Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the DVT-4000S device. It does not contain a study demonstrating acceptance criteria for the device's performance in terms of its intended use (preventing DVT/PE by increasing venous blood flow).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (DVT-2600) based on technological characteristics and compliance with electrical safety and electromagnetic compatibility standards.

Therefore, many of the requested details about acceptance criteria, device performance against those criteria, sample sizes, expert involvement, and ground truth establishment are not present in this document.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria for DVT/PE prevention or venous blood flow increase, nor does it report performance metrics against such criteria. The "specifications" listed are more about the device's operational parameters rather than clinical outcomes.

Metric/Characteristic	Acceptance Criteria (Not explicitly stated for clinical outcomes)	Reported Device Performance (Operational Specifications for DVT-4000S)
Intended Use	Device prevents DVT/PE by increasing venous blood flow	A device designed to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE. (This is the intended use, not a performance metric.)
Power Source	N/A (for clinical outcome)	100-240VAC, 50/60Hz, 90VA
Pressure (LEG)	N/A (for clinical outcome)	20-60mmHg
Pressure (FOOT)	N/A (for clinical outcome)	120-140mmHg
Battery	N/A (for clinical outcome)	3500mAh
Number of chambers	N/A (for clinical outcome)	3
Electrical Safety	Compliance with IEC 60601:2005/A1:2012	Complies with IEC 60601:2005/A1:2012
Electromagnetic Compatibility	Compliance with IEC 60601-1-2:2014	Complies with IEC 60601-1-2:2014
Biocompatibility (in vitro cytotoxicity)	Compliance with ISO 10993-5:2009	Complies with ISO 10993-5:2009
Biocompatibility (irritation and skin sensitization)	Compliance with ISO 10993-10:2010	Complies with ISO 10993-10:2010

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

Clinical Test Set: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the DVT-4000S to its predicate device." Therefore, there is no clinical test set mentioned, and thus no sample size or data provenance for such a test.
Non-Clinical Test Set: For electrical safety, EMC, and biocompatibility, the sample size is not specified, but these are typically tested on a representative number of devices (e.g., a small batch) during product development and regulatory submission. The provenance would be from laboratory testing performed by the manufacturer or a certified testing facility.

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

Not applicable, as no clinical test set requiring ground truth establishment by experts was conducted or reported.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication was conducted or reported.

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. This device is a mechanical compression device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a mechanical compression device, not an algorithm.

7. The type of ground truth used:

Not applicable, as no clinical test involving ground truth for disease detection/prevention was performed. The ground truth for electrical safety or biocompatibility would be defined by the standards themselves (e.g., does it conduct electricity safely, does it cause cell death).

8. The sample size for the training set:

Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.

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

Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.

Summary of Study (as presented in the document):

The "study" presented is a substantial equivalence comparison to a legally marketed predicate device (DVT-2600). The manufacturer asserts that the DVT-4000S is substantially equivalent to the DVT-2600 based on:

Identical Indications for Use: Both devices are intended to prevent DVT/PE by increasing venous blood flow.
Similar Technological Characteristics: The operating principle (sequential inflation of air chambers) is the same. Key specifications like pressure range and number of chambers are identical.
Minor Differences Justified: The differences (power consumption and inclusion of a battery in DVT-4000S) were deemed not to raise new questions of safety or effectiveness. Performance tests confirmed that the device functions equivalently when using AC power or battery.
Compliance with Voluntary Standards: The DVT-4000S complies with recognized standards for electrical safety (IEC 60601-1:2012), electromagnetic compatibility (IEC 60601-1-2:2014), and biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).

The basis for market clearance, in this case, is not a clinical study demonstrating performance against specific clinical acceptance criteria, but rather a demonstration of substantial equivalence to an already cleared device and compliance with relevant safety and performance standards.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

March 28, 2021

Daesung Maref CO., LTD. Su Hyeon So Assistant Researcher 298-24. Gongdan-Ro Gunpo-Si, Gyeonggido 15809 Korea, South

Re: K203417

Trade/Device Name: DVT-4000S Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: February 15, 2021 Received: February 24, 2021

Dear Su Hyeon So:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K203417

Device Name DVT-4000S

Indications for Use (Describe)

A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.

Type of Use (Select one or both, as applicable)
	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

510(K) Summary

1. Data Prepared [21 CFR 807.92(a)(a)]

November 13, 2020

2. Submitter's Information [21 CFR 807.92(a)(1)]

● Name of Manufacturer : DAESUNG MAREF CO., LTD.

