BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) by JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.

Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with over-exertion, strains, sprains, arthritis, stiffness, and muscle spasm.

Temporarily relieves minor menstrual pain.

Temporarily increases local blood circulation.

Device Description

BENGAY™ Heat Therapy is a disposable, single-use, airactivated pain relieving patch which adheres to the skin by means of a hydrogel adhesive and generates heat by the oxidation of iron powder.

The device consists of 6 components:

Oxygen-impermeable, primary packaging; .
. Breathable fabric sachet containing the heating element mixture;
Heating element mixture; .
Backing sheet which separates the heating element . mixture from the hydrogel layer;
. Hydrogel layer to provide adhesion to the skin surface; and,
Release liner to protect the adhesive hydrogel laver . prior to consumer use

When the air-tight, protective packaging is opened, the heating element mixture reacts with oxygen in the air, and the patch begins to warm up. It takes up to 30 minutes for the patch to reach its target temperature range. The patch stays warm for at least 8 hours.

BENGA Y™ Heat Therapy reaches its target temperature range in 30 minutes or less, and remains in this temperature range for a minimum of 8 hours.

BENGAY™ Heat Therapy provides moist heat as demonstrated by user perception and laboratory experiments.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (BENGAY™ Heat Therapy heat patch) and an FDA clearance letter. It is not a study report or clinical trial document that would typically include detailed acceptance criteria tables and performance metrics for an AI/algorithmic device. The information requested (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is standard for AI/ML device evaluations, but is not present in this type of regulatory submission for a heat therapy patch.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will answer based on the information that is present, noting where information is missing or not applicable to this type of device.

Acceptance Criteria and Device Performance for BENGAY™ Heat Therapy

This submission is for a heating patch, not an AI/ML device. Therefore, the "acceptance criteria" and "device performance" are focused on the physical characteristics, safety, and functionality of the heat patch itself, rather than diagnostic accuracy or algorithmic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional/Safety)	Reported Device Performance
Heat Generation & Duration:
Reaches target temperature range	Reaches target temperature range in 30 minutes or less.
Time to reach target temperature	30 minutes or less.
Stays warm for a minimum duration	Stays warm for a minimum of 8 hours.
Moist Heat Delivery:
Provides moist heat therapy	Demonstrated by user perception and laboratory experiments.
Safety - Biocompatibility:
Safe for body contact surface	Demonstrated by relevant biocompatibility testing (in vitro cytotoxicity, sensitization, dermal irritation studies).
Safety - Clinical (Skin effects):
Low potential for cumulative irritation	Demonstrated in a clinical study comparing with predicate device.
Low potential for thermal-related injury	Demonstrated in a clinical study comparing with predicate device.
Acceptable change in skin surface temperature	Demonstrated in a clinical study comparing with predicate device.

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

Test Set Sample Size: Not explicitly stated for any of the studies mentioned (clinical safety study, biocompatibility tests, or moist heat demonstration studies).
Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the studies were conducted by Johnson & Johnson Consumer Products Company, likely in the US, but this is not confirmed.
Retrospective or Prospective: The clinical safety study suggests a prospective design (comparing BENGAY™ Heat Therapy with the predicate device). Biocompatibility and laboratory experiments are typically prospective.

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

Not applicable/mentioned. This device is not an AI/ML diagnostic system where expert-established ground truth is typically required for evaluation. The "ground truth" for this device relates to physical properties (temperature, duration) and biological responses (skin irritation, circulation), which are measured objectively or through clinical observation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/mentioned. Adjudication methods are typically relevant for resolving disagreements among multiple human readers/experts in diagnostic imaging or clinical assessment, which is not the context for this device.

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:

No. This is not an AI-assisted device, so MRMC studies are not applicable.

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

Not applicable. This is a physical heat patch, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Moist heat: User perception and laboratory experiments.
Biocompatibility: Results from standardized in vitro and dermal irritation studies.
Clinical Safety (irritation, thermal injury, skin temperature): Direct clinical observation, measurements of skin temperature, and assessment of skin reactions by medical professionals involved in the clinical study.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for a machine learning model.

Summary

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KO7/7/0

BENGAY™ Heat Therapy -- 510(k) Notification Amendment - August 6, 2007

5.0 510(k) SUMMARY

Date Prepared:

August 6, 2007

Applicant:

Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 201 Tabor Rd. Morris Plains, NJ 07950 Telephone: 973-385-4619 Fax: 973-385-4300

Contact Person:

Proprietary Name: Common Name:

Classification Name: Product Code:

Predicate Device:

Description:

Intended Use:

Dagmar Oette, MD, JD Director, Global Regulatory Affairs

BENGAY™ Heat Therapy Heat Patch/Pad/Wrap; Air-Activated Heat Patch/Pad/Wrap; Pain Relieving Heat Patch/Pad/Wrap Pack, Hot or Cold, Disposable IMD

ThermaCare® Heat Wrap (various) K953442 Procter & Gamble Co. 1 Procter & Gamble Plaza Cincinnati, OH 45202

BENGAY™ Heat Therapy is a disposable, single-use, airactivated pain relieving patch which adheres to the skin by means of a hydrogel adhesive and generates heat by the oxidation of iron powder.

Is intended for over-the-counter (non-prescription) use by the consumer.

Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with overexertion, strains, sprains, arthritis, stiffness, and muscle spasm.

Temporarily relieves minor menstrual pain.

Temporarily increases local blood circulation.

AUG 1 4 2007

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Technological Characteristics:

The device consists of 6 components:

Oxygen-impermeable, primary packaging; .
. Breathable fabric sachet containing the heating element mixture;
Heating element mixture; .
Backing sheet which separates the heating element . mixture from the hydrogel layer;
. Hydrogel layer to provide adhesion to the skin surface; and,
Release liner to protect the adhesive hydrogel laver . prior to consumer use

BENGA Y™ Heat Therapy reaches its target temperature range in 30 minutes or less, and remains in this temperature range for a minimum of 8 hours.

BENGAY™ Heat Therapy provides moist heat as demonstrated by user perception and laboratory experiments.

The safety (potential for cumulative irritation and thermalrelated injury; and, change in skin surface temperature) of BENGAY™ Heat Therapy was demonstrated in a clinical study that compared BENGAY™ Heat Therapy with the predicate device.

Based on the results of relevant biocompatibility testing (in vitro cytotoxicity; sensitization; and, dermal irritation studies), the final product is safe for use as a body contact surface medical device.

Performance Data:

Biocompatibility Testing:

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2007

Johnson & Johnson Consumer Products, Inc. % Dagmar Oette, MD, JD Director, Global Regulatory Affairs 201 Tabor Road Morris Plains, New Jersey 07950

Re: K071710

Trade/Device Name: BENGAY® Heat Therapy Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: IMD Dated: June 20, 2007 Received: June 22, 2007

Dear Dr. Oette:

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.

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

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Page 2 - Dagmar Oette, MD, JD

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for Melkerson
Mark Melkerson W.Se. D.ly.

Mark Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.0 INDICATIONS FOR USE STATEMENT

510(k) Number:

K071710

Device Name:

BENGAY™ Heat Therapy

Indications for Use:

Is intended for over-the-counter (non-prescription) use by the consumer.

Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with over-exertion, strains, sprains, arthritis, stiffness, and muscle spasm.

Temporarily relieves minor menstrual pain.

Temporarily increases local blood circulation.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) arrence of CDRH, Office of Device Evaluation (ODE)

Concrete

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K07110
510(k) Number

Prescription Use (Per 21 CFR $801.109)

Over-the-Counter Use

Regulation Number and Section

§ 890.5710 Hot or cold disposable pack.

(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.