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

Device Description

DVT-Pro 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 basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called "DVT-Pro," a compressible limb sleeve system used to prevent Deep Vein Thrombosis (DVT). The document outlines the device's characteristics and compares it to a predicate device (DVT-2600) to demonstrate substantial equivalence, but it does not contain information on acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML device (e.g., sensitivity, specificity, or reader studies). The "performance data" section primarily refers to safety and software validation testing, not clinical performance for its stated indications.

Therefore, I cannot provide the detailed information requested in the prompt, especially points related to:

A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like accuracy, sensitivity, specificity).
Sample size used for the test set or training set for clinical performance evaluation.
Data provenance, number of experts, adjudication methods, or ground truth types for clinical performance.
MRMC comparative effectiveness study or standalone performance.

The document focuses on demonstrating that the DVT-Pro device is substantially equivalent to an existing device (DVT-2600) based on:

Intended Use: Both devices are for "Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency." The DVT-Pro explicitly states it's for DVT prevention by improving blood velocity.
Technological Characteristics Comparison (See the table on page 8-9): This table highlights similarities in mechanical and electrical specifications, such as mode of compression (sequential), pressure ranges (with slight differences in maximums for leg/foot), and general design.
Safety and Software Validation:
- Biocompatibility testing: ISO10993-5, ISO10993-10 were performed.
- Electrical safety and performance testing: Conducted according to IEC 60601-1:2005 + CORR.1(2006) + CORR(2007).
- EMC testing: Conducted according to IEC 60601-1-2:2007.
- Software Verification and Validation Testing: Documented as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was classified as "minor" level of concern. All test results were satisfactory.

Key Missing Information (as per your prompt):

The document does not detail any clinical performance study (e.g., to measure the device's effectiveness in preventing DVT) with specific acceptance criteria like accuracy, sensitivity, or specificity. The "performance data" discussed is related to engineering and software validation for safety and proper functioning, not clinical outcomes directly demonstrating DVT prevention efficacy against a defined ground truth.

Therefore, I cannot populate the table or answer the specific questions regarding clinical performance studies, test set/training set sizes, expert involvement, or adjudication methods, as this information is not present in the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.

Public Health Service

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

May 12, 2016

DaeSung Maref Co., Ltd. % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K150980

Trade/Device Name: DVT-Pro Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 31. 2016 Received: April 5, 2016

Dear Dave Kim:

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 device

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.

M.A. Hilleman

for

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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Indications for Use

510(k) Number (if known) K150980

Device Name DVT-Pro

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared: May 4, 2016

I. SUBMITTER

Submitter's Name :	DaeSung Maref Co., Ltd.
Submitter's Telephone:	298-24, Gongdan-Ro, Gunpo-shi, Gyeonggi-Do, Republic of Korea, 435-862
Submitter's Telephone:	+82-31-459-7200
Contact person:	Jae-Wha Lee / President
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
(U.S. Designated agent)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

II. DEVICE

Trade/proprietary name:	DVT-Pro
Common or Usual Name:	The Venous Assist System
Regulation Name :	Compressible Limb Sleeve
Classification:	21 CFR 870.5800 (Product Code: JOW)
Regulatory Class:	II

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III. PREDICATE DEVICE

1) Primary Manufacturer	: DaeSung Maref Co., Ltd.
Device	: DVT-2600
510(k) Number	: K112677 (Decision Date – Jan. 13, 2012)

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

Device Identification:
(1) Adaptor Specification
- (1) Input Voltage and Frequency: 100-240V~, 47~63Hz
- (2) Input Current: 0.5A max. (at 90Vac input)
- Output Voltage : 9Vdc/2A, 15W (3)