● Address :

298-24, Gongdan-ro Gunpo-si, Gyeonggido Republic of Korea

• Contact Name :

Su Hyeon, So
Telephone No. : 82-31-459-7211
Fax No. :
- 82-31-459-7215
Email Adress : rndra@dsmaref.com
Registration No. : 3004116008

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade / Device Name	DVT-4000S
Regulation Number	21 CFR 870.5800
Classification Name	Compressible Limb Sleeve
Regulation Class	II
Product Code	JOW

1

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

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

Predicate Device

510(k) Number :
K112677
Applicant : DAESUNG MAREF CO.,LTD.
Trade / Device Name :

The Venous Assist System DVT-2600

Regulation Number : 21 CFR 870.5800
· Regulation Name :
- Compressible Limb Sleeve
Regulation Class:

Product Code:
- JOW

Predicate device has not been subject to a design-related recall.

5. Description of the Device [21 CFR 807.92(a)(4)]

A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE.

6. Indications For Use [21 CFR 807(a)(5)]

A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.

2 / 5

{5}------------------------------------------------

7. Determination of Substantial Equivalence

Summary of technological characteristics of the device compared to the predicate device. [21CFR
807.92(a)(6)]

The DVT-4000S is substantially equivalent to legally marketed predicate device (DVT-2600) with respect to indications for use and technology characteristics.
The table below presents comparisons for device :

[Table 1. Comparison of Proposed Device to Predicate Device]
--------------------------------------------------------------	--

	Proposed Device	Predicate Device
Model Name	DVT-4000S	DVT-2600
510(k) Number	K203417	K112677
Manufacturer	DAESUNG MAREF CO., LTD.	DAESUNG MAREF CO., LTD.
Product Code	JOW	JOW
Device Class	II	II
RegulationNumber	21 CFR 870.5800	21 CFR 870.5800
RegulationName	Compressible Limb Sleeve	Compressible Limb Sleeve
Indications For Use	A device intended to prevent Deep VeinThrombosis/Pulmonary Embolism (DVT/PE) byincreasing venous blood flow to a patient who has arisk of DVT/PE.	A device intended to prevent DVT/PE by increasingvenous blood flow to a patient who has a risk ofDVT/PE.
Intended Useenvironment	Professional healthcare environment	Professional healthcare environment

/ 5 ന

{6}------------------------------------------------

Accessories	Calf sleeveThigh sleeveFoot sleeveBoots sleeve	Calf sleeveThigh sleeveFoot sleeveBoots sleeve
Specifications
Power Source	100-240VAC, 50/60Hz90VA	100-240VAC, 50/60Hz35VA
Pressure	LEG : 20-60mmHgFOOT : 120-140mmHg	LEG : 20-60mmHgFOOT : 120-140mmHg
Battery	3500mAh	-
Number of chamber	3	3

The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices.

[Table 2. Little differnence with Predicate Device]

Justification to Support Substantial Equivalence The DVT-4000S hardly different from the DVT-2600 except for some specification. (Power consumption, Battery) But power consumption is innherent characteristics of device. And the presence or absence of a battery does not significantly affect the purpose of use or action. In addition, it was confirmed through the performance test report whether it can perform the same performance as used by connecting AC power when operating with a battery. And it was confirmed with the product performance test report that it did not affect the performance when using the

battery.

Therefore, the differences in technological characteristics do not raise different questions of safety and effectiveness.

Non-Clinical Test Summary

The DVT-4000S complies with voluntary standards for electromagnetic compatibility, use in the home healthcare environment and usability.

The following data were provided in support of the substantial equivalence determination :

4 / 5

{7}------------------------------------------------

Electrical Safety, Electromagnetic Compatibility and Performance

The DVT-4000S comply with the electrical safety and electromagnetic compatibility requirements established by the standards.

· IEC 60601 : 2005/A1:2012, Medical Electrical Equipment:Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601 60601-1-2:2014, Medical Electrical Equipment Part 1 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
• ISO 10993-5:2009 Third edition 2009-12-15, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

• ISO 10993-10 Thrid Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Clinical Test Summary

Clinical testing was not required to demonstrate the substantial equivalence of the DVT-4000S to its predicate device.

8. Conclusion [21 CFR 807.92(b)(3)]

The DVT-4000S has similar intended use and technical characteristics to the predicate device. Based on that information, we conclude that the differences between the proposed device and predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness.

/ 5 റ

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).