SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

K964005 · Synergetics, Inc. · MPA · Jun 9, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964005
• Device Name: SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
• Applicant: Synergetics, Inc.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Jun 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Synergetics Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.

Device Story

Synergetics Synerlight Fiber Optic Lightsource is a stand-alone, arc-lamp based light source for vitreoretinal surgery. It utilizes a 24-watt metal-halide lamp (Welch Allyn Hi-Lux) with an integral reflector. The device features a standard connector mount for endoilluminator fibers, a brightness control knob with an internal dimming wheel, and an internal filter wheel with six factory-installed imaging-enhancing filters. The device provides white light (5500°K) with integrated UV and IR blocking filters to reduce phototoxicity and heat damage to the eye. It is operated by surgeons in an OR setting. The device includes a high-power mode, indicated by a red LED, audible beep, and tactile detent, to alert the user. Output is delivered via fiber optic cables to the surgical site. The device improves safety over predicate systems by providing superior UV and IR attenuation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing compared spectral output (UV, IR, and visible light) and power output (mW) against the predicate device. Results demonstrated that the subject device provides superior attenuation of harmful UV (<420nm) and IR (>700nm) radiation compared to the predicate.

Technological Characteristics

Arc-lamp based light source; 24-watt metal-halide lamp (Welch Allyn Hi-Lux) with integral reflector; standard fiber optic connector mount with internal detent; brightness control via internal dimming wheel; six-position internal filter wheel; UV/IR blocking filters; high-power mode with LED/audible/tactile indicators.

Indications for Use

Indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.

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

• Dutch Ophthalmic, USA Xenon Illumination System catalog number 1266-X (K964005)

Reference Devices

• Welch Allyn LCI 200 Integrated Illumination and Imaging System
• Storz Premiere II Microsurgical System

Submission Summary (Full Text)

{0}

K964005
JUN - 9 1997

# Section XI - Summary of Safety and Effectiveness

Date of Preparation: April 14, 1997

Device Name: Synergetics, Inc. Synerlight Fiber Optic Lightsource

Classification Name: Ophthalmic Endoilluminator 86 MPA

Manufacturer: Tayman Medical, Inc. located at 15 Foxhunt Drive, Chesterfield, Missouri 63017

Predicate Device: The Synergetics lightsource is substantially equivalent in intended use, safety and effectiveness and construction to the Dutch Ophthalmic, USA Xenon Illumination System catalog number 1266-X manufactured by Dutch Ophthalmic, USA (D.O.R.C.) located at Two Marshall Road, Kingston NH 03848. Telephone number [phone].

Device Description: The Synergetics lightsource is a stand alone arc-lamp based lightsource that incorporates a standard connector mount used by most endoilluminators. It has a brightness control, accessory filter control and lamp life timer display.

Intended Use: The Synergetics Fiber Optic light Source is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.

# Clinical and Non-Clinical Similarities and Differences

| Predicate
D.O.R.C. Lightsource | New
Synergetics, Inc. Lightsource | Safety and Effectiveness
Information |
| --- | --- | --- |
| The D.O.R.C, Inc. Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye. | The Tayman Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye. | There are no differences in regards to safety and effectiveness. |
| Filter Selection Knob - The filter selection knob is detented and turns an internal filter wheel that allows the user to select from up to six different accessory filters. | Filter Selection Knob - The filter selection knob is detented and turns an internal filter wheel that allows the user to select from up to six different accessory filters. | There are no differences in regards to safety and effectiveness. |

{1}

Connector Mount - The connector mount is a standard design that accepts most commercially available endoilluminator light fibers. It has an internal detent that holds the light fiber in place and helps to confirm that the light fiber is fully inserted.

Brightness Control - The brightness control knob turns an internal light dimming wheel that allows the user to adjust the light output of the fiber. There is no front panel labeling that shows the knob position indicators in regards to the brightness control knob.

Lamp - The lamp is an arc-lamp based ILC 75 watt Cermax lamp with integral reflector. The Cermax lamp is manufactured by ILC Technology. It is a xenon lamp.

Connector Mount - The connector mount is a standard design that accepts most commercially available endoilluminator light fibers. It has an internal detent that holds the light fiber in place and helps to confirm that the light fiber is fully inserted.

Brightness Control - The brightness control knob, turns an internal light dimming wheel that allows the user to adjust the light output of the fiber. The brightness control knob has a small indicator arrow that aligns with the indicating artwork. The brightness artwork depicts the off, standard and high output settings. A red LED next to the high power label, an audible beep and a tactile detent will alert the user when the light source is used in the high power mode.

Lamp - The lamp is an arc-lamp based Welch Allyn 24 watt Hi-Lux lamp with integral reflector. The Hi-Lux lamp is manufactured by Welch Allyn Lighting Products Division. It is a metal-halide lamp.

There are no differences in regards to safety and effectiveness.

There are no differences in regards to safety and effectiveness as the relative differences are addressed by explicit product labeling and warning indicators.

There are no differences in regards to safety and effectiveness as this same Welch Allyn Hi-Lux lamp is currently used in other medical fiberoptic products such as the:

- Welch Allyn LCI 200 Integrated Illumination and Imaging System. This system is manufactured by Welch Allyn Lighting Products Division

- Storz Instrument Company, Inc. uses the same lamp in its Storz Premiere II Microsurgical System which is also used with endoilluminators in vitreoretinal surgery.

