Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.

Device Description

The Fetal Pillow is an inflatable balloon device which consists of the following components:

Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation
Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.

The Fetal Pillow is a single use, disposable, sterile device.

The subject device is a dome shaped, balloon, cephalic evaluation device that enables the elevation of the fetal head to facilitate delivery of the fetus. The inflation and application of the device only occurs under direct control of the user.

AI/ML Overview

This FDA 510(k) clearance letter for the "Fetal Pillow" does not describe performance acceptance criteria or a study that proves the device meets those criteria. Instead, it states that the purpose of this 510(k) submission is to update clinical references in the Instructions for Use based on current literature, implying no new performance testing was conducted for this specific submission.

The letter explicitly mentions:

"There were no design changes between the subject and predicate device, therefore, no additional performance data was presented as part of this 510(k) submission."
"The information provided demonstrates that the Fetal Pillow is as safe and effective as the predicate device and supports a determination of substantial equivalence."

Therefore, based solely on the provided text, it's impossible to answer your questions about acceptance criteria and a study proving its performance, as no such study was conducted for this particular 510(k) submission. The clearance is based on the substantial equivalence to a predicate device (DEN150053), which would have had performance testing for its initial De Novo classification.

However, I can extract information related to the predicate device (DEN150053) as hinted by the included references, and explain why a detailed answer to your request isn't possible from this document.

Analysis based on the provided document (and limitations for your detailed request):

The document is a 510(k) clearance for a device called "Fetal Pillow." The key takeaway is that this specific submission (K243799) is not about proving new performance through new studies because the device's design is identical to its predicate (DEN150053). The purpose of this 510(k) was to update clinical references in the Instructions for Use. Therefore, the detailed questions about performance studies (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be answered from this document because such studies were not performed for K243799.

The reference to "United States Food and Drug Administration. De Novo Classification Request For Fetal Pillow. De Novo Summary (DEN150053). 2015;1-14" strongly suggests that the original performance data would be found in the De Novo Summary for the predicate device, DEN150053.

Attempted Answer (highlighting what can't be answered from the provided text):

Since new performance data was not presented for K243799 due to substantial equivalence, the following sections cannot be populated with information from this document. Any information would be speculative or would require accessing the original DEN150053 De Novo summary.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance	Comments from K243799
Not specified for this 510(k)	Not specified for this 510(k)	This 510(k) did not present new performance data. The device is substantially equivalent to the predicate, meaning its performance implicitly meets criteria established for the predicate (DEN150053).

2. Sample Size and Data Provenance:

Test Set Sample Size: Not applicable/Not provided in this 510(k). No new test set data was generated for K243799.
Data Provenance: Not applicable/Not provided. The clinical references cited (Lassey et al., Hanley et al.) are external literature reviews/studies, not a primary study conducted for this 510(k). The original De Novo submission (DEN150053) for the predicate device would contain this information.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable/Not provided in this 510(k). No new ground truth establishment was described as no new performance study was conducted.

4. Adjudication Method:

Not applicable/Not provided in this 510(k). No new performance study required adjudication.

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

Not applicable/Not provided in this 510(k). No MRMC study was conducted or referenced as part of this submission for K243799. The device is a physical, interventional device, not an AI or imaging device, so conventional MRMC studies (as typically seen for diagnostic AI) would be less relevant.

6. Standalone Performance (Algorithm Only):

Not applicable. The "Fetal Pillow" is a physical medical device, not a software algorithm. Its performance is tied to its physical characteristics and user interaction, not an algorithm's output.

7. Type of Ground Truth Used:

Not applicable/Not provided in this 510(k). Any ground truth used would have been for the predicate device's original clearance, likely clinical outcomes from trials.

8. Training Set Sample Size:

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.

9. How Ground Truth for Training Set was Established:

Not applicable. Same as above.

Summary regarding the provided document:

The provided 510(k) clearance letter for the "Fetal Pillow" (K243799) is a substantial equivalence determination. This means the FDA found the device to be as safe and effective as a legally marketed predicate device (DEN150053) without requiring new clinical performance data for this specific submission. The stated purpose of K243799 was to update clinical references in the Instructions for Use, not to present new performance studies. Therefore, the detailed questions about sample sizes, expert adjudication, ground truth, and AI/MRMC studies are not addressed within this document, as these types of studies were not conducted for K243799. The information you seek would typically be found in the original De Novo classification summary (DEN150053) for the predicate device.

