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510(k) Data Aggregation
(81 days)
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.
These devices are latex sheaths, closely related to condoms which have been used in the past for this purpose. However, these sheaths have different dimensions, depending on which probe they are designed to be used. They may range in size from about 30 cm. length, and 10 cm. in diameter to 6 cm. in length to 2 cm. in diameter with the 20 cm x 5 cm being the most common.
This 510(k) pertains to a medical device, specifically the CLK™ Int'l, Sanitary Latex Probe Cover. The submission focuses on demonstrating substantial equivalence to predicate devices already on the market rather than proving performance against novel acceptance criteria through a specific study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Properties | Meet requirements of ASTM D3578-95 for latex exam gloves. | "Tests show they meet the requirements of ASTM D3578-95 for latex exam gloves." |
| Biocompatibility | Meet requirements of Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1. | "Biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1." (Implied compliance through data submission) |
| Physical Characteristics (Pre-aging) | Not explicitly stated, but implied to be similar to predicate devices. | Summary of Test Data: "Physical characteristics, before and after aging." (Implied to be acceptable for equivalence) |
| Physical Characteristics (Post-aging) | Not explicitly stated, but implied to be similar to predicate devices. | Summary of Test Data: "Physical characteristics, before and after aging." (Implied to be acceptable for equivalence) |
| Intended Use | Same as predicate devices: to aid in avoiding contamination of ultrasonic probes by bodily fluids and facilitate cleaning. | "These products have the same intended use... These are the same as those of the predicate devices." |
| Technological Characteristics | Same as predicate devices and those made from latex materials currently on the market. | "The technological characteristics for this product are the same as those for the predicate devices and those currently on the market that are prepared from latex materials." |
| Descriptive Information | Materials are substantially equivalent to (nearly identical with) similar products currently on the market. | "Descriptive information provided shows that the materials from which the CLK Ultrasound Probes are made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of an accuracy or performance study for the device. The data mentioned (ASTM D3578-95, ISO-10993) refers to standardized material and biocompatibility testing. The sample sizes for these types of tests are typically defined by the respective standards. The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission. The "ground truth" here is compliance with established material and biocompatibility standards, not expert consensus on device performance in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in studies where multiple observers or algorithms are evaluated against a "ground truth" established by experts. Here, compliance is determined by laboratory testing against predefined specifications.
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
This is not applicable. The device is a physical probe cover, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical probe cover, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence and device safety/effectiveness for this product relies on:
- Established industry standards for material properties: ASTM D3578-95 for latex exam gloves.
- Established international standards for biocompatibility: ISO-10993 (as modified by FDA G95-1).
- Comparison to legally marketed predicate devices: The characteristics and intended use of the CLK probe cover were compared to several existing cleared devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device. The device is a physical product.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
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