(143 days)
Not Found
No
The description focuses on the physical construction and intended use of a guidewire, with no mention of AI or ML capabilities.
No.
The guidewire is used to aid in the placement of therapeutic devices, but it is not therapeutic itself.
No
The NovaGold Guidewire is described as aiding in the placement of diagnostic and therapeutic devices, but it is not itself described as performing diagnostic functions. Its intended use is for selective cannulation of biliary ducts, which is a procedural step rather than a diagnostic one.
No
The device description explicitly states it is a physical guidewire constructed from metallic and polymer materials, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the NovaGold Guidewire is for "selective cannulation of the biliary ducts... and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures." This describes a device used within the body for procedural guidance and access, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical guidewire with a metallic core, coatings, and a tip. This is consistent with an interventional medical device, not an IVD which would typically involve reagents, test strips, or analytical equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NovaGold Guidewire does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OCY
Device Description
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts including 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)
To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances.
These data provides an acceptable assurance of the safety and effectiveness of the NovaGold guidewire and demonstrated the device is equivalent to the predicate.
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.
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K133076 Page 1 of 3
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Image /page/0/Picture/2 description: The image shows the word "NEOMETRICS" in a serif font. There is a curved line above the "O" and below the "N". The text is black and the background is white.
510(k) Summary
| Submitter: | NeoMetrics, Inc.
2605 Fernbrook Lane North, Suite J
Plymouth, MN 55447 | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Eugene Champeau, President
2605 Fernbrook Lane North, Suite J
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
OCY) | |
| Classification: | Class II | |
| Predicate Device: | The subject device is equivalent to K122816; Endscopic Wire
Guide manufactured by Wilson-Cook Medical. | |
| Device Description: | The NovaGold Guidewire is constructed from a steerable,
metallic core with a PTFE polymer coating over the shaft. A
hydrophilic coating is applied over the distal portion of the
device. The guidewire has a radiopaque, floppy tip. | |
| Indication 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. | |
| Functional and Safety
Testing: | To verify that device design met functional and performance
requirements, representative samples of the device underwent
bench testing in accordance to applicable standards and
guidances.
These data provides an acceptable assurance of the safety and
effectiveness of the NovaGold guidewire and demonstrated the
device is equivalent to the predicate. | |
| Comparative
Technology
Characteristics | A comparison of the characteristics of the proposed device and
the predicate device shows the NovaGold guidewire to have the
same or similar technological characteristics to the predicate
which has received 510(k) clearance.
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
Submitted | The following tests were performed to support NovaGold's
substantial equivalence.
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 | |
1
:
2
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.
.
3
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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure.
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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'