K Number
K100081
Device Name
ENTEROSCOPY OVERTUBE, MODEL 00712140
Date Cleared
2010-04-12

(90 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.
Device Description
The device is an endoscopic accessory designed to provide external support to and maintain a path for an endoscope to minimize the formation of gastric looping by the endoscope and to minimize mucosal pinching, while inserting, advancing, and removing the endoscope during endoscopic procedures in the upper gastrointestinal tract, including the small intestine. The device is intended for prescription use, is non-sterile, is intended for single use, and is not intended for reprocessing.
More Information

Not Found

No
The summary describes a mechanical accessory for endoscopy and makes no mention of AI or ML.

No.
The device description and intended use indicate that the device is an accessory used to aid in the insertion, advancement, and removal of endoscopes during procedures, rather than directly providing a therapeutic effect itself.

No

This device is an overtube designed to assist in the insertion, advancement, and removal of endoscopes during diagnostic and therapeutic procedures. It is an accessory to the endoscope and does not perform diagnostic functions itself.

No

The device description clearly states it is an "endoscopic accessory designed to provide external support" and mentions "components that come into direct contact with the patient," indicating it is a physical hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states that this device is an "endoscopic accessory" used to "aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices" during procedures in the gastrointestinal tract. It provides physical support and guidance for the endoscope.
  • Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. Its function is purely mechanical and procedural.

Therefore, the Enteroscopy Overtube is a medical device used during an endoscopic procedure, but it does not perform in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.

Product codes

FED

Device Description

The device is an endoscopic accessory designed to provide external support to and maintain a path for an endoscope to minimize the formation of gastric looping by the endoscope and to minimize mucosal pinching, while inserting, advancing, and removing the endoscope during endoscopic procedures in the upper gastrointestinal tract, including the small intestine. The device is intended for prescription use, is non-sterile, is intended for single use, and is not intended for reprocessing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper gastrointestinal tract, including the small intestine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

prescription use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Substantial equivalence for the new device was based on design characteristics, a comparison to legally marketed predicate devices, and performance testing. Performance testing consisted of functional bench testing. All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K040836, K080050, K903842, K092221

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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K100081 Page 1 of 2

CONFIDENTIAL United States Endoscopy Group, Inc. January 11, 2010

510(k) Premarket Notification: Traditional Enteroscopy Overtube

510K Summary Enteroscopy Overtube

APR 1 2 2010

Submitter Information

Contact:

Bob Bishui Regulatory Affairs Manager Craig Moore General Counsel

Address:

5976 Heisley Road Mentor, Ohio 44060

Telephone:

440-639-4494

Device Name

Trade Name:

None at this time

Enteroscopy Overtube Endoscopic access overtube, gastroenterology-urology

Device Classification:

Common/usual Name:

Classification Name:

Class II, per 21 CFR 876.1500

Product Code:

78 (FED)

Predicate Device

Disposable Overtube (Guardus ® overtube disposable)510(k) 040836
Endo-Ease Endoscopic Overtube510(k) 080050
St-E1 Overtube510(k) 903842
Colonic Splinting Overtube510(k) 092221

Description of Device

The device is an endoscopic accessory designed to provide external support to and maintain a path for an endoscope to minimize the formation of gastric looping by the endoscope and to minimize mucosal pinching, while inserting, advancing, and removing the endoscope during endoscopic procedures in the upper gastrointestinal tract, including the small intestine. The device is intended for prescription use, is non-sterile, is intended for single use, and is not intended for reprocessing.

1

K100081 Poy.2.ofz

Revised 118

CONFIDENTIAL United States Endoscopy Group, Inc. January 11, 2010

510(k) Premarket Notification: Traditional Enteroscopy Overtube

Indications for Use

The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.

Summary Of Safety Performance

Substantial equivalence for the new device was based on design characteristics, a comparison to legally marketed predicate devices, and performance testing. Performance testing consisted of functional bench testing. All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible.

Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the proposed US Endoscopy Enteroscopy Overtube has been shown to be safe and effective for its intended use.

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

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

Mr. Bob Bishui Regulatory Affairs Manager United States Endoscopy 5976 Heisley Road MENTOR OH 44060

APR 1 2 2010

Re: K100081

Trade/Device Name: Enteroscopy Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: January 11, 2010 Received: January 12, 2010

Dear Mr. Bishui:

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. 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

3

Page 2 --

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 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,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

CONFIDENTIAL United States Endoscopy Group, Inc. January 11, 2010

510(k) Premarket Notification: Traditional Enteroscopy Overtube

13

Page __ 1_ of __ 1

INDICATIONS FOR USE

nous 510(k) Number (if known):

Device Name: Enteroscopy Overtube

Indications for Use:

The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the mall intestine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K100081