STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES

K971439 · Storz Instrument Co. · HQC · Jun 17, 1997 · Ophthalmic

Device Facts

• Record ID: K971439
• Device Name: STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.

Device Story

Phacoemulsification needles are cylindrical metal tips attached to ultrasonic handpieces; used by ophthalmologists during cataract surgery. Device functions as conduit for irrigation fluid entering eye and aspiration of emulsified lens material exiting eye. Ultrasonic energy from handpiece drives needle to fragment crystalline lens. Used in clinical surgical settings. Benefits include efficient lens removal during cataract procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Ti-6Al-4V titanium alloy. Form factor: Cylindrical metal tips, straight or angled shaft configurations. Function: Ultrasonic phacofragmentation accessory. Connectivity: Mechanical attachment to phacoemulsification handpiece. Sterilization: Not specified.

Indications for Use

Indicated for use as accessories to a phacoemulsification handpiece for the ultrasonic surgical removal of cataractous crystalline lenses in patients requiring cataract surgery.

Regulatory Classification

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.

Predicate Devices

• Storz MicroFlow Phaco Needles (K954340)
• Storz MicroSeal Phaco Needles (K952259)
• Surgin High-Performance Phaco Tips (K943102)
• Storz Standard Phaco Needles (K946176)

Submission Summary (Full Text)

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K971439

# JUN 17 1997

### Storz Instrument Company Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles 510(k) Summary of Safety and Effectiveness

The following information is submitted in accordance with the requirements of 21 CFR § 807.92:

Submitted by:

Mill H. Satter

Michael H. Southworth RAC Group Manager, Regulatory Affairs Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122

Contact Person: Patrick G. Balsmann, 314-225-5051, ext. 5538

Date Prepared: 16 April 1997

Proprietary Name: Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles

Common/Usual Name: Phacoemulsification Needles

Classification Name: System, Phacofragmentation, 86(HQC). Phacoemulsification needles are accessories to "Phacofragmentation Systems" which are Class II medical devices in accordance with 21 CFR § 886.4670.

Intended Use: The new Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, which is intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.

Device Description: A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens. Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.

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Predicate Devices: The Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles are substantially equivalent to legally marketed predicate devices. The Storz MicroFlow Plus and Storz MicroFlow Plus Angled Phaco Needles are subsatantially equivalent to the existing Storz MicroFlow Phaco Needles (K954340), the Storz MicroSeal Phaco Needles (K952259), and the Surgin High-Performance Phaco Tips (K943102). The Storz Standard Angled Phaco Needles are substnatially equivalent to the existing Storz Standard Phaco Needles (K946176) and the Surgin High-Performance Phaco Tips (K943102). Charts comparing basic characteristics of these new Storz Phaco Needles to those of the predicate devices, demonstrating substantial equivalence, are attached.

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| Device<br>Characteristic | Storz MicroFlow Plus | Storz MicroFlow Plus,<br>Angled | Storz MicroFlow | Storz MicroSeal | Surgin High-<br>Efficiency |
|-----------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| 510(k) | present | present | K954340 | K952259 | K943102 |
| Intended Use | Accessory to phaco<br>handpiece used in lens<br>removal. | Accessory to phaco<br>handpiece used in lens<br>removal. | Accessory to phaco<br>handpiece used in lens<br>removal. | Accessory to phaco<br>handpiece used in lens<br>removal. | Accessory to phaco .<br>handpiece used in lens<br>removal. |
| Number of<br>Models | Four | Four | Four | Two | Two |
| Model Variations | Needle tip bevel angle | Needle tip bevel angle | Needle tip bevel angle | Needle tip bevel angle | Degree angled shaft |
| Angled Shaft | No | Yes | No | No | Yes |
| Material(s) | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Titanium<br>(alloy unknown) |
| Needle I.D.<br>(inches) | 0.024 | 0.024 | 0.020 | 0.024 | 0.026 |
| Needle O.D.<br>(inches) | 0.046 | 0.046 | 0.046 | 0.042 | 0.036 |
| Recommended<br>Surgical Incision<br>Size (mm) | 2.8 | 2.8 | 2.5 | 2.5 | 2.75 |
| Number of Uses<br> Recommended | 10 | 10 | 10 | 5 | Unknown |

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# Substantial Equivalence Chart Storz MicroFlow Plus and MicroFlow Plus Angled Phaco Needles

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## Substantial Equivalence Chart Storz Standard Angled Phaco Needles

| Device Characteristic | Storz Standard, Angled | Storz Standard | Surgin High-<br>Efficiency |
|-----------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|
| 510(k) | present | K946176 | K943102 |
| Intended Use | Accessory to phaco<br>handpiece used in lens<br>removal. | Accessory to phaco<br>handpiece used in lens<br>removal. | Accessory to phaco<br>handpiece used in lens<br>removal. |
| Number of Models | Three | Three | Two |
| Model Variations | Needle tip bevel angle | Needle tip bevel angle | Degree angled shaft |
| Angled Shaft | Yes | Yes | Yes |
| Material(s) | Ti-6Al-4V | Ti-6Al-4V | Titanium<br>(alloy unknown) |
| Recommended<br>Surgical Incision Size<br>(mm) | Unspecified<br>(3.2 mm typical) | Unspecified<br>(3.2 mm typical) | 2.75 |
| Needle I.D. (inches) | 0.036 | 0.036 | 0.026 |
| Needle O.D. (inches) | 0.042 | 0.042 | 0.036 |
| Number of Uses<br>Recommended | Unspecified | Unspecified | Unknown |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1997

Mr. Michael H. Southworth, RAC Group Manager, Regulatory Affairs Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694

Re: K971439

Trade Name: Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles Regulatory Class: II Product Code: 86 HQC Dated: April 16, 1997 Received: April 18, 1997

Dear Mr. Southworth:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further unnouncements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Michael H. Southworth, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

| Device Name: | Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz<br>Standard Angled Phacoemulsification Needles |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard<br>Angled Phacoemulsification Needles are accessories to a<br>phacoemulsification handpiece, intended for use in the ultrasonic<br>surgical removal of the cataractous crystalline lens. |

Emeath R. Been

(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number_ K971439

Prescription Denied ✓