LX7(V7) 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

LX7(V7) is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle 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 called the "Compressible Limb Therapy System LX7(V7)". This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints. Therefore, a direct table of acceptance criteria and reported device performance, as typically seen in efficacy studies, is not applicable or present in this document.

The core of this submission is a comparison of the new device (LX7(V7)) to two predicate devices (Lympha Press Plus and WHF-324 (POWER-Q1000 Plus)) to demonstrate that it is "as safe and effective". The "Performance Characteristics" section lists various standards the device applied and conducted tests to, which are related to safety and quality management, but it does not detail specific performance metrics or their acceptance thresholds.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not present quantitative acceptance criteria or numerical performance data of the LX7(V7) in the way one would expect from an efficacy study. Instead, substantial equivalence is established by comparing the new device's features, intended use, and adherence to safety standards with those of legally marketed predicate devices.

The table below summarizes the comparison between the LX7(V7) and its predicate devices, which serves as the basis for the substantial equivalence determination rather than a direct performance acceptance criteria table.

Feature	LX7(V7)	Lympha Press Plus (Predicate 1)	WHF-324 (POWER-Q1000 Plus) (Predicate 2)
K Number	None yet (being applied for)	K013331	K100656
Classification	Class II Device / IRP (21 CFR 890.5650)	Class II Device / JOW (21 CFR 870.5800)	Class II Device / IRP (21 CFR 890.5650)
Intended Use	Intended for use by medical professionals and patients at home, under medical supervision, in treating: Primary lymphedema, Edema following trauma and sport injuries, Post-immobilization edema, Venous insufficiencies, Lymphedema.	Treatment of Lymphatic disorders, Venous disorder, Post-mastectomy Lymphedema and Dysfunction of the Muscle Pump.	Intended for use by medical professionals and patients at home, under medical supervision, in treating: Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.
Standards Applied	EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2	EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2	EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2
Indications	Primary lymphedema, Edema following trauma and sport injuries, Post-immobilization edema, Venous insufficiencies, Lymphedema.	- (Listed under Intended Use)	Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.
Mode of Compression	Sequential	Sequential	Sequential
Mode description	2 modes	2 modes (Lympha, Gradient12, Wave, Ballancer, and Pre-Therapy)	1 mode
Power Source	230 V~, 50/60 Hz; 35W	230 V~, 50/60 Hz	220~240V 50/60Hz; 25 watts
Therapy Time	0-30 minutes	0-10 minutes	0-30 minutes
Max/Min Pressure	0-230mmHg	0-200mmHg	0-235mmHg
Number of Chambers	4 to 8 chambers	12 chambers	4 to 8 chambers
Compression Cycle Time	30 min	30 min	30 min
Garment Sleeve Material	Nylon	-	Nylon

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

The document does not describe a clinical study with a "test set" in the context of evaluating diagnostic or predictive performance. Instead, it relies on bench and laboratory testing against established safety and quality standards to demonstrate the device's characteristics. Therefore, information on sample size and data provenance for a test set in a performance study is not applicable. The data provenance for the device is from Korea (manufacturer Daesung Maref Co., Ltd.). The study described is a premarket notification for substantial equivalence, not a clinical trial.

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

This information is not provided because the submission is not based on a clinical study where expert-established ground truth would be necessary for a test set.

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

Not applicable, as no test set data requiring adjudication is presented.

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. The device is a 'Powered Inflatable Tube Massager' without AI components or diagnostic capabilities that would involve human readers interpreting images or data.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

The "ground truth" in this context refers to compliance with recognized international and national standards for medical device safety and quality. The device demonstrated conformance to standards such as:

Council Directive 93/42/EEC (medical devices)
IEC 980:2003 (graphical symbols)
IEC1041:1998 (information supplied by manufacturer)
ISO 13485:2003 (quality management systems)
ISO 14155-1:2003 (clinical investigation, Part 1: General requirements - this standard specifies requirements for the design, conduct, recording, and reporting of clinical investigations performed on human subjects to assess the clinical performance or safety of medical devices. Its mention here suggests the potential for clinical investigations, but the document itself doesn't detail one.)
ISO 14971:2007 (risk management)
IEC 60601-1 (general requirements for safety)
IEC 60601-2-10 (safety of nerve and muscle stimulators)
IEC 60601-1-2 (electromagnetic compatibility)

The "ground truth" for the substantial equivalence claim is that the device's characteristics and performance are comparable to (i.e., "as safe and effective as") the predicate devices, which have already been cleared by the FDA.

