(90 days)
No
The device description and intended use clearly define the device as a collection of surgical accessories (drapes, tubes, cassettes, etc.) used in conjunction with existing phacoemulsification systems. There is no mention of any software, algorithms, or data processing capabilities that would indicate the presence of AI or ML.
Yes
The device is used in phacoemulsification, a surgical procedure to treat cataracts, which directly addresses a medical condition.
No
The device is a surgical accessory pack used in phacoemulsification, a procedure for removing cataracts, not for diagnosing a condition.
No
The device description explicitly lists multiple physical components such as drapes, tubes, cassettes, and other accessories, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical accessory pack used in conjunction with microsurgical systems for phacoemulsification, a surgical procedure to remove cataracts from the eye. This is an in vivo procedure (performed on a living organism), not an in vitro diagnostic test (performed outside the body on samples).
- Device Description: The components listed are all accessories used during a surgical procedure (drapes, tubing, collection cassette, etc.). None of these components are designed for testing biological samples to diagnose or monitor a medical condition.
- Lack of IVD Indicators: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information.
Therefore, the STORZ DP4310 surgical accessory pack is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven ultrasonic handpiece which 1) emulsifies the lens; 2) facilitates the irrigation of the anterior chamber; and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eye. The Storz DP4310 Pack provides the accessories necessary to enable use of the Storz Phacoemulsification Handpieces (K935926) with the above Storz microsurgical systems.
Product codes
86 HQC
Device Description
The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K934445, K953078, K921758, K950114, K894278, K921460, K946227, K854508, K935926
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/0 description: The image shows the "storz" logo. The logo is white text on a black background. The "R" in a circle is in the upper right corner of the logo.
MAR 28 1965
K9559ci
Premarket Notification Storz Instrument Company
510(k) SUMMARY OF SAFETY AND EFFICACY
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Audrey Swearingen, Regulatory Affairs Associate
Date Prepared: December 28, 1995
Proprietary Name: STORZ DP4310 Deluxe Phaco Pack Without Reflux.
Common/Usual Name: Ophthalmic surgical system accessory pack for phacoemulsification.
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven ultrasonic handpiece which 1) emulsifies the lens; 2) facilitates the irrigation of the anterior chamber; and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eye. The Storz DP4310 Pack provides the accessories necessary to enable use of the Storz Phacoemulsification Handpieces (K935926) with the above Storz microsurgical systems.
Predicate Device: The Storz DP4310 is substantially equivalent to the Storz Universal I/A and Phacoemulsification Pack (K882240).
Predicate Comparison: A chart comparing the Storz DP4310 Deluxe Phaco Pack
STORZ 3365 Tree Court Industrial Blvd. St. Louis MO 6 1122-6694 37.41 205 ----------Telex 981:01 STORZ STORZ STI AX (314) . 1 : 3 : 365
1
Without Reflux to the predicate device, 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
2
DEVICE COMPARISON CHART
| DEVICE
CHARACTERISTIC | STORZ DP4310 | STORZ UNIVERSAL I/A
PACK |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Pack Contents | Aux drape, Arm Drape,
Collection Cassette, I/A
Tubing, Test Chambers,
Infusion Sleeves, Stopper,
Cap, Wrench | Collection Cassette, I/A
Tubing, Test Chamber |
| Indication for Use | Irrigation/Aspiration and
Phacoemulsification | Irrigation/Aspiration and
Phacoemulsification |
| Applicable
Ophthalmic
Microsurgical
System | Storz DAISY®, PREMIERE®,
and Protegé® Systems | Storz DAISY®, PREMIERE®
and Protegé® Systems |
| Patient Contact
Material | Medical Grade Silicone | None |
| Instructions for Use
Included in Each
Pack? | YES | YES |
| Labeled Per 21CFR
§801.109? | YES | YES |
| Labeled For Single
Patient Use? | YES | NO |
| Provided Sterile? | YES | NO |
| Packaging | PETG Tray with TYVEK Lid | Polybag |
)
ﻣﺴﺘﻌ