(56 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 device is a guidewire intended to aid in the placement of diagnostic and therapeutic devices, but it is not therapeutic itself.
No
The device description indicates that the Neo ERCP Guidewire is used to aid in the placement of diagnostic and therapeutic devices, but it is not described as a diagnostic device itself.
No
The device description clearly states it is a physical guidewire constructed of metal alloy and polymer, and the performance studies involve bench testing and biocompatibility, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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 conditions.
- Device Description: The description details a physical guidewire with specific materials and features designed for insertion into anatomical structures. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on those samples, or providing diagnostic information based on the analysis of those samples.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Neo ERCP 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
OCY
Device Description
The Neo ERCP Guidewire is constructed of a core wire of nickel titanium based alloy, a proximal polymer jacket and a radiopaque distal tip. It also features a hydrophilic coating and either straight or angled distal tip configurations. The distal end of the guidewire has a radiopaque distal tip (10cm). The wire family has two models, the Phantom refers to .025" OD models and the Palomino refers to .035" OD models. Both the Phantom and Palomino come in 260cm and 480cm lengths.
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)
Non-clinical testing of the Neo ERCP Guidewire includes bench testing, biocompatibility testing, shelf-life testing, packaging testing and sterilization evaluation. The following tests were conducted:
- Sterility
- Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Injection
- Packaging Integrity
- Device Compatibility
- Reverse Bend
- Tensile Strength
- Fracture Resistance
- Corrosion Resistance
- Dielectric Insulation
- Simulated Use
- Shelf Life
Results of this testing demonstrate that the guidewire design meets the product specifications and intended uses.
A comparison of the characteristics of the proposed device to the predicate device shows the proposed device to have the following same or similar technological characteristics to the device which has received 510(k) clearance:
- Same intended use;
- Same operating principle;
- Same shelf life and sterilization process;
- Similarities in Design, Material Types, and Technology include:
- Nominal diameters: 0.025" and 0.035"
- Similar Lengths: 260 & 480 cm
- Nitinol alloy core wires
- Distal radiopaque polymer tip
- Lubricious coatings
To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices:
- FDA Coronary and Cerebrovascular Guidewire Guidance January 1995 sections 1, 2, 3a, 3e, 3f and 3g
- Sterile Package Integrity per ASTM F 2096-04
- Sterile Package Integrity per ASTM F 88-09
- Reverse Bend (Fatigue Failure) per ISO 11070
- Tensile testing per ISO 11070
- Fracture Resistance per ISO 11070
- Corrosion Resistance per ISO 11070
- Radiodetectability per ISO 11070
- Rail Support per NeoMetrics' test method TM-3002
Due to the destructive nature of some of the tests and the availability of predicate devices not all testing was conducted on each predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.
Traditional 510(k)
K1234
Section 5.0: 510(k) Summary
5.1 Administrative Information
JAN 0 3 2013
| Name: | NeoMetrics, Inc. |
|---|---|
| Address: | 2605 Fernbrook Lane North, Suite |
| Plymouth, MN 55447 | |
| Contact Person: | Gene Champeau |
| Title: | President |
| Phone: | (763)-559-4440 |
| Fax: | (763) 559-7676 |
. 2135342 FDA Registration Number: December 17, 2012 Date:
5.2 Device Information
| Name of Device: | Neo ERCP Guidewire |
|---|---|
| Common Name: | Endoscopic Guidewire |
| Classification Name: | Endoscopic Guidewire, Gastroenterology – Urology (876.15) |
| Product Code: | OCY |
5.3 Predicate Device Information
The following commercially available guidewire is a predicate device for Neo ERCP Guidewire.
| 510(k) Number | Trade or Model Name | Manufacturer |
|---|---|---|
| K922302 | JagWire | Boston Scientific Corp. |
5.4 Device Description
The Neo ERCP Guidewire is constructed of a core wire of nickel titanium based alloy, a proximal polymer jacket and a radiopaque distal tip. It also features a hydrophilic coating and either straight or angled distal tip configurations. The distal end of the guidewire has a radiopaque distal tip (10cm). The wire family has two models, the Phantom refers to .025" OD models and the Palomino refers to .035" OD models. Both the Phantom and Palomino come in 260cm and 480cm lengths.
5.5 Intended Use
The Neo ERCP 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.
21
1
K123 439 Page 2 of 3
Traditional 510(k)
5.6 Differences in the Intended Use Statements
Differences in the indications for use statements between Neo ERCP Guidewire and the JagWire IFU are not significant. The JagWire IFU refers to bronchoscopic procedures. An endoscope is the tool used in bronchoscopic and endoscopic procedures. The Neo ERCP Guidewire is not indicated for use in bronchoscopic procedures.
5.7 Technological Characteristics
·
A comparison of the characteristics of the proposed device to the predicate device shows the proposed device to have the following same or similar technological characteristics to the device which has received 510(k) clearance:
- Same intended use; .
- Same operating principle; ●
- Same shelf life and sterilization process; .
- Similarities in Design, Material Types, and Technology include:
- Nominal diameters: 0.025" and 0.035" 0
- Similar Lengths: 260 & 480 cm 0
- Nitinol alloy core wires 0
- Distal radiopaque polymer tip O
- Lubricious coatings O
To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices:
- FDA Coronary and Cerebrovascular Guidewire Guidance January 1995 sections 1, 2, . 3a, 3e, 3f and 3g
- Sterile Package Integrity per ASTM F 2096-04 .
- Sterile Package Integrity per ASTM F 88-09 ●
- Reverse Bend (Fatigue Failure) per ISO 11070 .
- Tensile testing per ISO 11070 �
- Fracture Resistance per ISO 11070 ●
- Corrosion Resistance per ISO 11070 .
- Radiodetectability per ISO 11070 ●
- Rail Support per NeoMetrics' test method TM-3002 .
Due to the destructive nature of some of the tests and the availability of predicate devices not all testing was conducted on each predicate device.
2
K123 439 Page 3 of 3
Traditional 510(k)
5.8 Summary of Non-Clinical Testing
Non-clinical testing of the Neo ERCP Guidewire includes bench testing, biocompatibility testing, shelf-life testing, packaging testing and sterilization evaluation. The following tests were conducted:
- . Sterility
- Biocompatibility . .
- Cytotoxicity 0
- Sensitization ಂ
- Intracutaneous Irritation O
- Acute Systemic Injection 0
- Packaging Integrity ●
- Device Compatibility ●
- Reverse Bend ●
- Tensile Strength
- Fracture Resistance .
- Corrosion Resistance .
- Dielectric Insulation ●
- Simulated Use .
- Shelf Life
Results of this testing demonstrate that the guidewire design meets the product specifications and intended uses.
5.9 Substantial Equivalence Conclusion
The Neo ERCP Guidewire described in this 510(k) is substantially equivalent to the device listed in section 5.3. The intended use, design, material types, technology, and performance of the Neo ERCP Guidewire are equivalent to the predicate device. There are no differences between devices which would raise issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD. 20993-0002
January 3, 2013
Neometrics, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K123439
Trade/Device Name: Neo ERCP Guidewire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: December 7, 2012 Received: December 28, 2012
Dear Mr. Job:
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.
4
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 (OS) 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,
Herbert P. Lerner
for 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
5
Section 4: Indications for Use Statement
Indications for Use
510(k) Number (if known): K (23439
Device Name: Neo ERCP Guidewire
Indications for Use:
The Neo ERCP 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 (Part 21 CFR 801 Subpart D) 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)
Herbert P. Lerner
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number K123439