To be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.

Device Description

The Bard® Endoscopic Overtube consists of a flange bonded to a plastic sheath and is inserted into the esophagus through an initially placed bite block.

AI/ML Overview

Here's an analysis of the provided text regarding the Bard® Endoscopic Overtube VI, focusing on acceptance criteria and study details:

This document is a 510(k) summary for a premarket notification to the FDA. It does not contain detailed information about specific acceptance criteria or a comprehensive study with performance metrics in terms of a table of reported device performance. Instead, it describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.

Therefore, many of the requested sections (e.g., sample sizes for test sets, number of experts, MRMC studies, standalone performance, specific performance metrics, training set details) are not available in this document because it reports on non-clinical performance testing rather than clinical trials with human subjects or AI-driven systems.

However, I will extract as much relevant information as possible from the provided text to address your request.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary of Findings: The provided 510(k) summary indicates that the Bard® Endoscopic Overtube VI's safety and effectiveness were established through nonclinical, tensile performance testing and biocompatibility testing. The submission aims to demonstrate substantial equivalence to existing predicate devices (Bard® Endoscopic Overtube and Olympus Splinting Tube ST-C3) based on similar design, materials, intended use, and performance characteristics in these nonclinical tests. No clinical study data (e.g., related to reader performance or diagnostic accuracy) or AI algorithm performance data is presented, as this is a medical device, not an AI/medical imaging software product.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed reported performance values (like sensitivity, specificity, accuracy) are not explicitly stated. The document broadly claims safety and effectiveness based on nonclinical testing.

Acceptance Criteria Category (Inferred)	Reported Device Performance Summary (from text)
Mechanical Performance	"Tensile performance testing" conducted.
Biocompatibility	"Biocompatibility testing" conducted.
Durability/Reuse	Indicated for twenty-five (25) reuses.
Material Composition	Flange bonded to plastic sheath, UV bonded to polyvinyl chloride sheath, distal tapered tip, encapsulated stainless steel tempered wire coiled internally.
Design Characteristics	Similar design to predicate Bard® Overtube, employs encapsulated stainless steel wire coil similar to Olympus Splinting Tube.
Protection Characteristics	Designed to protect the hypopharynx from trauma, airway from aspiration, and esophagus during extraction of sharp objects.
Labeled Warnings/Contraindications	Labeled warnings and contraindications remain the same as predicate device.

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

Sample Size (Test Set): Not applicable for the type of testing reported. The document refers to "nonclinical, tensile performance testing and biocompatibility testing." These types of tests typically involve a certain number of device units or material samples, but specific sample sizes are not disclosed in this summary.
Data Provenance: Not applicable in the context of human data. The tests are nonclinical, likely conducted in a lab environment.

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

Not applicable. No human "ground truth" or expert adjudication for performance metrics is relevant here as this relates to non-clinical device testing, not an AI or diagnostic imaging study.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described as this is non-clinical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study was not done. This device is an endoscopic overtube, not an AI-driven diagnostic tool where human reader performance would be a primary focus.

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

No. This is not an AI algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

Engineering/Material Specifications & Benchmarking: The "ground truth" for the nonclinical tests would have been established against engineering specifications, material standards, and performance benchmarks derived from the predicate devices. For example, tensile strength measured against a predefined minimum requirement, or biocompatibility assessed against established ISO or FDA standards for medical device materials.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. No training set exists for this type of device.

Summary

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K 97 3500

pg/cg 3

Bard Interventional Products Division

C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989

BAN

OCT 16 1997

510(k) Summary for the Bard® Endoscopic Overtube VI

As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (I)(3)(A) of the Act, an adequate summary of any information respecting safety and effectiveness follows.

A. Submitter Information:
- Name and address of submitter: -Bard Interventional Products Division, C.R. Bard. Inc. 129 Concord Road, Building 3 Billerica, MA 01821

-Telephone (978) 663-8989 Fax (978) 262-4878

Contact Person: -Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator
Date of Preparation: -October 8, 1997

B. Device Name:

ﺖ

Bard® Endoscopic Overtube Trade Name:
Common/Usual Name: Overtube -
Classification Name: Endoscope and accessories -(per 21 CFR 876.1500)

C. Predicate Device Name:

Trade Name: Bard® Endoscopic Overtube --
- Trade Name: Olympus Splinting Tube ST-C3

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K97 3500 pg 2 of 3

D. Device Description:
- The Bard® Endoscopic Overtube consists of a flange bonded to a plastic sheath and is inserted into the esophagus through an initially placed bite block.
E. Intended Use of Device:
- The Bard® Endoscopic Overtube is intended to be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.
F. Technological Characteristics Summary:
- Both of the proposed and existing Bard® overtubes share a similar design consisting of a proximal cryolite flange, UV bonded to a polyvinyl chloride sheath with a distal tapered tip and is intended for use with an initially placed bite block. Both overtubes are indicated for twenty-five (25) reuses.

The proposed overtube also employs an encapsulated stainless steel tempered wire coiled along the length of its sheath and externally encapsulated within the polyvinyl chloride as does the Olympus Splinting Tube.

Similarities and Differences Summary:

-Similarities
Both the proposed and existing Bard® overtubes share a similar design consisting of a proximal flange UV bonded to a sheath with a distal tapered tip and is intended for use with an initially placed bite block. Either device is designed to protect the hypopharynx from the trauma of repeated intubations, the airway from aspiration and the esophagus during extraction of sharp objects or foreign bodies. The labeled warnings and contraindications remain the same and both overtubes are indicated for twenty-five (25) reuses.

The proposed Bard® Endoscopic Overtube is similar in technological

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K97 3500 Pg 3 of 3

characteristic as the Olympus, Splinting Tube ST-C3, with a wire coil along the length of its sheath that is encapsulated. Additionally, an overtube has a similar intended use as a splinting tube in aiding endoscope insertion through the tube to reach a target area and perform a specific function, while the surrounding anatomy is protected from potential trauma of endoscope reinsertion.

Differences

The proposed Bard® Endoscopic Overtube will be somewhat longer and the distal tip will have a beveled rather than blunt taper. The sheath will include a frosted polyvinyl chloride for a lower friction surface and will have an encapsulated coil to maximize shaft ID for repeated intubations.
். Performance Data:
- The Bard® Endoscopic Overtube has been subjected to nonclinical, tensile performance testing and biocompatibility testing. These tests conclude that this device is safe and effective.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1997

Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road Billerica, Massachusetts 01821-7031

Dear Ms. Gordon:

Re: K973500

Bard® Endoscopic Overtube Dated: September 15, 1997 Received: September 16, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 KOG

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, subject to the general controls provisions of 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K9Z3500____________________________________________________________________________________________________________________________________

____ Bard® Endoscopic Overtube________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

To be used with an endoscope when repeated endoscopic intubation is anticipated,
of management of the l o be used with an endoscope when repeated chaosepts in the management of management of the foreign bodies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off	Robert P. Saling
-------------------	------------------

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K973500
---------------	---------

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

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.