TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

K043075 · Tenacore Holdings, Inc. · HGM · Aug 18, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K043075
• Device Name: TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
• Applicant: Tenacore Holdings, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

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 Story

Tenacore transducers serve as direct replacement accessories for existing perinatal monitoring systems. The device includes two types of transducers: an ultrasound transducer utilizing Doppler shift technology to detect fetal heart rate, and a tokodynamometer transducer utilizing a strain gauge to measure the duration, frequency, and relative pressure of uterine contractions. These transducers connect to compatible fetal monitors (e.g., Hewlett Packard 1350 series, Corometrics 115-150 series) which display the graphical relationship between labor and fetal heart rate. Used in clinical settings by healthcare providers, the output provides real-time physiological data to assist in labor management and fetal monitoring, potentially benefiting the patient by enabling continuous assessment of fetal well-being and labor progression.

Clinical Evidence

Bench testing only. The manufacturer declared conformance to consensus performance standards for electrical, electromagnetic compatibility, mechanical, efficacy, safety, and biocompatibility.

Technological Characteristics

Transducers for fetal ultrasound and tokodynamometer monitoring. Ultrasound transducer uses Doppler shift technology; tokodynamometer uses strain gauge technology. Designed as direct replacements for specific Hewlett Packard and Corometrics fetal monitor series. Conforms to consensus performance standards for electrical, electromagnetic, mechanical, and biocompatibility.

Indications for Use

Indicated for use in gravid patients during labor to monitor fetal heart rate and uterine contractions via compatible fetal monitoring systems. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Corometrics 116 (5700 & 2260) (K891S95)
• Epic Medical Equipment Services transducer (K992811)

Submission Summary (Full Text)

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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.

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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

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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 |
| Other | | 240-276-0100 |

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 [phone] or [phone] 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 TFH102 | For use with Hewlett Packard 1350 Series Fetal Monitors |
|--------------|----------------------------------------------------------------------------------|
| Model TFC102 | For use with Corometrics Model 115, 116, 118, 120, and 150 Series Fetal Monitors |
| Model TFH101 | For use with Hewlett Packard 1350 Series Fetal Monitors |
| Model TFC101 | For use with Corometrics Model 115, 116, 118, 120, and 150 Series Fetal Monitors |

Prescription required.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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