NDO SURGICAL SURGICAL OVERTUBE

K002018 · Surgical, Inc. · FED · Aug 17, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K002018
• Device Name: NDO SURGICAL SURGICAL OVERTUBE
• Applicant: Surgical, Inc.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Aug 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The NDO Surgical, Inc. Overtube is intended for use with an endoscope when repeated endoscopic intubation is anticipated.

Device Story

NDO Surgical Overtube is an extruded, flexible, polyvinyl chloride (PVC) tube reinforced with stainless steel wire braiding; features a bonded polyurethane flange at the proximal end. Device is inserted through the patient's mouth into the esophagus by a physician during endoscopic procedures. Acts as a protective channel for the passage of an endoscope and/or endoscopic instruments into the esophagus. Facilitates repeated endoscopic intubation by maintaining access, reducing the need for multiple esophageal intubations. Benefits include improved procedural efficiency and reduced potential for mucosal trauma during repeated instrument exchanges.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Extruded, flexible polyvinyl chloride (PVC) tube; reinforced with stainless steel wire braiding fully encapsulated within the PVC; proximal end features a bonded polyurethane flange. Device is a passive accessory for endoscopic procedures. Sterilization method not specified.

Indications for Use

Indicated for endoscopic use when repeated endoscopic intubation is anticipated in patients requiring such procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• C. R. Bard Endoscopic Overtube (K973500)
• C. R. Bard Endoscopic Overtube (K942044)

Submission Summary (Full Text)

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

NDO Surgical, Inc. Mr. Jeff Cerier Director of Product Development 125 High Street, Suite 7 Mansfield, MA 02048

JUL 2 7 2015

Re: K002018

> Trade/Device Name: NDO Surgical Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated (Date on orig SE Itr): June 29, 2000 Received (Date on orig SE ltr): July 3, 2000

Dear Mr. Cerier,

This letter corrects our substantially equivalent letter of August 17, 2000.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (7) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1150.

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 [phone] or [phone] 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 [phone] or [phone] 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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Page 1 of 1

Koo 2018 510(k) Number (if known):

NDO Surgical, Inc. Overtube Device Name:

Indications For Use:

The NDO Surgical, Inc. Overtube is indicated for endoscopic use when repeated endoscopic intubation is anticipated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K002018

()(un) ] [

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## AUG 1 7 2000

Image /page/3/Picture/1 description: This image shows the logo and contact information for NDO Surgical, Inc. The address is 125 High Street, Suite 7, Mansfield, MA 02048. The phone number is 508-337-8881, and the fax number is 508-337-8882. The text "510K Summary" is also present in the image.

- 1. Sponsor Name Sponsor/Manufacturer: NDO Surgical, Inc. 125 High Street, Suite #7 Mansfield, MA 02048 Telephone: [phone] Contact Individual: Jeff Cerier
- 2. Device Name NDO Surgical, Inc. Overtube
- 3. Identification of Predicate or Legally Marketed Device C. R. Bard Endoscopic Overtube K973500, K942044

## 4. Device Description

The NDO Surgical, Inc. Overtube is an extruded, flexible, polyvinyl chloride tube, reinforced with stainless steel wire braiding. The stainless steel reinforcing is fully encapsulated in the PVC tube. The proximal end of the Overtube has a polyurethane flange that is bonded to the tube.

The NDO Surgical, Inc. Overtube is inserted through the patient's mouth into the esophagus following standard medical procedures. Once in place, the NDO Surgical, Inc. Overtube is used as a channel for passage of an endoscope and/or endoscopic instruments into the esophagus. It is designed and intended for circumstances in which repeated endoscopic intubation may be necessary.

## ર. Intended Use

6.

The NDO Surgical, Inc. Overtube is intended for use with an endoscope when repeated endoscopic intubation is anticipated.

Comparison of Technological Characteristics

The NDO Surgical, Inc. Overtube is substantially equivalent to the predicate of the Bard Endoscopic Overtube in intended use, technological characteristics of the material compostion and processes used in its application. These characteristics support the concept of substantial equivalence.