(76 days)
The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
The Zutron Colonoscope Stiffening Device performs the same functions as several other devices on the market. Additionally, the subject device is composed of the same materials and has similar dimensions to some of the predicate devices.
The provided 510(k) summary for the Zutron Colonoscope Stiffening Device (Ko51068) does not contain information about a study that establishes acceptance criteria or proves the device meets specific performance metrics. This submission relies on substantial equivalence to predicate devices based on similar intended use, technological characteristics (materials, dimensions), and function.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided (N/A) | Not provided (N/A) |
Explanation: The document states, "We believe the differences are minor and conclude that the subject device is as safe and effective as the predicate devices." This is a general statement of equivalence, not a report on specific performance metrics against defined acceptance criteria. There are no quantitative or qualitative performance results presented.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned (no test set data presented). The submission implies a comparison of device characteristics rather than a study with a test set.
3. Number of Experts Used and Qualifications:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
Explanation: There is no indication of a study involving expert assessment or ground truth establishment.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not mentioned.
Explanation: As no test set study is detailed, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No.
- Effect Size: Not applicable, as no MRMC study was conducted or reported.
6. Standalone Performance Study (Algorithm Only):
- Standalone Study Done? Not applicable. This is a mechanical device, not an AI or algorithm-based device.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. There is no mention of a study requiring ground truth. The submission relies on a comparison of physical characteristics and intended use to predicate devices.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is a physical medical device, not an algorithm that requires training data.
9. How Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not applicable.
Summary of Device-Specific Information from the Text:
- Device Name: Zutron Colonoscope Stiffening Device
- Intended Use: To allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
- Predicate Devices:
- Steel Wire PreAmendment Device
- Guide Wires and Cables (e.g., Sullivan Variable Stiffness Cable, GIP/Medi-Globe Guide Wires, Endo-Glide Guidewire)
- Colonoscopes with Stiffness Controls (e.g., Olympus PCF-160AL/I)
- Basis of Equivalence: Performs the same functions, composed of same materials, and has similar dimensions to some predicate devices. The conclusion is that differences are minor and the device is as safe and effective as predicates.
- Regulatory Class: Class II
- Product Code: KOG
- Regulation Number: 21 CFR §876.1500 (Endoscope and accessories)
§ 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.