NOVAGOLD HIGH PERFORMANCE GUIDEWIRE

K133076 · Neometrics, Inc. · OCY · Feb 20, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133076
• Device Name: NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
• Applicant: Neometrics, Inc.
• Product Code: OCY · Gastroenterology, Urology
• Decision Date: Feb 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

Device Story

NovaGold High Performance Guidewire is a steerable, metallic guidewire used during endoscopic procedures (e.g., ERCP). It features a Nitinol alloy core, a PTFE polymer shaft coating, a hydrophilic distal coating, and a radiopaque floppy tip. Operated by physicians in clinical settings, the device facilitates the navigation of biliary ducts and the subsequent placement of diagnostic or therapeutic instruments. It functions as a mechanical guide to assist clinicians in accessing specific anatomical sites within the biliary tree.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility (cytotoxicity, sensitization, irritation, intracutaneous reactivity), coating adherence, corrosion resistance, dimensional measurements, fracture resistance, tensile strength, torqueability, and 13-month accelerated aging shelf-life testing.

Technological Characteristics

Nitinol alloy core wire; PTFE polymer shaft coating; hydrophilic distal coating; radiopaque floppy tip; .018" nominal diameter; 260 cm and 480 cm lengths. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring selective cannulation of biliary ducts (common bile, pancreatic, cystic, right and left hepatic) and placement of diagnostic or therapeutic devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Endscopic Wire Guide (K122816)

Submission Summary (Full Text)

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K133076 Page 1 of 3

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## 510(k) Summary

| Submitter: | NeoMetrics, Inc.<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Eugene Champeau, President<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 | |
| Date Prepared: | November 8, 2013 | |
| Trade Name: | NovaGold™ High Performance Guidewire | |
| Common Name | ERCP Guidewire | |
| Classification Name | Endoscope and accessories (21 CFR 876.1500, Product Code<br>OCY) | |
| Classification: | Class II | |
| Predicate Device: | The subject device is equivalent to K122816; Endscopic Wire<br>Guide manufactured by Wilson-Cook Medical. | |
| Device Description: | The NovaGold Guidewire is constructed from a steerable,<br>metallic core with a PTFE polymer coating over the shaft. A<br>hydrophilic coating is applied over the distal portion of the<br>device. The guidewire has a radiopaque, floppy tip. | |
| Indication for Use: | The NovaGold Guidewire is intended for use in selective<br>cannulation of the biliary ducts including the common bile,<br>pancreatic, cystic, right and left hepatic ducts, and to aid in the<br>placement of diagnostic and therapeutic devices during<br>endoscopic procedures. | |
| Functional and Safety<br>Testing: | To verify that device design met functional and performance<br>requirements, representative samples of the device underwent<br>bench testing in accordance to applicable standards and<br>guidances.<br><br>These data provides an acceptable assurance of the safety and<br>effectiveness of the NovaGold guidewire and demonstrated the<br>device is equivalent to the predicate. | |
| Comparative<br>Technology<br>Characteristics | A comparison of the characteristics of the proposed device and<br>the predicate device shows the NovaGold guidewire to have the<br>same or similar technological characteristics to the predicate<br>which has received 510(k) clearance.<br>Same intended use Same operating principle Same packaging and sterilization process Similarities in design, material types, and technology include Nominal diameter: .018" Similar lengths: 260 and 480 cm Nitinol alloy core wires Distal radiopaque tip Lubricious coatings | |
| Non-Clinical Tests<br>Submitted | The following tests were performed to support NovaGold's<br>substantial equivalence.<br><br>Biocompatibility testing Cytotoxicity, L-929 MEM Elution Cytotoxicity, Colony Microassay by Elution Guinea Pig Maximization Sensitization Irritation, Intracutaneous Reactivity Chemical Characterization Bench testing Coating adherence Corrosion resistance Dimensional measurements Fracture resistance Tensile strength Torqueability Shelf Life Testing 13 month accelerated aging | |

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Conclusion: NeoMetrics Inc. considers the NovaGold guidewire to be equivalent to the predicate device. This conclusion is based upon the fact that device has an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 20, 2014

NeoMetrics, Inc. David Liebl President and Chief Technology Officer 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447

Re: K133076

Trade/Device Name: NovaGold™ High Performance Guidewire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: January 21, 2014 Received: January 24, 2014

Dear David Liebl,

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 cither 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 - David Liebl

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher-S" in a bold, sans-serif font. The letters "in" are stylized with a geometric pattern, and the letters "FDA" are also stylized with a geometric pattern. The text is black against a white background.

Beniamin 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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## 5.0 Indications for Use Statement

(21 CFR 801 Subpart D)

:

| 510(k) Number | K133076 | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device Name: | NovaGold™ High Performance Guidewire | |
| Indications for Use: | The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures. | |
| Prescription Use _X | AND/OR | Over-The-Counter Use _______ |

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S
2014.02.20 15:08:06 -05'00'