(60 days)
Not Found
No
The description focuses on standard physiological measurement techniques (PVR, oscillometric blood pressure) and does not mention any AI/ML terms or capabilities.
No
The device is used to assist in the diagnosis of vascular disease by assessing peripheral arterial disease and calculating the Ankle Brachial Index; it does not treat or prevent disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is used "to assist in the diagnosis of vascular disease."
No
The device description explicitly mentions hardware components such as pneumatic volume plethysmography recording (PVR), oscillometric systolic blood pressure measurement, four connected cuffs, an internal battery, and an external line-powered supply.
Based on the provided information, the Vantage ABI 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.
- Vantage ABI function: The description clearly states that the Vantage ABI is a non-invasive device that uses pneumatic volume plethysmography and oscillometric blood pressure measurements. It works by applying cuffs to the limbs and measuring physical parameters (volume changes and pressure) externally.
- No sample analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, the Vantage ABI falls under the category of a non-invasive medical device used for diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.
Product codes
IOM, DXN
Device Description
The Vantage ABI performs the ankle-brachial index examination to assist in the diagnosis of peripheral arterial disease. The system will be used to assess peripheral arterial disease using pneumatic volume plethysmography recording (PVR), estimate the systolic blood pressure for each limb and calculate the Ankle Brachial Index. The unit will record a PVR waveform at each ankle and measure pressures in each limb. Four cuffs will be connected. This unit can be powered from its internal battery or from an external line-powered supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremity arterial system, each ankle, each limb
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)
Not Found
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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K103693 pg 1 of 1
FEB 1 5 2011
SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. Vantage ABI
Name and Address: Summit Doppler Systems, Inc. 4680 Table Mountain Dr. #150 Golden, CO 80403 Phone: (303) 423-7572 Fax: (303) 431-5994 Contact: Ken Jarrell - President Preparation Date: November 30, 2011 Device Name: Vantage ABI Common Name: Plethysmograph Classification: Class II: FR Number Product Code Cardio Vascular Monitoring Device 820.2780 IOM Indications for Use: The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease. Description: The Vantage ABI performs the ankle-brachial index examination to assist in the diagnosis of peripheral arterial disease. The system will be used to assess peripheral arterial disease using pneumatic volume plethysmography recording (PVR), estimate the systolic blood pressure for each limb and calculate the Ankle Brachial Index. The unit will record a PVR waveform at each ankle and measure pressures in each limb. Four cuffs will be connected. This unit can be powered from its internal battery or from an external line-powered supply. Substantial Equivalence: The Vantage ABI is substantially equivalent to the cleared devices shown below. BioMedix, PADnet K042616, Cleared 10/12/2004 Summit Doppler Systems, Vista AVS K063600, Cleared 12/22/2006 This device uses pneumatic volume plethysmography recording (PVR) and Technologies Summary: Ankle Brachial Index (ABI) to assist in the diagnosis of vascular disease in the same manner as the predicate devices. Based on comparisons of device features, materials, intended use and Conclusion: performance, and user instructions, the Vantage ABI is shown to be substantially equivalent to the commercially available and legally marketed device indicated above.
1
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Summit Doppler Systems, Inc. c/o Ms. Dawn Tibodeau Responsible Third Party Official TUV SUD America, Inc. 1775 Old Highway 8 NW New Brighton, MN 55112-1891
FEB 1 5 201
Re: K103693
Trade Name: Vantage ABI Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: January 28, 2011 Received: January 31, 2011
Dear Ms. Tibodeau:
.
the same of the states of the
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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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.fdaggov/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For 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: K103693
Device Name:
Vantage ABI
The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.
× 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 CDRH, Office of Device Evaluation (ODE)
W.M.A.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103693