SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045

K032680 · Smith & Nephew, Inc. · GCJ · Sep 26, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032680
• Device Name: SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope. The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.

Device Story

300 Watt Xenon light source for endoscopic surgery; provides illumination for articular/body cavities, hollow organs, and thoracic cavity. Features 'Hermes-Ready' communication interface; enables remote control of light intensity, mode selection (manual/automatic), and standby/activation states via Hermes Digital O.R. Control Center. Operated by surgeons in OR setting using voice commands or pendant control. Benefits include centralized control of surgical environment and improved workflow efficiency.

Clinical Evidence

Bench testing only. Verification and validation data demonstrate device safety and performance as intended.

Technological Characteristics

300 Watt Xenon lamp; communication interface for Hermes Digital O.R. Control Center; voice and pendant control capability. Standards: UL 2601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures requiring illumination of articular cavities, body cavities, hollow organs, canals, or the thoracic cavity, when used with an appropriately indicated endoscope.

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

• Smith & Nephew 300XL Xenon Illuminator

Submission Summary (Full Text)

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K0326A0 1/2

Endoscopy Smith & Noonow In 150 Minuteman Road Andover MA 01810

72 749 1500 Far ww smith-nenhow com We are and in the

### Exhibit F

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as

SEP 2 6 2003

required by the safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

#### Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device

Date Prepared: August 28, 2003

#### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA

#### B. Company Contact:

Deborah Connors Regulatory Affairs Manager Phone: [phone] Fax: [phone]

#### C. Device Name

Smith & Nephew 300XL Xenon Illuminator-HERMES Ready Trade Name: Common Name: Endoscopic Light Source Classification Name: General and Plastic Surgery

#### D. Predicate Devices

The Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution: Smith & Nephew 300XL Xenon Illuminator.

#### E. Description of Device

The Smith & Nephew 300 XL Illuminator - HERMES Ready is a 300 Watt Xenon Illuminator indicated for use in endoscopic surgical procedures. The Hermes-Ready™ feature will enable voice and pendant control of light intensity, manual and

> Smith & Nephew, Inc 300XL Illuminator Hermes-Ready Page 105 of

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automatic mode control and standby and activation mode control from a central

location when used in conjunction with a Hermes™ Digital O.R. Control Center.

#### Intended Use F.

The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.

The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.

# G. Comparison of Technological Characteristics

The Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device has the same technological characteristics and intended use as the predicate device, Smith & Nephew 300XL Xenon Illuminator. The addition of the communication interface for voice activation with the Hermes™ control center offers the surgeon direct communication without changing the intended use or features of the Smith & Nephew 300XL Xenon Illuminator.

Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device will be tested with the following domestic and international standards:

- . UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
- . EN 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + Amendments1 and 2
- . EN 60601-1-1: Medical Electrical Equipment General Requirements for Safety 1, Collateral Standard: Safety Requirements for Medical Electrical Systems
- EN 60601-1-2: Medical Electrical Equipment General Requirements for Safety2, Collateral Standard: Electromagnetic Compatibility- Requirements and Tests

# H. Summary Performance Data

All verification and validation data demonstrates that the device is safe and effective and performs as intended.

Delilah Correa

Deborah Connors Regulatory Affairs Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The bird symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Public Health Service

SEP 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah Connors Regulatory Affairs Manager Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810

Re: K032680

Trade/Device Name: Smith & Nephew 300XL Xenon Illuminator-HERMES Ready™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 28, 2003 Received: August 29, 2003

Dear Ms. Connors:

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.

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Page 2 - Ms. Deborah Connors

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), please contact the Office of 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 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

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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### Indications for Use

K032680

510(k) Number (if known):

Device Name: Smith & Nephew 300XL Xenon Illuminator-HERMES Ready™

Indications For Use: The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.

The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.

(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 _

Miriam C. Provost

I, Restorative

510(k) Number K032680