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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:

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.

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The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

The G210 InviCell Plus with SignipHy™ pH Monitoring System is an assisted reproduction incubator that includes an accessory pH monitoring feature. The incubator component of this device (G210 Invicell) is regulated under 21 CFR 884.6120, product code PBH (exempt). The incubator includes 10 incubation chambers and one larger preparation chamber that is used for the equilibration of plates/oil before use. The tri-gas incubator provides a controlled environment (temperature, CO2/O2/N2) for gametes and embryos in the incubation chambers.

The pH monitoring feature of the G210 InviCell Plus with SignipHy™ pH Monitoring System is controlled separately and does not impact the operation or incubator functions of the device. The SignipHy™ pH Monitoring System consists of the following components:

• . SignipHy™ TrakPod – An LED-based, optical pH measurement instrument. The SignipHy TrakPod is physically supported within the chassis of the incubator and allows monitoring of one incubator chamber. It is a USB connected fluorescent measurement device with a fiber optic cable and fixture that connects to the SignipHy sv2 Sensor inside an incubator chamber. The SignipHy TrakPod and SignipHy sv² Sensor together detect the pH of a liquid sample.
• . SignipHy™ sv2 Sensor – The SignipHy sv2 Sensor is a single-use, polystyrene, ethylene oxide sterilized vessel that is loaded with a sample of bicarbonate-buffered assisted reproduction technology (ART) media with a pH between 6.8 and 7.2 for pH tracking. The bottom of the sensor includes a membrane that is impregnated with a dye that is affected by the pH of the media sample. The sensor fits into the SignipHy TrakPod fiber optic fixture located in an incubation chamber. SignipHy sv2 Sensors can be used for measuring pH at one-minute intervals for three days or 30-minute intervals for seven days.
• . SignipHy™TrakStation – A tablet computer running proprietary software that initiates pH readings, displays results, and stores pH measurement data over time. Up to eight SignipHy TrakPods can be connected to a single SignipHy TrakStation.
• SignipHy™ qc² Alignment Tool - A fluorescent reference device for use in system alignment and quality control.

To make a pH measurement, the SignipHy TrakPod sends green light flashes (peak 518 nm) through the fiber optic fixture. The dye in the membrane reacts by sending back flashes of light at a different wavelength (peak 600 nm). The SignipHy TrakPod reads this result and calculates the pH of the media sample that is then displayed on and stored in the SignipHy™TrakStation.

Here's a breakdown of the acceptance criteria and the studies performed for the G210 InviCell Plus with SignipHy™ pH Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative values for "all specifications" for pH monitoring, or the exact numerical results for linearity, stability, precision, accuracy, and interfering substances, are not detailed in the provided text. The document states they "met all specifications."

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

The document does not explicitly state the sample sizes used for the test sets in the "Non-Clinical Performance Testing" section. It describes the types of tests conducted:

• Shelf-Life of SignipHy™ sv2 Sensors: Tested "real-time aged samples after shipping/distribution." The number of samples is not specified.
• Mouse Embryo Assay (MEA): Tested under "worst-case conditions (samples taken every minute for 96h)." The number of embryo samples is not specified.
• pH Monitoring Validation Testing: Tested various parameters, but the number of samples for each is not provided.

The data provenance is not explicitly mentioned (e.g., country of origin). Based on the context of an FDA submission for a US company (CooperSurgical Inc., Trumbull, CT), it is highly likely the studies were conducted in the US or in compliance with US regulatory standards. The studies appear to be prospective in nature, as they involve testing the device's performance under specified conditions.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the specific performance tests mentioned.

