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The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. It is comprised of 3 components: Plunger, O-ring and external tubing. Suction is created by pulling the plunger with a handle outward. It has a small OD of 2.6mm, which minimizes pain and discomfort to the patient. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

The provided document is a 510(k) summary for a medical device called the "Rocket Mucus Sampler Syringe." It claims substantial equivalence to existing predicate devices, rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance outcomes. Therefore, much of the requested information regarding acceptance criteria and a study to prove performance is not available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or functional thresholds). Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.

The table provided (paragraph 14) compares technological characteristics of the Rocket Mucus Sampler with three predicate devices:

Interpretation: The "Performance: Equivalent (E)" entry in the table is the closest to an "acceptance criterion," implying that the Rocket Mucus Sampler is expected to perform at a level comparable to the predicate devices for its intended use, which is optimal suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. However, no specific metrics or thresholds are provided for this "performance."

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

Not applicable. The document does not describe a performance study with a test set. The 510(k) submission is based on demonstrating substantial equivalence to existing devices through a comparison of technological characteristics, not through new clinical or performance data.

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

Not applicable. No test set or ground truth derived from expert consensus is mentioned in the document.

4. Adjudication Method for the Test Set

Not applicable. No test set adjudication method is described.

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 physical medical instrument (a mucus sampler syringe), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study involving human readers and AI is not relevant to this submission.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

Not applicable. The submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than establishing a new ground truth based on pathology, outcomes data, or expert consensus from a new study. The "ground truth" here is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

Not applicable. This is not an algorithmic device that requires a training set.

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

Not applicable. No training set is described.

Summary of 510(k) Approach:

The K974032 submission for the Rocket Mucus Sampler Syringe is a 510(k) premarket notification which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer asserts that their new device is as safe and effective as, and has the same intended use and similar technological characteristics to, a legally marketed device that does not require premarket approval (PMA).

The "study" in this context is the comparison of technological characteristics against the predicate devices (Aspirette Endocervical Aspirator, SelectMucus, and Cervical Mucous Aspiration Catheter). The acceptance "criteria" are implicitly met if the FDA agrees that the Rocket Mucus Sampler Syringe is substantially equivalent to these predicates based on the provided comparison. No new clinical trials or performance studies with specific acceptance criteria are detailed in this summary. The FDA's letter (DEC 22 1997) confirms their finding of substantial equivalence, allowing the device to be marketed.

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The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility.

The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility. The Cervical Mucous Aspiration Catheter will be made from TFE and nylon. TFE is widely known and accepted in the medical field, therefore, biocompatibility is assured. Biocompatibility testing has been performed on the nylon and the results show a reasonable assurance of safety and effectiveness.

The provided document, K960263, is a 510(k) Premarket Notification for a cervical mucous aspiration catheter from Cook OB/GYN, submitted in 1996. This document is a summary of safety and effectiveness, and its primary purpose is to demonstrate substantial equivalence to predicate devices, not to present a comprehensive study proving performance against defined acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, specific study details, ground truth establishment, expert involvement, and reader studies is not available within this 510(k) summary.

Here's a breakdown of what information can and cannot be extracted from the provided text according to your request:

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

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

• Sample Size for Test Set: Not applicable / Not mentioned. This document does not describe a clinical study with a test set to evaluate device performance against specific criteria.
• Data Provenance: Not applicable / Not mentioned. The document references biocompatibility testing but does not provide details of a clinical study or its data origin.

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)

• Number of Experts: Not applicable / Not mentioned.
• Qualifications of Experts: Not applicable / Not mentioned.

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

• Adjudication Method: Not applicable / Not mentioned.

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

• MRMC Study: No. This device is a physical medical instrument (catheter), not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: No. This device is a physical medical instrument, not an algorithm.

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

• Type of Ground Truth: Not applicable / Not mentioned. The document primarily relies on demonstration of substantial equivalence to existing devices. For the biocompatibility testing mentioned, the "ground truth" would likely be laboratory standards for material safety, but the specifics are not detailed.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not mentioned. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable / Not mentioned. As above, this is not an AI/ML device.

Summary based on the provided document:

The 510(k) Premarket Notification for the Cook OB/GYN Cervical Mucous Aspiration Catheter aims to demonstrate substantial equivalence to predicate devices. It relies on similarities in indications for use, design, materials (TFE and nylon), manufacturing process controls, and quality assurance programs. Biocompatibility testing for nylon is mentioned, with results showing "reasonable assurance of safety and effectiveness." However, this document does not contain information about specific performance acceptance criteria or a detailed study designed to prove the device meets such criteria through clinical trials, expert reviews, or data-driven performance metrics typically associated with modern device evaluations. The focus is on regulatory equivalence based on existing devices.

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The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse.

The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse. This device will be made from polyurethane and polyethylene.

Here's an analysis of the provided 510(k) summary for the K9549D3 Pedi Vaginal Aspirator, identifying the absence of information related to typical AI/software device acceptance criteria and study details.

The provided 510(k) summary describes a physical medical device, specifically a Pedi Vaginal Aspirator, and not a software or AI-driven diagnostic device. Therefore, the questions related to acceptance criteria, study methodologies, ground truth, and reader performance typically associated with AI/software devices are not applicable to this submission.

The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device, primarily in terms of:

• Indications for Use: The purpose for which the device is intended.
• Technological Characteristics: The materials, design, and operating principles of the device.
• Safety and Effectiveness: Assurances that the new device is as safe and effective as the predicate.

Given this context, I cannot extract the requested information as it does not exist within the provided text. The submission relies on a comparison to the Bard® Rubber Utility Catheter, Radiopaque, to establish substantial equivalence, implying that its safety and effectiveness are derived from the predicate's established history.

Here's a breakdown of why each numbered point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not applicable. For physical devices, performance often relates to material biocompatibility, sterility, functionality (e.g., aspiration capability), and physical integrity, which are typically addressed through bench testing and manufacturing controls, not performance metrics like sensitivity/specificity against a ground truth.
2. Sample sized used for the test set and the data provenance: Not applicable. There's no "test set" in the sense of patient data for diagnostic performance evaluation. Testing would involve engineering and biocompatibility evaluations.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. There's no diagnostic ground truth to establish for a physical aspirator.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for diagnostic interpretation, not for a physical aspirator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no algorithm to train.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided 510(k):

The 510(k) for the Pedi Vaginal Aspirator demonstrates substantial equivalence by:**

• Indications for Use: Stating it is "substantially equivalent to predicate devices in terms of indications for use." The indication is "to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse."
• Technological Characteristics: Made from "polyurethane and polyethylene," similar to existing devices.
• Manufacturing and Quality: Emphasizing manufacturing according to "specified process controls and a Quality Assurance Program" and undergoing "packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN."
• Predicate Device: Bard® Rubber Utility Catheter, Radiopaque.

The 510(k) relies on the established safety and effectiveness of the predicate device and sound manufacturing practices, rather than clinical study data demonstrating diagnostic performance, to meet the substantial equivalence requirements.

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