(85 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of such technologies.
No
Explanation: A therapeutic device is used for treatment. This device is used for detection and confirmation, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use" states "early detection of fetal life and confirmation of continued life." This aligns with the definition of a diagnostic device, as it is used to identify or confirm a medical condition (presence and viability of fetal life).
No
The device description and input imaging modality (Ultrasonic) strongly suggest this is a hardware device that uses ultrasound technology to detect fetal heart sounds, not a software-only device.
No, 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 Sonicaid®One Fetal Heart Detector uses ultrasonic technology to detect fetal heart sounds. This is a non-invasive method that does not involve testing samples taken from the body.
- Intended Use: The intended use is to detect and confirm fetal life, which is a direct assessment of a physiological process within the body, not an analysis of a biological sample.
Therefore, based on the provided information, the Sonicaid®One Fetal Heart Detector is a medical device, but it falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Sonicaid®One Fetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.
Product codes
85 HGM, 85 HGL
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
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" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 22 2003
Mr. Michael Edwards Regulatory Affairs & Quality Systems Manager Oxford Instruments Medical, Ltd. Manor Way, Old Woking Surrey GU22 9JU UNITED KINGDOM
Re: K023618
Trade Name: Sonicaid® One Fetal Heart Detector Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulation Number: 21 CFR 884.2960 Regulatory Name: Obstetric ultrasonic transducer and accessories Regulatory Class: II Product Code: 85 HGM and HGL Dated: December 19, 2002 Received: December 23, 2002
Dear Mr. Edwards:
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 Sonicaid® One Fetal Heart Detector, as described in your premarket notification:
Transducer Model Number
2MHz Continuous Wave
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
1
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 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 (OS) 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 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.
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, 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".
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Page 3 – Mr. Edwards
If you have any questions regarding the content of this letter, please contact Kathy Daws-Kopp at (301) 594-1180.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Attachment 2
Indications for Use Statement
510(k) Number (if known)
Device Name
Sonicaid®One Fetal Heart Detector
Indications for Use
The Sonicaid®One Fetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use____ OR Over-The-Counter Use_ (Per 21 CFR 801.109)
Nancyc brogdon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023618