(82 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device description and intended use focus on mechanical compression for DVT prevention and circulation enhancement.
Yes
The device is intended to treat multiple medical conditions such as DVT, pain and swelling, and venous stasis, fitting the definition of a therapeutic device.
No
The intended use describes the device as a treatment for various conditions, such as preventing DVT, reducing pain and swelling, and enhancing circulation. It does not mention any diagnostic capabilities.
No
The provided 510(k) summary describes a device called "Phlebo Press DVT 603" and its intended uses, which are related to physical treatment (prevention of DVT, reduction of pain/swelling, enhancement of venous circulation, etc.). The name "Phlebo Press" strongly suggests a physical compression device. The summary lacks a "Device Description" section, which would typically clarify if it's software or hardware. Without a description explicitly stating it is software-only, and given the name and intended uses pointing towards a physical device, it cannot be confirmed as software-only.
Based on the provided information, the Phlebo Press DVT 603 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Phlebo Press DVT 603 Function: The intended use describes the Phlebo Press DVT 603 as a device for treating conditions like DVT prevention, pain reduction, and circulation enhancement. This is a therapeutic or preventative physical therapy device, not a diagnostic test performed on a sample.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or pathogens.
- Providing diagnostic information based on laboratory analysis.
Therefore, the Phlebo Press DVT 603 falls under the category of a medical device used for treatment and prevention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Phlebo Press DVT 603 is intended for use by medical 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
-
- Reduction of compartmental pressures
The device is intended for hospital, home and clinic use
- Reduction of compartmental pressures
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medical 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central graphic. The graphic depicts three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2015
Mego Afek AC Ltd Aharon Cohen QA & RA Manager Kibbutz Afek Afek, 30042, Israel
Re: K142772
Trade/Device Name: Phlebo Press DVT 603 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Dated: September 30, 2014 Received: October 3, 2014
Dear Aharon Cohen:
This letter corrects our substantially equivalent letter of December 16, 2014.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
for
Sincerely vours.
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)
Device Name Phlebo Press DVT 603
Indications for Use (Describe)
The Phlebo Press DVT 603 is intended for use by medical 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
-
- Reduction of compartmental pressures
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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