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.

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.

AI/ML Overview

The provided document describes a 510(k) submission for a medical device called the "Neo ERCP Guidewire." This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance. Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not typically found or required in a Traditional 510(k) submission like this one.

Here's why and what can be extracted from the document:

Traditional 510(k) Focus:
A Traditional 510(k) submission (like K123439) primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This usually involves:

Comparison of technological characteristics: Showing similarities in design, materials, manufacturing processes, and fundamental operating principles.
Bench testing: Verifying that the proposed device performs comparably to the predicate device or meets relevant standards for its intended use, typically through non-clinical (laboratory) tests. This is to ensure the new device doesn't raise new questions of safety or effectiveness.
Biocompatibility, sterility, shelf-life, and packaging studies: To ensure the device is safe for patient contact and remains sterile and functional over time.

Information Not Found (and why):

Acceptance Criteria for Device Performance and Reported Performance Table: This document does not present specific clinical performance metrics (e.g., sensitivity, specificity, accuracy) with associated acceptance criteria, as it's not a clinical performance study. The "performance" referred to in this document relates to bench testing (e.g., tensile strength, flexibility), not clinical outcomes or diagnostic accuracy.
Sample Size for Test Set and Data Provenance: Not applicable for a Traditional 510(k) based on bench testing. There is no "test set" in the sense of patient data.
Number of Experts, Qualifications, and Adjudication Method: These concepts are related to establishing ground truth for clinical studies, which are not part of this submission type.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a type of clinical study often done for diagnostic imaging devices to evaluate human reader performance with and without AI. It is not relevant to a guidewire submission.
Standalone (algorithm-only) performance: This refers to AI-driven diagnostic accuracy and is not applicable to a physical medical device like a guidewire.
Type of Ground Truth Used (expert consensus, pathology, outcomes data): Ground truth is established for clinical studies. For a guidewire, "performance" is assessed through engineering and material tests, not clinical ground truth.
Sample Size for Training Set & How Ground Truth for Training Set was Established: These are terms related to AI/ML development and are not relevant to this device or submission type.

What is available in the provided document (related to your prompt's themes):

While the document doesn't fit the clinical study paradigm implied by your questions, it does describe the type of testing and comparisons performed to support substantial equivalence.

Here's a breakdown of the closest relevant information:

1. Acceptance Criteria and Reported Device Performance (as interpreted for a 510(k) bench study):

The "acceptance criteria" for a 510(k) of this nature are typically defined by meeting established engineering standards and demonstrating comparable performance to the predicate device in specific bench tests. The "reported device performance" indicates that the device met these criteria.

Acceptance Criteria (Implied by Standards/Predicate Equivalence)	Reported Device Performance
Material & Design Equivalence: Similar in materials (Nitinol, polymer, radiopaque tip), nominal diameters (0.025", 0.035"), and lengths (260cm, 480cm) to predicate.	Confirmed: Similarities in Design, Material Types, and Technology (Nitinol alloy core wires, Distal radiopaque polymer tip, Lubricious coatings, Nominal diameters, Similar Lengths).
Mechanical Performance: Meet or be comparable to predicate for: Reverse Bend (Fatigue Failure), Tensile Strength, Fracture Resistance, Corrosion Resistance.	Confirmed: Testing conducted per ISO 11070 (Reverse Bend, Tensile testing, Fracture Resistance, Corrosion Resistance). Results demonstrate the guidewire design meets product specifications.
Functional Performance: Meet or be comparable to predicate for: Radiodetectability, Rail Support.	Confirmed: Testing conducted per ISO 11070 (Radiodetectability) and NeoMetrics' test method TM-3002 (Rail Support). Results demonstrate the guidewire design meets product specifications.
Sterility: Achieve sterility assurance level.	Confirmed: Sterility evaluation conducted.
Biocompatibility: Pass tests for cytotoxicity, sensitization, intracutaneous irritation, acute systemic injection.	Confirmed: Biocompatibility testing conducted (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Injection).
Packaging Integrity: Maintain sterile barrier per ASTM F 2096-04 and ASTM F 88-09.	Confirmed: Packaging Integrity testing conducted.
Shelf-Life: Maintain functional performance and integrity over specified shelf-life.	Confirmed: Shelf-Life evaluation conducted.
Device Compatibility: Function as intended when used with other devices, as implied by "intended use" and "simulated use."	Confirmed: Device Compatibility and Simulated Use testing conducted.

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not specified in terms of units for many bench tests, and the concept of "test set" for patient data is not applicable. For destructive tests, a sufficient number of samples would be used to ensure statistical validity for engineering testing, but explicit numbers for each test are not detailed in this summary.
Data Provenance: Not applicable in the context of clinical data. The data originates from internal laboratory bench testing conducted by NeoMetrics, Inc.

3. Number of Experts, Qualifications, and Adjudication Method:

Not applicable as this is not a clinical study involving human judgment on patient data. Engineering tests are evaluated against predefined standards and specifications.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a physical medical device, not a diagnostic AI system, so such a study would not be performed.

6. Standalone (algorithm only) performance:

No. This is a physical medical device with no AI component.

7. Type of Ground Truth Used:

For bench testing, the "ground truth" is typically defined by:
- Validated engineering standards: (e.g., ISO 11070, ASTM F 2096-04, ASTM F 88-09).
- Predicate device characteristics: The performance of the predicate device (JagWire - K922302) serves as a benchmark for comparison.
- Internal product specifications: The manufacturer's own defined performance requirements for the guidewire.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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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, SuitePlymouth, 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

5.5 Intended Use

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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.

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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.

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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

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Section 4: Indications for Use Statement

Indications for Use

510(k) Number (if known): K (23439

Device Name: Neo ERCP Guidewire

Indications for Use:

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

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.