WHF-324 (POWER-Q1000 PLUS) is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema. Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Device Description

WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration.pressure, cvcle time and gradient setting. Power unit features visual operation statusand fault indicators.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS))". This notification seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the document does not contain details about specific acceptance criteria, a standalone study proving the device meets those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on establishing substantial equivalence based on intended use, technological characteristics, and performance characteristics (though these are broadly stated as adherence to international standards rather than specific device performance metrics).

Therefore, I cannot provide the requested information regarding detailed acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop study results. The document primarily highlights compliance with general medical device standards.

However, I can extract the information that is present regarding the device's regulatory pathway and the nature of the submitted evidence:

Here's a breakdown of what the document does provide in relation to your questions, and where it lacks the requested information:

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

Acceptance Criteria: Not explicitly stated as specific performance thresholds for the device itself (e.g., pressure accuracy within X mmHg, cycle time deviation within Y seconds). The document establishes "substantial equivalence" as the primary acceptance criterion for regulatory clearance.
Reported Device Performance: Not reported in terms of specific, quantifiable device performance metrics (e.g., pressure output, cycle duration, gradient range, accuracy). Instead, the document states: "WONJIN MULSAN Co., Ltd. that Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) has conducted and applied by standard of..." followed by a list of general medical device and quality management standards (e.g., Council Directive 93/42/EEC, IEC 60601-1, ISO 13485:2003, ISO 14971:2007). This indicates that the device's performance is deemed acceptable because it complies with these recognized standards for safety, quality, and electrical compatibility, rather than through specific performance tests against proprietary acceptance criteria.

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

Not Applicable. The document does not describe a "test set" for performance evaluation in the way you might expect for an AI or diagnostic device. The evaluation is based on demonstrating compliance with standards and substantial equivalence to a predicate device, not on clinical performance data from a specific patient cohort. The mention of "bench as well as laboratory testing to applicable standards" suggests internal engineering and safety tests, not a clinical test set.

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. As no clinical "test set" is described for performance evaluation, there is no mention of experts or ground truth establishment in this context.

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

Not Applicable. No clinical test set.

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 "Powered Inflatable Tube Massager," not an AI diagnostic or assistive device for human readers. It has no AI component, and thus no MRMC study would be relevant.

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

Not Applicable. This device is hardware for physical therapy; it does not involve algorithms or human-in-the-loop performance in the context of AI.

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

Not Applicable. No clinical ground truth is discussed in relation to device performance. The "ground truth" for regulatory clearance is the established predicate device and compliance with international safety and performance standards.

8. The sample size for the training set

Not Applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

Not Applicable. No training set.

Summary

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K100656

MAY 2 6 2010

510(K) SUMMARY

[as required by 807.92(c)]

A. 510k Number:

B. Applicant:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Company name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Contact person: Mr Brandon Choi Phone: 714-523-1592 Fax: 714-523-1592

C. Proprietary and Established Names: WONJIN MULSAN Co., Ltd Address: 10B-7L 623-6 Namchon-dong, Namdong-gu Incheon, Korea

D. Requlatory Information

1. Classification Name: Massager, Powered Inflatable Tube
Common / Usual Name: Powered Inflatable Tube Massager 2.
ဒေ Proprietary Name: Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS))
ধ, Classification / Product Code: Class II / IRP (21 CFR 890.5650)

E. Intended Use

F. Device Description

G. Substantial Equivalence Information

1. Predicate Device
- 510(k) number: K080134
- Name: Compressible Limb and Circulation Therapy Systems (WHF-314

(POWER-Q1000))

Classification: 2

2. Comparison with predicate

Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) has substantial equivalent intended use as the-market-cleared WHF-314 (POWER-Q1000) and has substantial equivalent technological and

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performance characteristics.

After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of WONJIN MULSAN Co., Ltd. that Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns. Consequently, it is clear that it substantially equivalent to the predicate devices

H. Performance Characteristics (If/when applicable)

WONJIN MULSAN Co., Ltd. that Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) has conducted and applied by standard of

· Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
· IEC 980:2003, Graphical symbols for use in the labeling of medical devices
· IEC1041:1998, Information supplied by the manufacturer with medical devices
· ISO 13485:2003, Medical devices Quality management systems -Requirements for regulatory purposes
· ISO 14155-1:2003, Clinical investigation of medical devices for human subjects - Part 1: General requirements
· ISO 14971:2007, Medical devices Application of risk management to medical devices
· IEC 60601-1 Medical electrical equipment Part 1:General requirements for safety (IEC 60601-1:1988/A1:91/A2:95)
· IEC 60601-2-10:2000/A1:01, Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-1-2:2001/A1:2006, Medical electrical equipment Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -

Requirements and tests

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle or other bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

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

MAY 2 5 2010

Wonjin Mulsan Co., Ltd. % Pats Corporation Mr. Brandon Choi 49 Candlewood Way Buena Park, California 90621

Re: K100656

Trade/Device Name: Compressible Limb Therapy System (WHF-324 (POWER-01000 PLUS)) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP Dated: May 1, 2010 Received: May 6, 2010

Dear Mr. Choi:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Brandon Choi

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. 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):

Device Name: Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS))

Indications For Use: WHF-324 (POWER-Q1000 PLUS) is intended for use by WHF-324 (r OWEN & 1000 P & 000) at home, who are under medical professionals and pullomany conditions, such as :
medical supervision, in treating many conditions, and enort medical supervision, in themaling trauma and sport Philialy lymphedema, Edema, Venous insufficiencies, Lymphedema.

× Prescription Use _ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K.100656

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).