(60 days)
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:
| Technological Characteristic | Rocket Mucus Sampler vs. Predicate Devices (Summary) |
|---|---|
| Indications for Use | Equivalent (E) |
| Target population | Equivalent (E) |
| Design | Similar (S) |
| Materials | Similar (S) |
| Performance | Equivalent (E) |
| Sterility | Similar (S) |
| Biocompatibility | Not applicable (N/A) / No information (N/I) |
| Mechanical Safety | Equivalent (E) |
| Chemical Safety | Equivalent (E) |
| Anatomical sites | Similar (S) |
| Human Factors | Not applicable (N/A) |
| Energy used and/or delivered | Equivalent (E) |
| Compatibility w/ environment & devices | Equivalent (E) |
| Where used | Equivalent (E) |
| Standards met | Equivalent (E) |
| Electrical Safety | Not applicable (N/A) |
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.
§ 884.1050 Endocervical aspirator.
(a)
Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.(b)
Classification. Class II (performance standards).