The FeatherLite Aqua™Toco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite Aqua™Toco is not intended for home monitoring of pre-term labor.

Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients, It is held on the surface of the abdomen using a standard button hole or Velcro™ type belt.

The product is supplied non-sterile and is intended for single use only.

Device Description

The FeatherLite Aqua™ tocodynamometer (toco) is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The fetal monitor is not intended for home monitoring or pre-term labor. It can be used in both dry and fully submerged environments It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the FeatherLite Aqua™ Tocodynamometer. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of statistical performance metrics, sample sizes, expert qualifications, and ground truth establishment is not available in this document.

However, I can extract information related to the device's intended use and its comparison to predicate devices, which implicitly serves as the "acceptance criteria" for 510(k) clearance – demonstrating substantial equivalence in safety and effectiveness.

Here's a breakdown of the available information and areas where data is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are implicitly defined by establishing substantial equivalence to the predicate devices. The performance is assessed by comparing characteristics and functionalities. Specific quantitative performance data from a dedicated study demonstrating superiority or meeting predefined statistical thresholds is not presented.

Implicit "Acceptance Criteria" (based on substantial equivalence to predicate devices)	Reported Device Performance (FeatherLite Aqua™ Toco)
Intended Use: For evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting.	Intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Clinical setting only.
Environment: Operates in both dry and fully submerged environments (compared to Corometrics 2264).	Can be used in both dry and fully submerged environments.
Sensing Principle: Same principle of sensing the change in muscle tone of the uterus.	Uses a flexible nipple and silicone gel to transmit changes in uterine wall muscle tone to a resistive type strain gauge pressure sensor.
Material: Housing molded from rigid thermoplastics.	Housing materials are the same (molded from rigid thermoplastics).
Attachment: Same attachment methods for abdominal placement.	Held on the surface of the abdomen using an elastic belt.
Servicing: Cannot be serviced.	Cannot be serviced.
Connectivity: Requires an adaptor to connect to the fetal monitor.	Uses an adaptor to connect the universal connector of the cable to the specific fetal monitor.
Filter: Minimizes unwanted noise.	Adapter includes a digital filter to minimize unwanted noise.
Gain: Allows for effective monitoring of obese patients (implied function of a toco, enhanced by switch).	Adapter has a switch to allow the user to increase the toco gain for more effective monitoring of obese patients.
Usage: Single-use only.	Intended for single use only.
Telemetry compatibility: Used with telemetry units when submersible.	Shall ONLY be used with telemetry units.

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

Not provided. This document does not detail a clinical study with a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The evidence for substantial equivalence is based on engineering comparisons and design changes.

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

Not applicable/Not provided. No specific "ground truth" establishment by experts for a test set is mentioned in the context of this 510(k) summary. The comparison is made against the established performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not mentioned as part of this 510(k) submission. The device is a physical medical device (tocodynamometer), not an AI/software-based interpretive system that would typically undergo such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Implied Ground Truth: The "ground truth" for the FeatherLite Aqua™ Tocodynamometer's substantial equivalence is the performance and safety characteristics of the predicate devices (FeatherLite™ Tocodynamometer under K013477 and Corometrics 2264 under K982651), as recognized by the FDA. The new device demonstrates similar performance characteristics and design for its intended use, with enhancements that do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable/Not provided. As this is a physical medical device comparison, not an AI model, there is no "training set."

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

Not applicable/Not provided. As there is no training set for an AI model, this information is not relevant to this submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Ventrex, Inc. The logo features a stylized "V" made of diamond shapes, followed by the word "Ventrex" in a bold, sans-serif font with a line above it. Below the company name is the tagline "Vision in Design and Manufacturing" in a smaller font.

