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.

AI/ML Overview

Here's an analysis of the provided text regarding the Synergetics, Inc. Synerlight Fiber Optic Lightsource, focusing on acceptance criteria and the study proving its performance.

It's important to note that this document is a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing novel safety and effectiveness. Therefore, some of the requested information, particularly regarding formal acceptance criteria with specific thresholds, detailed study designs, and human reader performance comparisons, is not explicitly present in the provided text. The "study" described herein is a comparison between the new device and a predicate device.

Acceptance Criteria and Device Performance

The acceptance criteria for the Synergetics Synerlight Fiber Optic Lightsource are implicitly derived from its comparison to the predicate device, the Dutch Ophthalmic, USA Xenon Illumination System (D.O.R.C.). The core acceptance criterion is substantial equivalence in intended use, safety, and effectiveness. The reported device performance is measured against that of the predicate device across various parameters.

Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implicit from Predicate)	Reported Synergetics Synerlight Performance	Device Meets Criteria?
Intended Use	During anterior and posterior vitreoretinal surgery to illuminate the eye.	During anterior and posterior vitreoretinal surgery to illuminate the eye.	Yes
Filter Selection Knob	Detented, turns internal filter wheel, allows selection from up to six different accessory filters.	Detented, turns internal filter wheel, allows selection from up to six different accessory filters.	Yes
Connector Mount	Standard design, accepts most commercially available endoilluminator light fibers, internal detent for secure fit.	Standard design, accepts most commercially available endoilluminator light fibers, internal detent for secure fit.	Yes
Brightness Control	Allows user to adjust light output.	Allows user to adjust light output, small indicator arrow, artwork depicts off/standard/high settings, red LED/audible beep/tactile detent for high power mode. Differences addressed by labeling and warnings.	Yes (with additional safety features)
Lamp Type	Arc-lamp based, ILC 75 watt Cermax (xenon lamp).	Arc-lamp based, Welch Allyn 24 watt Hi-Lux (metal-halide lamp). Differences addressed by labeling and warnings, and it's used in other predicate devices.	Yes (with justification)
Accessory Filters	Five different accessory filters (e.g., Green, Yellow, Red, Blue, Daylight).	Six different imaging enhancing filters (White light, Triple-band, UV/Blue light, Blue narrow band, Green narrow band, Red narrow band). Synergetics #1 equivalent to D.O.R.C. without filters. Other filters either have no D.O.R.C. equivalent (e.g., UV/Blue safety) or are narrower spectrum.	Yes (with enhanced safety/features)
Visible Light Output	Produces "white" 5600°K temperature light. Overall power output: 17.8mW.	Produces "white" 5500°K temperature light. Overall power output: 36.1mW (max), approximately 15.0 mW (standard/small fiber).	Yes (with higher potential, but controlled)
UV Light Output	Produces a substantial amount of light below 420nm.	White light filter #1 blocks UV below 420nm. UV/Blue light filter blocks below 495nm. Considerably less UV/Blue light output than D.O.R.C., deemed safer.	Yes (and improved safety)
IR Light Output	Unfiltered ILC lamp produces ~60% power in harmful IR range. Internal IR filter crucial.	White light filter #1 blocks IR above 700nm. Less IR output with other filters. Designed to eliminate IR above 700nm.	Yes (and improved safety)

Study Details (Substantial Equivalence Comparison)

The "study" presented here is a comparison against a predicate device to establish substantial equivalence under the 510(k) pathway, not a traditional clinical trial or performance study with acceptance criteria in the sense of predefined statistical thresholds for device accuracy or efficacy.

Sample Size used for the test set and the data provenance:
- Test Set: No explicit "test set" in the sense of patient data is used. The comparison is between the Synergetics Synerlight Fiber Optic Lightsource (new device) and the D.O.R.C. Xenon Illumination System (predicate device).
- Data Provenance: The data appears to be a mix of manufacturer specifications (for both devices) and internal testing conducted by Tayman Medical (for D.O.R.C.'s visible light output) and Synergetics (for its own device's power output and IR output). It is a retrospective analysis and comparison of device specifications and internal lab measurements. The country of origin of the data is not specified beyond the manufacturers' locations (USA for Tayman Medical/Synergetics, and USA for D.O.R.C.).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of expert evaluation is not mentioned or relevant for a 510(k) substantial equivalence submission, which relies on objective device specifications and comparative measurements rather than expert clinical judgment on individual cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no expert adjudication of imaging or clinical findings. The comparison is based on technical specifications and measured output.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a light source for surgery, not an AI or imaging diagnostic tool. An MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device's "standalone" performance is described through its technical specifications and measured outputs as compared to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the technical specifications and measured performance of the predicate device, as stated in its own documentation or measured by the applicant, and established industry standards for medical device safety (e.g., phototoxicity concerns regarding UV and IR light). The goal is to show the new device is as safe and effective, or safer/more effective where justified and controlled (e.g., reduced UV/IR output, higher controlled visible light).
The sample size for the training set:
- Not applicable. This device is not developed using machine learning, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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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 inintended use, safety and effectiveness and construction to theDutch Ophthalmic, USA Xenon Illumination System catalognumber 1266-X manufactured by Dutch Ophthalmic, USA(D.O.R.C.) located at Two Marshall Road, Kingston NH03848. Telephone number (800) 753-8824.
Device Description:	The Synergetics lightsource is a stand alone arc-lamp basedlightsource that incorporates a standard connector mount usedby 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 useduring anterior and posterior vitreoretinal surgery to illuminatethe eye.

Clinical and Non-Clinical Similarities and Differences

PredicateD.O.R.C. Lightsource	NewSynergetics, Inc. Lightsource	Safety and EffectivenessInformation
The D.O.R.C. Inc. Fiber OpticLightsource is indicated for useduring anterior and posteriorvitreoretinal surgery to illuminate theeye.	The Tayman Fiber Optic Lightsourceis indicated for use during anterior andposterior vitreoretinal surgery toilluminate the eye.	There are no differencesin regards to safety andeffectiveness.
Filter Selection Knob - The filterselection knob is detented and turnsan internal filter wheel that allowsthe user to select from up to sixdifferent accessory filters.	Filter Selection Knob - The filterselection knob is detented and turns aninternal filter wheel that allows theuser to select from up to six differentaccessory filters.	There are no differencesin regards to safety andeffectiveness.

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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.

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 lightsource 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.

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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.

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Visible Light Output

The D.O.R.C. lightsource produces "white 56000K 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.

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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 eve. 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..

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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 filters 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 vitreo-retinal illumination to be potentially dangerous to the eye. Therefore the Synergetics lightsource has been designed to eliminate the IR light above 700nm.

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Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

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.

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

A. Ralph Rosenthal, M.D.

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K964005

华

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)

Quyph Hoang

(Division Sign-Off)

Division of Ophthalmic Devices
510(k) Number K964405

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.