DVT-2600

K203016 · Daesung Maref Co., Ltd. · JOW · Dec 5, 2020 · Cardiovascular

Device Facts

• Record ID: K203016
• Device Name: DVT-2600
• Applicant: Daesung Maref Co., Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 5, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

DVT-2600 is a compressible limb sleeve system for DVT/PE prophylaxis in professional healthcare environments. Device uses air motor to deliver pressurized air to multi-chambered sleeves (calf, thigh, foot, or boot styles). Air is delivered sequentially through solenoid valves to inflate chambers, promoting venous blood flow. System operates on AC power (100-240VAC) with an auxiliary battery (3200mAh/3350mAh) for portability. Healthcare providers apply sleeves to patients; device operation is automated via internal controls. Output is mechanical compression (Leg: 20-60mmHg; Foot: 120-140mmHg). Clinical benefit is reduced risk of DVT/PE through improved circulation.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Compressible limb sleeve system; 3-chamber design; solenoid valve-controlled sequential inflation. Power: 100-240VAC, 50/60Hz; auxiliary battery (3200mAh/3350mAh). Pressure: Leg 20-60mmHg, Foot 120-140mmHg. Standards: IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2014, ISO 10993-5:2009, ISO 10993-10:2010.

Indications for Use

Indicated for patients at risk of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) requiring increased venous blood flow for prophylaxis.

Regulatory Classification

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.

Predicate Devices

• THE VENOUS ASSIST SYSTEM (K112677)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 :
- [e-mail]
- 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:

II

- 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 |
| Regulation<br>Number | 21 CFR 870.5800 | 21 CFR 870.5800 |
| Regulation<br>Name | Compressible Limb Sleeve | Compressible Limb Sleeve |
| Indications For Use | A device intended to prevent Deep Vein<br>Thrombosis/Pulmonary Embolism (DVT/PE) by<br>increasing venous blood flow to a patient who has a<br>risk of DVT/PE. | DVT-2600 is a system to prevent DVT (Deep Vein<br>Thrombosis) by improving the blood velocity of<br>patients.<br>DVT-2600 is Circulation Enhancement, Deep Vein<br>Thrombosis Prophylaxis, Edema - Acute, Edema -<br>Chronic, Extremity Pain Incident to Trauma or<br>Surgery Leg Ulcers, Venous Stasis / Venous<br>Insufficiency |
| Intended Use<br>environment | Professional healthcare environment | Professional healthcare environment |

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

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| Accessories | Calf sleeve<br>Thigh sleeve<br>Foot sleeve<br>Boots sleeve | Calf sleeve<br>Thigh sleeve<br>Foot sleeve<br>Boots sleeve |
|-------------------|------------------------------------------------------------|------------------------------------------------------------|
| Specifications | | |
| Power Source | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz |
| Pressure | LEG : 20-60mmHg<br>FOOT : 120-140mmHg | LEG : 20-60mmHg<br>FOOT : 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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1) 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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