(240 days)
Not Found
No
The device is a simple mechanical accessory (a grip extension) and the summary contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The Storz device is described solely as an accessory providing a grip extension for a surgical instrument, and it does not affect the functioning of the cutter or provide any therapeutic effect itself.
No
The device is described as a "snap-on grip extension" accessory for a vitrectomy cutter, intended to facilitate manipulation of the instrument. It explicitly states that it "does not affect the functioning of the cutter." Its purpose is to aid in the physical handling of another surgical tool, not to provide information for diagnosis.
No
The device description explicitly states it is a "snap-on grip extension," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to a surgical instrument (vitrectomy cutter) to facilitate manipulation. It does not mention analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Device Description: The description reinforces that it's a grip extension for a surgical tool and does not affect the cutter's function. There is no mention of any diagnostic capabilities.
- Lack of IVD Characteristics: The document lacks any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Providing diagnostic results.
- Mention of reagents, assays, or analytical methods.
Therefore, the Storz device described is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument.
Product codes
SeHOC
Device Description
The Storz D7116 does not affect the functioning of the cutter. A drawing of the the D7116 and a drawing of the cutter are attached as Exhibits 1 and 2 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and have a rounded appearance. There is a registered trademark symbol in the upper right corner of the image. The background is a rounded rectangle.
Premarket Notification AUG 2 9 1996 STORZ Instrument Company
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Manager, Requlatory Affairs
Date Prepared: December 28, 1995
Proprietary Names: STORZ D7116 Microvit® Vitrectomy Cutter Extension,
Common/Usual Name: Ophthalmic surgical system accessory grip extension for vitrectomy cutter.
Classification Name: Instrument, vitreous cutting and aspirating, AC powered (SeHOC).
Device Description/Intended Use: The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument. The D7116 does not affect the functioning of the cutter. A drawing of the the D7116 and a drawing of the cutter are attached as Exhibits 1 and 2 respectively.
Predicate Device: The Storz D7116 is substantially equivalent to a Storz MVS-3201 Vitrectomy Probe Pack (K953575).
Predicate Comparison: A chart comparing the Storz D7116 to the predicate device, demonstrating substantial equivalence, is attached.
Submitted by:
Will H. Little
Michael H. Southworth Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis. MO 63122 Ph. 314/225-5051
STORZ 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694 1314) 225-5051 FAX (314) 225-7365
1
DEVICE COMPARISON CHART
| Device
Characteristic | Storz MVS-3201
Vitrectomy Probe | Vitrectomy Probe With
D7116 Extension |
|-----------------------------------|----------------------------------------------|----------------------------------------------|
| Rear Aspect Annular
Grip? | Yes | Yes |
| Indication for Use | Vitrectomy, Surgeon's
Preferred Technique | Vitrectomy, Surgeon's
Preferred Technique |
| Alterations to Probe
Required? | No | No |