(2) Battery Specification

(1) Battery Cell type and quantity : Li-ion 18650(ICR18650 B4 2600mAh), 4-cell(2s x 2p)
Battery Voltage : 7.4V(5200mAh) (2)
Safety circuit : PCM equipped (overcharge, over discharge, overcurrent prevention) (3)
(3) Specification
- (1) Time range : unlimited (using time can be set : ~999hour 50min, unit : 10min)
- Interval time range : 28s, 48s (2)
- (3) Pressure range : Leg : 20 ~ 65mmHg(unit 5mmHg), Foot : 120~~140mmHg(unit 10mmHg), AUX : 20~~50mmHg(unit:5mmHg)
- Mode : DVT mode (4)

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Photos (4)

1) Main Body

Image /page/5/Figure/3 description: The image shows three different views of a black handheld device. The views are labeled as "Front", "Right", and "Left". The front view shows a screen and several buttons, while the right and left views show the side profiles of the device. The device appears to be some sort of electronic instrument.

Top

Back

Image /page/5/Picture/6 description: The image shows two views of a black, square-shaped electronic device. The left view displays the front of the device, which features a screen, several buttons, and the text "OS MAREF" printed on the side. The right view shows the back of the device, revealing a smooth surface with four screws located at each corner.

Image /page/5/Picture/7 description: The image shows two different types of hoses. The first hose is labeled "2) Air Hose" and appears to be a black air hose with metal connectors on each end. The second hose is labeled "3) AUX" and appears to be a black AUX cable connected to a black device.

1. Garments(cuffs)
  Image /page/5/Figure/9 description: The image shows two different medical devices, a calf cuff and a foot device, used for DVT (Deep Vein Thrombosis) mode. The calf cuff has 3 chambers and provides a pressure of 20-65mmHg with a unit of 5mmHg. The foot device has 1 chamber and provides a pressure of 120-140mmHg with a unit of 10mmHg.

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Image /page/6/Picture/12 description: The image shows three different products with descriptions. The first product is non-woven and has dimensions of 620mm and 360mm. The second product is also non-woven and has dimensions of 420mm and 230mm. The third product is 2M PVC.

Device Characteristics (address all that apply)

(1) Components

The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot.

(2) Characteristics of the device

1. Operation
  The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).

PCB consists of user input switch, LED or LCD display and button for pressure control and controls the air pump and solenoid via micro controller.

Air pump is connected to the hose and supplies air to the distributor.

Air distributor supplies the air to each air chamber in order and thus, repeats the inflation of Chamber 1 → inflation of Chamber 2 → inflation of Chamber 3 → in this order until the end of the set time.

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(2) Electric Characteristics(Adaptor)
- a. Rated Voltage: 100-240V~
- b. Rated Frequency: 47~63Hz
c. Power Consumption: 0.5A max (at 90Vac Input)
(3) Protection against electric shock

Class II , Type BF

4 Software
a. File Name: DVT-PRO.c
b. Version: V 1.0
c. Main features: switch, display, pump, solenoid, pressure control

V. Indications For Use:

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

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

Device Name	DVT-PRO	DVT-2600
510(k) Number	K150980	K112677
Classification	Class II Device / JOW(21 CFR 870.5800)	Class II Device / JOW(21 CFR 870.5800)
Intended Use	DVT-PRO is a system to preventDVT (Deep Vein Thrombosis) byimproving the blood velocity ofpatients. DVT-PRO is CirculationEnhancement, Deep VeinThrombosis Prophylaxis Edema –Acute, Edema – Chronic, ExtremityPain Incident to Trauma or SurgeryLeg Ulcers, Venous Stasis / VenousInsufficiency	DVT-2600 is a system to preventDVT (Deep Vein Thrombosis) byimproving the blood velocity ofpatients. DVT-2600 is CirculationEnhancement, Deep VeinThrombosis Prophylaxis Edema –Acute, Edema – Chronic, ExtremityPain Incident to Trauma or SurgeryLeg Ulcers, Venous Stasis / VenousInsufficiency
Contraindications	- Pre-existing deep veinthrombosis, phlebothrombosisor pulmonary embolism- Presumptive evidence ofCongestive Heart Failure- Inflammatory Phlebitis Process- Severe arteriosclerosis or otherischemic vascular disease- Decompensated cardiacinsufficiency- Carcinoma metastasis in theaffected Extremity- Lymphatic return is undesirable- Severe arteriosclerosis or activeinfection- Acute pulmonary edema- Acute thrombophlebitis- Acute congestive cardia failure- Acute infections- Episodes of Pulmonaryembolism- Wounds lesions or tumors at orin the vicinity of application	- Pre-existing deep veinthrombosis, phlebothrombosisor pulmonary embolism- Presumptive evidence ofCongestive Heart Failure- Inflammatory Phlebitis Process- Severe arteriosclerosis or otherischemic vascular disease- Decompensated cardiacinsufficiency- Carcinoma metastasis in theaffected Extremity- Lymphatic return is undesirable- Severe arteriosclerosis or activeinfection

