(65 days)
Not Found
No
The device description and performance studies focus on mechanical operation and standard electrical/biocompatibility testing, with no mention of AI/ML terms or data-driven performance metrics.
Yes
The device is intended to prevent DVT/PE by increasing venous blood flow, which is a therapeutic intervention aimed at preventing a medical condition.
No
The device is intended to prevent DVT/PE by increasing venous blood flow, not to diagnose a condition. Its function is stated as preventing a condition, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly mentions hardware components like an air motor, sleeves with air chambers, and solenoid valves, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent DVT/PE by increasing venous blood flow. This is a therapeutic/prophylactic action performed directly on the patient's body.
- Device Description: The device description details a mechanical system (air motor, sleeves, air chambers, solenoid valve) that physically interacts with the patient to achieve the intended effect.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device operates in vivo (inside or on the body) to provide a physical therapy.
N/A
Intended Use / Indications for 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.
Product codes
JOW
Device Description
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.
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
Professional healthcare environment
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)
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 DVT-2600 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
Clinical Test Summary:
Clinical testing was not required to demonstrate the substantial equivalence of the DVT-2600 to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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:
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 | ||
| Number | 21 CFR 870.5800 | 21 CFR 870.5800 |
| Regulation | ||
| Name | Compressible Limb Sleeve | Compressible Limb Sleeve |
| Indications For 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. | 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 | ||
| Intended Use | ||
| environment | Professional healthcare environment | Professional healthcare environment |
[Table 1. Comparison of Proposed Device to Predicate Device]
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| Accessories | Calf sleeve
Thigh sleeve
Foot sleeve
Boots sleeve | Calf sleeve
Thigh sleeve
Foot sleeve
Boots sleeve |
|-------------------|------------------------------------------------------------|------------------------------------------------------------|
| Specifications | | |
| Power Source | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz |
| Pressure | LEG : 20-60mmHg
FOOT : 120-140mmHg | LEG : 20-60mmHg
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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- 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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