| at this time, the material | ||
| will adhere to the wound | ||
| and form a barrier, | ||
| protecting the wound | ||
| from further irritation and | ||
| pain. | When contact with moist oral | |
| mucosa, the material dissolves and | ||
| transforms into a gelatinous | ||
| material. By applying gentle | ||
| pressure at this time, the material | ||
| will adhere to the wound and form | ||
| a barrier, protecting the wound | ||
| from further irritation and pain. | ||
| Material | Regenerated cellulose | Regenerated cellulose |
| Size | $5mm×7mm$ (plug), | |
| $6mm×8mm$ (plug), | ||
| $11mm×11mm$ (pack), | ||
| $15mm×15mm$ (pack), | ||
| $19mm×19mm$ (pack), | ||
| $30mm×30mm$ (sheet) | $5mm × 7mm$ (plug), | |
| $6mm×8mm$ (plug), | ||
| $15mm × 15mm$ (sheet), | ||
| $50mm × 50mm$ (sheet) | ||
| Structure | Textile | textile |
| Fabric Type | Knitted Fabric | Woven Fabric |
| Single Use | Yes | Yes |
| Sterilization | Radiation | Radiation |
Table 5.1 Comparison of Technology Characteristics of Proposed and Predicate Device
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The indication for use of proposed device is included in that of predicate device, therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device.
The proposed device has more size specifications than that of predicate device. The size will not affect the function and performance of the product. And more size will give user more choice per wound area. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device.
The fabric type of the proposed is knitted fabric, and the fabric type of the predicate device is woven fabric. But the different of fabric type do not affect the safe and effective performance.
SUNTOUCH® Dental Dressing and its predicate device are both made from regenerated cellulose, and utilize the same mechanism. They are both indicated for protecting the oral wound.
We recorded the infrared spectra of SUNTOUCH® Dental Dressing and Benacel® Dental Dressing. The almost identical spectra indicated both devices are very similar in chemical structure.
The performance tests between proposed device and predicate device were conducted to evaluate the properties of the proposed and predicate device. The following parameters were monitored: Water absorbency, Gelation time, Weight per unit area, Content of sodium (USP Carboxymethylcellulose Sodium), Degree of polymerization (ASTM D 1795), Heavy metals (USP ), Chloride, pH value (USP ), Degree of etherification (ASTM D
7
- and Adhesion force. The results showed that the proposed and predicate device were substantially equivalent.
SUNTOUCH® Dental Dressing was evaluated in a porcine (minipig) model to evaluate the local reaction and absorption time as compared to predicate device. The results showed that the proposed and predicate device were substantially equivalent.
The biocompatibility testing was conducted to confirm the safe performance of SUNTOUCH® Dental Dressing. The biocompatibility tests (Table 5.2) were conducted following procedures outlined in the respective consensus standards, and the results met all relevant requirements in the test standards.
| Description | proposed device | |
|---|---|---|
| Ames | ||
| In vitro Mammalian Chromosome | ||
| Aberration | No Toxic Effect | |
| (ISO 10993-3) | ||
| In Vivo Mammalian Erythrocyte | ||
| Micronucleus | ||
| Cytotoxicity | No Toxic Effect | |
| (ISO10993-5) | ||
| Subcutaneous implantation | No Effect (ISO 10993-6) | |
| Skin Sensitization | ||
| Intracutaneous Reactivity | No Effect (ISO 10993-10) | |
| Oral Mucosa Irritation | ||
| Acute Systematic Toxicity | No Effect (ISO 10993-11) | |
| Pyrogenicity | No Effect (ISO 10993-11) | |
| Subacute Systematic Toxicity | No Effect (ISO 10993-11) |
Table 5.2 Biocompatibility Test
7. Substantial Equivalent Statement
Based on the comparisons of intended use, design, materials, size, structure, performance test, animal test and biocompatibility test.
8
SUNTOUCH® Dental Dressing is substantial equivalent to its predicate device.