STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX

K954816 · Storz Instrument Co. · HQE · Mar 4, 1996 · Ophthalmic

Device Facts

• Record ID: K954816
• Device Name: STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
• Applicant: Storz Instrument Co.
• Product Code: HQE · Ophthalmic
• Decision Date: Mar 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Surgical accessory packs containing vitrectomy probe, tubing set, and collection cassette; used with STORZ PREMIERE® or DAISY® Microsurgical Systems. Probe utilizes pneumatic guillotine cutting mechanism; 20-gauge needle size. Used in ophthalmic surgery by surgeons. Safety feature: probe cutter opens when turned off. Single-patient use; provided sterile in PETG tray with TYVEK lid. Facilitates vitreous cutting and aspiration during posterior vitrectomy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Type 304 stainless steel probe; pneumatic drive mechanism; guillotine cutting action; 20-gauge needle. Sterile, single-patient use. Packaging: PETG tray with TYVEK lid.

Indications for Use

Indicated for patients undergoing posterior vitrectomy procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• STORZ MVS-3201 (K953575)
• STORZ DP4400 (K953575)
• STORZ DP4400VP (K953575)

Submission Summary (Full Text)

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LOTZ

MAR - 4 1996

K954816

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 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.

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:

Michael H. Southworth
Storz Instrument Company
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122
Ph. 314/225-5051

Court Industrial Blvd.
MO 63122-6094
5051
491 STORZ STI
225-2365

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# 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 |
| --- | --- | --- | --- | --- |
| 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 |

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# 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 |