(167 days)
No
The description focuses on basic Doppler technology for detecting and displaying FHR, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a fetal ultrasonic monitor intended for displaying fetal heart rate and allowing the user to hear the heartbeat sound, not for treating any medical condition.
Yes
The device is described as a fetal ultrasonic monitor that detects and displays FHR, and it is explicitly stated that it is "especially suitable for routine use in OB/GYN," indicating its role in providing objective medical information for monitoring purposes.
No
The device description explicitly mentions hardware components such as an ultrasound sensor, LCD display, speaker, and battery operation, indicating it is a physical device, not software-only.
Based on the provided information, the BABYCARE device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- BABYCARE's Function: BABYCARE uses ultrasonic energy to detect and display the fetal heart rate and allow the user to hear the fetal heartbeat. It interacts directly with the pregnant woman's body and does not analyze samples taken from the body.
Therefore, BABYCARE falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
Product codes
85 HEP
Device Description
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
Being operated with battery, it allows babies to be checked anywhere, at any time. Using high sensitive and harmless ultrasound sensor, it detects and displays the accurate FHR on the LCD. BABYCARE is especially suitable for routine use in OB/GYN.
Features:
- Accurate FHR detection & display -
- Clear sound offered from separate speaker -
- Cap-shaped speaker for probe protection -
- -Compact size and battery operated
- Harmless ultrasound sensor "
- Easy to use -
Technical Specifications:
- Display: 3-digit segment ー
- FHR Measuring Range: 50-240 bpm -
- Measurement Resolution: ± 3bpm -
- Speaker output power: 1 W -
- Ultrasound frequency: 2.0 Mhz -
- Power: 9V batterv -
- Sensitivity: 12 Weeks Fetus -
- Weight: 290g (without battery) ~
- Standard Accessory: Gel, 9V battery --
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
continuous wave (doppler) echoscopy
Anatomical Site
Not applicable
Indicated Patient Age Range
Not Found
Intended User / Care Setting
obstetrician, gynecologist, nurse, midwife.
maternity hospital
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)
This device is safe and effective as the predicate device.
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
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
K.023082
MAR 0 3 2003
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: BIONET Co., LTD
2-Address: #501, KICOX Venture Center, 188-5, Guro-Dong, Guro-Gu Seoul, South Korea 3-Phone:
+82 2 6300 6419 / +82 2 6300 6418
4-Fax:
5-Contact Person: Dong-Joo Kang, CEO
6-Date summary prepared: September 10th, 2002
7- Official Correspondent: Mansour Consulting LLC
+82 2 6300 6425
8- Address:
D
9- Phone: 10- Fax:
Alpharetta, GA 30022 USA (678) 908-8180 (425) 795-9341
1308 Morningside Park Dr
11- Contact person:
Jay Mansour, president 12-Device Trade or Proprietarv Name: BABYCARE
13-Device Common or usual name: HEP
14-Device Classification Name: MONITOR, BLOOD-FLOW,
ULTRASONIC
15-Substantial Equivalency is claimed against the following device: IMEX's Pocket, 510k #K910462 (refer to Appendix 2 for FDA website printout). This notification for BABYCARE is of the ABBREVIATED type
16-Description of the Device:
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
Being operated with battery, it allows babies to be checked anywhere, at any time. Using high sensitive and harmless ultrasound sensor, it detects and displays the accurate FHR on the LCD. BABYCARE is especially suitable for routine use in OB/GYN.
3/1
Features:
- Accurate FHR detection & display -
- Clear sound offered from separate speaker -
- Cap-shaped speaker for probe protection -
- -Compact size and battery operated
- Harmless ultrasound sensor "
- Easy to use -
Technical Specifications:
- Display: 3-digit segment ー
- FHR Measuring Range: 50-240 bpm -
- Measurement Resolution: ± 3bpm -
- Speaker output power: 1 W -
- Ultrasound frequency: 2.0 Mhz -
- Power: 9V batterv -
- Sensitivity: 12 Weeks Fetus -
- Weight: 290g (without battery) ~
- Standard Accessory: Gel, 9V battery --
1
17-Intended use of the device: (Indications for use typed on a separate FDA form) BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
18-Safety and effectiveness of the device:
This device is safe and effective as the predicate device.
- This is better expressed in the tabulated comparison (Paragraph 19 below)
19-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that BABYCARE is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.
| FDA file reference number | 510k # K910462 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical: |
| Refer to indications for use details within submission | |
| Target population | Identical: |
| Predicate device and our device are used by obstetrician, gynecologist, nurse, midwife. | |
| Design | Similar: |
| Predicate is designed for separable sensor | |
| BabyCare is designed for separable speaker | |
| Materials | Similar: |
| Predicate is made of ABS materials. | |
| BabyCare is made of ABS and | |
| ULTEM(PolyEtherImid) materials. | |
| Performance | Identical: |
| Both predicate and BabyCare, it is possible to measure fetal heart rate after the 12 weeks of pregnancy. | |
| output≤ 100mW/cm2 | |
| FHR: 50bpm~240bpm | |
| Sterility | Not applicable |
| Biocompatibility | Not Applicable |
| Mechanical safety | Similar: |
| A coarse surface and a sharp corner of a device which has cause of patient damage of predicate device and our device are removed and covered. | |
| Further technical details: | |
| BabyCare is designed to protect weak sensor, so it has separable speaker which can protect sensor. | |
| Chemical safety | Not applicable |
| Anatomical sites | Not applicable |
| Human factors | Not applicable |
| Energy used and/or delivered | Similar: |
| Predicate- NiCad rechargeable battery | |
| BabyCare-9V alkaline battery | |
| Compatibility with | |
| environment and other devices | Identical: |
| Predicate and BabyCare are suitable for | |
| EMI and EMC test. | |
| Where used | Identical: maternity hospital |
| Standards met | Identical: |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |
2
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are connected and form a flowing, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 3 2003
Bionet Co., Ltd. % Mr. Jay Mansour President Mansour Consulting, LLC 1308 Morningside Park Drive ALPHARETTA GA 30022
Re: K023082
Trade/Device Name: BabyCare Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 HEP Dated: January 7, 2003
Received: January 10, 2003
Dear Mr. Mansour:
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 vour 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
K.O.2008
Page
510(k) Number (if known): K123082
Device Name: BABYCARE
Indications for Use:
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
Prescription Use
Vanay C. Evagdon
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)