(86 days)
Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
The Spirus Medical Lubricant is a water-based lubricant intended for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device.
The provided text describes a 510(k) premarket notification for the Spirus Medical Lubricant, a Class I patient lubricant. The information given is limited and focuses on the regulatory aspects rather than detailed study results to prove acceptance criteria.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Biocompatibility | "Biocompatibility testing was conducted on the finished device in accordance with ISO 10993." (Implied acceptance met due to "predetermined acceptance criteria") |
| Effectiveness: | |
| Substantial Equivalence to Predicate Device | "Substantial Equivalence for the Spirus Medical Lubricant has been established by comparison of the chemical formula for the proposed device vs. that of the predicate devices." (Implied acceptance met due to "predetermined acceptance criteria") |
| Lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices | The device is "intended for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device." The conclusion states it "meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness." This implies the lubricant successfully performs its intended function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or the data provenance. It mentions "biocompatibility testing" and "comparison of the chemical formula" but provides no details on the studies themselves.
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)
This information is not available in the provided document. The submission relies on chemical comparison and biocompatibility testing, not on expert-driven "ground truth" establishment in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, which is not described here.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to a patient lubricant. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists analyzing medical images with and without AI assistance).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a medical lubricant. A lubricant does not involve an algorithm or "standalone" performance in the way a diagnostic AI would.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" would be established by the biological response of cells/tissues to the lubricant, as defined by the ISO 10993 standards. For substantial equivalence, the ground truth is the chemical formula of the predicate devices. There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not available in the provided document. The device is a lubricant, not a machine learning model, so typical "training set" concepts do not apply.
9. How the ground truth for the training set was established
This information is not available and not applicable.
Summary of Device Acceptance:
The Spirus Medical Lubricant "meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness." The study that proves this is based on:
- Chemical Comparison: Substantial equivalence was established by comparing the chemical formula of the proposed device to that of predicate devices (K-Y Lubricating Jelly and Probe Personal Lubricant). This comparison is the primary method for demonstrating effectiveness in terms of physical properties expected of a lubricant.
- Biocompatibility Testing: The device underwent testing in accordance with ISO 10993 standards to ensure safety for patient contact.
The document explicitly states: "The Spirus Medical Lubricant meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Spirus Lubricant is substantially equivalent to the predicate devices." This concise statement confirms that the studies performed (chemical comparison and biocompatibility) were deemed sufficient to meet the regulatory requirements for a Class I patient lubricant seeking 510(k) clearance. Specific data, sample sizes, and detailed methodology of these tests are not provided in this summary.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.