CAREDOP II

K982635 · Nicolet Biomedical · JAF · Aug 7, 1998 · Radiology

Device Facts

• Record ID: K982635
• Device Name: CAREDOP II
• Applicant: Nicolet Biomedical
• Product Code: JAF · Radiology
• Decision Date: Aug 7, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1540
• Device Class: Class 2

Intended Use

Monitoring of blood flow in veins and arteries to assist in the detection of vascular disease and detection of early fetal heartbeat Instrument used in doctor's office, clinic or hospital, by use for on the order of a physician. The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.

Device Story

CareDop II is a non-invasive Doppler ultrasound device used in clinical settings (doctor's office, clinic, hospital) by physicians or under their order. It monitors blood flow in veins and arteries to assist in vascular disease detection and early fetal heartbeat identification. The device operates by emitting ultrasound signals, receiving reflections from moving blood cells, and processing these signals to provide audible or visual feedback to the clinician. This output assists the physician in assessing vascular health or fetal status, facilitating clinical decision-making regarding patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-invasive Doppler ultrasound device. Intended for clinical use. Operates via ultrasound signal transmission and reception for blood flow monitoring. Class II device under 21 CFR 892.1540.

Indications for Use

Indicated for monitoring blood flow in veins and arteries to assist in detecting vascular disease and early fetal heartbeat. For use in clinical settings (doctor's office, clinic, hospital) by or on order of a physician. Contraindications: non-intact skin, eyes.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1998

David Wagner Director/Quality Assurance & Regulatory Affairs Nicolet Vascular Inc. 6355 Joyce Dr. Golden, CO. 80403

Re:

K982635 CareDop II Dated: June 22, 1998 Received: July 13, 1998 Regulatory class: II 21 CFR 892.1540/Procode: 90 JAF

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 (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.

If your device is classified (see above) into either class II (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510%) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k)

Device Name: CareDop II

Indications for Use:

Monitoring of blood flow in veins and arteries to assist in the detection of vascular disease and detection of early fetal heartbeat Instrument used in doctor's office, clinic or hospital, by use for on the order of a physician.

The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

hilliards

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982635

Prescription Use X (per 21 CFR 801.109)

OR

Over-the-Counter Use***_***_