(83 days)
No
The device description and intended use clearly state that the device is a collection cassette for aspirated fluid and tissue, acting as a reservoir. There is no mention of any computational processing, algorithms, or learning capabilities.
No
The device is an accessory (a collection cassette) for ophthalmic microsurgical systems, designed to collect aspirated fluid and tissue, not to treat a medical condition itself.
No
The device description clearly states its purpose is "as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures," indicating it is used for collection during surgery, not for diagnosis.
No
The device description explicitly states it is a "collection cassette," which is a physical component intended to collect fluid and tissue. This is a hardware accessory, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect aspirated fluid and tissue during surgical procedures. This is a collection device used within the surgical process itself, not for analyzing samples outside the body to diagnose a condition.
- Device Description: The description reinforces its role as a reservoir for collected material during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on biological specimens, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely for collection during a surgical procedure.
N/A
Intended Use / Indications for Use
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
Product codes
HQC
Device Description
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected 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)
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 on a black background. The letters are stylized and have a rounded appearance. There is a registered trademark symbol to the right of the word. The background is a rounded rectangle.
UG 6 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 DP5100 Anterior Collection Cassettte Pack
Common/Usual Name: Ophthalmic microsurgical system accessory pack for anterior segment surgical procedures.
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
Predicate Device: The modified Storz DP5100 is substantially equivalent to the existing Storz DP5100 Ambulatory Surgery Center (ASC) Collection Cassette Pack (K894278, K921758), and to the Storz DP4101 Basic Irrigation / Aspiration Pack (K953078).
Predicate Comparison: A chart comparing the Storz DP5100, as modified, to the predicate devices, demonstrating substantial equivalence, is attached,
Submitted by:
Lindsey Swearingen
Audrey Swearingen Storz Instrument Company
STORZ * 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694 (314) 225-5051 FAX (314) 225-7365
1
DEVICE COMPARISON CHART
Storz DP5100 Anterior Collection Cassette Pack
| Device | Storz DP5100, modified | Storz DP5100, existing | Storz DP4101 |
|---|---|---|---|
| Intended Use | Collection of Aspirant during | ||
| Anterior Segment Ophthalmic | |||
| Surgery | Collection of Aspirant during | ||
| Anterior Segment Ophthalmic | |||
| Surgery | Delivery of Irrigant and | ||
| Collection of Aspirant during | |||
| Anterior Segment Opthalmic | |||
| Surgery | |||
| Components | Anterior Collection Cassette, | ||
| Instruction Sheet | Anterior Collection Cassette | I/A Tubing, Test Chamber, | |
| Anterior Collection Cassette, | |||
| Instruction Sheet | |||
| Single Patient Use? | Yes | Yes | Yes |
| Cassette Material | Phillips K-Resin® | LEXAN™ | Phillips K-Resin® |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization | |||
| Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Tyvek® and PET/PE Pouch, | ||
| Six pouches per Box | Tyvek® and PET/PE Pouch, | ||
| Six pouches per Box | High-impact Polystyrene Tray | ||
| With Tyvek® Lid, | |||
| Six Packs per Box |
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