(81 days)
No
The description focuses on the device's function as an air exchange line and accessory to existing microsurgical systems, with no mention of AI or ML capabilities.
No
The device is described as an accessory that provides a pathway for air into the eye during surgery; it does not directly treat or cure a condition.
No
The device is described as an accessory for air and fluid exchange during surgical procedures, routing air into the eye, and does not mention any diagnostic function.
No
The device description explicitly states it is an "Air Exchange Line" and provides a "pathway through which air...is routed," indicating a physical, hardware component.
Based on the provided information, the Storz D4600 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Storz D4600 is used during surgical procedures to introduce air into the eye. It does not analyze or test any biological samples.
- The intended use clearly describes a surgical accessory. The description focuses on its role in air and fluid exchange within the eye during surgery, not on diagnostic testing of a sample.
Therefore, the Storz D4600 is a surgical device accessory, not an IVD.
N/A
Intended Use / Indications for Use
The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
Product codes
HQC
Device Description
The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
The device is provided sterile via Gamma Irradiation, for single patient use, and packaged singly in Tyvek® and PET/PE Pouch, with ten pouches per box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior chamber 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)
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 modern look. There is a registered trademark symbol to the right of the word. The background is a rounded rectangle.
AUG 23 1996
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: Regulatory Affairs Associate
Date Prepared: May 31, 1996
Proprietary Name: Storz D4600 Air Exchange Line Pack.
Common/Usual Name: Ophthalmic surgical system accessory pack for posterior segment procedures.
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
Predicate Device: The proposed Storz D4600 Air Exchange Line Pack is substantially equivalent to the existing Storz D4600 Air Exchange Line Pack (K894278), and to the International, Inc. TR-9006-11 Air Delivery Tubing System (K832761).
Predicate Comparison: A chart comparing the Storz D4600 to the predicate devices, demonstrating substantial equivalence, is attached.
Submitted by:
Audrey Swearingen
Audrey Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051
A . 2 . 112
1
DEVICE COMPARISON CHART
Storz D4600 Air Exchange Line Pack
| Device | Storz D4600,
modified | Storz D4600,
existing | Intek International
TR9006-11 |
|-----------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | To deliver air to the eye
during posterior
ophthalmic surgical
procedures | To deliver air to the eye
during posterior
ophthalmic surgical
procedures | To deliver air to the eye
during ophthalmic
surgical procedures |
| Recommended
System | Storz PREMIERE® or
Storz Daisy™
Microsurgical Systems | Storz PREMIERE® or
Storz Daisy™
Microsurgical Systems | Escalon™ CFAE-40
Air/Fluid Exchange
Pump |
| Instructions For Use
Included? | Yes | No | Unknown |
| Single Patient Use? | Yes | Yes | Yes |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Unknown |
| Packaging | Singly in Tyvek® and
PET/PE Pouch,
Ten pouches per Box | Singly in Tyvek® and
PET/PE Pouch,
Ten pouches per Box | Unknown package type,
Ten units per Box |