These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Device Description

Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use (Measure fetal heart rate and uterine contractions in the gravid patient.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended to measure fetal heart rate and uterine contractions.
Anatomical Sites (Ultrasound transducer on maternal abdomen aimed at fetal heart; toco transducer on maternal abdomen over fundal area of uterus.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended for the same anatomical placement.
Target Patient Population (Gravid patients, especially during labor.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended for the same patient population.
FHR Range (Dependent upon monitor specifications.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are dependent on the connected monitor for FHR range.
Uterine Activity Range (Dependent upon monitor specifications.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are dependent on the connected monitor for uterine activity range.
Patient Use/Reuse (Reusable.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are reusable.
Sterility (Non-Sterile.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are non-sterile.
Description of Patient Attachment (Attach to patient with elastic straps around the mother.)	Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and attach with elastic straps.
Cable Length (8 feet.)	Same as predicate devices (8 feet).
Acoustic Output	< 20mW/cm² ave.
Operational Characteristics (Ultrasound Transducers)	EFU100-20 = Pulsed DopplerEFU200-20 = Pulsed DopplerEFU300-25 = ContinuousEFU400-25 = Pulsed Doppler Comparing to predicate devices: Coro 5600 = Continuous, Coro 5700 = Pulsed Doppler; HP 8040 = Pulsed Doppler, HP 1356 = Pulsed Doppler. While specific types vary, the devices offer both pulsed and continuous Doppler options, similar to the predicates.
Specifications (Ultrasound Center Frequency)	Epic EFU100-20 = 1.0 MHzEpic EFU200-20 = 1.0 MHzEpic EFU300-25 = 2.3 MHzEpic EFU400-25 = 1.151 MHz Comparing to predicate devices: Corometrics 5600 = 2.3 MHz, Corometrics 5700 = 1.151 MHz; HP 8040 = 1.024 MHz, HP 1356 = 0.9984 MHz. The frequencies are in a similar range to the predicate devices.
Bench Testing Performance	Bench testing demonstrates that the devices perform as intended.
Conformity to Consensus Standards	The company has declared conformity to consensus standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility.

The document states that the Epic Medical Equipment Services transducers are "equivalent to the following legally-marketed devices" (predicate devices). The performance data primarily focuses on demonstrating that the Epic transducers meet the same general functional requirements, specifications, and safety standards as the predicate devices.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Acoustic output testing" and "Bench testing" but does not provide details on the number of units or test cases used for these tests.
Data Provenance: Not explicitly stated (e.g., country of origin). Since it's bench testing and acoustic output testing, it would likely be laboratory-based rather than from clinical patient data. The context implies it's retrospective device testing performed by the manufacturer, Epic Medical Equipment Services, Inc., located in Plano, TX, USA.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for Test Set

Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through specifications, acoustic output, and bench testing, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No. This device is a transducer, a hardware accessory for a medical monitor, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable.

7. Type of Ground Truth Used

Type of Ground Truth: For the "Performance Data & Conclusions," the "ground truth" is implied to be:
- Measurements: Actual acoustic output measurements for the acoustic output testing.
- Engineering Specifications/Functional Requirements: For bench testing, the "ground truth" would be whether the device meets its design specifications and functional requirements as intended when connected to the monitors.
- Consensus Standards: Declaration of conformity to relevant Electrical/Mechanical/Thermal Safety and Biocompatibility standards.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware accessory (transducer), not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as this is not an AI/machine learning device.

Summary

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K992811. page 1/2

Providing Solutions Through Innovation and Creativity

Image /page/0/Picture/2 description: The image shows the logo and address of Epic Medical Equipment Services. The address is 1800 10TH STREET, SUITE 300, PLANO, TEXAS 75074. The image also shows the date JAN 1 8 2000.

Appendix C Page 1 of 2

510(k) Summary

Submitter Information:

Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074

Contact:

Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: (972) 801-9854 Fax: (972) 801-9859

Date Prepared:

August 17, 1999

Product Name:

Classification Name: Perinatal Monitoring System Accessories Common Name: Transducers for ultrasound and tocodynamometer fetal monitoring

Predicate Device:

These devices are equivalent to the following legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) - K843385 116 (5700 & 2260) - K891595 118 (5700 & 2260) - K934959 120 (5700 & 2260) - K964770

Hewlett Packard Models 8040 (15245 & 15248) - 510(k) unknown 1350 (1356 & 1355) - K900480

Description:

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Appendix C Page 2 of 2

Intended Use:

These devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rate and uterine contractions.

	Epic	Corometrics	Hewlett Packard
Intended use	Measure fetal heart rate and uterinecontractions in the gravid patient.	Same	Same
Anatomicalsites	The ultrasound transducer is placed on thematernal abdomen aimed at the fetal heart andthe toco transducer is placed on the maternalabdomen over the fundal area of the uterus.	Same	Same
Target patientpopulation	Gravid patients, especially during labor	Same	Same
FHR Range	Dependent upon monitor specifications	Same	Same
UterineActivity Range	Dependent upon monitor specifications	Same	Same
Patientuse/reuse	Reusable	Same	Same
Sterility	Non-Sterile	Same	Same
Description ofpatientattachment	These devices attach to the patient with elasticstraps around the mother.	Same	Same
Cable length	8 feet	Same	Same
Accessories	Transducer Belts and Ultrasonic Gel	Same	Same
Connectordesign	Transducer connectors are color- coded andkeyed to fit into the appropriate fetal monitors.	Same	Same
Acoustic output	< 20mW/cm2 ave.	Same	Same
OperationalCharacteristics	EFU100-20 = Pulsed DopplerEFU200-20 = Pulsed DopplerEFU300-25 = ContinuousEFU400-25 = Pulsed Doppler	Coro 5600 =ContinuousCoro 5700 =Pulsed Doppler	HP 8040 = PulsedDopplerHP 1356 = PulsedDoppler
Specifications(UltrasoundCenterFrequency)	Epic EFU100-20 = 1.0 MHzEpic EFU200-20 = 1.0 MHzEpic EFU300-25 = 2.3 MHzEpic EFU400-25 = 1.151 MHz	Corometrics5600 = 2.3 MHzCorometrics5700 = 1.151 MHz	HP 8040 = 1.024MHzHP 1356 = 0.9984MHz

Comparison to Predicate Device:

Performance Data & Conclusions:

Acoustic output testing shows < 20mW/cm2 avg. ●
Bench testing demonstrates that the devices perform as intended. ◆
The company has declared conformity to consensus standards relating to ● Electrical/Mechanical/Thermal Safety and Biocompatibility.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

JAN 1 8 2000

Ms. Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Epic Medical Equipment Services, Inc. 1800 10th Street, Suite 300 Plano, TX 75074

Re: K992811

Transducers for Ultrasound and Tocodynamometer Fetal Monitoring Dated: November 16, 1999 Received: November 29, 1999 Requiatory Class: II 21 CFR §884.2720/Procode: 85 HFM 21 CFR §884.2660/Procode: 85 HEL

Dear Ms. Oakes:

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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 the Electronic Product 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 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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications For Use

0 7 510(k) # ਸੀ। Device Name: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

Indications for Use:

These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Required information relating to ultrasound transducer indications for use is attached.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

David h. Segerson

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Regulation Number and Section

§ 884.2720 External uterine contraction monitor and accessories.

(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).