(76 days)
No
The device description and intended use describe a standard irrigation administration tube set that uses air pressure for fluid delivery, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an "accessory" used for maintaining intraocular pressure during surgical procedures, not for treating a condition itself. It facilitates a medical procedure rather than having a direct therapeutic effect.
No.
The document states that the device is used in the "maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures" and as an "irrigation administration tube set." Its function is to deliver irrigation fluid at a user-selected rate, not to diagnose a condition.
No
The device description clearly states it is a "standard irrigation administration tube set with an additional line" and connects to a "microsurgical system console," indicating it is a hardware accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain intraocular pressure during anterior segment ophthalmic surgical procedures. This is a surgical accessory used during a procedure on a patient, not for testing samples in vitro (outside the body).
- Device Description: The device is described as an irrigation administration tube set that delivers fluid during surgery. This aligns with a surgical accessory, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
Therefore, the Storz DP4600 surgical accessory pack, specifically the Anterior Intraocular Pressure (IOP) Tube Set Assembly, is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Storz DP4600 is a standard irrigation administration tube set with an additional line that connects the irrigation bottle to an air port on the microsurgical system console. Controlled positive air pressure from the system pressurizes the irrigation bottle and delivers the irrigation fluid at the user-selected rate.
Product codes
HQC
Device Description
The Storz DP4600 surgical accessory pack contains an Anterior Intraocular Pressure (IOP) Tube Set Assembly. This component is to be used as an accessory to the Storz PREMIERE® (K894278. K921460, and K946227) and Storz DAISY™ (K854508) Microsurgical Systems in the maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior segment 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)
K894278, K921460, K946227, K854508
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 logo for "storz" in white text on a black background. The logo is in a rectangular shape with rounded corners. There is a registered trademark symbol to the right of the logo.
K961820 JUL 25 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 9, 1996
Proprietary Name: Storz DP4600 Anterior Intraocular Pressure Control Pack.
Common/Usual Name: Ophthalmic microsurgical system accessory pack for anterior intraocular pressure (IOP) control.
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz DP4600 surgical accessory pack contains an Anterior Intraocular Pressure (IOP) Tube Set Assembly. This component is to be used as an accessory to the Storz PREMIERE® (K894278. K921460, and K946227) and Storz DAISY™ (K854508) Microsurgical Systems in the maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures. The DP4600 is a standard irrigation administration tube set with an additional line that connects the irrigation bottle to an air port on the microsurgical system console. Controlled positive air pressure from the system pressurizes the irrigation bottle and delivers the irrigation fluid at the user-selected rate.
Predicate Devices: The proposed Storz DP4600 Anterior Intraocular Pressure Control Pack is substantially equivalent to the existing Storz DP4600 IOP Control Pack (K894278) and to the Storz DP4101 Basic I/A Pack (K953078).
Predicate Comparison: A chart comparing the proposed Storz DP4600 to the predicate devices, demonstrating substantial equivalence, is attached,
Submitted by:
Audrey Swearingen
Audrey Swearingen Storz Instrument Company
STORZ' 3365 Tree Court Industrial Blvd St. Louis, MO 63121 6694 (314) 225 505 : FAX (314) 2014 1315
1
DEVICE COMPARISON CHART
Storz DP4600 Intraocular Pressure Control Pack
| Device | Storz DP4600, modified | Storz DP4600, existing | Storz DP4101 Basic I/A Pack |
|---|---|---|---|
| Intended Use | Controlled Delivery of Irrigation | ||
| Solution during Anterior | |||
| Segment Ophthalmic Surgery | Controlled Delivery of Irrigation | ||
| Solution during Anterior | |||
| Segment Ophthalmic Surgery | Controlled Delivery of Irrigation | ||
| Solution and Removal of | |||
| Aspirant during Anterior | |||
| Segment Ophthalmic Surgery | |||
| Components | IOP Tube Set, with irrigation | ||
| administration line and filtered | |||
| air line, and Instruction Sheet | IOP Tube Set, with irrigation | ||
| administration line and filtered | |||
| air line, and Instruction Sheet | Irrigation/Aspiration (I/A) | ||
| Tubing, I/A Test Chamber, | |||
| Collection Cassette, and | |||
| Instruction Sheet | |||
| Manual Adjustment of | |||
| Flow? | Yes | Yes | Yes |
| Flow Control Variable | Irrigation Reservoir Pressure | Irrigation Reservoir Pressure | Irrigation Reservoir Height |
| Single Patient Use? | Yes | Yes | Yes |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Singly in Tyvek® / PET Pouch, | ||
| Ten pouches per Box | High-impact Polystyrene Tray | ||
| with Tyvek® Lid, | |||
| Six Trays per Box | High-impact Polystyrene Tray | ||
| with Tyvek® Lid, | |||
| Six Trays per Box |
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