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FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.

Here's a breakdown of the acceptance criteria and the studies mentioned for the FemVue MINI Saline-Air Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that "all predetermined acceptance criteria were met" for various tests. Therefore, the table below is constructed by inferring the acceptance criteria from the type of test conducted.

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

The document does not specify the sample sizes used for the individual bench performance tests. It only states that these tests were conducted. It also does not explicitly state the data provenance (e.g., country of origin) or if the studies were retrospective or prospective, though bench testing is inherently prospective.

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

This information is not provided in the document. The tests described are primarily physical, chemical, and functional bench tests, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the bench tests, it's unlikely a formal adjudication method (like 2+1, 3+1) would be applicable. The tests likely have objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance data for a device, not a diagnostic algorithm that would typically require such a study to assess human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (algorithm only) was not done. This device is a manual instrument, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance studies described, the "ground truth" refers to established engineering standards, material specifications, and functional requirements for a medical device. This is determined by the specific ASTM and ISO standards cited (e.g., ISO 11135 for sterility, ISO 10993 for biocompatibility, ASTM F1980-16 for accelerated aging). The concept of expert consensus, pathology, or outcomes data as ground truth is not applicable to these types of engineering and functional tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a hardware product, not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.

The provided text is a 510(k) summary for the FemChec Controlled Saline-Air Device (FCD-250), which is a medical device and not an AI or software device. Therefore, the questions related to AI/algorithm performance, training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data for a physical medical device.

However, I can extract the acceptance criteria and a summary of the studies performed from the provided text for the FemChec device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the studies conducted are non-clinical bench performance and material compatibility studies for a physical device, not a performance study involving a test set of data points or images.

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

This information is not applicable. Ground truth establishment by experts is relevant for AI/software devices requiring interpretation of data (e.g., medical images), which is not the case for this physical medical device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies where multiple readers/experts assess cases, which is not applicable to the non-clinical studies for this physical device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance studies for a physical device.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the context of AI/software performance. For the described bench tests, the "ground truth" would be established by the specifications and standards (e.g., flow rates, material properties, sterility levels) defined in the test protocols themselves, which are based on recognized international and ASTM standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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

This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance

The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health.

Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance. Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.

The provided text describes the FemaSeed Intratubal Insemination device and its comparison to a predicate device, along with a summary of non-clinical performance data. However, it does not include detailed acceptance criteria or a study proving the device meets them in the format requested. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It lists various tests performed and their general outcomes (e.g., "all predetermined acceptance criteria were met"), but it doesn't quantify those criteria or the specific performance metrics for each, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment for a device performance acceptance criteria table as requested.

Therefore, the following response will extract the available information and highlight the missing details based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantified acceptance criteria and reported device performance are generally not detailed. The document often states that "predetermined acceptance criteria were met" without specifying what those criteria were. However, some specific acceptance criteria and performance are mentioned:

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The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: further evaluation of an abnormal Pap smear; cervical lesions extending into the endocervical canal; undiagnosed uterine bleeding.

The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for FemCerv™ Endocervical Sampler

1. Table of Acceptance Criteria and Reported Device Performance:

• Device functionality and integrity over cycle testing of opening and closing the sample collection chamber.
• Insertion capability in a model of the endocervical canal.
• Sheath opening functionality.
• Rotational functionality.
• Sheath closure.
• Sample release into a specimen container. | "A sample set of 29 devices was tested and passed all criteria." |
  | Shelf Life | Shelf life integrity up to 1 year accelerated aging:
• Same test methodology and acceptance criteria as bench testing. | "A sample set of 29 devices was tested and passed all criteria." |
  | Biocompatibility | ISO 10993 standards:
• Cytotoxicity.
• Irritation.
• Sensitization. | "Biocompatibility of components according to ISO 10993 standards: cytotoxicity, irritation, and sensitization was conducted and passed all criteria." |
  | Clinical Performance | Clinical Study:
• Insertion.
• Device opening and closing.
• Adequate sampling capability based upon a pathologist's evaluation. | "An 85.7% sample adequacy rate was based on sampling with 7 devices." (This is the reported performance for "adequate sampling capability") |

2. Sample size used for the test set and the data provenance:

• Bench Testing: 29 devices
• Shelf Life Testing: 29 devices
• Clinical Study: 7 devices
• Data Provenance: The document does not explicitly state the country of origin. The clinical study involved subjects prior to scheduled hysterectomy, which implies a prospective collection of samples for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The clinical study's sample adequacy was "based upon a pathologist's evaluation." The document does not specify the number of pathologists or their specific qualifications (e.g., years of experience).

