To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

Device Description

The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).

AI/ML Overview

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the OverTube™ Endoscopic Access System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the OverTube™ Endoscopic Access System. Instead, it states that "Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence." The tests conducted are listed as:

Insertion and removal force requirements
Shaft deflection
Leakage rate
Bond strength
Foreign body removal
Biocompatibility (in accordance with ISO 10993-1:2009)
Sterilization cycle validation (in accordance with ISO 11135-1:2007)

The document asserts that these tests "show that the differences between the OverTube™ Endoscopic Access System and predicate device do not raise any questions regarding its safety and effectiveness." This implies that the device performed comparably to, or within acceptable limits for, its predicate device for each of these parameters, thereby meeting the implicit acceptance criteria for substantial equivalence.

Since specific numerical acceptance criteria and reported performance values are not provided, the table below reflects what is stated in the document about the performance evaluation.

Acceptance Criteria Category	Reported Device Performance/Evaluation
Functional Performance	Testing included:
	- Insertion and removal force
	- Shaft deflection
	- Leakage rate
	- Bond strength
	- Foreign body removal
	(Implied: Performed equivalently to predicate or within acceptable ranges)
Biocompatibility	Evaluated in accordance with ISO 10993-1:2009
Sterilization	Validated in accordance with ISO 11135-1:2007 (for EO sterilization)
Overall Safety & Effectiveness	Differences from predicate do not raise any questions regarding safety and effectiveness. Device is determined to be substantially equivalent.

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

The document does not specify the quantitative sample sizes for the performance tests (e.g., how many over-tubes were tested for insertion force or leakage rate). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) summary for a medical device that relies on substantial equivalence to a predicate, these tests are typically bench and/or in-vitro tests, not clinical studies involving patient data provenance from specific countries.

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

This information is not provided in the document. For bench/functional testing of a device like an overtube, the "ground truth" is typically established by engineering specifications, standard test methods, and comparison to the predicate device's known performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of the described performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving expert reviews for ground truth establishment, which is not the type of study described here.

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/provided. The device described is an endoscopic access system (a physical medical device), not an AI algorithm or a diagnostic tool that involves "human readers" interpreting output. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

This information is not applicable/provided. As mentioned above, this filing concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the functional performance tests (insertion/removal force, shaft deflection, leakage, bond strength, foreign body removal), the "ground truth" would be the engineering specifications, established test methodologies, and the performance characteristics of the legally marketed predicate device (Guardus® Disposable Overtube). The goal was to demonstrate that the new device performs acceptably within these engineering and predicate-based parameters.

For biocompatibility, the ground truth is established by the requirements of ISO 10993-1:2009.
For sterilization, the ground truth is established by the requirements of ISO 11135-1:2007.

8. The Sample Size for the Training Set

This information is not applicable/provided. As this is a submission for a physical medical device based on substantial equivalence and performance testing, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable/provided for the same reason as point 8.

Summary

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K122270

-1

Section 5. 510(k) Summary for OverTube™ Endoscopic Access System

Company:

Apollo Endosurgery, Inc. 7000 Bee Cave Road, Suite 350 Austin, TX, USA 78746

Contact Person:

Heather Crawford, RAC Director of Quality and Regulatory Email: heather.crawford@apolloendo.com Office phone: 512.328.9990 extension 244 Fax: 512.328.9994

K040836: US Endoscopy Disposable Overtube

Date Prepared:

Device:

18 September 2012

Trade Name: Regulation Number: Regulation Description: Product Code: Classification Panel:

Device Classification:

OverTube™ Endoscopic Access System 21 CFR § 876.1500 Endoscope and accessories FED Gastroenterology/Urology Class II

Predicate Device(s):

Indications for Use:

Device Description:

To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

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K122270
-2

Technological Characteristics and Substantial Equivalence

The following table compares the OverTube™ Endoscopic Access System to the predicate device with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

