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.

Device Description

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.

AI/ML Overview

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.

Summary

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K 97/937 Pg 1 of 3

SECTION II Summary and Certification

AUG 1 5 1997

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

CLIMBER - Partially Coated Guide Wire for Endoscopic Use Proprietary Device Name:

Classification Name: Accessories, Bite Blocks, for Endoscope

INTENDED USE

Note: This is the same intended use as the Terumo 450 cm Guide Wire for G.I. Use cleared under 510(k) K910722.

DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The CLIMBER - Partially Coated Guide Wire for Endoscopic Use submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo 450 cm Guide Wire for G.I. Use (K910722); the Microvasive GEENEN ENDOTORQUE™ Guide Wire; and the WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip.

PRINCIPLE OF OPERATION/TECHNOLOGY

The CLIMBER - Partially Coated Guide Wire for Endoscopic Use is operated manually or by a manual process.

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K971937 Pg 2 of 3

SECTION II Summary and Certification

DESIGN/MATERIALS

DESIGN/MATERIALS	CLIMBER	TERUMO 450 CM
Wire	Nickel-Titanium alloycoated w/polyurethane	Nickel-Titanium alloycoated w/polyurethane
Core Wire	single taper	single taper
Exterior Coating	hydrogel/silicone	hydrogel
SPECS
Wire Diameter	0.035"	0.035"
Wire Length	450 cm	450 cm
Tip Configuration	straight/angled	straight/angled

PERFORMANCE

The performance of the Terumo CLIMBER - Partially Coated Guide Wire for Endoscopic Use is substantially equivalent to the performance of the cleared Microvasive GEENEN ENDOTORQUE™, the WILSON-COOK® TRACER™ and the Terumo 450 cm Guide Wire for G.I. Use (K910722).

The following tests were performed demonstrating the substantial equivalence of the Terumo CLIMBER submitted in this 510(k) 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.

Butting Load ●
Tip Flexibility Test ●
Shaft Flexibility Test ●
Memory Retention Test ●
Shapeability Test
Sliding Resistance ●
Tensile Strength .
Torque Failure Test ●
Torque Transmission Test ●

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SECTION II Summary and Certification

K 971937

Pg 3 of 3

ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the European Standard, EN 550 (1994); Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization, to provide a Sterility Assurance Level (SAL) of 10 °.

Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended).

Manufacturing control test methods include: functional, extraction and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." [External Communicating Devices. Blood Path Indirect, Limited Duration of Contact (<24 hours).] days). The blood contacting materials were found to be biocompatible.

The expiration dating for the CLIMBER - Partially Coated Guide wire for Endoscopic Use has been established to be 24 months.

CONCLUSION

Date Prepared	May 22, 1997
Prepared by	Kristine Wagner
	Regulatory Affairs Specialist
Prepared for	Terumo Medical Corporation
	125 Blue Ball Road
	Elkton, MD 21921
	Phone (410) 392-7241 or (410) 392-7231
	Fax (410) 398-6079

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 1997

Ms. Kristine Wagner Regulatory Affairs Specialist Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921

Re: K971937

CLIMBER - Partially Coated Guide Wire for Endoscopic Use ........................................................................................................................................................... Dated: May 23, 1997 Received: May 27, 1997 Regulatory Class: II 21 CFR §876.1500/Product Code: 78 KOG & FDT

Dear Ms. Wagner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/odth/dsmamain.html".

Sincerely vours

W.Liau Yi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: CLIMBER - Partially Coated Guide Wire for Endoscopic Use Indications For Use: ... .....................................................................................................................................................

The CLIMBER - Partially Coated Guide Wire for Endoscopic Use is designed ror endoscopic use. The CLIMBER is used for supporting cannulation or insertion into bile duct strictures and pancreatic duct strictures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter R. Sather
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K97 1932

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.