DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

Device Description

DVT-2600 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and 3 types(Non-woven, Fabric, Oxford) garments. The system offers Sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated.

AI/ML Overview

The provided 510(k) summary for K112677, "The Venous Assist System DVT-2600", does not contain details about specific acceptance criteria or a study that definitively proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SCD Express™4 system, K040511) through:

Comparison of Intended Use: Stating that the DVT-2600 has "substantial equivalent intended use" to the predicate.
Comparison of Technological and Performance Characteristics: Claiming "substantial equivalent technological and performance characteristics," and that it 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."
Adherence to Standards: Listing several international standards (IEC, ISO) that the device complies with, which are general safety and quality management standards rather than specific performance metrics for DVT prevention efficacy. These include:
- Council Directive 93/42/EEC
- IEC 980:2003
- IEC1041:1998
- ISO 13485:2003
- ISO 14155-1:2003
- ISO 14971:2007
- IEC 60601-1
- IEC 60601-1-2

The document explicitly states "After analyzing both bench as well as laboratory testing to applicable standards," but does not provide any specific results or data from these tests, nor does it describe a clinical study measuring performance against acceptance criteria for DVT prevention efficacy. This is typical for a 510(k) submission seeking substantial equivalence for devices of this type, where performance often relies on demonstrating similar operational principles and safety to already-cleared devices, rather than a new clinical efficacy trial with detailed performance metrics.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or is stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate (SCD Express™4 system)	The device is as safe and effective as the predicate.
Few technological differences compared to predicate	Few technological differences reported.
No new indications for use compared to predicate	No new indications for use reported.
No new safety and/or effectiveness concerns compared to predicate	No new safety and/or effectiveness concerns reported.
Compliance with relevant international standards (e.g., IEC, ISO)	Bench and laboratory testing to applicable standards completed. (Specific results not provided)
Improvement of blood velocity (implied mechanism of action)	Claims to "improve the blood velocity of patients." (Specific metrics not provided)

Missing: Specific quantitative acceptance criteria (e.g., target increase in blood velocity, DVT incidence reduction, specific pressure ranges, cycle times, etc.) and direct performance data to demonstrate meeting these criteria.

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

Missing. The document does not describe a clinical "test set" involving human subjects or data that would typically have a sample size for performance evaluation. The "bench as well as laboratory testing" mentioned likely refers to engineering tests and basic safety assessments, not a clinical study on patient outcomes or diagnostic performance.

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

Missing. No information on experts or ground truth establishment is provided, as no clinical performance study akin to a diagnostic device trial is detailed.

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

Missing. No adjudication method is mentioned.

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

Missing. This device is an intermittent pneumatic compression system for DVT prophylaxis, not an AI-powered diagnostic or decision support tool for human readers. Therefore, an MRMC study is not applicable to its function.

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

Missing. This is not an algorithm-only device. It is a physical medical device.

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

Missing. As no clinical performance study is described with detailed results, no ground truth type is specified. For a device like this, clinical ground truth would typically be DVT incidence or objective measures of blood flow.

8. The sample size for the training set

Missing. This device is not an AI/ML model that would have a "training set."

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

Missing. Not applicable, as this is not an AI/ML model.

In summary: The provided 510(k) emphasizes substantial equivalence to a predicate device and adherence to general medical device safety and quality standards (e.g., ISO, IEC). It does not detail a specific clinical study with quantitative performance acceptance criteria, sample sizes, or ground truth establishment for measuring the device's efficacy in preventing DVT. This approach is common for devices demonstrating substantial equivalence where the predicate has already established clinical effectiveness.

Summary

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K112677 pg 1 of 2

510(K) SUMMARY

[as required by 807.92(c)]

JAN 1 3 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

Requlation Number: 21 CFR 870.5800 Requlation Name: Compressible Limb Sleeve Requlatory Class: Class II Product Code: JOW Proprietary Name: The Venous Assist System DVT-2600

E. Intended Use

F. Device Description

We recommend using the device separately or with anti-coagulant materials or

compression stocking to help prevent DVT and PE under a doctor's consultant.

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K112677 pg 2 of 2

G. Substantial Equivalence Information
- Predicate Device 1
- 510(k) number: K040511
- Name: SCD Express"4 system
- Classification: 2
- 1. Comparison with predicate

The Venous Assist System DVT-2600 has substantial equivalent intended use as the-market-cleared SCD Express"4 system and has substantial equivalent technological and performance characteristics with SCD Express"4 system. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of The Venous Assist System DVT-2600 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)
- 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

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the eagle.

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

JAN 1 3 2012

DAESUNG MAREF CO., LTD. c/o Mr. Daniel Nam General Manager PATS CORP. 4568 West 1st Street, Suite 104 Los Angeles, CA 90004

Re: K112677

Trade/Device Name: The Venous Assist System DVT-2600 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 3, 2012 · Received: January 9, 2012

Dear Mr. Nam:

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.

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Page 2 - Mr. Daniel Nam

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 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. I

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,

M. A. Aillelen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112677

Indications for Use

510(k) Number (if known):

The Venous Assist System DVT-2600 Device Name:

Indications For Use: DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

Prescription Use X (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)

VM S. Hillehem

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K112677

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).