(26 days)
Not Found
No
The description focuses on standard Doppler ultrasound principles and calculations (velocity * cross-sectional area) without mentioning any AI or ML components for analysis or interpretation.
No.
The device is described as a diagnostic tool for measuring blood flow, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for invasive and noninvasive diagnostic blood flow measurements."
No
The device description explicitly states it is a "dualbeam, angle independent, pulse-wave Doppler ultrasound system" and mentions a "Flexible Probe and Vessel Stabilizer," indicating it includes hardware components beyond just software.
Based on the provided information, the Quantix/OR Blood Flow Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The Quantix/OR Blood Flow Monitor is described as performing "invasive and noninvasive diagnostic blood flow measurements" directly on blood vessels within the body using ultrasound.
- The device description focuses on measuring blood flow in vivo (within a living organism). It describes using ultrasound Doppler to measure blood flow velocity and calculate blood flow volume in target blood vessels. This is a direct measurement of a physiological process happening inside the body.
Therefore, the Quantix/OR Blood Flow Monitor falls under the category of a diagnostic medical device used for in-vivo measurements, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quantix/OR™ Flexible Probe and optional Vessel Stabilizers are intended for invasive and noninvasive diagnostic blood flow measurements.
The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.
Product codes (comma separated list FDA assigned to the subject device)
DPW
Device Description
The Quantix/OR™ Blood Flow Monitor with Flexible Probe and Vessel Stabilizer is a dualbeam, angle independent, pulse-wave Doppler ultrasound system for the invasive and noninvasive blood vessel flow measurements. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/OR™ Flexible Probe technology utilizes ultrasound Doppler methods to obtain real-time measurements according to the definition of blood flow volume to target blood vessels. By definition, blood flow is the product of velocity cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-sectional area of the blood vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
blood vessels
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): 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.
K018303, K030357, K041180, K992305, K872048
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
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
FEB - 8 2005
1.8 - Summary of Safety and Effectiveness
Premarket Notification
1.8.1 Applicant
Cardiosonix, Ltd. A Neoprobe Company 425 Metro Place North, Suite 300 Dublin, Ohio 43017-1367 U.S.A. Telephone: +1 614-793-7500 Facsimile: +1 614-793-7520
1.8.2 Official Correspondent
| Name: | Rodger A. Brown |
|---|---|
| Address: | 425 Metro Place North |
| Suite 300 | |
| Dublin, Ohio 43017-1367 U.S.A | |
| Telephone: | +1 614-822-8342 |
| Facsimile: | +1 614-822-8343 |
| E-mail: | rbrown@neoprobe.com |
1.8.2 Device Identification
| Device Name: | Quantix/OR TM Blood Flow Monitor |
|---|---|
| Device Trade or proprietary Name: | Quantix/OR TM Flexible Probe; Quantix/OR TM |
| Vessel Stabilizer | |
| Common Name: | Blood Flowmeter |
| Classification Name: | Cardiovascular Blood Flowmeter, Class II, |
| 870.2100 |
1.8.3 Predicate Device
The Quantix/OR™ Blood Flow Monitor with Flexible Probe and vessel Stabilizer is substantially equivalent to the following device(s):
| Device | Manufacturer | 510(k) No |
|---|---|---|
| FlowGuard probe | Biosonix, Ltd. | K018303 |
| Quantix/ORTM Blood Flow Monitor (Rigid probe) | Cardiosonix, Ltd. | K030357 |
| Quantix/ORTM Vessel Stabilizer (Flexible probe) | Cardiosonix, Ltd. | K041180 |
| Butterfly Flowmeter BF1000 – BF2004 | Medi-Stim | K992305 |
| Flowmeter | Transonic | K872048 |
1.8.4 Intended Use
The Quantix/OR™ Flexible Probe and optional Vessel Stabilizers are intended for invasive and noninvasive diagnostic blood flow measurements.
1
1.8.5 Description of the Device
The Quantix/OR™ Blood Flow Monitor with Flexible Probe and Vessel Stabilizer is a dualbeam, angle independent, pulse-wave Doppler ultrasound system for the invasive and noninvasive blood vessel flow measurements. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ORTM Flexible Probe technology utilizes ultrasound Doppler methods to obtain real-time measurements according to the definition of blood flow volume to target blood vessels. By definition, blood flow is the product of velocity cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-sectional area of the blood vessel.
1.8.6 Technological Characteristics
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Flexible Probe and Vessel Stabilizer modifications are substantially equivalent to the predicate devices cited above.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
Public Health Service
FEB - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neoprobe Corporation c/o Mr. Rodger A. Brown Vice President, Regulatory Affairs and Quality Assurance 425 Metro Place North, Suite 300 Dubin, OH 43017-1367
Re: K050088
Quantix/OR™ Blood Flow Monitor, Flexible Probe with optional Vessel Stabilizer Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: January 10, 2005 Received: January 13, 2005
Dear Mr. Brown:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Rodger A. Brown
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Durna D. Jochner
( 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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1.1 - Indications for Use Statement
Page 1 of 1
K050088 510(k) Number (if known):
Device Name: Quantix/OR™ Blood Flow Monitor
Indications for use:
The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.
Prescription Use 区 (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use [ (Optional Format 1-2-96)
008
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Diving Lecture 1
(Di ision Sign-Off) Di ion of Cardiovascular Devices
1 Number 105008 8