Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Device Description

The Endo-Glide Guidewire has a range of diameters from 0.025" to 0.035" and lengths from 250cm to 450cm. The wires are offered with and without a 50mm radiopaque platinum distal tip (curved and straight). The wires are assembled with a solid nitinol or stainless steel core wire, which can be tapered at the distal tip. A lubricious coating (PTFE or hydrophilic) surrounds the entire core and/or tip, which also provides insulation.

AI/ML Overview

This is a 510(k) premarket notification for a guidewire, which is a physical medical device, not an AI/ML powered device. As such, the concepts of "acceptance criteria," "device performance study," "sample size," "ground truth," "MRMC study," "standalone study," "training set," and "adjudication method" as they relate to AI/ML device evaluations are not applicable in this context.

The document discusses the substantial equivalence of the Endo-Glide Guidewire to predicate devices based on technological characteristics, intended use, design, materials, and method of operation. It does not contain information about the performance criteria, study design, or results in the way it would for an AI/ML device.

Here's a breakdown of what is available in the document, framed to address your request where possible, but highlighting the inapplicability to AI/ML:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Applicable (N/A) for AI/ML performance metrics.	Not Applicable (N/A) for AI/ML performance metrics.
The device (Endo-Glide Guidewire) was found substantially equivalent to predicate devices based on:	The device's technological characteristics (design, materials, method of operation) and intended use are "substantially similar" to the predicate devices: Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document pertains to the substantial equivalence of a physical medical device (guidewire) to legally marketed predicate devices. The concept of a "test set" and "data provenance" in the context of performance evaluation for an AI/ML device is not relevant here. The evaluation focuses on physical characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" to establish for a test set in the AI/ML sense for this type of device submission. The FDA reviews the device's design, materials, manufacturing processes, and intended use for substantial equivalence, relying on established standards for medical devices and comparison to approved predicates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is mentioned or relevant for this type of device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, so no MRMC study, human readers, or AI assistance is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, so "standalone algorithm performance" is not a relevant concept.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Ground truth, in the context of AI/ML, is not relevant for this device. The "truth" for substantial equivalence is based on engineering principles, materials science, and comparison to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

In summary, the provided document is a 510(k) clearance letter for a physical guidewire, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML performance evaluation, such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, and expert involvement for algorithm validation, are not applicable to the information contained within this document. The "study" here is essentially the comparison of the new device's characteristics to those of already approved predicate devices to demonstrate substantial equivalence.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Endo-Therapeutics. Inc. Mr. Todd Adkisson 1183 Cedar Street Safety Harbor, FL 34695

JUL 2 7 2015

K023603 Re: Trade/Device Name: Endo-Glide Guidwire Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY, GCA Dated (Date on orig SE Itr): January 23, 2003 Received (Date on orig SE ltr): January 27, 2003

Dear Mr. Adkisson,

This letter corrects our substantially equivalent letter of February 19, 2003.

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

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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. 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 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 contact 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. 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,

Benjamin R. Fisher -S

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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K 023603

510(k) INDICATIONS FOR USE STATEMENT

KU23603 510(k) Number (If KNOWN):

Device Name: Endo-Glide Guidewire

Applicant Name: Endo-Therapeutics, Inc

Indications for Use: Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Signature: President

Date: 9/2/02

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David Lee Ingram
(Division Sign-Off)

Division of Reproductive and Radiological De 510(k) Numbe

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K023603

510(k) Summary: Endo-Therapeutics Endo-Glide Guidewires

(1)	Endo-Therapeutics Inc.1183 Cedar st.Safety Harbor, FL 34695	FEB 1 9 2003
Contact Person:	Todd Adkisson
Date Prepared:	9/2/02
510(k) #:	K
(2) Trade or Proprietary Name:	Endo-Glide Guidewire
Common Name:	Guidewire
Classified Name:	Gastrointestinal Guidewire

(3) Equivalent Predicate Devices:

Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759)

(4) Description of Device:

Intended Use: (5)

Endo-Glide Guidewire is used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Technological Characteristics: (6)

The Endo-Therapeutics Endo-Glide Guidewires have essentially the same technological characteristics as the predicate device. The intended use, design, materials and method of operation are all substantially similar to the before mentioned guidewires.

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.