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

Device Description

Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Witinol) with a polymer jacket (polyurethane) coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Guidewires are available in 260cm length and in diameters 0.018", 0.025" depending on specific design requirements. Guidewires may have a straight or a pre-shaped distal tip and are available in different tip flexibilities, which are dependent on the grind configuration of the core.

AI/ML Overview

The provided text describes a 510(k) submission for the NaviPro™ Guidewire. The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance testing and biocompatibility, as this is a medical device approval. The document states that the device is "substantially equivalent" to predicate devices, meaning it does not claim superiority, but rather equivalent safety and effectiveness based on similar design and performance.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results. Instead, it broadly states that testing was performed to establish requirements and demonstrate functionality.

Acceptance Criteria Category	Reported Device Performance (Summary)
Non-clinical Performance	Test pieces inspected for visual/tactile, dimensional, and mechanical attributes.
Material/Design Attributes	Functionality and performance characteristics are comparable to similar currently marketed devices.
Biocompatibility	Risk analysis concluded no additional testing required, implying it meets established biocompatibility standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Test pieces were tested and inspected," but does not quantify how many pieces were in the test set.
Data Provenance: The studies are described as "non-clinical" and "biocompatibility testing," suggesting laboratory-based testing rather than human subject data. The manufacturer is Lake Region Medical, located in Chaska, MN, USA, implying the testing was conducted or overseen by them. No mention of retrospective or prospective data in a clinical sense, as it refers to device performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this 510(k) submission. The "ground truth" for a medical device like a guidewire is established through engineering and material science testing against predefined specifications and industry standards (e.g., ISO standards like 10993, 11070, 15223, EN 980, ISO 594, which the device is stated to comply with). It doesn't involve expert consensus on medical images or patient outcomes in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where human interpretation is involved. For non-clinical device performance testing, the "adjudication" is based on meeting engineering specifications and test methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of how much human readers improve with AI vs. without AI assistance. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like guidewires.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a guidewire, a physical medical instrument, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, industry standards (e.g., ISO), and comparison to functionally equivalent predicate devices. The non-clinical testing "demonstrate[d] the device is as safe, as effective and performs as safely and effectively as the legally marketed device."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The development process would involve iterative design, prototyping, and testing, but not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical medical device.

Summary

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K124052
pg. 1 of 2

SECTION 1.0: 510(k) SUMMARY

1:1 MANUFACTURER / REGISTRATION INFORMATION CONTRACTION Lake Region Medical Contact Person: Tracy Mever 340 Lake Hazeltine Drive Title: Regulatory Specialist Chaska, MN 55318-1029 USA Telephone: 952-641-8510 FDA REGISTRATION NUMBER: 2126666 Fax: 952-448-3441

1:24 TRADE (RAME (PROPRIETATY NAME) ... (PA) ... (2) ... ) ... (2012) ... (2012) ... (2012) ... (2012) ... (2012) ... (2012) ... (2012) ... (2012) ... (2012) ... (2012) ... ( NAVIPRO™ Guidewire

1:3 DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAMES CLASSIFICATION NAMES CLASS CLASS CLASS CLASS CLASS CLASS CLASS CLASS CLASS CLASS CLASS CLASS C These devices are commonly known as guides, Guidewires, or spring Guidewires. The current classification names and product codes are Gastroenterology/Urology (OCY).

11:40 CLASS OF DEVICE (1) 1979 - 1 (3) 2008 - 12 (300 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 This type of Guidewire was originally listed as a Class II device by the Gastroenterology/Urology (OCY) review panel.

1:5 {{CATIDENTIFICATION OF PREDICATE'DEVICE(s){ } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }

510(k) Number	Manufacturer	Device Name
K081708	Lake Region Medical	Taxi Endoscopic Guidewire
K000011	Lake Region Medical	Hydrophilic Coated Guidewire (ZIPwire)

4.6 KE COEVICE DESCRIPTION PARTICLE FOR CONTROLLERS COLOR COLOR COLOR COLOR COLOR COLLECTION CONSECTION CONSECTION Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Witinol) with a polymer jacket (polyurethane) coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Guidewires are available in 260cm length and in diameters 0.018", 0.025" depending on specific design requirements. Guidewires may have a straight or a pre-shaped distal tip and are available in different tip flexibilities, which are dependent on the grind configuration of the core.

