(85 days)
No
The description focuses on the device's function as an irrigation fluid pathway accessory and does not mention any AI/ML capabilities or related concepts like image processing, training/test sets, or performance metrics associated with AI/ML.
No
The device is described as an accessory that delivers irrigation fluid and does not directly provide therapeutic action.
No
The device is described as an accessory for delivering irrigation fluid during ophthalmic surgical procedures. This function is supportive for surgical procedures and does not involve diagnosing a medical condition.
No
The device description explicitly states it is a "pathway for delivery of irrigation fluid," which indicates a physical component for fluid transfer, not solely software.
Based on the provided information, the Storz DP5200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used as an accessory to deliver irrigation fluid during ophthalmic surgical procedures. This is a surgical device used in vivo (within a living organism), not in vitro (outside of a living organism, typically on biological samples).
- Device Description: The description reiterates its function in delivering irrigation fluid during surgery.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any other activities typically associated with IVD devices.
Therefore, the Storz DP5200 is a surgical accessory, not an IVD.
N/A
Intended Use / Indications for Use
The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
Product codes
HQC
Device Description
The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic
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)
K854508, K921758, K950114, K894278, K921460, K946227
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 against a black background. The letters are bold and sans-serif. The background is a rounded rectangle.
AUG 6 1998
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 9, 1996
Proprietary Name: Storz DP5200 Irrigation Administration Set Pack,
Common/Usual Name: Microsurgical system accessory pack for delivery of irrigation fluid during ophthalmic surgical procedures.
Classification Name: System, Phacofragmentation (86 HQC),
Device Description/Intended Use: The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
Predicate Devices: The modified Storz DP5200 is substantially equivalent to the Storz existing DP5200 Ambulatory Surgery Center (ASC) Irrigation Administration Set Pack (K894278, K921758) and to the Storz DP4310 Deluxe Phaco Pack (K955901).
Predicate Comparison: A chart comparing the Storz DP5200 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
Contrologion 18 12 St Loss MOn 31.1148 :
1
DEVICE COMPARISON CHART
سمي
Storz DP5200 Irrigation Administration Set Pack
ﺴﺖ
| Device | Storz DP5200,
modified | Storz DP5200,
existing | Storz DP4310 |
|------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Delivery of Irrigation Fluid
during Ophthalmic Surgical
Procedures | Delivery of Irrigation Fluid
during Ophthalmic Surgical
Procedures | Delivery of Irrigation Fluid and
Removal of Aspirant during
Ophthalmic Surgical Procedures |
| Pack Components | Irrigation Administration Set,
Instruction Sheet | Irrigation Administration Set | Irrigation Administration Set, I/A
Tubing, I/A test Chamber, Tube
Stopper, Irrigation Sleeve,
Collection Cassette, Mayo Arm
Drape, Auxillary Drape, Needle
Wrench, Luer cap, Instruction
Sheet |
| Recommended
Systems | Storz Protegé®, PREMIERE®,
and DAISY® Microsurgical
Systems | Storz Protegé®, PREMIERE®,
and DAISY® Microsurgical
Systems | Storz Protegé®, PREMIERE®,
and DAISY® Microsurgical
Systems |
| Single Patient Use? | Yes | Yes | Yes |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Tyvek® and PET/PE Pouch | Tyvek® and PET/PE Pouch | High impact Polystyrene Tray with
Tyvek Lid |