A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE. 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 text is a 510(k) premarket notification for the DVT-2600 device, a compressible limb sleeve intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, the information required for a detailed description of acceptance criteria and a study proving those criteria are met is not available in the provided text.

Here's an explanation based on the available text:

A table of acceptance criteria and the reported device performance:
- The document does not provide a table of specific performance acceptance criteria (e.g., minimum pressure levels, pulsation rates, blood flow increase percentages, etc.) that the DVT-2600 device was tested against.
- Instead, it compares the technological characteristics of the DVT-2600 to a predicate device (also named DVT-2600, K112677 from DAESUNG MAREF CO., LTD.) to establish substantial equivalence. The performance listed relates to general specifications like pressure ranges and number of chambers, which are compared to the predicate device, not against predefined acceptance criteria from a study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the DVT-2600 to its predicate device." This means there was no clinical "test set" in the context of a performance study to prove new acceptance criteria.
- The non-clinical tests mentioned (electrical safety, EMC, biocompatibility) are general compliance tests for standards, not performance studies against specific clinical acceptance criteria.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable, as no clinical test set for performance evaluation was conducted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set for performance evaluation was conducted.
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. The DVT-2600 is a physical medical device (compressible limb sleeve), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as it's not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical performance study was conducted to establish ground truth for efficacy. The "ground truth" for the submission is the substantial equivalence to the predicate device based on similar technological characteristics and non-clinical safety/EMC standards compliance.
The sample size for the training set:
- Not applicable, as no machine learning or AI model was developed for this device that would require a training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary from the provided text:

The DVT-2600 received 510(k) clearance based on "substantial equivalence" to a predicate device (K112677, also named The Venous Assist System DVT-2600 from DAESUNG MAREF CO., LTD.).

Acceptance Criteria & Performance: The document provides a comparison of specifications between the proposed device and the predicate device, claiming they are largely identical except for the inclusion of a battery in the proposed device. The "performance" assessment is based on this comparative technical specification rather than a dedicated study with defined acceptance criteria.
- Proposed Device (DVT-2600):
  - Power Source: 100-240VAC, 50/60Hz
  - Pressure: LEG: 20-60mmHg, FOOT: 120-140mmHg
  - Number of chambers: 3
  - Battery: 3200mAh, 3350mAh
- Predicate Device (DVT-2600 / The Venous Assist System):
  - Power Source: 100-240VAC, 50/60Hz
  - Pressure: LEG: 20-60mmHg, FOOT: 120-140mmHg
  - Number of chambers: 3
  - Battery: -
- Justification for Substantial Equivalence: The battery difference was deemed not to affect performance, confirmed by a product performance test report (though the report itself is not included in the provided text).
Study Data: No clinical performance study data against specific "acceptance criteria" is provided or stated to have been conducted. The submission relies on non-clinical tests for electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility for the sleeves (ISO 10993-5, ISO 10993-10). These are compliance tests to standards, not performance studies against medical efficacy acceptance criteria.
Ground Truth: The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the legally marketed predicate device, to which the new device is substantially equivalent.
Sample Size: Not applicable for performance studies.
Experts: Not applicable for performance studies.
Adjudication/MRMC/Standalone AI: Not applicable as the device type does not involve these methodologies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 5, 2020

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

Re: K203016

Trade/Device Name: DVT-2600 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 21, 2020 Received: October 1, 2020

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

for 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

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Indications for Use

510(k) Number (if known) K203016

Device Name DVT-2600

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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1. Data Prepared [21 CFR 807.92(a)(a)]

November 02, 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-2600
Classification Name	Compressible Limb Sleeve
Regulation Number	21 CFR 870.5800
Regulation Class	II
Product Code	JOW

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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

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.

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.

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.

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7. Determination of Substantial Equivalence

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

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

	Proposed Device	Predicate Device
Model Name	DVT-2600	DVT-2600
510(k) Number	K203016	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.	DVT-2600 is a system to prevent DVT (Deep VeinThrombosis) by improving the blood velocity ofpatients.DVT-2600 is Circulation Enhancement, Deep VeinThrombosis Prophylaxis, Edema - Acute, Edema -Chronic, Extremity Pain Incident to Trauma orSurgery Leg Ulcers, Venous Stasis / VenousInsufficiency
Intended Useenvironment	Professional healthcare environment	Professional healthcare environment

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

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Accessories	Calf sleeveThigh sleeveFoot sleeveBoots sleeve	Calf sleeveThigh sleeveFoot sleeveBoots sleeve
Specifications
Power Source	100-240VAC, 50/60Hz	100-240VAC, 50/60Hz
Pressure	LEG : 20-60mmHgFOOT : 120-140mmHg	LEG : 20-60mmHgFOOT : 120-140mmHg
Number of chamber	3	3
Battery	3200mAh, 3350mAh	-

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-2600(Proposed device) is hardly different from the DVT-2600(Predicate device) except for battery. However, the battery is not the main power source of this device, it is an auxiliary power source. In addition, 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-2600 comply with voluntary standards for electromagnetic compatibility. And a biocompatibility test was conducted for the sleeves, not for device, an accessory used with DVT-2600. The following data were provided in support of the substantial equivalence determination :

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Electrical Safety, Electromagnetic Compatibility and Performance

The DVT-2600 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-2600 to its predicate device.

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

The DVT-2600 has same intended use and technical characteristics to the predicate device except some item. 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.

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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).