(261 days)
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.
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.
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.
§ 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.