(361 days)
K921957/A
K921957/A
No
The description focuses on basic fetal monitoring functions using ultrasound and standard components, with no mention of AI or ML capabilities.
No
The device is a fetal monitor used for diagnostic purposes (monitoring fetal heart rate and uterine activity) and does not provide any therapeutic intervention.
Yes
The device is described as a "fetal monitor to perform cardiotocographs ("CTG"), i.e., fetal monitoring." Fetal monitoring, specifically cardiotocography, involves recording the fetal heart rate and uterine contractions to assess fetal well-being and identify potential distress, which is a diagnostic activity.
No
The device description explicitly lists multiple hardware components including a main unit, transducers, printer, power cord, etc., indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Baby Dopplex® 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Baby Dopplex® 3000 uses ultrasound to directly monitor the fetus within the body. It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use is fetal monitoring (cardiotocographs), which is an in vivo procedure. This involves using a device on or within a living organism to gather information.
The description clearly indicates the device's function is to detect the fetus using ultrasound and perform cardiotocographs, which are real-time recordings of fetal heart rate and uterine contractions. This is a diagnostic procedure performed directly on the patient, not on a sample taken from the patient.
N/A
Intended Use / Indications for Use
The Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs ("CTG"), i.e., fetal monitoring. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.
Product codes
85 HGM
Device Description
The Baby Dopplex® 3000 is supplied complete with the following components: the main unit, a single crystal transducer, a contractions or uterine activity transducer, a patient event marker, an integral thermal printer, paper, belts, gel, a detachable power cord, and a user manual. The Baby Dopplex® 3000 includes all the basic functions and features that are internationally recognized as essential requirements for fetal monitors.
With the exception of the power switch, all user controls and displays on the Baby Dopplex® 3000 main unit are arranged on a control panel which is located on the top face of the unit. Controls take the form of membrane type push buttons with tactile feedback. The Baby Dopplex® 3000 utilizes ultrasound energy at 2 MHz to detect the fetus. The power level, frequency, pulse duration and repetition rate are all preset at the manufacturing stage and there are no user controls or adjustments affecting any of these parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
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)
K921957/A
Reference Device(s)
Not Found
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
6963711 page 1/2
SEP 1 2 1997
510(k) SUMMARY
FOR HUNTLEIGH HEALTHCARE'S
BABY DOPPLEX® 3000
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Audrey Witko Compliance Officer Huntleigh Healthcare 227 Route 33 East Manalapan, NJ 07726
(908) 446-2500 Phone: Facsimile: (908) 446-1938
Contact Person: same as above
August 16, 1996 Date Prepared:
Name of Device and Name/Address of Sponsor
Baby Dopplex® 3000
Huntleigh Healthcare 227 Route 33 East Manalapan, NJ 07726
Classification Name
Fetal Ultrasonic Monitor and Accessories (21 C.F.R. § 884.2660)
Predicate Device
Hewlett Packard GmbH Model 1351A Fetal Monitor (K921957/A)
1
Intended Use
Huntleigh Healthcare's Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.
Technological Characteristics and Substantial Equivalence
The Baby Dopplex® 3000 is supplied complete with the following components: the main unit, a single crystal transducer, a contractions or uterine activity transducer, a patient event marker, an integral thermal printer, paper, belts, gel, a detachable power cord, and a user manual. The Baby Dopplex® 3000 includes all the basic functions and features that are internationally recognized as essential requirements for fetal monitors.
With the exception of the power switch, all user controls and displays on the Baby Dopplex® 3000 main unit are arranged on a control panel which is located on the top face of the unit. Controls take the form of membrane type push buttons with tactile feedback. The Baby Dopplex® 3000 utilizes ultrasound energy at 2 MHz to detect the fetus. The power level, frequency, pulse duration and repetition rate are all preset at the manufacturing stage and there are no user controls or adjustments affecting any of these parameters.
The Baby Dopplex® 3000 is substantially equivalent to Hewlett Packard GmbH's Model 1351A Fetal Monitor ("HP 1351A") (K921957/A). The Baby Dopplex® 3000 and the HP 1351A each have the same intended uses and principles of operation. As with its predicate device, the Baby Dopplex® 3000 is designed to transmit and receive ultrasonic energy into and from a pregnant woman, by means of a pseudo-continuous wave (Doppler).
Both the Baby Dopplex® 3000 and its predicate device offer three user selectable chart speeds of 1, 2 or 3 cm/min. Each device provides an LED display for fetal heart rate and uterine activity and each incorporates a computer interface. Based on a U.S. standard of 30 bpm/cm, both units measure fetal heart rate ("FHR") over the range of 50 to 210 bpm. Both devices conform to electrical safety standards UL544 and IEC601-1. As with its predicate device, the Baby Dopplex® 3000 has a PC/ABS alloy plastic casing.
As with its predicate device, the Baby Doplex® 3000 incorporates the use of a transducer that is held in place on the abdomen by elastic straps. While the HP 1351A utilizes an annular array of crystals operating at 1 MHz, the Baby Dopplex® 3000 utilizes a single crystal with a divergent lens operating at 2 MHz.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 2 1997
Ms. Audrey Witko Compliance Manager Huntleigh Healthcare, Inc. A Huntleigh Technology Inc. Company 227 Route 33 East Manalapan, New Jersey 07726
Re: K963711 Baby Dopplex® 3000 Fetal Monitoring Device Dated: June 13, 1997 Received: June 16, 1997 Regulatory Class: II 21 CFR & 884.2740/Product Code: 85 HGM
Dear Ms. Witko:
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, 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 requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 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 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Page 1 of 1
510(k) Number (if known):
Baby Dopplex® 3000 Device Name:
Indications For Use:
The Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs ("CTG"), i.e., fetal monitoring. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K9637 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use