(198 days)
Not Found
No
The device description details standard Doppler ultrasound principles and calculations (velocity * area) without mentioning any AI/ML components or algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is intended for diagnostic purposes (measuring blood flow), not for treating a condition or disease.
Yes
The intended use explicitly states "Diagnostic blood flow measurements." The device description details how it measures blood flow velocity and volume, which are diagnostic indicators.
No
The device description explicitly states it is a "dual-beam, angle-independent, pulse-wave Doppler ultrasound system" and mentions a "miniature, sterilizable transducer," indicating the presence of hardware components beyond just software.
Based on the provided information, the Quantix/OR device 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. They are performed outside of the living body.
- Quantix/OR Function: The Quantix/OR device is described as being used for "intra-operative examinations of blood flow measurements" and for "direct application to exposed blood vessel". This indicates that the measurements are being taken directly on the living patient during surgery.
Therefore, because the device is used for measurements taken in vivo (within the living body) rather than in vitro (outside the living body), it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantix/OR device is intended for intra-operative examinations of blood flow measurements.
Intended Use: Diagnostic blood flow measurements
Product codes (comma separated list FDA assigned to the subject device)
74 DPW
Device Description
The Quantix/OR is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for intra-operative volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/OR technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in target blood vessels. By definition, blood flow is the product of velocity and 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-section area of the blood vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pulse-wave Doppler ultrasound
Anatomical Site
blood flow measurements in target blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intra-operative
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.
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
SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS
(Premarket Notification [510(k)] Number)
1. Applicant
Cardiosonix Ltd. 3 Hatedhar Str. P.O.B. 3035. Raa'nana 43654 ISRAEL Tel: +972-9-7766444 Fax: +972-9-7766445
Corresponding Official:
Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534
- Device Name
Device trade or proprietary name: Quantix/OR device Blood Flowmeter Common Name: Classification Name: Cardiovascular Blood Flowmeter, Class II, 870.2100
3. Predicate Devices
The Quantix/OR device is substantially equivalent to the following device:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| FlowGuard | Biosonix Ltd./Cardiosonix Ltd. | K013803 |
1
4. Intended Use
The Quantix/OR device is intended for intra-operative examinations of blood flow measurements.
5. Description of the Device
The Quantix/OR is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for intra-operative volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/OR technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in target blood vessels. By definition, blood flow is the product of velocity and 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-section area of the blood vessel..
6. Technological Characteristics Compared to Predicate Device
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Quantix/OR device are substantially equivalent to the predicate devices cited above.
Signature
General Manager, Dr. Danny Manor
Jan. 27, 2003
Date
Date
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal. The seal is circular and contains an image of an eagle. The words "Department of Health & Human Services USA" are written around the edge of the seal.
AUG 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiosonix Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consultant Beit Hapa'amon (Box 124) 20 Hata'as Street. 44425 Kfar Saba ISRAEL
Re: K030357
Quantix/OR Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: 74 DPW Dated: June 22, 2003 Received: June 26, 2003
Dear Ms. Stein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Bi-Directional Doppler Volume Flowmeter, as described in your premarket notification:
Model CSN 01095 Model CSN 01094
3
Page 2 - Ms. Ahava Stein
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 mav 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); 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.
This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. 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" (21 CFR Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Kachi Enyinna at (301) 443-8262.
Sincerely yours,
Nolatter
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Indications for Use Form Fill out one form for each ultrasound system and each transducer.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| Application | A | B | C | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| (Specify) | X | |||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-Skeletal | ||||||||||
| Conventional | ||||||||||
| Muscolo-Skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Specify) |
Intended Use: Diagnostic blood flow measurements
Additional Comments: Intra-operative (Specify): For direct application to exposed blood vessel (miniature, sterilizable transducer)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Indications for Use Form Fill out one form for each ultrasound system and each transducer.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030357