8. The sample size for the training set

Not applicable, as there is no mention of an algorithm or machine learning model that would require a training set.

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

Not applicable for the same reason as above.

Summary

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K102320
Page 1 of 3

MAR - 4 2011

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: DAESUNG MAREF CO LTD Address: 689-31 Gumjung-dong, Gunpo-si Gyeonggi-do 451-864 KOREA

D. Regulatory Information

1. Classification Name: Massager, Powered Inflatable Tube
1. Common / Usual Name: Powered Inflatable Tube Massager
1. Proprietary Name: Compressible Limb Therapy System LX7(V7)
1. Classification / Product Code: Class II / IRP (21 CFR 890.5650)

E. Intended Use

F. Device Description

G. Substantial Equivalence Information

1. Predicate Device
- -- Predicate Device 1
- 510(k) number: K013331
- Name: Lympha Press Plus
- Classification: 2

Predicate Device 2

510(k) number: K100656
Name: Compressible Limb and Circulation Therapy Systems

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K102320
page 2 of 3

(WHF-324 (POWER-Q1000 PLUS))

2. Comparison with predicate

Model Name	LX7(V7)	Lympha press plus	WHF-324(POWER-Q1000 Plus)
510(k) Number	None yet	K013331	K100656
Classification	Class II Device / IRP (21CFR 890.5650)	Class II Device / JOW (21CFR 870.5800)	Class II Device / IRP (21CFR 890.5650)
Intended Use	LX7(V7) is intended foruse by medicalprofessionals and patientsat home, who are undermedical supervision, intreating many conditions,such as:Primary lymphedema,Edema following traumaand sport injuries, Postimmobilization edema,Venous insufficiencies,Lymphedema.	Treatment of Lymphaticdisorders, Venous disorder,Post-mastectomyLymphedema andDysfunction of the MusclePump.	The WHF-324 (POWERQ1000 Plus) device isintended for use by medicalprofessionals and patientsat home, who are undermedical supervision, intreating many conditions,such as:Primary lymphedema,Edema following traumaand sport injuries,Post immobilization edema,Venous insufficiencies,Lymphedema.
Standard	EN ISO 14971EN 60601-1EN 60601-2-10EN 60601-1-2	EN ISO 14971EN 60601-1EN 60601-2-10EN 60601-1-2	EN ISO 14971EN 60601-1EN 60601-2-10EN 60601-1-2
Indications	Primary lymphedema,Edema following traumaand sport injuries,Postimmobilizationedema,Venous insufficiencies,Lymphedema.	-	Primary lymphedema,Edema following traumaand sport injuries,Post immobilization edema,Venous insufficiencies,Lymphedema.
Mode ofCompression	Sequential	Sequential	Sequential
Mode description	2 modes	2 modes(Lympha, Gradient12,Wave, Ballancer, andPre-Therapy)	1 mode
Power Source	Electricity Supply:230 V~,50/60 HzElectricityconsumption: ,35W	Electricity Supply:230 V~,50/60 Hz	Electricity Supply:220~240V 50/60Hzconsumption: 25 watts
Therapy Time	0-30 minutes	0-10 minutes	0-30 minutes
Maximum andMinimumPressure	0-230mmHg	0-200mmHg	0-235mmHg
Number ofChambers	4 to 8 chamber	12 chamber	4 to 8 chamber
CompressionCycle Time	30min	30 min	30min
Garments SleeveMaterial	Nylon	-	Nylon

Conclusion

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K102320
page 3 of 3

Compressible Limb Therapy System (LX7(V7)) has substantial equivalent intended use as the-market-cleared WHF-324 (POWER-Q1000 Plus) and has substantial equivalent technological and performance characteristics with Lympha Press plus .

After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of Compressible Limb Therapy System (LX7(V7)) 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)

LX7(V7)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, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
. IEC 60601-1-2, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -

Requirements and tests

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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

Daesung Maref Co., Ltd. % PATS Corporation Mr. Brandon Choi 205 S. Broadway, Suite 718 Los Angeles, CA 90012

MAR - 4 2011

Re: K102320

Trade/Device Name: Compressible Limb Therapy System LX7(V7) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 25, 2011 Received: March 1, 2011

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

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Page 2 - Mr. Brandon Choi

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aling B. R. Ja.

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): | | | | | 2 3 2 2

Device Name: Compressible Limb Therapy System LX7(V7)

Indications For Use: LX7(V7) 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.

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)

Sign-Off

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

510(k) Number K102320

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).