(57 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No.
The guidewire is an accessory device used for guiding other instruments during endoscopic procedures, not for treating a disease or condition itself.
No
Explanation: The device is an endoscopic guidewire used for selective cannulation and introduction/exchange of catheters during pancreatic-biliary procedures. Its purpose is to facilitate access and delivery, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical guidewire constructed from metallic and polymer materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is an "endoscopic guidewire" intended for use within the body during endoscopic procedures to facilitate the introduction and exchange of other instruments in the biliary and pancreatic ducts.
- Lack of Sample Testing: There is no mention of this device being used to test samples or provide diagnostic information based on analysis of bodily fluids or tissues. Its function is purely procedural and mechanical.
Therefore, this device falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OCY
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.
OUTSIDE DIAMETER: 0.018", 025" and .035"
LENGTHS: 260 cm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts including, but not limited to the common bile, pancreatic, cystic, 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)
NON-CLINICAL TESTING
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
Risk analysis concluded that there was no additional biocompatibility testing required.
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.
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
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:
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the control control control control control and the program and consistence of the supportunity of the may be any and |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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| 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
1
SECTION 1.0: 510(k) SUMMARY
1.8 INTENDED USE STATEMENT, CARDEN CONSELLER
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.
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.
2
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.
3
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
4
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
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