SOLARTEC SOURCE 270, MODEL # 90123

K983714 · Cogent Light Technologies, Inc. · FFS · Dec 23, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K983714
• Device Name: SOLARTEC SOURCE 270, MODEL # 90123
• Applicant: Cogent Light Technologies, Inc.
• Product Code: FFS · Gastroenterology, Urology
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The SolarTec™ Source 270 System is intended for use: To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlamps that contain fiber bundles or single fibers for illumination In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals. With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.

Device Story

SolarTec™ Source 270 is a high-intensity metal halide arc lamp illuminator; provides visible light to rigid/flexible endoscopes, surgical headlamps, and lighted tools via fiberoptic cables. Device operates in clinical settings (OR, clinics); used by physicians/surgeons. Input is electrical power; output is uniform white light. Safety features include: lamp replacement door interlock; forced air cooling; internal thermal protection to shut off power if overheating occurs; analog circuitry limiting lamp life to 1000 hours (below 4000-hour rating); internal baffles to dampen sound and confine debris in case of non-passive lamp failure. Uniform light output benefits surgical visualization compared to traditional fiber bundles that attenuate blue light. Device is intended for prescription use.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by bench testing and compliance with international electrical safety standards (IEC601-1, IEC601-2-18, UL2601-1).

Technological Characteristics

Metal halide arc lamp light source; forced air cooling; analog circuitry for lamp life management (1000-hour limit); internal baffles for sound/debris containment. Safety interlocks on lamp door. Complies with IEC601-1 (1993), IEC601-2-18 (1996), and UL2601-1. Standalone unit.

Indications for Use

Indicated for providing illumination for observation and manipulation of body cavities, tissues, hollow organs, and canals during endoscopic procedures (arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, vascular endoscopy) and open surgical procedures using surgical headlamps.

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.

Submission Summary (Full Text)

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Cogent Light Technologies 510(k) Premarket Notification for the SolarTec™ Source 270 DEC 2 3 1998

9837/4

## ATTACHMENT No. 6

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

Safety

The Subject Device is designed with a safety interlock on the lamp replacement door. If the cover is opened, the power to the device will be interrupted.

The Subject Device is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and/or fails to operate properly and the internal temperature of the device exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the lamp.

The lamp and power source may fail passively (i.e., just not turn on, or just go out). Typically, lamp and power source defects do not result in lamps going out during a surgical case. It is more likely that a lamp cannot be turned on during preparation for a surgical case. The consequences to the user is an inconvenience and a time delay. However, it is expected to result in no adverse medical condition in the patient.

To minimize such inconveniences, the Subject Device contains a user replaceable lamp fixture. Cogent Light encourages the operators to have a spare lamp available on site.

The lamp may fail in a non-passive mode, resulting in an audible sound. This sound may startle the user. Due to the inherent nature of all high intensity lamps. including those found in the Predicate Devices, it is impossible to guarantee against all such failures, although they are rare. To minimize such events, the Subject Device has incorporated several safety features into the product design. These safety features include:

- a) The lamp is never operated beyond its specified power range,
- b) The lamp life is limited to approximately 1000 hours by analog circuitry. This limit is significantly below the safe rated life expectancy of the lamp (approximately 4000 hours) as stated by the lamp manufacturer,
- c) The enclosure has interlor structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure.

The Subject Device will meet the following product safety standards:

- a) IEC601-1-2.1993 (Class B) Medical electrical equipment Part 1: General requirements for safety

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Cogent Light Technologies 510(k) Premarket Notification for the SolarTec™ Source 270

2. Collateral Standard: Electromagnetic compatibility - Requirements and tests.

- b) IEC601-2-18:1996 Medical electrical equipment Part 2: Particular requirements for the safety of endoscopic equipment
- c) UL2601-1 2nd ed. Standard for Safety Part 1: General Requirements for safety.

## Effectiveness

Metal halide arc lamps produce light that is spectrally similar to sunlight. The color of the light that is actually delivered to an endoscope, surgical headlight, or surgical instrument, is determined by optical coatings and the transmissive properties of the light delivery system.

The Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image. The output image is independent of the intensity of the light source. By contrast, other commercial fiber bundles and illuminators produce non-uniform images due to the construction of the bundles and optics in the illuminators. Any application involving direct illumination (e.g. surgical headlamp) uniform illumination is a plus.

Fiber bundles have been the standard for light delivery. Due to the transmissive properties of their materials, they will attenuate more in the blue than red region of the spectrum, producing a more yellow light. Cogent Light single fiberoptic cables, used as part of the Subject Device, transmits white light uniformly throughout the visible spectrum,

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings or feathers. The image is in black and white and appears to be a logo or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1998

Mr. Wayne Smith Vice President of Operations Cogent Light Technologies, Inc. 26145 Technology Drive Santa Clarita, CA 91355-1137

Re: K983714 Solar Tec™ Source 270

Dated: October 15, 1998 Received: October 21, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FFS

Dear Mr. Smith

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 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). 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT No. 5 (Indications for Use)

510(k) Number (if known): K983714

Device Name: SolarTec™ Source 270

The SolarTec™ Source 270 System is intended for use:

- To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical 1. headlamps that contain fiber bundles or single fibers for illumination
- In providing illumination for the purposes of allowing observation and manipulation of body cavities 2. and tissues, hollow organs, and canals.
- With applications that include, but are not limited to, headlights and/or externally illuminated 3. endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.

Prescription Use \$\swarrow\$

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