JUL 1 2 2006

510(K) SUMMARY FeatherLite™Aqua Tocodynamometer

Date:	April 10, 2006
Manufacturer:	Ventrex Inc.3007 Bunsen Avenue, Suite KVentura,CA 93003FDA Registration # 2029412
Owner/Operator:	Ventrex Inc.3007 Bunsen Avenue, Suite KVentura,CA 93003
Contact Person:	George AustriaDirector of Quality AssuranceVentrex, Inc.3007 Bunsen Avenue, Suite KVentura,CA 93003
Device Trade Name:	FeatherLite Aqua™Tocodynamometer
Common Name:	Toco
Classification Name:	Class II, 85HFM, External Uterine ContractionMonitor and Accessories
Regulatory Reference:	884.2720
Predicate Device:	FeatherLite™Tocodynamometer under 510k#K013477 and Corometrics 2264 underK982651.
Description andIntended Use:	The FeatherLite Aqua™ tocodynamometer(toco) is intended for use in conjunction withtelemetry systems for standard fetal monitorsfor the evaluation of external uterine activityduring antepartum and intrapartum periods in aclinical setting. The fetal monitor is notintended for home monitoring or pre-termlabor. It can be used in both dry and fullysubmerged environments It

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is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single use only.

Summary of Similarities and Differences:

Similarities:

Ventrex FeatherLite™ Toco under 510(k) K013477 (Predicate Device) and FeatherLite Aqua™ Toco (New Device):

Both are used in conjunction with fetal monitors for evaluation of external . uterine activity.
Same performance characteristics. .
Both use a flexible nipple and silicone gel to transmit the changes in uterine . wall muscle tone to the strain gauge pressure sensor housed inside.
The sensor for both FeatherLite™ and FeatherLite Aqua™ are the same. . (resistive type)
. The housing materials are the same . (molded from rigid thermoplastics)
The same attachment methods.
◆ Both devices cannot be serviced.
Both use an adaptor to connect the universal connector of the cable to the . specific fetal monitor.

Differences:

Atmospheric pressure referencing on the predicate device is achieved through . a vent hole on top of the housing while the venting on new device is achieved through a lumen in the cable.
The FeatherLite Aqua™ Toco may be used in a water environment. .
The cover is sealed to the housing using a water proof sealant for the new . device to prevent water from entering.
The adapter includes a digital filter to minimize unwanted noise without . interfering with performance.
The adapter has a switch to allow the user to increase the toco gain for more . effective monitoring of obese patients.
The FeatherLite Aqua™ is intended for single use only. .
The FeatherLite Aqua™ shall ONLY be used with telemetry units. .

Similarities: GE/Corometrics 2264 Tocodynamometer under K982651.

Same principle of sensing the change in muscle tone of the uterus as it . contracts by firmly holding a nipple-like appendage against the abdominal wall utilizing an elastic belt as the holding means.
. Both devices can be used in either water or non-water environments.
Both devices require a telemetry unit when used as a submersible device. .

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Differences:

Monitor connector is hard wired onto the cable of the predicate device. .
Predicate device has an electronic filtering circuitry in the toco. New device has . in the adaptor.

CONCLUSION:

The proposed FeatherLite Aqua™ (New Device) is comparable to its predicate . devices in safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 1 2 2006

Mr. George Austria Director of Quality Assurance Ventrex, Inc. 3007 Bunsen Avenue, Suite K VENTURA CA 93003

Re: K061044

Trade/Device Name: FeatherLite Aqua™ Tocodynamometer Regulation Number: 21 CFR 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: II Product Code: HFM Dated: April 10, 2006 Received: April 17, 2006

Dear Mr. Austria:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Booken o o(t) for device is substantially equivalent (for the indications for relevelocu above and nave acterimined warketed predicate devices marketed in interstate commerce use stated in the encreater to regally man of the Medical Device Amendments, or to devices that prov to way 20, 1970, and characterity the provisions of the Federal Food, Drug, and Cosmetic have bech reclaismed in accordances inst a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mative all device, bagon weequirements for annual registration, listing of devices, good controls provibitions or und prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your devise is exactive (500 are hadditional controls. Existing major regulations affecting your Apployally, it 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.

Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006". The logo is circular and contains stars. The image also contains the words "Protecting and Promoting Public Health" in a decorative font.

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Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 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), 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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C.Bogdon

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 Statement

Ventrex, Inc. Applicant:

510(k) Number: K061044

Device Name: FeatherLite Aqua™

Indication For Use

The product is supplied non-sterile and is intended for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use
(Per 21 CFR 801.109) √

ଠାର

Over-The Counter Use _

David R. Leggmm
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K061044

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).