{2}

# Accessory Filters

The D.O.R.C. lightsource is available with five different accessory filters. They are ordered at the time of initial purchase for factory installation. These filters are:

- 585 A Green Filter
- 585 B Yellow Filter
- 585 C Red Filter
- 585 D Blue Filter
- 585 E Daylight Filter

# Accessory Filters

The Synergetics lightsource incorporates five different imaging enhancing filters. These filters are installed at the factory. These filters are:

- Filter #1 - White light Filter
- Filter #2 - Triple-band filter
- Filter #3 - UV/Blue light filter
- Filter #4 - Blue narrow band filter
- Filter #5 - Green narrow band filter
- Filter #6 - Red narrow band Filter

The Synergetics #1 filter is equivalent to using the D.O.R.C. lightsource without any of its accessory filters. There is no difference in terms of the safety and effectiveness in regards to the filter #1 as it provides the basic white light output with UV and IR filtering.

The Synergetics #2 triple band filter has no equivalent in the D.O.R.C. lightsource. There are no differences in terms of safety and effectiveness as this filter only serves to block the light output in the areas that are in between that of the primary colors; blue, green and red. This can only reduce the overall power output as compared to the #1 white light filter.

The Synergetics #3 UV/Blue light filter has no equivalent in the D.O.R.C. lightsource. The D.O.R.C. lightsource produces a substantial amount of light below 495nm and does not incorporate this UV/Blue light safety feature.

There is no differences in regards to safety and effectiveness of the Synergetics filters #4,#5 and #6 as they are just color filters that transmit a narrower spectrum in their particular color range than the color filters used in the D.O.R.C. lightsource.

{3}

# Visible Light Output

The D.O.R.C. lightsource produces "white 5600°K temperature light. As tested by Tayman Medical the overall power output of the D.O.R.C. lightsource was 17.8mW.

# Visible Light Output

The Synergetics lightsource produces a "white" 5500°K temperature light. The overall power output potential of the Synergetics lightsource is 36.1mW's when using white light filter #1, a large fiber endoilluminator and the high power brightness range. When used in the standard power brightness range with a large fiber endoilluminator or the high power range with a small fiber endoilluminator the power output is approximately 15.0 mW. This power output is approximately the same power output as most existing vitreo-retinal lightsources. When used This filter provides the most light transmission and therefore all of the other filters would result in lower light output.

There are no differences in regards to safety and effectiveness as the extra power present in the lightsource is only used when it is attenuated by the use of small fiber endoilluminators, special image enhancing filters or when the specific surgical situations that requires and permits the use of this higher than standard power output are present. Various statements regarding the safe use of this lightsource in high power mode are provided in the device labeling and owners manual.

{4}

# UV Light Output

The D.O.C.R. lightsource produces a substantial amount of light below 420nm.

# UV Light Output

The Synergetics lightsource white light filter #1 blocks the lamps UV output below 420nm.

This filters provides the least UV attenuation and therefore the use of any of the other Synergetics Lightsource filters would result in even lower UV output.

The Synergetics lightsource also incorporates a UV/Blue light filter. This filter blocks the UV-blue light below 495nm and is for use in certain circumstances where it is desirable to have the UV-blue light component reduced even further than that achieved when using the white light filter # 1. This filter does result in a light output that is extremely yellow but there are times when this light quality verses additional safety is justified. Such instances may be when the surgeon will be spending a lot of time with the endoilluminator in close proximity to the retina. For example during membrane peeling procedures using a endoilluminator with integral pick. This UV/Blue light filter also incorporates the standard IR blocking as outlined below.

The UV/Blue light output is considerably less than the D.O.R.C. lightsource. Many studies have been done that show that the extended use of UV light below 420nm in vitreo-retinal illumination can cause phototoxicity damage to the eye. Therefore the illumination of the UV light below 420nm is critical to safe intraocular illumination. And, it is safer than the D.O.R.C. lightsource in this regard..

{5}

# IR Light Output

The unfiltered ILC lamp that the D.O.R.C. lightsource uses is expensive and very inefficient for visible light only applications. Testing by Synergetics and product information supplied by ILC show that the *unfiltered* lamp produces almost 60% of its power output in the harmful I.R. range. This results in a lightsource that could be very dangerous if its internal I.R. filter were to break or is removed for some reason.

# IR Light Output

The Synergetics lightsource white light filter #1 blocks the lamps IR output above 700nm.

This filter provides the least IR attenuation and therefore the use of any of the other filters would result in even less IR output.

There is no difference in terms of the safety and effectiveness in regards to the IR output of the Synergetics lightsource as many studies have been done that show that the extended use of heat producing IR light above 700nm in vitro-retinal illumination to be potentially dangerous to the eye. Therefore the Synergetics lightsource has been designed to eliminate the IR light above 700nm.

{6}

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 9 1997

Synergetics, Inc.
Mr. James Taylor
VP - Director of Quality Assurance
c/o Tayman Medical, Inc.
15 Foxhunt Drive
Chesterfield, MO 63017

Re: K964005
Trade Name: Synergetics Synerlight Fiber Optic Lightsource
Regulatory Class: II
Product Code: 86 MPA
Dated: April 14, 1997
Received: May 15, 1997

Dear Mr. Taylor:

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 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 II (Special Controls) or 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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.

{7}

Page 2 - Mr. James Taylor

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 at [phone].

Sincerely yours,


A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{8}

Page 1 of 1

510(k) Number (if known): K964005

Device Name: Synergetics, Inc. Synerlight Fiber Optic Lightsource

Indications For Use: The Synergetics Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Hoang
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K964005

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)