(138 days)
630.77 20G, 631.77 20G
Not Found
No
The device description and intended use are purely focused on a light source for surgical visualization, with no mention of any computational or analytical capabilities.
No
The device is used for illumination during surgery to improve visualization, not for treating a disease or condition.
No
The device is described as an illuminator used to provide visible spectrum light for improved visualization during surgery, not to diagnose a condition.
No
The device description clearly lists physical components (handpiece handle, handpiece tube, fiberoptic cable, fiber optic cable sheath, and 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:
- Intended Use: The intended use is to illuminate the intraocular portion of the eye during surgery for improved visualization. This is a direct interaction with the patient's body for a surgical procedure.
- Device Description: The description details components of a surgical tool used for illumination.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a surgical tool used for visualization during a procedure.
N/A
Intended Use / Indications for Use
The Syntec, Inc. Disposable Endo Illuminators is used to illuminate with visible spectrum light the intraocuiar portion of the eye for improved visualization during vitreo-retinal surgery.
Product codes
MPA
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.
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)
Grieshaber Disposable Standard Micro Lite Pipe catalog numbers 630.77 20G and 631.77 20G
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K9644555
Section 9 - Summary of Safety and Effectiveness
| 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 |
- 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 - 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 intraocuiar 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 Standard 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 the predicate device. These materials
meet US Pharmacopoeia Class VI criteria and are widely
used in many other medical products. The device is |
MAR 3 1 1997
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 differrences are cosmetic.