Who is the manufacturer of VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

Vitrotec, Inc. filed the 510(k) submission for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) (K964555).

What is the FDA product code for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

MPA. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)

K964555 · Vitrotec, Inc. · MPA · Mar 31, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K964555
Device Name	VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
Applicant	Vitrotec, Inc.
Product Code	MPA · Gastroenterology, Urology
Decision Date	Mar 31, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The Syntec, Inc. Disposable Endo Illuminators is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery.

Device Story

Device: Tru Light Endo Illuminator; fiberoptic instrument for intraocular illumination during vitreo-retinal surgery. Components: handpiece handle, tube, fiberoptic cable, cable sheath, connector. Operation: transmits visible spectrum light into eye to improve visualization for surgeon. Used in OR setting by ophthalmologists. Benefits: enhanced surgical field visibility. Materials: Delrin handle, surgical grade stainless steel tube, polystyrene core/polymethylmethacrylate cladding fiber, PVC sheath, 6063 aluminum connector. Sterilization: ethylene oxide (overkill method).

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through material composition, design, and performance specifications (light intensity/spot size) matching the predicate.

Technological Characteristics

Materials: Delrin (handle), surgical grade stainless steel (tube), polystyrene core/polymethylmethacrylate cladding (fiber), PVC (sheath), 6063 aluminum (connector). Biocompatibility: USP Class VI. Sterilization: Ethylene oxide (overkill method).

Indications for Use

Indicated for patients undergoing vitreo-retinal surgery requiring intraocular illumination.

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.

Predicate Devices

Grieshaber Disposable Standard Micro Lite Pipe catalog numbers 630.77 20G and 631.77 20G

Related Devices

K971338 — SYNTEC, INC. DISPOSABLE BARE END FIBER · Syntec, Inc. · May 6, 1997
K973293 — SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR · Vaughan Weeks · Nov 18, 1997
K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) · American Medical Devices, Inc. · Jun 24, 1997
K970875 — ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) · American Medical Devices, Inc. · May 20, 1997
K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES · Katalyst Surgical, LLC · Sep 15, 2014

Submission Summary (Full Text)

{0} K964555 # Section 9 - Summary of Safety and Effectiveness MAR 31 1997 Date of Preparation: March 11, 1997 Device Name: Syntec, Inc. Tru Light Endo Illuminator Classification Name: Ophthalmic Endoilluminator, 86MPA Manufacturer: Syntec, Inc. is located at 812 Truman Blvd. Crystal City, MO 63019. The phone number is (314) 931-2204 and the fax number is (314) 931-6029. 510(k) Submitter: Syntec, Inc. is located at 812 Truman Blvd. Crystal City, MO 63019. The phone number is (314) 931-2204 and the fax number is (314) 931-6029. Contact person: Nathan H. Lewis Predicate Device: Grieshaber Disposable Standard Micro Lite Pipe catalog numbers 630.77 20G and 631.77 20G manufactured by Grieshaber & Co. Inc. located at 1945 Vaughn Road, Kennesaw, GA 30144. Device Description: The Endo Illuminator is comprised of five basic components. The handpiece handle. The handpiece tube. The fiberoptic cable. The fiber optic cable sheath and the connector. Intended Use: The Syntec, Inc. Disposable Endo Illuminators is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery. Clinical and Non-Clinical Similarities and Differences: The Syntec, Inc. Tru Light Endoilluminator and the Grieshaber & Co. Disposable Standered Light Pipe are substantially equivalent since they both are used to for the same clinical purpose, ie: to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery. Both devices are of a similar design and are made using the exact same materials. The handpiece handle is made of Delrin, 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 and the connector is made of 6063 aluminum. The device is biocompatible with the body tissue and fluids that it comes in contact with 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 {1} 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.