(60 days)
The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath that is used as an accessory with the Imalux OCT Imaging System. The Imalux OCT Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.
The Imalux OCT (Optical Coherence Tomography) Probe Sheaths (Probe Sheaths) are sterile, single-use, protective sheaths for use with the Imalux OCT Imaging System. The sheaths are provided to fit the Imalux OCT Imaging System probe geometry and to help to prevent the transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the Probe. The Probe Sheath does not impair the imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material. The Probe Sheath is constructed of rigid tubing with a flexible end cap membrane window at one end and with a plastic handle at the other end. The probe is inserted into the tubing at the handle and fed through the tubing until the probe's distal tip is flush with the Probe Sheath's membrane window. The handle includes a lock nut to secure the probe in place. The Probe Sheath is provided in various dimensional configurations necessary to accommodate the probe as well as to assist the user in probe positioning. Probe Sheaths are provided as sterile, single-use sheaths, individually packaged in Tyvek/Mylar pouches.
The medical device is the Imalux OCT Probe Sheath. The information provided describes the device, its intended use, and the testing conducted to demonstrate its safety and performance for 510(k) clearance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | |
| - Cytotoxicity | Evaluated per AAMI/ANSI/ISO 10993: Device is non-toxic. |
| - Acute systemic toxicity | Evaluated per AAMI/ANSI/ISO 10993: Device is non-toxic. |
| - Intracutaneous reactivity | Evaluated per AAMI/ANSI/ISO 10993: Device is non-irritating. |
| - Sensitization | Evaluated per AAMI/ANSI/ISO 10993: Device is non-sensitizing. |
| - Ethylene oxide sterilization residuals | Evaluated per AAMI/ANSI/ISO 10993: Can be safely sterilized with ethylene oxide. |
| Imaging Performance | |
| - Not impair optical imaging performance of OCT system | The Probe Sheath's materials and design have been shown to not impair the optical imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material. |
| Mechanical Performance | |
| - Withstand normal use (e.g., tensile strength) | Mechanical verification of the Sheath, such as tensile strength, demonstrated that the Probe Sheath's distal end will withstand normal use. |
| Microbial Barrier Performance | |
| - Prevent transmission of microorganisms/fluids | Microbial barrier testing demonstrated that the Probe Sheath was capable of preventing the transmission of a challenge virus with a diameter of 25-27 nanometers (nm), smaller than most clinically relevant bacteria (1 µm diameter) and viruses (0.1 µm diameter), to a detection limit of less than 5.5 x 107 milliliters (mL) of challenge virus suspension. |
| Sterilization & Packaging Integrity | |
| - Successful sterilization | The Probe Sheath, individually packaged in its Tyvek/Mylar package, was successfully sterilized with 100% ethylene oxide. |
| - Sterility Assurance Level (SAL) | The sterilization was validated and verified to provide a sterility assurance level (SAL) of 10-6. |
| - Packaging strength and integrity | The Tyvek/Mylar package was verified for strength and integrity. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (biocompatibility, imaging, mechanical, microbial barrier, sterilization, packaging). It states "The Probe Sheath was verified for imaging, mechanical, and packaging performance" and "Microbial barrier testing demonstrated..." without providing specific numbers of units tested.
The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. These were laboratory and performance tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing described. The tests are laboratory-based performance and safety evaluations (e.g., sterilization validation, material strength, microbial barrier efficacy, biocompatibility). There is no "ground truth" established by human experts in the context of interpreting results, as would be the case for an AI diagnostic device.
4. Adjudication method for the test set
Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of subjective interpretations.
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 probe sheath, an accessory to an imaging system, not an AI diagnostic algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a probe sheath and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed is based on established scientific standards and methods, such as:
- Biocompatibility: Standards like AAMI/ANSI/ISO 10993 and FDA Blue Book Memorandum #G95-1, with results determined through laboratory assays for cytotoxicity, toxicity, reactivity, and sensitization.
- Mechanical & Imaging Performance: Engineering specifications and objective measurements (e.g., tensile strength testing, optical clarity measurements).
- Microbial Barrier: Laboratory challenge tests using a known virus size and concentration and measuring transmission.
- Sterilization: Validation per established sterilization standards to achieve a specific Sterility Assurance Level (SAL).
8. The sample size for the training set
Not applicable. This device is a physical accessory, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical accessory and does not involve a training set or AI model.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.