(119 days)
No
The description details standard Doppler ultrasound technology for fetal heart rate detection and display, with no mention of AI or ML for signal processing or interpretation.
No
The device measures fetal heart rate, which is a diagnostic function, not a therapeutic one. It provides information about fetal well-being but does not treat or alleviate any condition.
No
The device measures fetal heart rate as a general indicator of fetal well-being, but it does not diagnose any specific disease or condition. It provides a measurement rather than a diagnostic conclusion.
No
The device description explicitly states that the Babycom™ includes a "transducer module for transmitting and receiving ultrasound signals" and a "signal analysis, control and display module, that we refer to as the base". These are hardware components, making it a hardware device with associated software, not a software-only medical device.
Based on the provided information, the Babycom™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Babycom™ is applied to the woman's abdomen and uses ultrasound to directly measure the fetal heart rate in vivo (within the living body). It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use is to measure fetal heart rate as a general indicator of fetal well-being. This is a physiological measurement taken directly from the patient, not an analysis of a sample.
The Babycom™ is a medical device that uses ultrasound technology for physiological monitoring.
N/A
Intended Use / Indications for Use
The Babycom™ is meant to be applied to a woman's abdomen during pregnancy in order to measure the fetal heart rate (FHR) as a general indicator of fetal well-being.
Product codes
85 KNG
Device Description
The Babycom™ is a fetal ultrasonic heart rate monitor that is designed to transmit and receive ultrasonic energy into and from a pregnant woman by means of continuous wave doppler echoscopy. The Babycom™ is used to represent the fetal heart rate in an immediately perceptible form, i.e., a digital display of the rate in beats per minute (bpm) and by an audible beating signal of the same rate. The Babycom™ includes a transducer module for transmitting and receiving ultrasound signals and a signal analysis, control and display module, that we refer to as the base, that carries out all the other Babycom™ functions. The Babycom™ measures the fetal heart rate by determining the doppler shift between the transmitted and received signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
Anatomical Site
abdomen (of a pregnant woman)
Indicated Patient Age Range
Not Found
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.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).
0
FEB 2 0 2002
K013547
Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
PMG Medica Ltd., 47 HaTa'asiya St. P.O.B. 515 Tel Hanan 36603, Israel Tel: +972.4.820.2794; Fax:+972.820.2794 e-mail: pmg2@netvision.net.il
Name of the Device: Babycom™
Predicate Devices: The Babycom™ is substantially equivalent to the Fetal Dopplex II, manufactured by Huntco Healthcare, Inc. (subject of K930200).
Description of the Device: The Babycom™ is a fetal ultrasonic heart rate monitor that is designed to transmit and receive ultrasonic energy into and from a pregnant woman by means of continuous wave doppler echoscopy. The Babycom™ is used to represent the fetal heart rate in an immediately perceptible form, i.e., a digital display of the rate in beats per minute (bpm) and by an audible beating signal of the same rate. The Babycom™ includes a transducer module for transmitting and receiving ultrasound signals and a signal analysis, control and display module, that we refer to as the base, that carries out all the other Babycom™ functions. The Babycom™ measures the fetal heart rate by determining the doppler shift between the transmitted and received signals. The differences between the Babycom™ and the predicate device raise no new issues of safety or effectiveness.
21 od. 01
Jacob Levy
Date
Dr. Jacob Levy, President
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
PMG Medical, Ltd. % Dr. Eli M. Orbach Managing Director d.b.a. International Regulatory Consultants POB 6718, Efrat 90435 ISRAEL
Re: K013547 Trade/Device Name: Babycom Ultrasonic Fetal Heart Rate Monitor Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG Dated: February 4, 2002
Received: February 6, 2002
Dear Dr. Orbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to 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 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.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use (separate page):
| 510(k) Number (if known) | K013547 |
|---|---|
| Device Name | The Babycom |
Page 1 of 1Indications For Use:
The Babycom™ is meant to be applied to a woman's abdomen during pregnancy in order to measure the fetal heart rate (FHR) as a general indicator of fetal well-being.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over The Counter Use_
(Optional Format 1-2-96)
David A. Segner