• In the Shelf-Life of SignipHy™ sv2 Sensors performance testing, the ground truth for pH measurement was established by comparison to a "gold standard (blood gas analyzer)." This implies the use of a validated, established method as the reference truth, rather than expert consensus on subjective interpretation.
• For the Mouse Embryo Assay (MEA), the acceptance specification uses a clear biological endpoint ("≥90% blastocysts at 96h"), which would be objectively assessed rather than requiring expert consensus to establish ground truth for each case.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (e.g., 2+1, 3+1) for the test sets. The tests performed are objective performance measurements against established standards or gold standards (like a blood gas analyzer), which typically do not involve subjective expert adjudication.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is an incubator with a pH monitoring system, not an imaging or diagnostic device that requires human interpretation of outputs. Therefore, a study comparing human readers with and without AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance studies were done for the pH monitoring system. The "pH Monitoring Validation Testing" directly assesses the device's ability to measure pH against specifications for linearity, stability, precision, accuracy, and interfering substances, without human intervention in the pH measurement process itself. Similarly, the "Shelf-Life" testing on the SignipHy™ sv2 Sensor performance compared subject device pH measurements to a "gold standard (blood gas analyzer)." The MEA also assessed the device's impact directly.

7. Type of Ground Truth Used

The ground truth methods used in the performance studies include:

• Comparison to a Gold Standard: For pH measurement accuracy and performance at end of shelf-life, the device's pH measurements were compared to a "gold standard (blood gas analyzer)."
• Objective Biological Endpoint: For the Mouse Embryo Assay (MEA), the ground truth was the objective biological outcome of embryo development ("≥90% blastocysts at 96h").
• Established Industry Standards and Specifications: Many tests adhere to ISO, AAMI, ASTM, and IEC standards, where the ground truth is compliance with the defined parameters and limits of those standards (e.g., seal strength, electrical safety, EMC).

8. Sample Size for the Training Set

The document does not provide details on the sample size for any training set. The device appears to be a hardware-based system with proprietary software for measurement and display, rather than a machine learning/AI diagnostic system that typically requires large training datasets. The software documentation mentioned (minor level of concern) also suggests it's not primarily a learning algorithm.

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

Since no training set details are provided or implied for a learning algorithm, there is no information on how its ground truth might have been established. The documented testing focuses on validating the device's physical and functional performance against established benchmarks and specifications.

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The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.

The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

Based on the provided text, the device in question is the Wallace Dual Lumen Oocyte Recovery System, an ovulation retrieval needle. The document does not describe a study involving an AI/algorithmic device or human readers. Instead, it details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set ground truth establishment) are not applicable as they pertain to the evaluation of an AI or algorithm, which is not the subject of this 510(k) summary.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for the Wallace Dual Lumen Oocyte Recovery System

The device under review is an assisted reproduction needle, not an AI or algorithm. The acceptance criteria and performance data provided relate to the physical and biological characteristics of the device to demonstrate its safety and effectiveness, primarily through comparison to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical performance tests and their acceptance criteria (implicitly met as the conclusion states the device passed all testing).

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

• Sample Size: Not explicitly stated for each test (e.g., number of needles tested for mechanical performance, number of packages for integrity). However, the methods refer to standard test procedures (e.g., ISO, ASTM), which typically define sample sizes.
• Data Provenance: The document describes non-clinical laboratory testing of the device itself, not human clinical data or imaging data. Therefore, concepts like country of origin or retrospective/prospective are not applicable.

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

• Not Applicable. This device is a physical medical instrument, not an AI/algorithmic software. "Ground truth" in this context refers to the defined scientific and engineering standards and methods for assessing the device's physical, chemical, and biological properties, which are established by standard organizations (e.g., ISO, ASTM, USP) and verified by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing of a physical device, there is no "adjudication" of expert opinions in the sense of image interpretation. Test results are objective measurements against defined standards.

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

• No. This is not an AI/algorithmic device or diagnostic tool. An MRMC study would be irrelevant.

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

• Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's ability to meet its specifications independently, which is what the non-clinical performance testing aimed to demonstrate.

7. The Type of Ground Truth Used

• Defined Standards and Measurable Performance Metrics: The "ground truth" for this device's performance is based on established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for sterility, biocompatibility, mechanical properties, and packaging integrity. Tests evaluate quantitative and qualitative measures directly against these benchmarks (e.g., specific thresholds for endotoxin, percentage of embryo development, strength limits, leak absence).

8. The Sample Size for the Training Set

• Not Applicable. This refers to an AI/algorithmic device, not a physical medical instrument. There is no concept of a "training set" for the type of evaluation described.

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

• Not Applicable. Again, this is for AI/algorithmic development. The "ground truth" for evaluating this physical device is established through adherence to recognized industrial and medical device testing standards and protocols.

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