(60 days)
The Stryker Scope Warmer is indicated for use with endoscopes. As such, this product is indicated for use prior to and during surgeries in which an endoscope is indicated. The Stryker Scope Warmer is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope.
The Stryker Scope Warmer is an endoscopic accessory, composed of PVC and sodium acetate.
The provided text is a 510(k) summary for the Stryker Scope Warmer. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner requested.
Therefore, the requested information elements related to a study proving the device meets acceptance criteria, such as sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies, are not present in the provided document.
Here’s what can be extracted based on the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance targets like sensitivity, specificity, accuracy, or fogging reduction percentages. Instead, it relies on substantial equivalence to a predicate device and conformance to voluntary safety and performance standards.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Substantially equivalent to Applied Medical's Scope Warmer (K931895). |
| Intended Use | To heat endoscopes, prior to and during surgeries, to minimize fogging of the scope. |
| Material Composition | Composed of PVC and sodium acetate. |
| Standards Conformance | Conforms to ISO 10993, EN 550, ASTM D999, ASTM D1140, ASTM D4728, ASTM 5276, ASTM F88-94, EN 868-1, ISO 11607, and ASTM D4169. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The 510(k) summary for this device, an endoscope warmer, does not describe a clinical study with a "test set" in the context of diagnostic or AI-driven devices. Substantial equivalence for this type of device is typically demonstrated through bench testing, material compatibility, and engineering assessments rather than clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are not relevant for this type of device submission.
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. An MRMC study is not relevant as this is an endoscope warmer, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. Ground truth is not established in the typical sense for an endoscope warmer. Compliance is shown through engineering and material standards.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" for this device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no "training set" for this device.
Summary of what the document does convey about the device's demonstration of safety and effectiveness:
The Stryker Scope Warmer's safety and effectiveness are established through:
- Substantial Equivalence: It is deemed substantially equivalent to the legally marketed predicate device, Applied Medical's Scope Warmer (K931895). This implies that its fundamental technology, intended use, and performance characteristics are similar enough not to raise new questions of safety or effectiveness.
- Compliance with Voluntary Standards: Conformance to a comprehensive list of international and industry standards (ISO 10993, EN 550, ASTM D999, ASTM D1140, ASTM D4728, ASTM 5276, ASTM F88-94, EN 868-1, ISO 11607, and ASTM D4169). These standards cover aspects like biocompatibility (ISO 10993), electromagnetic compatibility (EN 550), packaging (EN 868-1, ISO 11607, ASTM F88-94), and performance of plastics (various ASTM D standards).
- Technological Differences: The submission explicitly states that "The technological differences between the Stryker Scope Warmer and the identified predicate device... do not affect the safety or efficacy of the product." This is a key assertion in a 510(k) submission, indicating that any differences were assessed and found not to introduce new risks or alter performance significantly.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.