(121 days)
Not Found
No
The description focuses on the mechanical operation of an intermittent pneumatic compression system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to prevent DVT and PE, improve blood velocity, and address conditions like acute/chronic edema, extremity pain, leg ulcers, and venous stasis/insufficiency, all of which are therapeutic aims.
No
The device, DVT-2600, is described as a system to prevent DVT by improving blood velocity and flow, and for circulation enhancement and edema treatment. Its mechanism involves intermittent pneumatic compression to promote blood movement. It does not mention any function for diagnosing conditions, but rather treating or preventing them.
No
The device description explicitly states the system consists of a controller, tubing sets, and garments, which are all hardware components.
Based on the provided information, the DVT-2600 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is designed to prevent DVT by improving blood velocity and addresses various circulatory issues. This is a therapeutic and preventative function performed directly on the patient's body.
- Device Description: The description details an intermittent pneumatic compression system that applies pressure to the extremities to enhance blood flow. This is a physical intervention, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The DVT-2600 does not fit this description. It is a therapeutic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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
F. 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.
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.
1
K112677 pg 2 of 2
- G. Substantial Equivalence Information
- Predicate Device 1
- 510(k) number: K040511
- Name: SCD Express"4 system
- Classification: 2
-
- 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
2
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.
3
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
4
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