K Number

Device Name

Manufacturer

UNICARE BIOMEDICAL

Date Cleared

2009-07-24

(140 days)

Product Code

OLR,MGQ

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

K173196

Intended Use

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.

Device Description

Benacel® Dental Dressing is an absorbable wound dressing made of oxidized regenerated cellulose material. Upon 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. Benacel® Dental Dressing is sterile packaged and supplied in a variety of configurations and sizes.

AI/ML Overview

The provided 510(k) summary for the Benacel® Dental Dressing does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative results to "prove" the device meets acceptance criteria in the manner an AI/ML device would typically be evaluated. This document is for a traditional medical device (wound dressing), and its regulatory pathway focuses on substantial equivalence to predicate devices through in vitro and in vivo testing demonstrating similar performance, rather than complex statistical performance metrics.

Therefore, I cannot populate all the requested fields as they are designed for the evaluation of AI/ML-based medical devices. However, I will extract the relevant information that is present in the document.

Here's a breakdown based on the provided text, and where the requested information is not available for this type of device:

1. Table of acceptance criteria and the reported device performance:

The 510(k) summary states that "In vitro and in vivo tests demonstrate that Benacel® Dental Dressing performs substantially equivalent to predicate devices." This is a general statement rather than specific, quantitative performance against predefined acceptance criteria. The specific results of these tests are not detailed in the provided summary.

2. Sample sized used for the test set and the data provenance:

Not specified in the document. For in vitro and in vivo testing of a physical wound dressing, the "test set" would refer to the number of samples tested or animals/humans included in the in vivo study, and this detail is missing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable or specified. For a physical wound dressing, ground truth is typically established through direct observation of physical properties, biocompatibility, and wound healing in controlled environments (in vitro) or animal/human subjects (in vivo). Expert consensus in the way it's used for AI/ML image interpretation is not relevant here.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human expert performance or resolving discrepancies in AI/ML outputs against ground truth. This is not a human-reader-based interpretation task.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical wound dressing, not an AI/ML-based diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used:

Based on the mention of "in vitro and in vivo tests," the ground truth would likely be based on:

Biocompatibility testing results: (e.g., cytotoxicity, sensitization, irritation)
Physical performance characteristics: (e.g., absorption, adherence, dissolution time)
Wound healing observations: In in vivo models (e.g., rate of healing, reduction in inflammation, pain management efficacy).
Comparison to predicate device performance: The core of 510(k) substantial equivalence.

8. The sample size for the training set:

Not applicable or specified. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary derived from the document:

The Benacel® Dental Dressing is intended for use as an absorbable wound dressing for extraction sites, alveolar osteitis, oral surgical wounds, and oral lesions. The claim for meeting acceptance criteria is through "substantial equivalence" to predicate devices (SaliCept®, "Sock It" oral pain gel, Hemcon®).

The study that proves the device meets the acceptance criteria is described as "in vitro and in vivo tests that demonstrate that Benacel® Dental Dressing performs substantially equivalent to predicate devices."

Key aspects provided by the document:

Predicate Devices: SaliCept®, "Sock It" oral pain gel, Hemcon®
Testing Types: In vitro and in vivo tests.
Performance Claim: Substantially equivalent to predicate devices.

The document does not provide the granular detail requested for AI/ML device studies.

Summary

{0}------------------------------------------------

K0906612

510(K) SUMMARY

JUL 2 4 2009

(As Required by Section 807.92 (c))

1. Submitter

Name: Address: Contact: Date:
Unicare Biomedical, Inc. 22971-B Triton Way, Laguna Hills, CA 92653 Stan Yang, 949-643-6707 March 3, 2009

2. Device Name

Trade Name: Common Name: Classification Name: Device Classification: Benacel® Dental Dressing Wound Dressing Dressing Unclassified

3. Predicate Devices

SaliCept®, "Sock It" oral pain gel, Hemcon®

4. Device Description

5. Intended Use

{1}------------------------------------------------

including sores, ulcers, and injuries, such as cuts, lacerations and abrasions of the oral mucosa.

6. Comparison with Predicate Devices

Benacel® Dental Dressing is substantially equivalent to devices currently in US commercial distribution, including SaliCept®, "Sock It" oral pain gel and Hemcon®, These products are made of biocompatible wound dressing material with similar performance.

7. Device Testing

In vitro and in vivo tests demonstrate that Benacel® Dental Dressing performs substantially equivalent to predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stan Yang Vice President Unicare Biomedical, Incorporated 22971 Triton Way, Unit B Laguna Hills, California 92653

JUL 2 4 2009

Re: K090612

Trade/Device Name: Benacel® Dental Dressing Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MGQ Dated: July 15, 2009 Received: July 21, 2009

Dear Mr. Yang:

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 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.

{3}------------------------------------------------

Page 2- Mr. Yang

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasc go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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,

Shison Puonn

Susan Runner, D.D.S., M.A

Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K090612

510(k) Number (if known): K090612

Benacel® Dental Dressing Device Name: _

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090617

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Regulation Number and Section

N/A