The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.

Device Description

The Acu-Strap™ Travel and Motion Sickness Band product comprises a pair of wristbands, each with a round button added to the interior face of the band. Because the Acu-Strap™ Travel and Motion Sickness Band is stretchable, it will be sold in only one size. The Acu-Strap™ Travel and Motion Sickness Band operates by placing a constant pressure on an acupressure point (the P6 or "Nei-Kuan" point) near the wrist.

AI/ML Overview

This document is a 510(k) summary for the Acu-Strap™ Travel and Motion Sickness Band. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not describe any clinical study with acceptance criteria for device performance.

Here's an analysis of why the requested information cannot be provided from the given document:

1. A table of acceptance criteria and the reported device performance:

The document states: "Acu-Strap™ Travel and Motion Sickness Band has been subjected to testing for dimensions, elasticity, and relative pressure."
It does not provide any specific acceptance criteria for these tests (e.g., "dimension must be X +/- Y mm", "elasticity must be within Z range") nor does it report the results or performance data of these tests.
More importantly, it does not describe any clinical performance study (e.g., efficacy in reducing nausea) with associated acceptance criteria. The 510(k) relies on substantial equivalence to a predicate device, not on demonstrating clinical efficacy through a new study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set for clinical performance is mentioned. The only "tests" referred to are for physical characteristics: "dimensions, elasticity, and relative pressure." No sample sizes for these physical tests are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no clinical test set requiring expert ground truth establishment.

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

Not applicable.

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 not an AI-assisted diagnostic tool and no MRMC study is mentioned.

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

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

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

Not applicable, as no clinical performance study is described.

8. The sample size for the training set:

Not applicable, as no algorithm or machine learning model is being trained.

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

Not applicable.

Conclusion:

The provided 510(k) summary for the Acu-Strap™ Travel and Motion Sickness Band focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics (dimensions, materials, mechanical characteristics) and intended use. It does not include details of a clinical study aimed at proving the device meets specific performance acceptance criteria for its intended clinical effect (nausea relief). Therefore, none of the requested information regarding acceptance criteria or a study proving clinical performance can be extracted from this document. The "performance testing" mentioned refers only to physical properties of the band, not its efficacy in treating nausea.

Summary

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OCT 8 - 2004

510(k) Summary for Acu-Strap™ Travel and Motion Sickness Band K041877

1. SPONSOR

Health Enterprises, Incorporated 90 George Leven Drive North Attleboro, MA 02760 (508) 695-0727

Contact Person: Glenn Leman, Chief Executive Officer

2. DEVICE NAME

Proprietary Name: Acu-Strap Travel and Motion Sickness Band Common/Usual Name: Motion sickness band Classification Information:

Motion sickness bands have not yet been classified by FDA, but have been given the following classification name and product code:

Name	Product Code	21 CFR Ref.	Panel
Acupressure device	MVV	To Be Determined	Neurology

3. PREDICATE DEVICES

Acu-Strap™ Travel and Motion Sickness Band is substantially equivalent to the Sea-Band, 510(k) No. K033268.

4. DEVICE DESCRIPTION

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5. INTENDED USE

The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausca. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Acu-Strap™ Travel and Motion Sickness Band is made of a stretchable fabric material with a hard plastic button that is snapped in place during manufacturing process. It is similar to the predicate device in terms of dimensions, materials, and mechanical characteristics.

7 PERFORMANCE TESTING

Acu-Strap™ Travel and Motion Sickness Band has been subjected to testing for dimensions, elasticity, and relative pressure.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 - 2004

Health Enterprises, Inc. C/o Mr. Daniel J. Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K041877 Trade/Device Name: Acu-Strap™ Travel and Motion Sickness Band Regulatory Name: Acupressure Device Regulatory Class: Unclassified Product Code: MVV Dated: September 20, 2004 Received: September 22, 2004

Dear Mr. Dillon:

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 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.

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Page 2 - Mr. Daniel J. Dillon

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) 276-0120. 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/dsma/dsmamain.html

Sincerely yours.

Mark A. Millmann

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041877

Acu-Strap™ Travel and Motion Sickness Band Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Milkers

Sion-Division of General, Restorative, and Neurological Devices

510(k) Number K041877

Regulation Number and Section

N/A