(87 days)
Not Found
No
The description focuses on a microprocessor-controlled pneumatic pump with preset pressure cycles, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
Yes.
The device is designed to prevent DVT (Deep Vein Thrombosis) by aiding blood flow, which is a therapeutic purpose.
No
The device is designed to prevent DVT by aiding blood flow, not to diagnose the condition. Its function is therapeutic/prophylactic rather than diagnostic.
No
The device description explicitly states it is a "microprocessor controlled pneumatic pump" and includes "single chamber leg garments (sleeves) or foot garments (sleeves)," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the Venodyne DVT Advantage 810 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to compress the lower limbs to aid blood flow and prevent DVT. This is a physical intervention applied to the patient's body.
- Device Description: The device is a pneumatic pump that inflates garments on the patient's limbs. This is a mechanical action.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The Venodyne DVT Advantage 810 does not interact with any specimens in this way.
The device is a therapeutic device used to treat or prevent a medical condition through physical means.
N/A
Intended Use / Indications for Use
The Venodyne DVT Advantage 810 venous compression system is an instrument designed to reduce the incidence of venous thromboembolism by preventing the lower limbs or feet aiding the blood flow back toward the heart to help prevent DVT (Deep Vein Thrombosis) in Patients at risk.
The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Vein Thrombosis) in patients at risk.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Venodyne DVT Advantage 810 compression system is a microprocessor controlled pneumatic pump that inflates and deflates a set of single chamber leg garments (sleeves) or foot garments (sleeves), which are placed on the patient's lower limbs or feet. During the inflation cycle, the inflatable garments compress the limb or foot along with the veins contained within to a preset pressure. This assists in propelling blood from the lower limbs or feet towards the heart. During the deflation cycle, the veins are allowed to fill with blood. The cycle is repeated intermittently.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs or feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing was performed on the proposed Venodyne DVT Advantage 810 compression system to confirm substantial equivalence to the predicate device(s). Testing included Electrical Safety testing according to UL 60601-1, CAN/CSAC22.2 601 .- M90, CAN/CSA C22.2 601.1S1-94, and CAN/CSA C22.2 601.1B-98, Radio Disturbance according to EN 55011:2007, Radio Noise Emissions according to FCC part 18 and Electromagnetic Compatibility according to EN 60601-1-2:2007. In addition Verification and Validation testing was performed on general controller features, compression cycle operation, alarm modes, and battery operations. Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s).
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
510(k) Summary -- K110358
Submitter Information:
Microtek Medical, Inc. 602 Lehmberg Road Columbus, Mississippi 39702
| Contact person: | Amy Fowler |
|---|---|
| Contact address: | Ecolab Inc. EUC 9 370 Wabasha Street North St. Paul, MN 55102 |
| Contact e-mail address: | amy.fowler@ecolab.com |
| Office telephone: | 651-293-2237 |
| Fax: | 651-225-3122 |
Date Prepared: April 14, 2011
Device Name:
Proprietary name: Microtek Medical, Inc. Venodyne DVT Advantage, 810 Compression System
Common name: Compressible Limb Sleeve Pump
Classification name: Compressible Limb Sleeve Pump, 21 CFR 870.5800
Predicate Devices:
- K040511 SCD Express Portable Compression System, Tyco Healthcare/Kendall
- Venodyne Model 610, Microtek Medical, Inc. K001802
Venodyne DVT Advantage Plus 710, Microtek Medical, Inc. K011318
Description of Device:
The Venodyne DVT Advantage 810 compression system is a microprocessor controlled pneumatic pump that inflates and deflates a set of single chamber leg garments (sleeves) or foot garments (sleeves), which are placed on the patient's lower limbs or feet. During the inflation cycle, the inflatable garments compress the limb or foot along with the veins contained within to a preset pressure. This assists in propelling blood from the lower
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limbs or feet towards the heart. During the deflation cycle, the veins are allowed to fill with blood. The cycle is repeated intermittently.
Intended Use:
The Venodyne DVT Advantage 810 venous compression system is an instrument designed to reduce the incidence of venous thromboembolism by preventing the lower limbs or feet aiding the blood flow back toward the heart to help prevent DVT (Deep Vein Thrombosis) in Patients at risk.
Technological Characteristics:
Testing was performed on the proposed Venodyne DVT Advantage 810 compression system to confirm substantial equivalence to the predicate device(s). Testing included Electrical Safety testing according to UL 60601-1, CAN/CSAC22.2 601 .- M90, CAN/CSA C22.2 601.1S1-94, and CAN/CSA C22.2 601.1B-98, Radio Disturbance according to EN 55011:2007, Radio Noise Emissions according to FCC part 18 and Electromagnetic Compatibility according to EN 60601-1-2:2007. In addition Verification and Validation testing was performed on general controller features, compression cycle operation, alarm modes, and battery operations. Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Microtek Medical, Inc. c/o Mr. Tom Bonner Vice President, Regulatory Affairs 602 Lehmberg Road Columbus, MS 39702
MAY - 5 2011
Re: K110358
Trade/Device Name: Venodyne V810 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: April 18, 2011 Received: April 20, 2011
Dear Mr. Bonner:
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. 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.
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Page 2 - Mr. Tom Bonner
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Venodyne DVT Advantage Model 810
Indications For Use:
The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Vein Thrombosis) in patients at risk.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of &DRH, Office of Device Evaluation (ODE)
(Division Sign Off)
(Division Sign-Off) Division of Cardio 510(k) Number
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