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510(k) Data Aggregation
(15 days)
To snare, grasp, hold and manipulate cervical and intravaginal tissue.
GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
The GYN Disposables Tenaculum 356T is a medical device used to snare, grasp, hold, and manipulate cervical and intravaginal tissue. The device is made of glass-reinforced polycarbonate and is supplied sterile by gamma radiation.
Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them:
Acceptance Criteria and Reported Device Performance
The document describes several tests conducted to ensure the device's safety and performance. The acceptance criteria are generally qualitative (e.g., "met the minimum acceptance criteria," "did not induce cytotoxicity," "passed").
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Strength | The advanced composite design can easily withstand forces during normal use. The instrument met the minimum acceptance criteria for flexibility, arm strength, tip strength, rack strength, force needed to lock, and hinge pin strength. Does not degrade due to gamma sterilization and extended shelf life. | All test reports (flexibility & arm strength, tip strength, rack strength & locking force, hinge pin strength) showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life. |
| Biocompatibility | Cytotoxicity: No induction of cytotoxicity relative to positive and negative controls. Pyrogenicity/Sensitization/Irritation: No increase in temperature (in rabbits). Hemolysis: No damage to blood cells. Dermal Sensitization: Passed (in guinea pig). Systemic Toxicity (Acute): Passed (in mouse). Intracutaneous Irritation: Passed (in rabbit). Vaginal Irritation: Passed (in rabbit). All tests meet and exceed criteria established in FDA's 510(k) Memorandum #G95, Table 1 for minimal contact duration (<24 hours), "External Communicating Device", and "Blood Path, Indirect" classification. | Cytotoxicity: The test article did not induce cytotoxicity. Pyrogenicity/Sensitization/Irritation: The as-made instrument did not cause any increase in temperature. Hemolysis: The average % hemolysis was determined to be 0.0%, meaning that the extract did not cause damage to blood cells. Dermal Sensitization: GYN material passed. Systemic Toxicity (Acute): GYN material passed. Intracutaneous Irritation: GYN material passed. Vaginal Irritation: GYN material passed. These seven tests meet and exceed the criteria established in FDA's 510(k) Memorandum #G95, Table 1. |
| Sterilization | Product qualification for irradiation sterilization met acceptance criteria (Initial verification dosing, bioburden, bacteriostasis/fungistis, sterility testing). | Acceptance criteria were met for initial verification dosing, bioburden, bacteriostasis/fungistis, and sterility testing. |
| Packaging Integrity | Product packaging met requirements of burst test at non-aged and 1-year accelerated aged time point. Product packaging met requirements of dye penetration test both non-aged and 1-year aged. | The product packaging met the requirements of the burst test at the non-aged and 1 year accelerated aged time point. Product packaging met the requirements of the dye penetration test both non-aged and 1 yr aged. |
Study Information
2. Sample sizes used for the test set and the data provenance:
- Material Strength Tests: The document doesn't explicitly state the sample size for each individual strength test (flexibility, arm strength, tip strength, rack strength, hinge pin strength). It mentions testing "non sterile, gamma sterilized non-aged, and gamma sterilized aged product" in four ways. This implies multiple samples for each condition.
- Biocompatibility Tests:
- In vitro cytotoxicity: Not specified, but standard lab practices involve replicates.
- Pyrogen test: Rabbits (number not specified, but typically N=3 for such tests).
- Hemolysis test: Rabbit blood (sample size not specified).
- Dermal sensitization: Guinea pig (number not specified, but typically N=10 for main study).
- Systemic toxicity: Mouse (number not specified, but typically N=10 for main study).
- Intracutaneous irritation: Rabbit (number not specified, but usually N=2 for a primary irritation test).
- Vaginal irritation: Rabbit (number not specified, but usually N=3 or N=5).
- Sterilization Validation: Not specified, but determined by ANSI/AAMI/ISO 11137-2:2006 guidelines.
- Packaging Tests: Not specified.
Data Provenance: The studies were conducted by GYN Disposables, Inc. internally or through contract labs (Steris and Nelson Laboratories for sterilization, Ethox for packaging aging). The data is prospective, as these tests are performed on the device itself as part of its development and validation. The country of origin for the data is not explicitly stated but can be inferred as the USA, where GYN Disposables, Inc. is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For all tests related to biocompatibility and material performance: The "ground truth" is established by the results of the scientific tests against pre-defined regulatory standards (e.g., ISO, FDA guidelines, internal acceptance criteria). There are no "experts" in the sense of clinical reviewers establishing a ground truth based on patient cases for these engineering and biological tests. These are objective measurements rather than subjective interpretations. The testing was performed by laboratories (e.g., Nelson Laboratories for sterilization, Ethox for aging) according to established protocols.
4. Adjudication method for the test set:
- Not applicable. The tests described are objective scientific and engineering measurements against pre-defined criteria, not subjective assessments requiring adjudication by multiple readers or experts.
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 performed. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical, manual instrument and does not involve any algorithms.
7. The type of ground truth used:
- For Material Strength and Packaging Integrity: The ground truth is based on engineering specifications and physical test measurements (e.g., force, flexibility, burst strength, dye penetration) against pre-defined acceptance limits.
- For Biocompatibility: The ground truth is based on biological responses (e.g., cell viability, temperature change, hemolysis percentage, irritation scores) observed in standardized animal and in vitro models, compared against established biological safety standards (e.g., ISO 10993 series which is referenced by the FDA's 510(k) Memorandum #G95).
- For Sterilization: The ground truth is based on microbial inactivation (sterility assurance level) determined by validated methods following standards like ANSI/AAMI/ISO 11137-2:2006.
8. The sample size for the training set:
- Not applicable. This device is a manual instrument, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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