The Verseo Air Pressure Massager is intended to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to the treated areas. The Verseo Air Pressure Massager simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Device Description

The Verseo Air Pressure Leg Massager is an inflatable cuff that wraps around the lower leg and is secured by a Velcro strap, operated via AA battery-powered electronic touch-pad controller with colored LED's denoting pressure increase, decrease and automatic massage function.

AI/ML Overview

The provided text describes a 510(k) submission for the "Verseo Air Pressure Leg Massager," a Class II powered inflatable tube massager. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with acceptance criteria and performance data in the typical sense for a diagnostic or treatment efficacy device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there is no explicit table of acceptance criteria or reported device performance for a clinical study. The submission emphasizes compliance with performance standards for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act, and the fact that "All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks." This refers to safety and electrical standards, not the clinical effectiveness or performance in terms of patient outcomes.

The "Indications for Use" section states: "The Verseo Air Pressure Massager is intended to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to the treated areas." The acceptance criteria would presumably relate to achieving these temporary effects, but no clinical study demonstrating these effects with specific metrics is detailed.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "Does the submission include clinical information? NO." Therefore, there is no test set, sample size, or data provenance related to a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical study was conducted or presented, no experts were used to establish ground truth for a test set. The device's safety and effectiveness are supported by its substantial equivalence to predicate devices and adherence to general electrical/safety standards.

4. Adjudication Method:

As no clinical study or test set is described, there is no information on an adjudication method.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed. The device is a massager, not a diagnostic tool where reader performance would be a primary concern. The submission focuses on device safety and equivalence.

6. Standalone Performance Study:

No standalone performance study (algorithm only performance, without human-in-the-loop) was conducted or presented. This device is a physical massager and does not involve an algorithm in the sense of AI or image analysis.

7. Type of Ground Truth Used:

Since no clinical study was performed, there is no mention of ground truth established through expert consensus, pathology, or outcomes data for the purpose of evaluating the device's stated indications for use (relief of minor muscle aches and pains, increased circulation). The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices.

8. Sample Size for the Training Set:

No training set is mentioned or applicable as no clinical performance study or AI algorithm development is described.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as no training set was used.

Summary of Device Acceptance and Study Limitations based on the K092435 Submission:

This 510(k) submission for the Verseo Air Pressure Leg Massager relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. The pathway for approval here does not mandate the conduct of a new clinical study to prove the device's efficacy in relieving minor muscle aches and pains or increasing circulation.

Instead, the acceptance criteria are implicitly met by:

Compliance with performance standards: "These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act." This likely refers to electrical safety and mechanical integrity standards.
OSHA/NRTL listing and constituent marks: Indicating adherence to recognized safety standards for electrical and radiological products.
Demonstrated safety and effectiveness of predicate devices: The core argument for substantial equivalence is that if the predicate devices are safe and effective for the stated indications, and the new device is substantially similar in technology and intended use, then it too can be considered safe and effective.

The submission explicitly states that no clinical information (i.e., a clinical study with detailed performance data) was included. Therefore, the questions regarding sample sizes, ground truth establishment, expert qualifications, and adjudication methods for a clinical study are not addressed by this document.

Summary

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K092435-

510(k) Summary

MAR - 9 2010

K Submission Date: August 4th, 2009

1. Submitter Information: AEGIS Regulatory, Inc. Robert T. Wagner 1131 Anthem View Lane Knoxville, TN 37922 Tel.: 865-982-5552 Email: bob@fdalistingconsultants.com
  For Manufacturer: King Tai Holdings Ltd. Attn: Mr. Li Shek King No. 26 Gongie Industrial Zone Xixiang Road, BoAn District Shenzhen, China Tel.: (01186) 755 279 11430

2. General Information

2.1 Classification Name: IRP - Powered Inflatable Tube Massager
Common/Usual Name: Inflatable Leg Massager 2.2
2.3 Proprietary Names: Verseo Air Pressure Leg Massager
2.4 Classification: Class II
2.5 Classification Number: 890,5650

3. Description:

4. Intended Use:

The Verseo Air Pressure Massager is intended Indications for Use: to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to the treated areas. The Verseo Air Pressure Massager simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

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5. Substantial Equivalence to Predicate Device(s):

This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce:

1. K040905 Wellness/Jolivette (Tohkai Precision Ind. Ltd.)
1. K030437 Relaxor Perfect ... (Salton, Inc.)
1. K071596 Portable Air Mass ... (Nihon Seimitsu Sokki Co. Ltd.)

6. Performance Standards:

These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks.

7. Labeling:

As appear in the User's Manuals and on the device itself -- Numerous technical warnings and advisements to insure proper use and maintenance.

Statement of Safety and Effectiveness: 8.

The information in this 510(k) submission was used to support the safety and effectiveness of this device with respect to its cited predicates.

9. Over-The-Counter Variance Request:

As identical predicates of this device have been in safe and effective applications by layperson users, Over-The-Counter Variance is requested.

10. Design and Use of the Device(s):

Is the device intended for prescription use?	NO
Is the device intended for over-the-counter use?	YES
Are its components derived from a tissue or other biologic source?	NO
Is the device provided sterile?	NO
Is the device intended for single use?	NO
Is the device a reprocessed single use device?	NO
Does the device contain a drug?	NO
Does the device contain a biologic?	NO
Does the device use software?	NO
Does the submission include clinical information?	NO
Is the device implanted?	NO

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight, with three lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

King Tai Holdings Ltd. % AEGIS, Inc. Mr. Robert T. Wagner 1131 Anthem View Lane Knoxville, TN 37922

Re: K092435

Trade/Device Name: Verseo Air Pressure Massager Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: February 22, 2010 Received: March 8, 2010

Dear Mr. Wagner:

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. 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

MAR 0 9 2010

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Page 2 - Mr. Robert T. Wagner

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Malkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092435

Device Name: Verso Leg Massager - Produced by King Tai Holdings Ltd.

Indications For Use:

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

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Kimbly H. Henry FOR Mr. MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K092435

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).