ESSEX ENDOSCOPE, MODEL SXD-1000

K023627 · Guidant Corp. · GCJ · Nov 12, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K023627
• Device Name: ESSEX ENDOSCOPE, MODEL SXD-1000
• Applicant: Guidant Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Essex Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.

Device Story

Essex Endoscope is a rigid endoscope used for visualization during minimally invasive surgery. Device features a shaft containing glass fibers for illumination and an optical lens system for image transmission. Distal end includes a viewing window; proximal hub includes a light guide post and eyepiece for camera coupler attachment. Operated by surgeons in clinical/surgical settings to provide direct visualization of the surgical field. Device facilitates surgical navigation and procedure monitoring by transmitting images to an external camera system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological comparison to the predicate device.

Technological Characteristics

Rigid endoscope; glass fiber illumination; optical lens system; right-angle viewing port; smaller diameter and shorter shaft compared to predicate. Materials are identical to the predicate device. Non-powered, optical visualization device.

Indications for Use

Indicated for patients undergoing general endoscopic or minimally invasive surgical procedures requiring visualization of a surgical working cavity.

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

• 5mm Endoscope (K960637)

Submission Summary (Full Text)

{0}------------------------------------------------

K023627 1/2

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### A. Name, Address, Phone and Fax number of the Applicant

Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Telephone: [phone] Fax: [phone]

### B. Contact Person

Anne Schlagenhaft Regulatory Affairs Associate

#### C. Date Prepared

September 9, 2002

#### D. Device Name

Trade Name: Guidant Essex Endoscope

Classification Name: Endoscope and accessories

#### E. Device Description

The Essex Endoscope consists of a shaft that houses glass fibers for light delivery and an optical lens system for image return. The distal shaft has a window for viewing. The proximal hub has a light guide post for attachment of light guides and an eyepiece with a clear viewing window for attachment of medical camera couplers. The Endoscope provides illumination and visualization of the working space during surgical procedures.

{1}------------------------------------------------

Ko23627 2/2

## Guidant Corporation Cardiac Surgery

510(k) Notification Essex Endoscope

#### F. Intended Use

The Essex Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.

#### G. Substantial Equivalence

The Endoscope is substantially equivalent to the 5mm Endoscope, cleared under K960637 on June 14, 1996. The design of the Essex Endoscope is identical to the current Endoscope with a slightly smaller diameter, shorter shaft, and a right angle viewing port. The subject device is composed of materials that are identical to the currently marketed device. The Endoscope is substantially equivalent in intended use, materials, manufacturing processes, technological characteristics, and components to the predicate device.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail.

### Public Health Service

NOV 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guidant Corporation c/o Ms. Michelle Weidman Office Assistant Coordinator KEMA Medical 4377 County Line Road Chalfont, PA 18914

Re: K023627

Trade/Device Name: Essex Endoscope Model SXD-1000 Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 25, 2002 Received: October 28, 2002

Dear Ms. Weidman:

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.

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.

{3}------------------------------------------------

Page 2 - Ms. Michelle Weidman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 1 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information 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,

Miriam C. Provost

Fov 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

{4}------------------------------------------------

02362 510(k) Number (if known): K

Device Name:

Guidant Essex Endoscope

Indications For Use:

The Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ 1

OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Miriam C. Provost (Optional Format 1-2-96)

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

510(k) Number K023627