(80 days)
The CLIMBER - Partially Coated Guide Wire for Endoscopic Use is designed for endoscopic use. The CLIMBER is used for supporting cannulation or insertion into bile duct strictures and pancreatic duct strictures.
The CLIMBER has a core of titanium nickel alloy coated with polyurethane. The distal tip up to 150 cm is coated again with polyurethane and then is coated with a hydrogel. The remaining 300 cm of the wire is coated with silicone. The wires are 450 cm in length and come in 0.035" diameter. The tip shape is available in straight or angled, shapeable; and straight or angled, non-shapeable.
Here's an analysis of the provided information regarding the CLIMBER - Partially Coated Guide Wire for Endoscopic Use, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a substantial equivalence determination, not a study with explicit acceptance criteria and corresponding performance metrics for a novel medical device feature or algorithm. Instead, the "acceptance criterion" is implicitly demonstrating that the CLIMBER device performs comparably to existing, legally marketed predicate devices.
| Acceptance Criterion (Implicitly "Substantially Equivalent To") | Reported Device Performance (CLIMBER compared to predicates) |
|---|---|
| Intended Use (supporting cannulation or insertion into bile duct and pancreatic duct strictures for endoscopic use) | Substantially Equivalent to the Terumo 450 cm Guide Wire for G.I. Use (K910722), Microvasive GEENEN ENDOTORQUE™ Guide Wire, and WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip. The document explicitly states: "Note: This is the same intended use as the Terumo 450 cm Guide Wire for G.I. Use cleared under 510(k) K910722." |
| Design/Materials | Substantially Equivalent to predicate devices. The table on page 2 compares the CLIMBER to the Terumo 450 cm. Key similarities include: |
- Wire: Nickel-Titanium alloy coated with polyurethane
- Core Wire: single taper
- Wire Diameter: 0.035"
- Wire Length: 450 cm
- Tip Configuration: straight/angled
A minor difference is noted in "Exterior Coating" (hydrogel/silicone for CLIMBER vs. hydrogel for Terumo 450 cm), which is deemed not to raise new safety/effectiveness issues. |
| Technology/Principles of Operation | Substantially Equivalent: Both the CLIMBER and the predicate devices are operated manually or by a manual process. |
| Performance (mechanical and biological properties) | Substantially Equivalent: "The following tests were performed demonstrating the substantial equivalence of the Terumo CLIMBER... to the Microvasive GEENEN ENDOTORQUE™ GUIDE WIRE, the WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip and the Terumo 450 cm Guide Wire for G.I. Use." Specific tests mentioned include: - Butting Load
- Tip Flexibility Test
- Shaft Flexibility Test
- Memory Retention Test
- Shapeability Test
- Sliding Resistance
- Tensile Strength
- Torque Failure Test
- Torque Transmission Test
- Biocompatibility (passed)
- Sterilization (validated)
- Expiration Dating (24 months established) |
| Safety (biocompatibility, sterility, residuals, expiration) | Substantially Equivalent: - Biocompatibility: Blood contacting materials tested in accordance with ISO-10993 and found to be biocompatible.
- Sterilization: Validated according to EN 550 (1994) to SAL of 10^-6. Ethylene oxide residuals within limits.
- Expiration: Established at 24 months. |
Study Proving Acceptance Criteria:
The "study" described is a comparison to predicate devices to demonstrate substantial equivalence, rather than a stand-alone clinical trial. The performance tests listed are a series of bench tests and material characterization tests designed to show that the CLIMBER device performs similarly to or within acceptable limits compared to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of patient numbers or independent devices. The "tests" listed (e.g., Butting Load, Tip Flexibility Test) imply testing on a sample of the CLIMBER guide wires, but the exact number of units tested for each parameter is not provided.
- Data Provenance: The tests performed are likely bench testing conducted by the manufacturer, Terumo Medical Corporation, in a laboratory setting. There is no indication of patient data, clinical data, or country of origin for such data in the context of this 510(k) submission. It’s a pre-market submission based on physical device characteristics and performance, not clinical outcomes.
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 type of submission. Ground truth, in the sense of expert consensus on clinical findings, is not established because the evaluation is based on engineering and material performance tests of the device itself, not on diagnostic interpretations or clinical observations. The "ground truth" for these tests would be the established engineering specifications and performance values of the predicate devices or relevant industry standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are typically used in clinical studies or reader studies where multiple experts interpret data. For a bench test comparing material properties and mechanical performance, the "adjudication" is based on objective measurements against predefined specifications or predicate device performance.
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. This submission is for a physical medical device (a guide wire), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is based on:
- Engineering Specifications and Performance Data of Predicate Devices: The CLIMBER's performance was compared to existing, legally marketed guide wires (Terumo 450 cm Guide Wire, Microvasive GEENEN ENDOTORQUE™, WILSON-COOK® TRACER™). The "ground truth" is that these predicate devices are deemed safe and effective based on their prior clearances and established performance.
- Industry Standards: References to European Standard EN 550 for sterilization and ISO-10993 for biological evaluation indicate adherence to established standards.
- Manufacturer's Internal Specifications: The various bench tests would have target values or ranges derived from internal company standards and/or comparison to predicate devices' known characteristics.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device.
§ 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.