STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM

K040390 · Stryker Endoscopy · HIH · May 17, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040390
• Device Name: STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra, and cold-slitting of urethral strictures Trans-urethral incision and resection of the prostate Trans-urethral removal of bladder tumors Trans-cervical resection and ablation of the endometrium Trans-cervical resection of fibroids

Device Story

System comprises endoscopes, sheaths, bridges, obturators, electrodes, and surgical accessories for minimally invasive urological and gynecological procedures. Device provides visualization and manipulation of anatomy; enables tissue ablation, biopsy, incision, and resection. Used in clinical settings by surgeons via natural orifices. Output is direct visualization of surgical site and mechanical/electrosurgical tissue modification. Benefits include minimally invasive access to surgical sites, reducing patient trauma compared to open surgery.

Clinical Evidence

Bench testing only. Conformance to IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, ANSI/AAMI HF-18, and ISO 10993 standards.

Technological Characteristics

System includes endoscopes, sheaths, electrodes, and mechanical accessories. Materials evaluated per ISO 10993. Electrosurgical components comply with ANSI/AAMI HF-18. Electrical safety per IEC 60601-1, 60601-2-2, and 60601-2-18. Connectivity: None (mechanical/optical/electrosurgical).

Indications for Use

Indicated for patients requiring minimally invasive urological or gynecological diagnostic and therapeutic procedures, including urethral dilation, prostate resection, bladder tumor removal, endometrial ablation, and fibroid resection. Contraindicated in patients with acute pelvic inflammatory disorder, inability to distend the uterus, cervical stenosis, cervical/vaginal infection, uterine bleeding/menses, known pregnancy, or invasive carcinoma of the cervix.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Reference Devices

• Henke Sass Wolf (unspecified)
• Omnitech Systems (unspecified)
• GIMMI (unspecified)
• ACMI (unspecified)

Submission Summary (Full Text)

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

K040390
Page 1 of 2

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Device Name

| Proprietary Name: | Stryker Urology and Gynecology Hardware System |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common and Usual Name: | Scope, Obturator, Working Element, Sheath, Bridge,<br>Electrode, Albarran Deflector, Timberlake Obturator,<br>Cutting Loop, Roller Ball, Cold Knives,<br>Dilator/Sound/Bougie, Bladder Syringe, Ellik<br>Evacuator, Forceps |
| Classification Name: | Endoscope and accessories, Cystoscopes,<br>Hysteroscope, Resectoscope, Sheaths, Electrode,<br>Urethrotome, Dilators, Evacuator, Non-Electric Biopsy<br>Forceps, G-U, Surgical Instruments |

The Stryker Urology and Gynecology Hardware System is substantially equivalent in terms of safety and effectiveness to many currently marketed devices and surgery systems currently marketed by Henke Sass Wolf, Omnitech Systems, GIMMI, and ACMI.

The Stryker Urology and Gynecology Hardware System is an extension of the Hystero-Resectoscope and Accessories as currently marketed by Stryker and OEM suppliers Henke Sass Wolf and Omnitech Systems. The Stryker Urology and Gynecology Hardware System is composed of endoscopes, sheaths, accessories, and applied parts which provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures.

The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:

Dilation of the urethra, and cold-slitting of urethral strictures

Trans-urethral incision and resection of the prostate

Trans-urethral removal of bladder tumors

Trans-cervical resection and ablation of the endometrium

Trans-cervical resection of fibroids

Contraindications:

Acute Pelvic Inflammatory Disorder (PID) Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent:

Inability to distend the uterus Cervical stenosis Cervical/vaginal infection Uterine bleeding or menses Known pregnancy Invasive carcinoma of the cervix Recent uterine perforation

The Stryker Urology and Gynecology Hardware System conforms to the following performance standards: IEC 60601-1 safety and voluntary Medical Electrical Equipment - General Requirements for Safety, IEC 60601-2-2 Medical Electrical Equipment - General Requirements for Safety, Collateral Standard, Electromagnetic Compatibility, IEC 60601-2-18 Particular Requirements for the Safety of Endoscopic Equipment, ANSI/AAMI HF-18 Electrosurgical Devices, ISO 10993 Biological Evaluation of Medical Devices.

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

K04039i
fuge 2f2

There are no significant technological or performance differences between the Stryker Urology and Gynecology Hardware System and the identified predicate devices and surgery Orology and "Gynoology" hardware ons raised regarding safety or effectiveness, therefore, the Stryker Urology and Gynecology Hardware System is substantially equivalent to the identified predicate devices and surgery systems.

Contact:

Christopher L. Cook

Date:

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Phone: [phone] Fax: Email: [e-mail]

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 7 2004

Mr. Christopher L. Cook Quality Engineer Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138

Re: K040390 Trade/Device Name: Stryker Urology and Gynecology Hardware System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscope electrosurgical unit and accessories Regulation Number: 21 CFR 876.4370 Regulation Name: Gastroenterology-urology-urology evacuator Regulatory Class: II Regulatory Class HIH, and 78 KOG, FAJ, FAS, and KQT Dated: February 10, 2004 Received: February 17, 2004

Dear Mr. Cook:

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 fisting (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and if you to organ and equivalence of your device of your device to a legally premaired 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), please If you dosh bpooms at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, to Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your roopener Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Device Name: Stryker Urology and Gynecology Hardware System

Indications for Use:

The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for The Stryker Urology and Gylecology Hauware oyselling in the product include the product include the endoscopic diagnostic and therapeulic surgical procedures: cicision, and resea, andro as
visualization and manipulation of anatomy, aslation, and researchirel and gunecol visualization and manipulation of any and one in eneral underse and grecological and grecological and grecological and grecological site the surgeon deems appropriate. surgery through the minimally invasite up to following types of procedures:
The system's use is intended for, but not limited to the following the

Dilation of the urethra, and cold-slitting of urethral strictures

Trans-urethral incision and resection of the prostate

Trans-urethral removal of bladder tumors

Trans-cervical resection and ablation of the endometrium

Trans-cervical resection of fibroids

## (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)

And of heym Over-The-Counter-Use_

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number .