IMEX STETHODOP by IMEX MEDICAL SYSTEMS, INC.

This document is a marketing clearance letter from the FDA for the IMEX StethoDop™ (Doppler Ultrasound Device) with a 5 MHz transducer, dated February 5, 1998. It establishes substantial equivalence to a predicate device and allows the manufacturer to market the device.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or how ground truth was established for training sets.

The document primarily focuses on regulatory approval, substantial equivalence, manufacturing practices, labeling regulations, and post-clearance reporting requirements related to acoustic output measurements. The "Indications for Use Form" in Appendix F lists various clinical applications and modes of operation for ultrasound systems but does not provide performance metrics or acceptance criteria for the IMEX StethoDop™.

Therefore, based solely on the provided text, I cannot complete the requested tables and information.

Summary

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are capitalized, and the ampersand symbol (&) is used to connect "HEALTH" and "HUMAN".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David W. Wagner Director, Quality Assurance and Regulatory Affairs Imex Medical Systems, Inc. 6355 Joyce Drive Golden, Colorado 80403

Re : K973336 IMEX StethoDop™ (Doppler Ultrasound Device) Dated: December 11, 1997 December 17, 1997 Received: Regulatory class: İI 90 JAF 21 CFR 892.1540/Procode:

Dear Mr. Wagner:

We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls The general controls provisions of the Act include provisions Act (Act). requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the IMEX StethoDop™, as described in your premarket notification:

Transducer Model Number

5 MHz

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good ……… Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

FEB - 5 1998

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Page 2 - David W. Waqner

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 and additionally 809.10 for in vitro diagnostic devices), 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 Paul Gammell at (301) 594-1212.

Sincerely yours,

Daniel A. Siggman
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, nd Radiological Devices ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973336

Appendix F

Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	PowerDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (specify)

Additional Comments: IMEX STETHODOP K973336

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109) Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K973336

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Regulation Number and Section

§ 892.1540 Nonfetal ultrasonic monitor.

(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.