(32 days)
Not Found
No
The description focuses on standard Doppler ultrasound principles and calculations (velocity * area) without mentioning any AI/ML techniques for image processing, data analysis, or decision support.
No
Explanation: The device is intended for intraoperative examinations of blood flow measurements, which is a diagnostic purpose, not a therapeutic one. It measures blood flow but does not treat or alleviate any condition.
Yes
The device is described as being intended for "intraoperative examinations of blood flow measurements," which is a diagnostic purpose to assess a physiological condition.
No
The device description explicitly states it is a "dual-beam, angle-independent, pulsewave Doppler ultrasound system," which describes hardware components necessary for generating and receiving ultrasound signals.
Based on the provided information, the Quantix OR + Vessel Stabilizer device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intraoperative examinations of blood flow measurements." This involves directly examining blood flow within the body during surgery.
- Device Description: The device is described as a "dual-beam, angle-independent, pulsewave Doppler ultrasound system used for intraoperative blood flow volume." It uses ultrasound to measure blood flow in vivo.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
The Quantix OR + Vessel Stabilizer device operates in vivo (within the living body) to measure blood flow directly, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Quantix OR + Vessel Stabilizer device is intended for intraoperative examinations of blood flow measurements.
Product codes (comma separated list FDA assigned to the subject device)
74 DPW
Device Description
The Quantix OR + Vessel Stabilizer accessory is a dual-beam, angle-independent, pulsewave Doppler ultrasound system used for intraoperative blood flow volume. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix OR + Vessel Stabilizer technology utilizes special applications of 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 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
Doppler ultrasound
Anatomical Site
Not Found
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.
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
JUN - 7 2004
KD41180
(Premarket Notification [510(k)] Number)
- Applicant
Cardiosonix Ltd. Beit Milenium 3 Hatidhar Str. Rananna, 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
| 2. Device Name: | Vessel Stabilizer | |||
|---|---|---|---|---|
| Device trade/proprietary name: Quantix OR + Vessel Stabilizer Device | ||||
| Common Name: | Blood Flowmeter | |||
| Classification Name: | Cardiovascular Blood Flowmeter, Class II, 870.2100 |
3. Predicate Devices
The Quantix OR + Vessel Stabilizer device is substantially equivalent to the following device:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| Quantix OR device | Cardiosonix Ltd. | K030357 |
1
4. Intended Use
The Quantix OR + Vessel Stabilizer device is intended for intraoperative examinations of blood flow measurements.
5. Description of the Device
The Quantix OR + Vessel Stabilizer accessory is a dual-beam, angle-independent, pulsewave Doppler ultrasound system used for intraoperative blood flow volume. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix OR + Vessel Stabilizer technology utilizes special applications of 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 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 + Vessel Stabilizer device are substantially equivalent to the predicate device cited above.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Cardiosonix Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consultant Beit Hapa'amon (Box 124) 20 Hata'as Street, 44425 Kfar Saba ISRAEL
Re: K041180
Quantix OR with Vessel Stabilizer Regulation Number: 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: 74 DPW Dated: April 26, 2004 Received: May 6, 2004
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 mersate continered price o hat 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 the general oonlines pro ragistration, 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 rr your device is enabilitional 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 that I Dr Has Intal statutes and regulations administered by other Federal agencies. You must or any I vath 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 premarket I his lotter will and in your ding of substantial equivalence of your device to a legally marketed predication. - The FD 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 If you debre 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 (201) 597 1039. Thise (21 CFR Part 807.97). Other general information on your presponsibilities 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". (2017) 113 6597 01 at wind a regarding the content of this letter, please contact Kachi Enyinna at (301) 443-8262.
Sincerely yours,
Donna R. Vachner
Image /page/3/Picture/7 description: The image contains a signature. The signature appears to be handwritten in cursive. The first letter is a capital B, and the rest of the signature is difficult to read.
/ 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 Statement
Page 1 of 1
510(k) Number (if known): K041| 8 O
Quantix OR device Device Name:
Indications for use: The Quantix OR Vessel Stabilizer device is intended for intra-The Quantinations of blood flow measurements.
Prescription Use (Per 21 C.F.R. 801.109) ાર
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dina R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices 25 104 510/k) Number K 02
5
Indications for Use Form
Fill out one form for each ultrasound system and each transducer. 510(k) No.: K0411 80 510(K) No.. - Ico411 80
Intended Use: Intra-operative examination of Blood Flow Measurements
Transducer: 4 MHz probe Mode of Oneration
| Clinical
Application | A | B | C | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|-------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| | | | | | | | | | | |
| Intra-operative | | | | X | | | | | | |
| (Specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| 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) | | | | | | | | | | |
Other (opens)
N= New Indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
(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)
| Donna R. Lechner | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number K 041180 |
6
Indications for Use Form
Fill out one form for each ultrasound system and each transducer. KO 411 80 510(k) No.: 10(x) No.. - RD 41) 30
Intended Use: Intra-operative examination of Blood Flow Measurements 8 MHz probe Transducer:
Mode of Operation Power Color Color Combined Other (Amplitude) Velocity CWD Doppler PWD Clinical A B C (Specify) (Specify) Imaging Doppler Application Ophthalmic Fetal Abdominal Inina-operative P (Specify) P Intra-operative Neurological 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)
Oner (Specify)
N= New Indication; P = Previously cleared by FDA; E = Added under Appendix E
Additional Comments:
(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)
Duna P. Vachaver
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
3 of 3