(77 days)
Not Found
No
The summary describes a simple illuminating and irrigating device with no mention of AI/ML, image processing, or data analysis.
No.
The device is used for illumination and irrigation during surgery, which are supportive functions for the surgical procedure itself, not direct therapeutic interventions.
No
The device is used to illuminate and irrigate the eye during surgery for improved visualization, not to diagnose a condition.
No
The device description explicitly lists physical components (handpiece tube, fiberoptic handle, fiber optic cable sheath, cable connector), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Syntec, Inc. True Light End Irrigating Endoilluminator is a surgical tool used during surgery to illuminate and irrigate the inside of the eye. It is used directly on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "illuminat[ing]... the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery." This is a surgical aid, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to irrigate tissue, during vitreo-retinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
86MPA
Device Description
The End Irrigating Endoilluminator comprises of five basic components. The handpiece The handpiece tube. The fiberoptic handle. The fiber optic cable sheath and the cable. connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraocular portion of the 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.
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.
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Nov. 13 1997 05:08PM P2 K973293
1
Section 9 - Summary of Safety and Effectiveness 00 | 8 |997
8/10/1997 Date of Preparation:
Syntec, Inc. True Light End Irrigating Device Name: Endoilluminator.
Opthamalic Endoilluminator, 86MPA Classification Name:
Syntec, Inc. is located at 733 Mansion Road, Manufacturer: Telephone (314) 566-6500 and Winfield, MO 63389. Fax number is (314) 566-6535
Syntec, Inc. is located at 812 Truman Blvd. 510(k) Submitter: Crystal City, MO Telephone (314) 931-2204 63389. and Fax number is (314) 931-6029.
Nathan H. Lewis Contact Person:
This device is substantially equivalent to the Predicate Device: Grieshaber Disposable End Irrigating Light Pipe catalog numbers 630.02G and 631.02 20G manufactured by Grieshaber & Co. Inc. located at 1945 Vaughn Road, Kennesaw, GA 30144. This device was the subject of Premarket Notification K884043.
- The End Irrigating Endoilluminator Device Description: comprises of five basic components. The handpiece The handpiece tube. The fiberoptic handle. The fiber optic cable sheath and the cable. connector .
- Intended Use: The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to irrigate tissue, during vitreo-retinal surgery.
Clinical and Non-Clinical Similarities and Differences:
The Syntec Inc. True Light End Irrigating Endoilluminator six basic components: the handpiece tube, the fiberoptic cable, the fiber optic cable sheath, the light source connector, and the irrigant connection.
The Syntec Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
The Syntec, Inc. True Light End Irrigating Endoilluminator and the Grieshaber Disposable End Irrigating Light Pipe are
1
2
both substantially equivalent in that they are used for the same clinical purpose, ie: to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
The devices are of a similar design and are made using the same materials except for the zinc connector used with the Syntec design. The handpiece tube is made of surgical grade stainless steel. The fiberoptic cable is made with a polystyrene core and a polymethylmethacrylate cladding. The fiber optic cable sheath is made of PVC tubing.
The device is biocompatible with the body tissue and fluids that it contacts as it is made of the same materials as the predicate device. These materials meet US Pharmacopoeia Class VI criteria and are widely used in many other medical products. The device is sterilized using ethylene oxide gas which is then validated by the overkill method.
The light output intensity and spot size is the same as the predicate device. The only device differences are cosmetic.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
Mr. Vaughan Weeks 7346 West River Rd. Caledonia, WI 53108
Re: K973293
Trade Name: Syntec, Inc., True Light End Irrigating Endoilluminator Regulatory Class: II Product Code: 86 MPA Dated: September 2, 1997 Received: September 2, 1997
Dear Mr. Weeks:
We have reviewed your Section 510(k) notification of intent to market the device referenced Gbove 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 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 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. Weeks
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Roerl. firenthal
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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Section 8 - Indications for Use Statement
510(k) Number(if known): __ K 97329 3
Syntec, Inc., True Light End Irrigating Device Name: Endoilluminator
The Syntec, Inc. True Light End Irrigating Indications for Use: Endoilluminator is used to illuminate with visible spectrum light the intra ocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Ja C. Callaway
(Division Sign-Off)
Division of Ophthalmic Devices K773297 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
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