(65 days)
No
The device description and performance studies focus on the physical properties and functional performance of a guidewire, with no mention of AI or ML capabilities.
No.
The device is a guidewire designed to assist in other procedures, guiding and exchanging endoscopic accessories and electrosurgical devices. While it is to be used with high-frequency therapeutic devices and meets insulation standards for them, it is not a therapeutic device itself. Its function is purely facilitative in nature.
No.
The device is a guidewire designed to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. Its function is interventional, not diagnostic – it facilitates other procedures rather than acquiring information for diagnosis.
No
The device description clearly details a physical guidewire constructed of Nitinol with a PTFE coating, indicating it is a hardware medical device, not software-only.
Based on the provided information, the FlexFinder® Guidewire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures" and for "selective cannulation of the biliary ducts." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of the guidewire itself (material, dimensions, flexibility, insulation for electrosurgery). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information about a patient's health status.
- Reagents, calibrators, or controls typically associated with IVD tests.
The FlexFinder® Guidewire is a medical device used for interventional procedures within the biliary system.
N/A
Intended Use / Indications for Use
The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
Product codes
Not Found
Device Description
The FlexFinder® Guidewire is available in a nominal diameter of 0.035" with marked and unmarked models encompassing lengths between 260 - 450 cm. The guidewire is constructed of a Nitinol, kink resistant core wire encapsulated in a PTFE coating. The core wire is tapered to provide flexibility of the distal tip. The guidewire will be available in both ink marked and unmarked models of each of the shaft flexibility's. For the marked models, the distal portion of the guidewire is marked visually with ink bands to allow for endoscopic detection of wire movement during a clinical procedure. The encapsulated guidewire enables it to be used with wire guided electrosurgical devices providing insulation from the electrosurgical current during a procedure. The insulation meets the AAMI standard for High frequency Therapeutic devices(HF 18) which describes testing for reliability, safety, and effectiveness. The guidewires are packaged, sterilized, and labeled and intended for one procedure use only(disposable).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts, common bile, cystic, pancreatic, and right and left hepatic ducts
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 guidewires have been verified as meeting specifications for electrosurgical devices providing insulation from the electrosurgical current; material integrity; dimensions; and, material biocompatibility. The results of functional testing were analyzed against product specifications and currently marketed devices. The test results demonstrate that the product meets requirements and is acceptable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 3 1997
K 964955
P192
Image /page/0/Picture/2 description: The image shows the logo for FlexMedics Corporation. The logo consists of the word "FLEXMEDICS" in bold, sans-serif font, with the word "CORPORATION" in a smaller font size underneath. To the right of the text is a stylized, geometric shape that resembles the letter "F".
SUMMARY OF SAFETY AND EFFECTIVENESS FlexMedics Corporation, FlexFinder® Guidewire
| A. | General Provisions | ||
|---|---|---|---|
| Submitter's Name: | FlexMedics Corporation | ||
| Submitter's Address: | 12400 Whitewater Drive | ||
| Minnetonka, Minnesota 55343 | |||
| Contact Person: | Pam L. Schaub | ||
| Regulatory Affairs Manager | |||
| Classification Name: | Gastrointestinal guidewire (Endoscope) 21 CFR | ||
| Part 876.1500 and (Electrosurgical) 21 CFR Part | |||
| 876.4300. | |||
| Common or Usual Name: | Guidewire | ||
| Proprietary Name: | FlexFinder® guidewire | ||
| B. | Name of Predicate Devices | ||
| Wilson-Cook Medical, Inc. | Protector Plus Guidewire | K910597 | |
| Boston Scientific Corporation | Zebra Guidewire | K931650 |
FlexMedics Corporation, Inc.
C. Device Description
The FlexFinder® Guidewire is available in a nominal diameter of 0.035" with marked and unmarked models encompassing lengths between 260 - 450 cm. The guidewire is constructed of a Nitinol, kink resistant core wire encapsulated in a PTFE coating. The core wire is tapered to provide flexibility of the distal tip. The guidewire is provided in two shaft flexibility's; regular shaft and stiff shaft. The guidewire will be available in both ink marked and unmarked models of each of the shaft flexibility's. For the marked models, the distal portion of the guidewire is marked visually with ink bands to allow for endoscopic detection of wire movement during a clinical procedure.
FlexFinder Guidewire
The encapsulated guidewire enables it to be used with wire guided electrosurgical devices providing insulation from the electrosurgical current during a procedure. The insulation meets the AAMI standard for High frequency Therapeutic devices(HF 18) which describes testing for reliability, safety, and effectiveness.
1
FlexMedics Corporation Premarket Notification FlexFinder® Guidewire
K964955
P2092
The guidewires are packaged, sterilized, and labeled and intended for one procedure use only(disposable).
D. Intended Use
The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
E. Summary of Technological Characteristics
The FlexFinder® Guidewire uses common biocompatible materials which are identical to those of currently marketed Gastrointestinal guidewires manufactured by FlexMedics Corporation in K942074, Boston Scientific Corporation in K931650, Wilson-Cook Medical, Inc. in K910497.
F. Non-Clinical Test Summary
The guidewires have been verified as meeting specifications for electrosurgical devices providing insulation from the electrosurgical current; material integrity; dimensions; and, material biocompatibility. The results of functional testing were analyzed against product specifications and currently marketed devices. The test results demonstrate that the product meets requirements and is acceptable for its intended use.
9