K Number
K043075
Device Name
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
Date Cleared
2005-08-18

(283 days)

Product Code
Regulation Number
884.2740
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.
Device Description
Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.
More Information

K891S95, #992811

Not Found

No
The device description and intended use focus on standard ultrasound Doppler and strain gauge technology for fetal monitoring, with no mention of AI or ML.

No.
The device is used to measure fetal heart rate and uterine contractions, which are diagnostic measurements, not therapeutic interventions.

Yes

The device measures fetal heart rate and uterine contractions, which are used to evaluate the physiological state during labor, thus providing diagnostic information about the pregnancy and labor progression.

No

The device description explicitly states it is a transducer, which is a hardware component (strain gauge and ultrasound Doppler technology).

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to measure fetal heart rate and uterine contractions in a gravid patient. This is a direct physiological measurement taken from the patient's body.
  • Device Description: The device uses ultrasound Doppler Shift Technology and a strain gauge to measure these physiological parameters. These are physical measurement techniques, not laboratory tests performed on samples taken from the body.
  • Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not perform such analysis on specimens.

Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Tenacore Transducers for Fetal Ultrasound and Tokodynamometer Monitoring arc intended to be used only as direct replacement accessories for appropriate Perinatal Monitoring Systems that display the graphical relationship between labor and fetal heart rate.

These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.

Product codes (comma separated list FDA assigned to the subject device)

HGM

Device Description

Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound Doppler Shift Technology

Anatomical Site

Not Found

Indicated Patient Age Range

gravid patient

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): 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.

K891S95, #992811

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.

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

§ 884.2740 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

043075

enacore Holding

647 East Young Street - Santa Ana, CA 92705

Ph: 714-444-4643 Fx: 714-549-73

Section 9: 510(k) Summary

AUG 1 8 2005

Contact Person:Brand Caso
Director Product Development
Tenacore Holdings, Inc
647 East Young Street
Santa Ana, CA 92705

March 1, 2004 Date Prepared:

Product Classification: Product Classification. Class 11-Transducers for use with perinatal monitoring systems as accessories as described in Title 21. Part 884, Subpart C, Classification 85 HGL, Regulation number Obstetrical Ultrasonic Transducer and Accessories and in Title 21, Part 884, Subpart C, Classification #85 HFM, Regulation number 884.2720 External Uterine Contraction Monitor and Accessories

Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring. Trade Name:

Common Name: Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring

Predicate devices:

Corometrics 116 (5700 & 2260), 510 (k) # K891S95 by GE Marquette a. Medical Systems Epic's transducer, 510(k) #992811 by Epic Medical Equipment Services. b.

Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Description: Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.

Intended Use: Tenacore Transducers for Fetal Ultrasound and Tokodynamometer Monitoring arc intended to be used only as direct replacement accessories for appropriate Perinatal Monitoring Systems that display the graphical relationship between labor and fetal heart rate.

Performance

Tenacore Holdings, Inc has declared to conform to consensus performance standards Standards: concerning Electrical Electromagnetic Compatibility / Mechanical / Efficacy / Safety and Biocompatibility aspects of the product.

1

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the HHS logo in the center. The logo is a stylized depiction of a human figure with three lines extending from the head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2005

Mr. Brand Caso Director of Product Development Tenacore Holdings, Inc. 647 East Young St. SANTA ANA CA 92705

Re: K043075

Trade/Device Name: Transducers for use with Perinatal Monitoring Systems and Accessories Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories

Regulatory Class: II Product Code: HGM Dated: July 1, 2005 Received: July 18, 2005

Dear Mr. Caso:

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 (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 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

2

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotton will and in yourse of substantial equivalence of your device to a legally premated notined 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:

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77). I Samall 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/industry/support/index.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

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Indications for Use

510(k) Number (if known): K043075/S2

Device Name: Transducers for use with perinatal monitoring systems as accessories

Indications For Use:

These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.

Tenacore

Compatible Monitors Transducer

Model TFH102For use with Hewlett Packard 1350 Series Fetal Monitors
Model TFC102For use with Corometrics Model 115, 116, 118, 120, and 150 Series Fetal Monitors
Model TFH101For use with Hewlett Packard 1350 Series Fetal Monitors
Model TFC101For use with Corometrics Model 115, 116, 118, 120, and 150 Series Fetal Monitors

Prescription required.

| Prescription Use

(Part 21 CFR 801 Subpart D)X
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

David h. Legnon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043075