4. Adjudication method for the test set:

• The document states that sample adequacy was based on "a pathologist's evaluation." It does not mention any specific adjudication method (e.g., 2+1, 3+1, none) among multiple experts, suggesting a single pathologist's assessment or an unstated internal process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an endocervical sampler, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• No, this is a physical medical device for collecting tissue samples, not an algorithm. Therefore, the concept of standalone algorithm performance is not applicable.

7. The type of ground truth used:

• Clinical Study: The ground truth for sample adequacy was established by pathological evaluation of the collected tissue samples.

8. The sample size for the training set:

• The document does not describe a "training set" in the context of machine learning or AI. The tests mentioned are for verifying the physical properties and performance of the device itself.

9. How the ground truth for the training set was established:

• Not applicable, as there is no mention of a training set for an algorithm or AI model.

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The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.

The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.

The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.

Here's an analysis of the FemChec™ Pressure Management Device's acceptance criteria and the study used to demonstrate its performance, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for FemChec™ Pressure Management Device

1. Table of Acceptance Criteria and Reported Device Performance

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The FemVue™ Saline-Air Device instills a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

The FemVue™ Saline-Air Device is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter to instill saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity.

The FemVue™ Saline-Air Device, as described in the K110288 510(k) submission, is a physical medical device, specifically a contrast media syringe, rather than an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

However, based on the provided text, the acceptance criteria and the study performed can be described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable for a physical device where the "test set" would typically refer to a dataset for an AI/ML algorithm. The testing described is non-clinical performance testing of the physical hardware itself. The document does not specify a numerical sample size for the devices tested, nor does it refer to data provenance in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical performance study of a physical device. Ground truth, in the context of expert review, is not relevant here. The "ground truth" for these tests is the physical and mechanical functionality of the device against predefined performance targets.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used when subjective assessments by multiple experts need to be reconciled for establishing ground truth in clinical or image-based studies. This submission describes non-clinical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and thus no MRMC study or AI assistance evaluation was performed or is relevant.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests would have been the pre-defined engineering specifications and performance targets for the device's mechanical and fluidic functionalities. For example, "continuous and consistent stream of an alternating pattern of saline and air" would have specific measurable parameters that the device was designed to meet.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is a physical device, and there is no training set as understood in AI/ML development.

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The FemVue™ Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.

The FemVue Cornual Balloon Catheter ("FCBC") is a latex-free Balloon Catheter within a transcervical Delivery Sheath.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document explicitly lists the types of tests performed to demonstrate substantial equivalence but does not provide specific numerical acceptance criteria (e.g., "tensile strength of X Newtons") or the exact numerical results for the device performance. The FDA's clearance indicates that the device met the necessary criteria for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical testing only. Therefore, there is no human subject test set in the traditional sense of a clinical study described in this submission. The tests performed are engineering and bench-top tests of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies solely on non-clinical, bench-top testing. There were no human experts establishing ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a catheter for delivering contrast media, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device (catheter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for a clinical ground truth. For the engineering tests, the "ground truth" was established by the specifications and performance characteristics of the predicate device and relevant international standards (e.g., ISO 10993 for biocompatibility).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm that requires a training set. The tests performed are for a physical medical device.

9. How the ground truth for the training set was established

Not applicable. As noted above, there is no training set for this type of device.

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The FemVue™ Catheter System is intended for the delivery of contrast media during hysterosalpingography (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.

The FemVue Catheter System ("FCS") is comprised of two components: a Sheath and a latex free balloon Catheter. The Sheath is used to deliver the Catheter into the uterus.

The provided text for the FemVue™ Catheter System (K083690) is a 510(k) summary and FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

The summary focuses on demonstrating substantial equivalence to predicate devices through:

• Equivalent device type, indication for use, principle of operation, and device description.
• Similar principles of operation for device placement, device description, and safety features.
• Substantially equivalent indication for use, placement location, and principle of operation for evaluation of the fallopian tubes.

The only "testing" mentioned is biocompatibility testing (cytotoxicity, irritation, and sensitization) in compliance with ISO 10993. This type of testing ensures the material safety of the device when in contact with tissues, but it does not evaluate the device's functional performance in terms of diagnostic accuracy or effectiveness for its intended use (e.g., evaluating fallopian tube patency or uterine abnormalities).

Therefore, based solely on the provided text, I cannot complete the requested tables and sections related to performance acceptance criteria and a study demonstrating that the device meets those criteria. Such information is typically found in the clinical study section of a 510(k) submission, which is not included here.

The document indicates that the device was cleared based on substantial equivalence to existing devices, implying that its performance is presumed to be similar to its predicates, rather than requiring a de novo performance study with specific acceptance criteria.

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