	Bone fractures or dislocations-at or in the vicinity ofapplication

	EN ISO 14971	EN ISO 14971
Standard	EN 60601-1EN 60601-1-2	EN 60601-1EN 60601-1-2
		EN 60601-1-4
Mode of
Compression	Sequential	Sequential

No of Modes	DVT mode 1	Lymph mode 1Foot mode 1

Therapy Time	Continuous	Continuous
Maximum and	20 ~ 65mmHg(Leg),
minimum pressure	120~140mmHg(Foot)	20 ~ 60 mmHg (Leg),
	20~50mmHg(AUX)	120~140 mmHg (Foot)
Number of	Calf cuff : 3chamber
chambers	Foot cuff : 1chamber	Leg sleeves / Foot cuffs
Compression cycle
time	40s,60s/1cycle	12 sec 1 cycle
Compressionapplicator garments
sleeve material
	Non-woven	Nylon / Fabric
Operating
Temperature	10~40 °C	-20C ~40° C

Operating Humidity	30 ~ 75%	90%
Atmospheric
Pressure	700 - 1060 hPa
Size	140 (W) x 143 (D) x 45 (H) mm	200 (W) x 170(D) x 190 (H) mm
Weight	0.8 kg	2 kg
Input Voltage100 ~240VAC / 47 ~ 63 Hz		100 ~~240V AC / 50~~ 60 Hz
Input Current0.5 A max at 90VAC Input
Output Voltage	9Vdc / 2A, 15W
	Li-ion 18650(ICR18650 B4
Battery Spec	2600mAh), 4-cell(2s x 2p)
Battery Voltage	7.4V (5200mAh)
	DVT-PRO	DVT-2600(3000)
Pump	200g	285g
Solenoid Valve	140g	250g
Internal frame	0g	325g
SMPS	0g	130g
Case	175g	469
Total	515g	1459g

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Image /page/10/Picture/1 description: The image contains two medical devices. The device on the left is black and has a screen and several buttons. The device on the right is white and also has a screen and buttons.

The contraindications is revised to include additional medical conditions which predate or concurrent to the treatment of DVT-Pro. Contraindications listed here should be considered for using a pneumatic device with cuffs. There is no direct cause and effect relationship between disease associated with the contraindication and the treatment of DVT equipment.

DVT-Pro was developed as a dedicated DVT treatment device and deleted the Lymph Mode of the predicate device to reduce the size and weight of the product. DVT-Pro was developed as a portable device with a built-in battery adapter and replaced SMPS (power supply circuits) with an external power supply for the user's convenience. DVT-Pro used the critical parts with less weight than the predicate device.

Weight of the critical components

Weight difference of the critical components is approximately 944g (1459 - 515).

The risk management report contains the analysis of overall hazard situations generated from the parts with less weight and adapting an external power adapter during the development of a portable device. The technical report of the device validated the outcome.

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VII. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination.

Biocompatibility testing (ISO10993-5, ISO10993-10)

Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for his device was considered as a "minor" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.

All test results were satisfactory.

VIII. CONCLUSIONS

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification DaeSung Maref Co. Ltd. concludes that DVT-Pro is substantially equivalent in comparison with DVT-2600. the predicate device as described herein.

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).