The USGI Shape Locking Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.

Device Description

The USGI Shape Locking Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly. The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to USGI Medical, Inc. regarding their Endoscopic Sheath. It primarily focuses on the device's substantial equivalence to a previously cleared predicate device (K023902).

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence to Predicate Device	Bench testing demonstrates that the devices are functionally equivalent.
Biocompatibility of Patient-Contacting Materials	All components that come in direct contact with the patient have a long history of use in medical devices and are biocompatible.
Performance as Intended (Mechanical & Functional)	Mechanical and functional bench testing demonstrate that the USGI Shape Locking Endoscopic Overtube performs as intended.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/algorithm-based device. The testing described is bench testing of the physical device. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The document refers to the device itself and its components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes a physical medical device and its mechanical/functional performance, not an AI or algorithm-based diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

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

This information is not applicable. The device is a physical endoscopic overtube, not an AI or algorithm that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the biocompatibility aspect, the ground truth is established by the "long history of use in medical devices" of the materials, implying a track record of safety and acceptance as biocompatible.

For the mechanical and functional performance, the ground truth is based on the device's ability to "perform as intended" as demonstrated by bench testing. This refers to engineering and design specifications rather than clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

In summary, the provided document describes a 510(k) submission for a physical medical device, the USGI Endoscopic Sheath. The acceptance criteria and testing focus on the device's physical and functional performance, as well as the biocompatibility of its materials, by demonstrating substantial equivalence to a predicate device through bench testing. The concepts of AI/algorithm performance, training/test sets, expert ground truth, and MRMC studies are not relevant to this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

JUL 27 2015

USGI Medical, Inc. Mr. Jeff Anderson Regulatory Consultant 1140 Calle Cordillera, Suite A & B San Clemente, CA 92673

Re: K033954

Trade/Device Name: USGI Endoscopic Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED, FDF Dated (Date on orig SE ltr): December 19, 2003 Received (Date on orig SE ltr): December 22, 2003

Dear Mr. Anderson,

This letter corrects our substantially equivalent letter of March 19, 2004.

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

{1}------------------------------------------------

Page 2 -

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 (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 vours.

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

{2}------------------------------------------------

INDICATIONS FOR USE STATEMENT 2.Q

Page 1 of 1

510(k) Number (if known): Ko 33 9 5 4

Device Name: USGI Endoscopic Sheath

Indications for Use:

The USG! Shape Locking Endoscopic Overtube is intended to be used with an The USGI Onape Edoking Endocopic, Onlonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use __________
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

CONFIDENTIAL
USGI Medical
December 19, 2003

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number: K033954

{3}------------------------------------------------

K033954

10.0 SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	USGI Medical, Inc.1140 Calle CordilleraSan Clemente, CA 92674
OFFICIALCORRESPONDENT	Jeffrey A. AndersonRegulatory ConsultantUSGI Medical, Inc.1140 Calle CordilleraSan Clemente, CA 92674Tel: (949) 633-5067FAX (949) 369-3891e-mail: Janderson@usgimedical.com
TRADE NAME:	USGI Shape Locking Endoscopic Overtube
COMMON NAME:	Overtube
CLASSIFICATIONNAME:	Endoscope and accessories
DEVICECLASSIFICATION:	Class 2 per 21 CFR §876.1500
PRODUCT CODE	78 (KOG)
PREDICATE DEVICE:	USGI Shape Locking Endoscopic Overtube (K0239021)

SUBSTANTIALLY EQUIVALENT TO:

USGI Shape Locking Endoscopic Overtube (cleared for market under K023902)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATION FOR USE:

{4}------------------------------------------------

TECHNICAL CHARACTERISTICS:

K033954 pg 2 of 2

The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.

PERFORMANCE DATA:

All components that come in direct contact with the patient have a long history of use in medical devices and are biocompatibile This 510(k) notice includes mechanical and functional bench testing that demonstrate that the USGI Shape Locking Endoscopic Overtube performs as intended.

Basis for Determination of Substantial Equivalence:

The USGI Shape Locking Endoscopic Overtube is substantially equivalent to the previous version of the USGI Shape Locking Overtube (cleared for market under K023902). Both devices have the same indication for use and are made of the same materials (patient-contacting materials). Bench testing demonstrates that the devices are functionally equivalent.

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.