(28 days)
Not Found
No
The document describes a Doppler flow probe and monitor system for blood flow monitoring. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The technology described is standard Doppler ultrasound for flow detection.
No
The device is used for monitoring blood flow, which is a diagnostic or observational function, not a therapeutic one that directly treats or cures a condition.
Yes
The device is used for "monitoring blood flow," which is a diagnostic activity to assess the physiological state of vessels.
No
The device description explicitly mentions a "COOK-Swartz Doppler Flow Probe" which is a physical, sterile, single-use hardware component intended for insertion into the body. The system includes both a probe and a monitor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The COOK-Swartz Doppler Flow Probe and Monitor System is used to monitor blood flow directly within the vessels of a patient during surgery and post-operatively. This is an in vivo (within the living body) measurement.
- Intended Use: The intended use clearly states "monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers." This describes a direct measurement on the patient, not testing of a specimen.
Therefore, based on the provided information, the COOK-Swartz Doppler Flow Probe and Monitor System is a medical device used for in vivo monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use
Product codes (comma separated list FDA assigned to the subject device)
90-ITX
Device Description
The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Diagnostic ultrasound imaging or fluid flow analysis
Anatomical Site
vessels
Indicated Patient Age Range
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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.)
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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.
D.C. #K964001
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
KOZ
6 2002
SEP
Special 510 (k) Device Modification COOK-Swartz Doppler Flow Probe and Monitor System
9 of 9
K. 510 (K) SUMMARY
Submitted By:
Thomas J. Kardos Vice President, Requlatory Affairs Cook Vascular Incorporated P.O. Box 529 Leechburg, PA 15656 (724) 845-8621 August 6, 2002
Device:
Trade Name:
COOK-Swartz Doppler Flow Probe
Common/Usual Name:
Blood Flow Sensor or Probe, Doppler Catheter
Proposed Classification Name:
Diagnostic Ultrasonic Transducer probe, 21 CFR Part 892.1580 (90-ITX)
Predicate Devices:
The Modified COOK-Swartz Doppler Flow Probe is substantially equivalent to the currently marketed COOK-Swartz Doppler Flow Probe D.C. #K964001, with respect to intended use, material composition, and method of operation.
Device Description:
The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to the currently marketed and distributed COOK-Swartz Doppler Flow Probe D.C. #K964001 by Cook Vascular Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510 (k) substantial equivalency.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002 SEP
Mr. Thomas J. Kardos Vice President. Regulatory Affaris Cook Vascular Incorporated P.O. Box 529, Route 66 River Road LEECHBURG PA 15656-0529
Re: K022649
Trade Name: Cook-Swartz Doppler Flow Probe Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: August 6, 2002 Received: August 9, 2002
Dear Mr. Kardos:
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 Cook-Swartz Flow Probe and Monitoring System, as described in your premarket notification:
Transducer Model Number
COOK-Swartz Doppler Flow Probe
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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean
2
that FQA 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 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
David A. Seipmann
/rr
Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Cook-Swartz Doppler Flow Probe Device Name:
. _
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | P |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David Chi Atayman
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) A
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022649
4
Device Name: Cook Vascular Blood Flow Monitor (D.C.#K964001)
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diag̀nostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | ||||||||||
| Intraoperative Neurological | P | ||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | P |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The Cook Vascular Blood Flow Monitor is used with the
Cook-Swartz Doppler Flow Probe (D.C. #K964001) and the Cook Vascular
Shapeable Doppler Flow Probe (D.C. #K002958) to monitor blood flow intra-
operatively, during intraoperative neuro-vascular procedures, and following
reconstructive micro-vascular procedures, re-implantation and free flap transfer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Arvid A. Slayton
and R. 510(k) Nur
Prescription Use (Per 21 CFR 801.109)
、
5
Special 510 (k) Device Modification COOK-Swartz Doppler Flow Probe and Monitor System
Page 1 of 1
510(k) Number (if known): K022649
Device Name: COOK- Swartz Doppler Flow Probe
Indications For Use:
The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
Perscription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________