Summary

FDA 510(k) Clearance Letter - Fetal Pillow

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 27, 2025

CooperSurgical, Inc.
Irina Fedorov
Regulatory Affairs Senior Specialist
95 Corporate Drive
Trumbull, CT 06611

Re: K243799
Trade/Device Name: Fetal Pillow
Regulation Number: 21 CFR§ 884.4350
Regulation Name: Fetal Head Elevator
Regulatory Class: II
Product Code: PWB
Dated: July 25, 2025
Received: July 28, 2025

Dear Irina Fedorov:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Page 2

K243799 - Irina Fedorov Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

Page 3

K243799 - Irina Fedorov Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243799

Device Name: Fetal Pillow

Indications for Use (Describe):

Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

K243799
Fetal Pillow

1. Submitter Information

Applicant: CooperSurgical, Inc.
Address: 95 Corporate Drive
Trumbull, CT 06611 U.S.A.

2. Correspondent Information

Company: CooperSurgical, Inc.
Contact: Michael Scott
Email: michael.scott@coopersurgical.com
Phone: 901-827-1855

3. Date prepared: August 28, 2025

4. Device Information

Device Name: Fetal Pillow
Common Name: Fetal Pillow
Regulation Number: 21 CFR 884.4350
Regulation Name: Fetal Head Elevator
Product Code: PWB (Obstetrics/Gynecology)
Regulatory Class: Class II

5. Predicate Device Information

Device Name: Fetal Pillow
510(k) Number: DEN150053
Sponsor: Safe Obstetrics System, Ltd.

The predicate device has not been subject to a design-related recall.

6. Device Description

The Fetal Pillow is an inflatable balloon device which consists of the following components:

Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation
Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.

The Fetal Pillow is a single use, disposable, sterile device.

Figure 1 below is an image of the Fetal Pillow

Page 6

The Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Cesarean Section at full dilation or those requiring a Cesarean Section after a failed instrumental vaginal delivery. The subject device is a dome shaped, balloon, cephalic evaluation device that enables the elevation of the fetal head to facilitate delivery of the fetus. The inflation and application of the device only occurs under direct control of the user.

The purpose of this 510(k) submission is to update clinical references in the Instructions for Use based on current literature.

7. Indications for Use Statement

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

Device & Predicate Device(s):	K243799	DEN150053	Comparison
Proprietary name	Fetal Pillow	Fetal Pillow	Same
Device Classification NameRegulation NumberFDA Product Code	Fetal head elevator884.4350PWB	Fetal head elevator884.4350PWB	Same
Indications for use	Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women	Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women	Same

Figure 1. Fetal Pillow

[Image description: The figure shows the Fetal Pillow device with labeled components including a 60cc syringe, silicone tube 100 cms long, two-way tap, silicone dome inflated to 60cc, and silicone base maximum thickness 4mm]

The purpose of this 510(k) submission is to update clinical references in the Instructions for Use based on current literature.

7. Indications for Use Statement

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

Device & Predicate Device(s):	K243799	DEN150053	Comparison
Proprietary name	Fetal Pillow	Fetal Pillow	Same
Device Classification NameRegulation NumberFDA Product Code	Fetal head elevator884.4350PWB	Fetal head elevator884.4350PWB	Same
Indications for use	Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women	Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women	Same

Page 7

	requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.	requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.
Single use/reusable	Single Use	Single Use	Same
Device operation	Requires direct control by physician user or on their order to inflate the balloon via sterile saline	Requires direct control by physician user or on their order to inflate the balloon via sterile saline	Same
Sterilization Method	ETO	ETO	Same
Device Design and Materials	1) one medical grade silicone dome and silicone base plate,2) tubing and tubing connection (both made of medical grade silicone),3) two-way stopcock, made of polycarbonates and polyethylene4) syringe made of polypropylene and isoprene.	1) one medical grade silicone dome and silicone base plate,2) tubing and tubing connection (both made of medical grade silicone),3) two-way stopcock, made of polycarbonates and polyethylene4) syringe made of polypropylene and isoprene.	Same

The indications for use of the subject and predicate device are identical and they have the same intended use. The technological characteristics of the subject device are identical to the predicate device and do not raise different questions of safety and effectiveness.

9. Summary Performance Testing

Page 8

There were no design changes between the subject and predicate device, therefore, no additional performance data was presented as part of this 510(k) submission.

Updates to the device instructions for use were supported by the inclusion of the following references:

Lassey SC, Little SE, Saadeh M, Patton N, Farber MK Bateman BT, Robinson JN. Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020;135(4):879-884.
Hanley I, Sivanesan K, Veerasingham M, Vasudevan J. Comparison of outcomes at full-dilation cesarean section with and without the use of a fetal pillow device. Int J Gynaecol Obstet. 2020;150(2):228–233.
United States Food and Drug Administration. De Novo Classification Request For Fetal Pillow. De Novo Summary (DEN150053). 2015;1-14

10. Conclusion

The information provided demonstrates that the Fetal Pillow is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.4350 Fetal head elevator.

(a)
Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.
(ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.
(iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted.
(5) Labeling must include the following:
(i) Contraindication for use in the presence of active genital infection;
(ii) Specific instructions regarding the proper placement and use of the device; and
(iii) A shelf life.