ENDO-GLIDE

K013701 · Sonotech, Inc. · GCJ · Feb 4, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013701
• Device Name: ENDO-GLIDE
• Applicant: Sonotech, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Endo-Glide will be used to lubricate the insertion and passage of imaging devices such as endoscopes, ultrasound transducers, and transesophageal echocardiography transducers, catheters and surgical instrumentation,

Device Story

Endo-Glide is a biocompatible, biodegradable lubricant designed for use with medical instrumentation. It functions as a film-forming agent, requiring only a thin coating to provide lubrication. Its formulation prevents 'snowplowing' during insertion, ensuring consistent coverage and avoiding dry spots on instruments, particularly endoscopes. The device is intended for use in clinical settings by healthcare professionals to facilitate the insertion and passage of imaging devices (endoscopes, ultrasound transducers, transesophageal echocardiography transducers) and surgical instruments (catheters). It is available in both sterile and non-sterile packaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Biocompatible, biodegradable lubricant; film-forming agent. Formulated for adherence to medical instruments to prevent dry spots during insertion. Available in sterile and non-sterile formats.

Indications for Use

Indicated for the lubrication of imaging devices and surgical instrumentation, including endoscopes, ultrasound transducers, transesophageal echocardiography transducers, and catheters, to facilitate insertion and passage.

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

• VivoSonic In Vivo Biocompatible/Biodegradable Sterile Ultrasound Couplant (K984562)
• K-Y Jelly (K780386)
• K-Y Jelly (K810310)

Reference Devices

• Surgilube

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for SONOTECH INC. The logo features a black and white design with a stylized dolphin leaping out of the water in front of a sun. The company name "SONOTECH" is written in bold, sans-serif font to the right of the dolphin, with "INC" stacked vertically in a smaller font to the right of the "H".

510(k) Application: Endo-Glide Lubricant

e Dr. Bellingham, WA 98225 fax [phone]

Registration # 2523891

2-4-02
K013701

# 510(k) Summary

Date Prepared: ________

### SONOTECH, INC.

774 Marine Drive Bellingham, WA 98225 Contact Person: Margaret J. Larson Telephone: [phone] Fax: [phone] e-mail: [e-mail]

Device Name

Proprietary name: Endo-Glide™

Common name: lubricant

Classification name: endoscopic, transurethral and surgical instrumentation lubricant

#### Statement of substantial equivalence

Endo-Glide is equivalent in formula to:

- A. VivoSonic In Vivo Biocompatible/Biodegradable Sterile Ultrasound Couplant; (Sonotech, Inc.) K984562, clearance received June 8, 1999; MUI; Class II
#### Endo-Glide is equivalent in use to:

- A. K-Y Jelly; for transurethral surgical instruments (Johnson & Johnson Professionals, Inc.) K780386, clearance received 04/13/1978; FHX78. Class =
- B. K-Y Jelly; patient lubricant (Johnson & Johnson Professionals, Inc.) K810310, clearance received 04/21/1981: KMJ. Class I

28

- C. Surgilube

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Image /page/1/Picture/0 description: The image shows the logo for SONOTECH INC. The logo features a stylized image of a dolphin jumping out of the water on the left side. To the right of the dolphin image is the company name, "SONOTECH," in large, bold, sans-serif font. To the right of the company name is the abbreviation "INC" in a smaller, sans-serif font.

Sonotech Inc. Marine Dr. Bellingham, WA 98225 371-9122 fax [phone]

510(k) Application: Endo-Glide Lubricant

Registration # 2523891

#### Device Description

Endo-Glide™ is a lubricant that is biocompatible with all hollow viscera, is in vivo biocompatible with tissue and body fluids, is in vivo biodegradable and is recognized as safe for oral administration'. Endo-Glide is an excellent film former, requiring a thin coating to adequately lubricate an instrument, thus using less material. A thin film of Endo-Glide has excellent adherence and will not "snowplow" when inserted into an orifice, which can create dry spots on an instrument, and most particularly on an endoscope. Endo-Glide will be offered in sterile and non-sterile packaging for endoscopic, transurethral and surgical instrumentation lubrication.

#### Intended Use

Endo-Glide will be used to lubricate the insertion and passage of imaging devices such as endoscopes, ultrasound transducers, and transesophageal echocardiography transducers, catheters and surgical instrumentation,

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design, with three stylized lines forming the bird's body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 0 4 2002

Ms. Margaret J. Larson President Sonotech, Inc. 774 Marine Drive Bellingham, Washington 98225

Re: K013701

Trade/Device Name: Endo-Glide Lubricant Regulation Number: 892.1570, 876.1500 Regulation Name: Diagnostic ultrasonic transducer, endoscope and accessories Regulatory Class: II Product Code: ITX, GCJ Dated: November 5, 2001 Received: November 8, 2001

Dear Ms. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use surved in the encreated of the enactment date of the Medical Device Amendments, or to commerce proc to rias 20, 2017 11:51 in accordance with the provisions of the Federal Food, Drug, devices that hat to oven require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dierestery mains of the Act include requirements for annual registration, listing of general controls provisitive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 - Ms. Margaret J. Larson

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and my Jowe FDA finding of substantial equivalence of your device to a legally premarked predicate device results in a classification 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 01 1 594-4659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 09 - - t the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Toganation on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ENDO-GLIDE LUBRICANT

Indications For Use:

Lubricate the insertion and passage of imaging devices and surgical instrumentation, such as endoscopes, ultrasound transducers, cransesponias instrumentation, Such as Chaoseoped, catheters and surgical instrumentation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801 109)

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Over-The-Counter Use.

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(Optional Formal 1-2-96)

Musiam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K013701 510(k) Number -