CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE

K971937 · Terumo Medical Corp. · OCY · Aug 15, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971937
• Device Name: CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
• Applicant: Terumo Medical Corp.
• Product Code: OCY · Gastroenterology, Urology
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

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 Story

The CLIMBER is a 450 cm long, 0.035" diameter guide wire used in endoscopic procedures. It features a nickel-titanium alloy core coated with polyurethane; the distal 150 cm is further coated with hydrogel, while the remaining 300 cm is coated with silicone. Available in straight or angled, shapeable or non-shapeable tip configurations. Operated manually by clinicians during endoscopic procedures to support cannulation or access strictures in the bile or pancreatic ducts. The device facilitates navigation through anatomical structures to assist in therapeutic or diagnostic interventions. Biocompatible materials ensure safety during limited-duration blood contact.

Clinical Evidence

Bench testing only. Performance validated via butting load, tip/shaft flexibility, memory retention, shapeability, sliding resistance, tensile strength, and torque failure/transmission tests. Biocompatibility testing performed per ISO-10993 standards for limited duration blood contact.

Technological Characteristics

Nickel-titanium alloy core; polyurethane, hydrogel, and silicone coatings. 450 cm length, 0.035" diameter. Manual operation. Sterilized via ethylene oxide per EN 550 (1994).

Indications for Use

Indicated for patients requiring endoscopic cannulation or insertion into bile duct and pancreatic duct strictures.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Terumo 450 cm Guide Wire for G.I. Use (K910722)
• Microvasive GEENEN ENDOTORQUE™ Guide Wire
• WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip

Submission Summary (Full Text)

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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

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.

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

#### 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 alloy<br>coated w/polyurethane | Nickel-Titanium alloy<br>coated 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

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. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

| 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 [phone] or [phone] |
| | Fax [phone] |

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)