(129 days)
Not Found
No
The description focuses on mechanical operation (air chambers, solenoid valves) and does not mention any AI/ML terms or data processing that would suggest AI/ML is used.
Yes.
The device is intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow, which is a medical intervention aimed at treating or preventing a disease or condition.
No
The device description states its intention is to prevent DVT/PE by increasing venous blood flow, not to diagnose a condition.
No
The device description explicitly mentions an "air motor," "sleeve composed of four air chambers," and "solenoid valve," which are all hardware components. The performance studies also focus on electrical safety and electromagnetic compatibility, further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended to prevent DVT/PE by increasing venous blood flow. This is a therapeutic or preventative action performed on the patient's body, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a mechanical device that uses air pressure to inflate sleeves on the patient's limbs. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
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-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 :
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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
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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) | |||
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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 |
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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 DVT-2600
- 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-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 |
| 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. | A device intended to prevent DVT/PE by increasing | |
| venous blood flow to a patient who has a risk of | ||
| DVT/PE. | ||
| Intended Use | ||
| environment | Professional healthcare environment | Professional healthcare environment |
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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
90VA | 100-240VAC, 50/60Hz
35VA |
| Pressure | LEG : 20-60mmHg
FOOT : 120-140mmHg | LEG : 20-60mmHg
FOOT : 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 :
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- 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.
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