MK300L 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

MK300L 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 is a 510(k) summary for the Compressible Limb Therapy System MK300L, which is a medical device and not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria in the context of AI/ML evaluation.

However, based on the provided text, I can extract information relevant to the device's regulatory review and intended use:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it meets the safety and effectiveness standards comparable to the predicate devices.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly quantitative)	Reported Device Performance (Implicitly met through substantial equivalence)
Intended Use Equivalence	Intended use is substantially equivalent to predicate devices.	MK300L has substantial equivalent intended use as the-market-cleared LX-7.
Technological Characteristics Equivalence	Technological characteristics are substantially equivalent to predicate devices.	MK300L has substantial equivalent technological characteristics with Lympha press plus and WIC-2008.
Performance Characteristics Equivalence	Performance characteristics are substantially equivalent to predicate devices, without new safety/effectiveness concerns.	Confirmed through bench and laboratory testing to applicable standards. Concluded that MK300L is as safe and effective as predicate devices.
Safety Standards Compliance	Compliance with relevant medical device safety, quality, and electromagnetic compatibility standards.	Conducted and applied by standards including Council Directive 93/42/EEC, IEC 980:2003, IEC 1041:1998, ISO 13485:2003, ISO 14155-1.2003, ISO 14971:2007, IEC 60601-1, IEC 60601-1-2.

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

The document mentions "bench as well as laboratory testing to applicable standards" but does not specify sample sizes for any test sets in terms of patient data or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically not included in a 510(k) summary focused on substantial equivalence for a non-AI/ML device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This question pertains to AI/ML device evaluation where expert consensus is often used for ground truth. For a physical medical device like a massager, ground truth would typically relate to physical measurements, engineering standards, or clinical outcomes, not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. This question is relevant to AI/ML evaluations where disagreements between experts need to be resolved. For a non-AI device, adjudication methods in this context are not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. MRMC studies are specific to evaluating how human readers' performance changes with or without AI assistance, which is not applicable to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical massager and does not involve an algorithm or AI component in the sense of a software-as-a-medical-device (SaMD) evaluated for standalone performance.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on compliance with established medical device standards (e.g., electrical safety, quality management, risk management, clinical investigation general requirements) and demonstrating that its performance is comparable to legally marketed predicate devices through "bench as well as laboratory testing." Clinical outcomes data might be inferred from the predicate devices' long-standing safety and effectiveness, but it's not explicitly stated as the ground truth for this specific device's evaluation.

8. The Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

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

Not applicable. This device does not have a training set.

Summary

{0}------------------------------------------------

510(K) SUMMARY

[as required by 807.92(c)]

JAN 1 7 2012

A. 510k Number:

B. Applicant:

Company name: PATS CORP Address: 205 S Broadway, Suite 718, Los Angeles California 90012 USA Contact person: Daniel Nam Phone: 213-626-1544

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 MK300L
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: K012320
Name: LX-7
Classification: 2

Predicate Device 3

510(k) number: K102319
Name: WIC-2008

{1}------------------------------------------------

Classification: 2
1. Comparison with predicate
  Compressible Limb Therapy System MK300L has substantial equivalent intended use as the-market-cleared LX-7 and has substantial equivalent technological and performance characteristics with Lympha press plus and WIC-2008.After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of Compressible Limb Therapy System MK300L 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)
MK300L 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 60601-1-2, Medical electrical equipment Part 1: General . requirements for safety - Collateral standard: Electromagnetic compatibility -

Requirements and tests

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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. Daniel Nam 205 South Broadway, Suite 718 Los Angeles, California 90012

JAN 1 7 2012

Re: K112441

Trade/Device Name: Compressible Limb Therapy System MK300L Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code IRP Dated: December 5, 2011 Received: December 9, 2011

Dear Mr. Nam:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused 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 conimeree prof to riay =classified in accordance with the provisions of the Federal Food, devices that have been totact) that do not require approval of a premarket approval application Drag, and obsince, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual the ree." The general conneces, good manufacturing practice, labeling, and prohibitions against regiountion, maning or arrange: 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 your device to additional controls. Existing major regulations affecting your device can it may be subject to additions, 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 I teast be actived that FDT I o teamination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You the ret of the Act's requirements, including, but not limited to: registration and linest comply with an the riot of the eart 801); medical device reporting (reporting of

{3}------------------------------------------------

Page 2 -- Mr. Daniel Nam

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 vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Compressible Limb Therapy System MK300L

Indications For Use: MK300L 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.

X ____________________________________________________________________________________________________________________________________________________________________________ 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)

Yung D. Luth

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

510(k) Number K112441

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).