(25 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any related concepts. The description focuses on basic blood flow monitoring.
No
The device is described as assisting in the detection of vascular disease and early fetal heartbeat, which are diagnostic purposes, not therapeutic ones.
Yes
The device is used to assist in the detection of vascular disease, which is a diagnostic purpose.
Unknown
The provided text does not contain a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes a function (monitoring blood flow and detecting fetal heartbeat) that typically requires hardware components (like a Doppler probe or sensor) to acquire the necessary data. Without a description of how this monitoring is achieved, it's impossible to definitively say if it's purely software processing data from an external source or if the device itself includes hardware for data acquisition.
Based on the provided information, this 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.
- Device Function: The intended use describes the device as monitoring blood flow in veins and arteries and detecting fetal heartbeat. This is done by applying the device externally to the body (non-invasive use).
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body.
The device appears to be a non-invasive diagnostic tool that interacts directly with the patient's body to gather information, rather than analyzing a sample in a laboratory setting.
N/A
Intended Use / 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.
Product codes
90 JAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Veins and arteries
Indicated Patient Age Range
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Intended User / Care Setting
doctor's office, clinic or hospital, by use for on the order of a physician.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized wing or feather shapes extending upwards.
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 (301) 594-4613. 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 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 (800) 638-2041 or (301) 443-6597 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
1
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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__