The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.

Device Description

The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.

AI/ML Overview

The provided text is a 510(k) Summary for the Taxi® Endoscopic Guidewire (K081708). This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one would for an AI/ML-driven diagnostic device.

Therefore, many of the requested categories for defining acceptance criteria and study details are not applicable to the information provided. The document describes non-clinical tests to demonstrate safety and effectiveness for a medical device (guidewire), not a diagnostic algorithm.

Here's an attempt to extract relevant information where possible, and indicate where the requested information is not present in the provided text:

Acceptance Criteria and Device Performance (Limited Information available for a medical device, not a diagnostic algorithm):

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Functionality	Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. (Implied acceptance: meeting these established requirements).	"The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices."
Biocompatibility	Acceptable per ISO 10993 series.	"Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable."
Material Composition	Nitinol core, PTFE proximal jacket, Polyurethane distal jacket, Hydrophilic distal coating, Polymer Adhesive / Accelerator for joining agents.	Device is constructed with Nitinol core, PTFE proximal jacket, Polyurethane distal jacket, Hydrophilic distal coating, Polymer Adhesive / Accelerator. (Matching the described construction).
Dimensions	Guidewire lengths: 260cm to 450cm; Guidewire diameters: .035"; Tip flexibility: 5CM Standard.	The device parameters specify: .035" Diameter, 260 - 450cm Length, Straight configuration, Standard flex, PTFE shaft, Hydrophilic coating. (Matching the specified parameters).
Sterilization Method	ETO	ETO

Study Details (Not applicable for most items, as this is for a medical device's 510(k) submission, not an AI/ML diagnostic study):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of specific number of guidewires tested, but "Test pieces" are mentioned.
- Data Provenance: Not applicable. The testing was conducted by the manufacturer, Lake Region Manufacturing, Inc. (LRM).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to established engineering and material science standards for device performance, not expert labels for diagnostic images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling for diagnostic studies.
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: Not applicable. This device is a guidewire, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guidewire, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this medical device's performance is based on established engineering requirements, material specifications (e.g., Nitinol core, PTFE jacket), and performance standards (e.g., ISO 10993 for biocompatibility). The document states, "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."
The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.
How the ground truth for the training set was established: Not applicable. This device does not involve a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of non-clinical tests performed by Lake Region Manufacturing, Inc. (LRM). These tests assessed the device's functionality, performance characteristics, and biocompatibility.

Non-Clinical Tests: "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." The conclusion was that "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices."
Biocompatibility Testing: "Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable."

The overall conclusion states that the device is "substantially equivalent" to the predicate device (JAGWIRE™ RECANALIZATION GUIDEWIRE K922302) based on these non-clinical evaluations. This substantial equivalence determination by the FDA indicates that the device is considered safe and effective for its intended use without requiring a full clinical trial for approval.

Summary

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K081708
1 of 3

510(k) SUMMARY

MANUFACTURER / REGISTRATION INFORMATION 5.1

MANUFACTURER NAME / LOCATION	ESTABLISHMENT REGISTRATION NUMBER
Lake Region Manufacturing, Inc.(d/b/a Lake Region Medical)340 Lake Hazeltine DriveChaska MN 55318-1029 USA	2126666

SUBMITTER / CONTACT PERSON 5.2

Contact Person: Deep Pal
Title:	Regulatory Affairs Specialist
Telephone:	(952) 448-5111, Ext. 6381
Fax:	(952) 448-3441
Email:	dpal@lakergn.com

5.3 TRADE NAME (PROPRIETATY NAME)

Taxi® Endoscopic Guidewire

5.4 DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAMES

These devices are commonly known as Guides, Guidewires, or Spring Guidewires. The current classification names and product codes are Endoscopic Guidewire, Gastroenterology-Urology (OCY).

5.5 CLASS OF DEVICE

This type of Guidewire is listed as a Class II device by the Gastroenterology / Urology Review Panel; OCY, Endoscope and accessories (21 CFR 876.1500).

PREDICATE DEVICE 5.6

510(k) NUMBER	MANUFACTURER	DEVICE NAME
K922302		lagwire TMTRecanalization Guidewire- 1 4 - 1 11 7 - 1 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -II III III III KISHI III III III KE KESHINDAHUAIN BALAMBAN BANK

사용

DEVICE DESCRIPTION 5.7

The quidewires are bound by the following parameters:

A the state of the first of the first of the state ofand the last the state of the comments of the same of the same		IP		COATING
A the state the state of the state the states of the		I FOR SCONFIGURATION I FLEX FLEX I PTFE HYDRO
.035"	260 - 450cm	Straight	Standard	Shaft	in

(Continues ... )

AUG 2 6 2008

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510(k) SUMMARY

(Continued ...)

TECHNOLOGICAL CHARACTERSTICS 5.8

The predicate device is constructed of a nitinol core, which is encapsulated in a stripped PTFE jacket and a polyurethane distal jacket with a hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings. The Taxi® Endoscopic Guidewire is constructed of similar materials but employs a gluing process to adhere the polyurethane segment.

APPLICABILITY OF PERFORMANCE STANDARDS 5.9

LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.

INTENDED USE STATEMENT 5.10

The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic billary procedures for catheter introduction and exchanges.

COMPARISION INFORMATION 5.11

PROPOSED DEVICE	PREDICATE DEVICE
TAXI® ENDOSCOPIC GUIDEWIRE	JAGWIRE(TM) RECANALIZATION GUIDEWIRE K922302
CORE
Nitinol	Nitinol
JACKET
PROXIMAL - PTFE	PROXIMAL - PTFE
DISTAL - Polyurethane	DISTAL - Polyurethane
COATING
DISTAL - Hydrophilic	DISTAL - Hydrophilic
JOINING AGENTS
Polymer Adhesive / Accelerator	No known adhesives used.
VARIOUS TIP FLEXIBILITIES
5CM Standard	5CM and 10CM
GUIDEWIRE LENGTHS
260cm to 450cm	260 and 450CM
GUIDEWIRE DIAMETERS
.035"	.025" and .035"
STERILIZATION METHOD
ETO	ETO

(Continues ... )

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510(k) SUMMARY

(Continued...)

QUALIFICATION TESTING 5.12

NON-CLINICAL TESTS

In order to demonstrate the safety and effectiveness of the Taxi® Endoscopic Guidewire, LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices.

BIOCOMPATIBILITY TESTING

Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes emanating from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2008

Mr. Deep Pal Regulatory Affairs Specialist Lake Region Medical™ 340 Lake Hazeltine Drive CHASKA MN 55318-1029

Re: K081708

Trade/Device Name: Taxi® Endoscopic Guidewire Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: June 13, 2008 Received: June 17, 2008

Dear Mr. Pal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indice includions for use stated in the enclosure) to legally marketed predicate devices marketed 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, Dr ug and Cosmetic act (Act) that do not require approval of any proval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device ean be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K081708

Device Name: Taxi® Endoscopic Guidewire

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ammhhan

(Division Sign-Division of Reproductive. Abdominal and Radiological De 510(k) Number

Page 1 of 1

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.