(275 days)
Not Found
Not Found
No
The device description and intended use do not mention any AI or ML capabilities. The device is described as a simple light source with basic controls.
No
The device is indicated for use during surgery to illuminate the eye, which is a supportive function rather than a direct therapeutic intervention.
No
Explanation: The device is a light source used for illumination during surgery, not for diagnosing a condition. Its purpose is to provide light for visualization, not to detect, identify, or monitor a disease or condition.
No
The device description explicitly states it is a "stand alone arc-lamp based lightsource," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "illuminate the eye" during surgery. This is a direct interaction with the patient's body for a surgical procedure, not for testing samples in vitro (outside the body).
- Device Description: The description details a light source for surgical illumination, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for surgical visualization.
N/A
Intended Use / Indications for Use
The Synergetics Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.
Product codes (comma separated list FDA assigned to the subject device)
86 MPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Dutch Ophthalmic, USA Xenon Illumination System catalog number 1266-X manufactured by Dutch Ophthalmic, USA (D.O.R.C.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
- Telephone number (800) 753-8824. |
| 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 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.
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 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.
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 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..
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 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.
6
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.
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 (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
8
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)