OUTSIDE DIAMETER: 0.018", 025" and .035"

LENGTHS:Status and any and the country of the first of the country of	come of the revelopment of the relations of the program more of the many of the many of the many of the many of the many of the many of the many260 cnCiriCompany of the program and the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the		and the country of the production of the first of the first of the first	(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) =the control control control control control and the program and consistence of the supportunity of the may be any and
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of Children Children	and the minister of market in the successful and the best of the country of the			below the country of the country of the provide the provide the provide ware support want any are and

1:7 COMPLIANCE WITH APPLICABLE STANDARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The NaviPro™ Guidewire is in compliance with ISO 10993, ISO 11070, ISO 15223, EN 980, ISO 594

FEB 2 6 2013

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SECTION 1.0: 510(k) SUMMARY

1.8 INTENDED USE STATEMENT, CARDEN CONSELLER

1:9 A CONTRAINDICATIONS CONTRAINDICATIONS CONTRACTOR CONTRACTORS CONTRACTOR None Known

1.10 COMPARISON COMPARISON COMMENT OF COMPARISON COMPARISON r 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 - 1 - 1 - 1 - 1 - 1 - The NaviPro™ Guidewire is substantially equivalent to the Taxi Endoscopic Guidewire with 510(k) number K081708 with desgin changes.

The design is of the NaviPro™ is substantially equivalent to the Hydrophilic Coated (ZIPwire) Guidewire with 510(k) K000011.

2.1110 QUALIFICATION TESTING: 14.5 2017 10:16 10.00 10.00 10.00 10.00 10.00 10.00 The conclusions drawn from non-clinical and biocompatibility testing demonstrate the device is as safe, as effective and performs as safely and effectively as the legally marketed device.

NON-CLINICAL TESTING CONSULT CONTRACT CONTRACT CONSULT CONTRACT CONTRACT 1000 1000 2000 2000 2000 2000 1000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 In order to demonstrate the safety and effectiveness of the NaviPro™ Guidewire, Lake Region Medical performed testing to establish 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 guidewire are comparable to the similar currently marketed devices. See section 13.0 for the results.

BIOCOMPATIBILITY TESTING . 00 Million Collection Collection Conce Risk analysis concluded that there was no additional biocompatibility testing required.

1:12 SUBSTANTIAL EQUIVALENCE DATA LA LA LA LEGENCE PORTER PO

The NaviPro™ Guidewire has a similar intended use as Taxi Endoscopic Guidewires legally marketed by Lake Region Medical and cleared by 510(k) K081708.

The NaviPro™ Guidewire is the exact same design as the ZIPwire, with a different intended use, legally marketed by Lake Region Medical and cleared by 510(k) K000011.

The NaviPro™ Guidewire has the exact same physical characteristics as the secondary predicate device (ZIPwire). The safety and effectiveness of these differences have been proven in the aforementioned Qualification Testing.

The NaviPro ""Guidewire is substantially equivalent to the Taxi Endoscopic Guidewires cleared under 510(k) K081708 and to the ZIPwire cleared under 510(k) K000011. All test results support the claim of substantial equivalence.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2013

Lake Region Medical % Ms. Tracy Meyer Regulatory Specialist 340 Lake Hazeltine Drive CHASKA MN 55318

Re: K124052

Trade/Device Name: NaviProTM Guidewire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: December 28, 2012 Received: December 31, 2012

Dear Ms. Meyer:

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 indications 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can 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.

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.

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Page 2 - Ms. Tracy Meyer

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/7 description: The image shows the text "Benjamin R. Fisher - S". The text is in a simple, sans-serif font and is black. The letters "R.F" are stylized with a geometric design, with the letters overlapping and outlined with multiple lines. The overall impression is a simple logo or nameplate.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

K124052 510(k) NUMBER (IF KNOWN):

DEVICE NAME: NaviPro™ Guidewire

INDICATIONS FOR USE:

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

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)

PAGE 1 of

Benjam 2013.02 2

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K124052

7 | P a g e

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.