(258 days)
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Not Found
No
The description focuses on the mechanical and pneumatic operation of the device, with no mention of AI or ML capabilities.
Yes
The device is used to cut intraocular tissue during ophthalmic surgical procedures, which is a therapeutic intervention.
No
The device is described as a surgical tool used to cut intraocular tissue, not to diagnose a condition.
No
The device description clearly states it is a reusable, electrically powered, pneumatic handpiece with mechanical components (piston, blades, manual over-ride lever) and connects to other hardware systems. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Storz D7108 Microscissors Handpiece is a surgical tool used directly on tissue inside the body (in vivo) during ophthalmic surgery. It cuts tissue, it doesn't analyze specimens.
The description clearly states its use is to "cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures." This is a surgical instrument, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.
Product codes
HOE
Device Description
The Storz D7108 Microscissors Handpiece is a reusable, electrically powered, pneumatic handpiece that is used to operate a variety of detachable microscissors. A selected microscissors attachment screws on to the tip of the D7108 Microscissors Handpiece The D7108 handpiece attaches to the Storz D7106 Microscissors Drive Tube, which in turn connects to the Storz PREMIERE® or the Storz DAISY™ Ophthalmic Microsurgical System. As the "Scissors" function of the microsurgical system is activated, the piston inside the D7108 handpiece is driven forward and backward by air pressure, causing the blades of the attached microscissors to open and close rapidly. The handpiece also has a manual over-ride lever near the tip of the handpiece that allows the physician to manually operate the scissors without requiring external power.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
posterior segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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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)
Escalon™ Trek Medical Vertical Automated Scissors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/0 description: The image is a logo for "storz" in a black box with rounded corners. The word "storz" is written in white, block letters. There is a registered trademark symbol in the upper right corner of the box.
K96006
Premarket Notification 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: Audrey Swearingen, Regulatory Affairs Associate
January 3, 1996 Date Prepared:
Proprietary Names: Storz D7108 Microscissors Handpiece and Storz D7106 Microscissors Drive Tube.
Microscissors handpiece and drive tube Common/Usual Names:
Vitreous aspiration and cutting instrument, AC-powered, (86HOE), Classification Name:
Device Description/Interided Use: The Storz D7108 Microscissors Handpiece is a reusable, electrically powered, pneumatic handpiece that is used to operate a variety of detachable microscissors. A selected microscissors attachment screws on to the tip of the D7108 Microscissors Handpiece The D7108 handpiece attaches to the Storz D7106 Microscissors Drive Tube, which in turn connects to the Storz PREMIERE® or the Storz DAISY™ Ophthalmic Microsurgical System. As the "Scissors" function of the microsurgical system is activated, the piston inside the D7108 handpiece is driven forward and backward by air pressure, causing the blades of the attached microscissors to open and close rapidly. The handpiece also has a manual over-ride lever near the tip of the handpiece that allows the physician to manually operate the scissors without requiring external power.
The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.
The Storz D7108 Microscissors Handpiece and D7106 Microscissors Predicate Device: Drive Tube, as used together, are substantially equivalent to the Escalon™ Trek Medical Vertical Automated Scissors.
Predicate Comparison: A chart comparing the Storz D7108 and D7106 to the predicate device, demonstration substantial equivalence, is attached.
1
Submittted By:
Audrey Swearingen
Audrey Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Phone: 314/225-5051
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Storz D7108 Microscissors Handpiece / Storz D7106 Microscissors Drive Tube
DEVICE COMPARISON CHART
| Device Characteristic | Storz D7108 and D7106 | Escalon™ Trek Medical
Vertical Automated Scissors |
|------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Intended Use | To be attached to
microscissors for cutting of
posterior intraocular tissue. | Cutting of posterior
intraocular tissue. |
| Components | D7108 Microscissor
Handpiece and D7106
Microscissor Drive Tube | Microscissor handpiece,
microscissors, and drive tube. |
| Recommended Microsurgical
System | Storz PREMIERE® and
Storz DAISY™ | Storz PREMIERE®, Alcon
STTO VM™, MVS XII™,
and MVS XX™ |
| Compatible with single and
multi cut modes? | Yes | Yes |
| Reusable? | Yes | Yes |
| Manual operation capability? | Yes | Unknown |
:
:
3 G