(80 days)
Not Found
No
The summary describes a physical guide wire and its material properties and performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a guide wire used to facilitate the insertion of other devices, not to treat a condition itself.
No
Explanation: The device is described as a guide wire designed for "supporting cannulation or insertion into bile duct strictures and pancreatic duct strictures." Its function is to facilitate the placement of other instruments, not to detect, diagnose, or monitor a disease.
No
The device description clearly outlines a physical guide wire made of titanium nickel alloy with various coatings, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for supporting cannulation or insertion into bile duct strictures and pancreatic duct strictures during endoscopic procedures. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a guide wire used for physical manipulation within the body. This is consistent with a surgical or interventional device, not a device used to examine specimens outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies listed (Butting Load, Tip Flexibility, etc.) are related to the physical properties and performance of the guide wire during insertion and manipulation, not to the accuracy of a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guide wire does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 KOG, FDT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bile duct strictures and pancreatic duct strictures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K910722, Microvasive GEENEN ENDOTORQUE™ Guide Wire, WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
K971937 Pg 2 of 3
SECTION II Summary and Certification
DESIGN/MATERIALS
| DESIGN/MATERIALS | CLIMBER | TERUMO 450 CM |
|---|---|---|
| Wire | Nickel-Titanium alloy | |
| coated w/polyurethane | Nickel-Titanium alloy | |
| 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 ●
2
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 (