(136 days)
Not Found
No
The summary describes a surgical accessory pack (vitrectomy probe and tubing) and makes no mention of AI or ML capabilities.
Yes
The device is a surgical accessory pack containing a vitrectomy probe and tubing set used in posterior vitrectomy, which is a therapeutic surgical procedure.
No
Explanation: The device is described as a "surgical accessory pack" containing a "vitrectory probe and attached tubing set" used for "posterior vitrectomy." This indicates the device is used for a surgical procedure, not for diagnosis.
No
The device description explicitly states it contains a vitrectomy probe and attached tubing set, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "surgical accessory pack" containing a "vitrectory probe and attached tubing set" used in conjunction with surgical systems for "posterior vitrectomy." This describes a surgical tool used during a procedure on a patient, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description reiterates the device's components and its use in conjunction with surgical systems for posterior vitrectomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectomy probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy.
Product codes (comma separated list FDA assigned to the subject device)
86HQE
Device Description
The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectory probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/0 description: The image is a black and white logo for "storz". The logo is in a black rectangle with rounded corners. The word "storz" is in white, with a dot over the "o". There is a registered trademark symbol in the upper right corner of the rectangle.
MAR - 4 1996
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: Manager, Regulatory Affairs
Date Prepared: October 16, 1995
Proprietary Names: STORZ DP4801 Basic Posterior Vitrectomy Pack; STORZ DP4800 Deluxe Posterior Vitrectomy Pack; STORZ Basic Posterior Vitrectomy Pack with Variable Port cutter.
Common/Usual Name: Ophthalmic surgical system accessory packs for posterior Vitrectomy
Classification Name: Instrument, vitreous cutting and aspirating, AC-powered (86HQE)
Device Description/Intended Use: The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectory probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy.
Predicate Device: The STORZ DP4801, DP4800, and DP4801VP are substantially equivalent to the STORZ MVS-3201, DP4400 and DP4400VP anterior vitrectomy packs (K953575).
Predicate Comparison: A chart comparing the STORZ DP4801, DP4800, and DP4801VP posterior vitrectomy packs to the predicate device, demonstrating substantial equivalence, is attached.
Submitted by:
Michel H. Sittol
Michael H. Southworth Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051
Court Industrial Blvd MO 63122-6694 5051 491 STORZ STL 1:295-7365
1
DEVICE COMPARISON CHART
Land Land Band
(")
| DEVICE CHARACTERISTIC | Storz DP4801 PACK | Storz DP4800 PACK | Storz DP4801VP PACK | PREDICATE DEVICES:
Storz MVS3201 PACK
Storz DP4400 PACK
Storz DP4400VP PACK |
|-------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------|
| Pack Contents | Vitrectomy Probe with Tube
Set and Collection Cassette | Vitrectomy Probe with Tube
Set, Collection Cassette plus
Deluxe Accessories | Vitrectomy Probe with Tube
Set and Collection Cassette | Vitrectomy Probe with Tube
Set |
| Indication For Use | Posterior Vitrectomy | Posterior Vitrectomy | Posterior Vitrectomy | Anterior Vitrectomy |
| Opthalmic Surgical System
to be Used | STORZ PREMIERE® and
DAISY® Systems | STORZ PREMIERE® and
DAISY® Systems | STORZ PREMIERE® and
DAISY® Systems | STORZ PREMIERE®,
Protegé, and DAISY®
Systems |
| Probe Cutting Mechanism
Type | Guillotine | Guillotine | Guillotine | Guillotine |
| Probe Drive Mechanism
Type | Pneumatic | Pneumatic | Pneumatic | Pneumatic |
| Does Probe Cutter Open
When Turned Off As A
Safety Measure? | YES | YES | YES | YES |
| Probe Needle Size | 20 Gauge | 20 Gauge | 20 Gauge | 20 Gauge |
| Patient Contact Materials | Type 304 Stainless Steel | Type 304 Stainless Steel | Type 304 Stainless Steel | Type 304 Stainless Steel |
| Instructions For Use
Included in Pack? | YES | YES | YES | YES |
2
DEVICE COMPARISON CHART
.
| DEVICE CHARACTERISTIC | Storz DP4801 PACK | Storz DP4800 PACK | Storz DP4801VP PACK | PREDICATE DEVICES:
Storz MVS3201 PACK
Storz DP4400 PACK
Storz DP4400VP PACK |
|-----------------------------------------|--------------------------|--------------------------|--------------------------|--------------------------------------------------------------------------------------|
| Labeled For Single Patient
Use Only? | YES | YES | YES | YES |
| Labeled Per 21CFR
§801.109(b)? | YES | YES | YES | YES |
| Provided Sterile? | YES | YES | YES | YES |
| Packaging | PETG Tray with TYVEK Lid | PETG Tray with TYVEK Lid | PETG Tray with TYVEK Lid | PETG Tray with TYVEK Lid |
1200 . ... .. .. ..