Parameter	Apollo EndosurgeryOverTube™ EndoscopicAccess System	US EndoscopyDisposable Overtube(Guardus®)
510(k) Number	To be assigned	K040836
Indications for Use	To be used in conjunction withan endoscope for foreign bodyremoval or endoscopicprocedures requiring multipleinsertions of the endoscopeinto the lower or uppergastrointestinal tract.	The disposable Overtube is adevice used in conjunctionwith a flexible endoscope forforeign body or tissueretrieval and/or forendoscopic proceduresrequiring multiple endoscopeintubations.
Regulation Number	876.1500	876.1500
FDA Product Code	FED	KOG
Prescription / OTC Use	Prescription	Prescription
Single-Use / Reusable	Single-Use	Single-Use
Dimensions
Effective Length	27 cm	25 cm - 50 cm
Overtube Shaft OD	19.5 mm	19.5 mm
Overtube Shaft ID	16.7 mm	16.7 mm
Tapered Tip ID	11 mm	10.4 mm (insertion tube)16.8 mm (outer tube)
Physical Characteristics
Overall Design	Single tube	Dual tube
Compatible Scope OD (mm)	10 mm – 16 mm	8.6 mm – 11.7 mm
Reinforcement Material	Wire coil design	Wire coil design
Tapered Tip	Yes	Yes
Insufflation Method	Cuff	Cap
Sterilization and Shelf Life
Sterility	Sterile and Non-sterile	Non-sterile only
Sterilization Method	Ethylene oxide	None
Primary Package	Pouch	Tray
Shelf Life (Use By Date)	Three (3) years	Three (3) years
Units per Shelf Box	Three (3)	Three (3)

Table 5-1. Device Comparison Table

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Summary of Non-Clinical Data Submitted

Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence. Functional performance testing included insertion and removal force requirements, shaft deflection, leakage rate, bond strength and foreign body removal. The OverTube™ Endoscopic Access System was subjected to biocompatibility evaluation in accordance with ISO 10993-1:2009. Additionally the OverTube™ Endoscopic Access System was adopted into the existing ethylene oxide sterilization cycle which was validated in accordance with ISO 11135-1:2007.

Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the OverTube™ Endoscopic Access System and predicate device do not raise any questions regarding its safety and effectiveness. The OverTube™ Endoscopic Access System, as designed and manufactured, therefore is determined to be substantially equivalent to the referenced predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Public Health Service

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

SEP
2 8 2012

Ms. Heather Crawford. RAC Director, Quality and Regulatory Apollo Endosurgery, Inc. 7000 Bee Cave Road, Suite 350 AUSTIN TX 78746

Re: K12270

Trade/Device Name: OverTube™ Endoscopic Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: July 27, 2012 Received: July 30, 2012

Dear Ms. Crawford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four because or self people is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreations of the enactment date of the Medical Device Amendments, or to Conimeres phor to may 20, 1970, are excordance with the provisions of the Federal Food, Drug, de noos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicitions 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 additionship. There new www. 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 It may be subject to additional controllar 2.1.2.2011 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 ore of the of the of Frease of advised that I DTT I risualled on on one complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that I DA has made a dolorimisations administered by other Federal agencies. You must Of any I cocrai statuates and regulations, but not limited to: registration and listing Comply with an the Act 5 requirements, includes, includes reporting (reporting of medical

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Page 2-

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-iclated adverse evones) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 11 you desire specific advice for your do need on on 2 tables offices/ucm115809.htm for go to mup.mww.ida.gov/rroodd Drical Health's (CDRH's) Office of Compliance. Also, please, p the Center for DOTICOS and Realers of the Premarket notification" (21CFR Part note the regulations 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 Tou may obtain other generational 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 K. Fisher

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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Indications for Use

510(k) Number (if known):

K122270

Device Name:

OverTube™ Endoscopic Access System

Indications for Use:

To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

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)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K122270

Page 1 of 1

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.