(26 days)
No
The summary describes a simple fiber optic cable for illumination during surgery and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used for illumination during surgery to improve visualization, not to treat, mitigate, or cure a disease or condition.
No
Explanation: The device is described as illuminating the eye for improved visualization during surgery, which is a therapeutic or assistive function, not a diagnostic one. It aids in performing a procedure rather than identifying a condition or disease.
No
The device description explicitly lists physical components (handpiece tube, fiberoptic cable, sheath, 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 with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery." This is a surgical tool used in vivo (within the living body) to aid in a medical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such testing on biological samples.
- Device Description: The description details components of a surgical illumination tool, not a diagnostic test kit or instrument.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Syntec, Inc. Disposable Bare End Fiber is a surgical illumination device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Syntec, Inc. Disposable Bare End Fiber is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery.
Product codes
86MPA
Device Description
The Bare End Fiber is comprised of five basic components: 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K971338: Grieshaber Disposable Monofilament catalog number 630.78 manufactured by Grieshaber & Co., Inc.
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
K971338
,
. •
MAY - 6 1997
র মাধ্যম
Section 9 - Summary of Safety and Effectiveness
| Date of Preparation: | March 15, 1997 |
|---|---|
| Device Name: | Syntec, Inc. Disposable Bare End Fiber |
| 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 Monofilament catalog |
| number 630.78 manufactured by Grieshaber & Co., | |
| Inc. located at 1945 Vaughn Road, Kennesaw, GA |
-
|
| Device Description: | The Bare End Fiber is comprised of five basic
components: the handpiece tube, the fiberoptic
cable, the fiber optic cable sheath and the connector. |
| Intended Use: | The Syntec, Inc. Disposable Bare End Fiber 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. Disposable Bare End Fiber and the
Grieshaber & Co. Disposable Monofilament are
substantially equivalent since they both are used 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 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. |
·
:
1
The device is biocompatable 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 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.