SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM

K972979 · Smith & Nephew, Inc. · FBO · Dec 11, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972979
• Device Name: SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
• Applicant: Smith & Nephew, Inc.
• Product Code: FBO · Gastroenterology, Urology
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for use in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

Device Story

Images Cystourethroscopes are manual endoscopic devices used for visualization of the bladder, urethra, and distal ureter. The device transfers light to the surgical site via glass fiber optics and provides visualization through a series of optical lenses and prisms. Sheathes and obturators are provided to facilitate access to the surgical site. The device is used by clinicians in a surgical or clinical setting to perform diagnostic and therapeutic procedures. The output is direct visualization of the anatomy, which assists the physician in identifying pathology and performing interventions. The device benefits patients by enabling minimally invasive access and examination of the urinary tract.

Clinical Evidence

bench testing only

Technological Characteristics

Manual endoscopic device; glass fiber optics for light transmission; optical lenses and prisms for visualization; includes sheathes and obturators for access.

Indications for Use

Indicated for patients requiring endoscopic examination of the bladder, urethra, and distal ureter, and for diagnostic and therapeutic procedures using manual instruments.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Karl Storz Endoscopy Cystourethroscopes and accessories

Submission Summary (Full Text)

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

6 1

# Endoscopy Division

Smith & Nephew. Inc. 160 Dascomb Road, Ancover, MA 01810 Telephone: [phone])

DEC `11`. 1997

### 510(k) Summary

Smith & Nephew, Inc., Endoscopy Division

Images Cystourethroscope and accessories

# 972979

# Substantial Equivalence:

The Smith & Nephew, Inc. Images Cystourethroscopes and accessories are substantially equivalent in design, materials, and intended use to Cystourethroscopes and accessories offered by Karl Storz Endoscopy.

# Predicate Device:

The predicate device for this submission is the Karl Storz Endoscopy Cystourethroscopes and accessories.

#### Summary of Device Function:

The Images Cystourethroscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Sheathes and obturators are offered to allow access to the surgical site.

#### Intended Use of Device:

Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

#### Comparison of Technological Characteristics of Predicate Device:

The basic design and function of the Images Cystourethroscopes and accessories is substantially equivalent to technologies, design and function of the Karl Storz Endoscopy Cystourethroscopes and accessories and present no new safety or effectiveness concerns.

Delmah J. Connor

Deborah J. Connors Regulatory Affairs Specialist

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | | 1997

Ms. Deborah J. Connors Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810 Re: K972979

Smith & Nephew Images Cystourethroscopes and Accessories Dated: October 30, 1997 Received: October 31, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FBO 21 CFR §876.4730/Product code: 78 KOA

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

6 1

# Endoscopy Division

Smith & Nephew. Inc. 160 Dascomb Road, Ancover, MA 01810 Telephone: [phone])

DEC `11`. 1997

### 510(k) Summary

Smith & Nephew, Inc., Endoscopy Division

Images Cystourethroscope and accessories

# 972979

# Substantial Equivalence:

The Smith & Nephew, Inc. Images Cystourethroscopes and accessories are substantially equivalent in design, materials, and intended use to Cystourethroscopes and accessories offered by Karl Storz Endoscopy.

# Predicate Device:

The predicate device for this submission is the Karl Storz Endoscopy Cystourethroscopes and accessories.

#### Summary of Device Function:

The Images Cystourethroscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Sheathes and obturators are offered to allow access to the surgical site.

#### Intended Use of Device:

Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

#### Comparison of Technological Characteristics of Predicate Device:

The basic design and function of the Images Cystourethroscopes and accessories is substantially equivalent to technologies, design and function of the Karl Storz Endoscopy Cystourethroscopes and accessories and present no new safety or effectiveness concerns.

Delmah J. Connor

Deborah J. Connors Regulatory Affairs Specialist

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | | 1997

Ms. Deborah J. Connors Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810 Re: K972979

Smith & Nephew Images Cystourethroscopes and Accessories Dated: October 30, 1997 Received: October 31, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FBO 21 CFR §876.4730/Product code: 78 KOA

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

972979

Page 1 of 1

510(k) Number: /( 97 2979

Device Name : Smith & Nephew, Inc., Endoscopy Division Images Cystourethroscope and accessories

Indications for Use :

Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for use in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

) (PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Robert D Sething |
|---------------|--------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K972979 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter |
|---------------------------------------|----|------------------|
|---------------------------------------|----|------------------|

(Optional Format 1-2-96)