Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.

Device Description

The Model 5700 and 2264 Series Non-Invasive Watertight Transducers are intended as accessories to Corometrics' Fetal and Fetal/Maternal Monitors. The Model 5700 Series Transducer provides for the detection of fetal heart rate and the Model 2264 Series Transducer provides for the detection of uterine activity.

AI/ML Overview

This 510(k) summary for the Corometrics Model 5700 and 2264 Watertight Transducer does not contain the detailed information typically found in a study report, as it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal scientific study as would be described in a clinical trial or performance evaluation.

Therefore, providing a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC study results, or training set information is not possible based on the provided text.

Here's an explanation of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The 510(k) summary explicitly states: "To date, the Food and Drug Administration have promulgated no performance standards relating to accessories of this type." This means there were no pre-defined formal acceptance criteria for device performance (like sensitivity, specificity, accuracy metrics) established by the FDA for this type of accessory at the time of submission.
The document implies that "extensive testing" was performed to meet requirements and design, but it does not specify what those requirements were or present the results of such testing in a quantitative format against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Missing. The document mentions "extensive testing" but does not provide any details about the sample size (number of patients, number of tests), the type of data used (e.g., retrospective recordings, prospective collection), or the origin of the data.

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

Missing. There is no mention of ground truth establishment by experts, as the document doesn't describe a study involving human interpretation or performance evaluation that would necessitate this.

4. Adjudication Method for the Test Set:

Missing. Without a described test set or expert involvement, there is no mention of an adjudication method.

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

No. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a transducer accessory, not an AI diagnostic algorithm.

6. Standalone (Algorithm Only) Performance:

No. This device is a physical transducer, not a standalone algorithm. Its function is to detect fetal heart rate and uterine activity, which are then processed by a separate Fetal and Fetal/Maternal Monitor.

7. Type of Ground Truth Used:

Missing. Since no formal performance study against a "ground truth" (such as pathology, outcomes, or expert consensus) is described, this information is not available. The primary "ground truth" or reference for this type of device would likely be its ability to accurately detect and transmit the physiological signals (FHR and UA) compared to established methods, but specific data is not provided.

8. Sample Size for the Training Set:

Not applicable. As this device is a physical transducer and not an AI/ML algorithm, there is no "training set" in the context of machine learning.

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

Not applicable. See point 8.

Summary of Device Acceptance (as described in the 510(k) Summary):

The acceptance of these devices (Corometrics Model 5700 and 2264 Watertight Transducers) was based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance criteria from a formal study.

The comparison focused on technological characteristics and intended use:

Model 5700 Watertight US Transducer:
- Intended Use: Fetal Heart Rate (FHR)
- Key Differentiators/Improvements over predicate (Model 5700 US Transducer): Watertight (Yes vs. No), Water Environment Application Use (Yes vs. No).
- Similarity to predicate (HP M1356A Watertight US Transducer): Both are watertight, perform FHR detection, and use pulsed Doppler. The Corometrics device uses 9 crystals compared to HP's 7.
Model 2264 Watertight Toco Transducer:
- Intended Use: Uterine Activity (UA)
- Key Differentiators/Improvements over predicate (Model 2260 Toco Transducer): Watertight (Yes vs. No), Water Environment Application Use (Yes vs. No).
- Similarity to predicate (HP M1355A Watertight Toco Transducer): Both are watertight, and perform UA detection.

The manufacturer states that "The Corometrics Model 5700 and 2264 Series Watertight Transducers have been extensively tested to meet their requirements and design." This implies internal validation and verification activities, but the 510(k) summary does not provide specific data from these tests or define the "acceptance criteria" met by these tests in a quantifiable manner typical of clinical studies for AI or diagnostic devices.

The FDA's letter (K982651) affirms that the device is "substantially equivalent" for the stated indications for use to legally marketed predicate devices, thereby permitting its market entry. The "acceptance criteria" from a regulatory perspective for this submission was successful demonstration of substantial equivalence.

Summary

{0}------------------------------------------------

182651 510(k)

DEC 1 1 1998

510(k) SUMMARY: Corometrics Model 5700 and 2264 Watertight Transducer

Prepared: 7/29/98

[ 807.92(a)1 ] Contact Information

Richard J. Cehovsky Regulatory Affairs Manager

Address: Corometrics Medical Systems 61 Barnes Park Road North Wallingford, CT 06492
Phone: 203-949-8320 203-284-9465 Fax:

[ 807.92(a)2 ] Device Name and Classification

The proprietary names of the devices to be introduced into interstate commerce are the Corometrics Model 5700 & 2264 Series Watertight Transducers. Common name includes: Ultrasound and Tokodynamometer Transducer.

Current classifications that applies to these devices are: 21 CFR part 888.2720 -"External Uterine Contraction Monitor and Accessories," Class II; and 21 CFR part 888.2740 "Perinatal Monitoring System and Accessories," Class II.

[ 807.92(a)3 ] Identification of Legally Marketed Equivalent Devices (Predicate Systems).

Predicate System	Manufacturer	K Number	Class
Model 5700 USTransducer	Corometrics MedicalSystems, Inc.	K891595	II
M1356A USWatertightTransducer	Hewlett Packard	K942887	II

Predicate System	Manufacturer	K Number	Class
Model 2260 TocoTransducer	Corometrics MedicalSystems, Inc.	K891595	II
M1355A TocoWatertightTransducer	Hewlett Packard	K942887	II

{1}------------------------------------------------

510(k)

510(k) SUMMARY Continued:

| 807.92(a)4 & 807.92(a)5 ] Device Description & Intended Use

[ 807.92(a)6 ] Predicate Device Comparison of Technological Characteristics

Mode	Model 5700 US	Model 5700 Watertight US	HP M1356A Watertight US
Indications for Use	FHR	FHR	FHR
Watertight	No	Yes	Yes
Pulsed Doppler	Yes	Yes	Yes
No. of Crystals	9	9	7
Water EnvironmentApplication Use	No	Yes	Yes

FHR: Fetal Heart Rate

Mode	Model 2260Toco	Model 2264WatertightToco	HP M1355AWatertightToco
Indications for Use	UA	UA	UA
Watertight	No	Yes	Yes
Water EnvironmentApplication Use	No	Yes	Yes

UA: Uterine Activity

[ 807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug Cosmetic Act

To date, the Food and Drug Administration have promulgated no performance standards relating to accessories of this type.

[ 807.92(d) ] Additional Information

The Corometrics Model 5700 and 2264 Series Watertight Transducers have been extensively tested to meet their requirements and design.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, with three overlapping faces suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.

DEC 1 1 1998

Richard Cehovsky Manager, Regulatory Affairs Corometrics Medical Systems, Inc. 61 Barnes Park Road North P.O. Box 333 Wallingford, CN 06492

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K982651 Corometrics Model 5700 and 2264 Watertight Transducer Dated: November 5, 1998 Received: November 6, 1998 Regulatory Class: II 21 CFR 884.2660/Procode: 85 HEL 21 CFR 884.2720/Procode: 85 HFM

Dear Mr. Cehovsky:

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, 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 (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 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 Pat 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 your

Lillian Yin, Ph.D.
Director, Division of Reproductive

Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 5700 & 2264 Series Watertight Transducer

Indications for Use:

To be assigned by FDA upon receipt of 510(k) submission.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i OR Over the Counter Use (Per 21 CFR 801.19) Optional Format 1-2-96 (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 000022 510(k) Number.

Regulation Number and Section

§ 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).