(98 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device description is not available, and there are no mentions of image processing, AI, DNN, or ML.
Yes
The device is intended for treating various medical conditions, including prevention of DVT, reduction of pain and swelling, enhancement of venous circulation, and treatment of chronic venous insufficiency, which categorizes it as a therapeutic device.
No
The "Intended Use / Indications for Use" section specifies the device for treating conditions like DVT prevention, pain/swelling reduction, and circulation enhancement, not for diagnosing them.
No
The intended use explicitly mentions "compression garments," which are physical components and not software. The device description is not available, but the mention of hardware in the intended use is sufficient to disqualify it as a software-only medical device.
Based on the provided information, the Phlebo Press DVT Model 760D is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for treating conditions like DVT prevention, pain/swelling reduction, circulation enhancement, etc. These are all conditions related to the physical body and its circulation, not the analysis of samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: While the description is "Not Found," the intended use clearly points to a device that applies external compression.
- No Mention of IVD Activities: There is no mention of analyzing samples, reagents, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Phlebo Press DVT Model 760D is a therapeutic device that applies external pressure to the limbs.
N/A
Intended Use / Indications for Use
The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as:
- Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- Reduction of pain and swelling after injury and surgery
- Enhancement of venous circulation
- Prevention of venous stasis
- Assistance in healing of cutaneous ulcers
- Reducing edema
- Treatment of chronic venous insufficiency
The device is intended for hospital, home and clinic use
Product codes
JOW
Device Description
Phlebo Press DVT Model 760D
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
healthcare professionals, and patients who are under medical supervision / hospital, home and clinic use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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).
0
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 3, 2017
Mego Afek AC Ltd. Ilan Sharon A 109 Neot Golf Caesarea, 3088900 Il
Re: K172277
Trade/Device Name: Phlebo Press DVT Model 760D Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 3. 2017 Received: August 7, 2017
Dear Ilan Sharon:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) 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,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172277
Device Name Phlebo Press DVT Model 760D
Indications for Use (Describe)
The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as:
- · Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- · Reduction of pain and swelling after injury and surgery
- · Enhancement of venous circulation
- · Prevention of venous stasis
- · Assistance in healing of cutaneous ulcers
- · Reducing edema
- · Treatment of chronic venous insufficiency
The device is intended for hospital, home and clinic use
| 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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