REPROCESSED PHACO TIPS

K012579 · Sterilmed, Inc. · NKX · Nov 8, 2001 · Ophthalmic

Device Facts

• Record ID: K012579
• Device Name: REPROCESSED PHACO TIPS
• Applicant: Sterilmed, Inc.
• Product Code: NKX · Ophthalmic
• Decision Date: Nov 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Device Story

Reprocessed phaco tip; component of phacoemulsification system. Attaches to ultrasonic transducer; oscillates at 27-64 kHz to fragment cataractous lens. Hollow needle design allows simultaneous irrigation and aspiration; irrigation fluid flows through collinear axial lumen; emulsified lens material aspirated through needle orifice. Used in surgical setting by ophthalmologists. Reprocessing restores device for reuse; involves cleaning, sterilization, and functional testing to ensure performance equivalent to original OEM device.

Clinical Evidence

Bench testing only. No clinical data. Validation included functional testing of representative samples and process validation for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional inspection.

Technological Characteristics

Titanium alloy phaco needle; 19-20 gauge; straight or curved shaft; bevel angles 0-60 degrees (round, oval, Kelman). Ultrasonic oscillation (27-64 kHz). Sterilization via EtO (SAL 10^-6).

Indications for Use

Indicated for patients undergoing phacoemulsification for the removal of a natural crystalline lens (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

• Alcon Limited Reuse Ultrasonic Tip (K981103)
• Phaco Tip (K914229)
• Surgin High Efficiency Phaco Tip (K943102)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three bars above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed, Inc. % Dr. Bruce Lester Vice President Research and Development 11400 73td Avenue, North Minneapolis, MN 55369

1 2004 NOV

Re: K012579 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: NKX Dated: October 15, 2001 Received: October 22, 2001

Dear Dr. Lester:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 8, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

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Page 2 - Dr. Bruce Lester

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's applicable requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

David Whipple

A. Ralph Rosenthal, M.D.

Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### ENCLOSURE

The following OEM models are covered under SVS for Phaco Tips (K012579):

## ALCON

## ALLERGAN, INC.

Small-Incision™ Phaco Tip 20 Gauge (0.9 mm)

- 54158 5430S 54458 5430H05 5430H20
Fluid-Dynamic™ Phaco Tip 19 Gauge (1.0 mm)

- 5115 2115F 2130 5130F 5145 5145F 6130 6130F 6145F
Turbosonics 20000 Legacy

| 20130M | 8065740632 |
|----------|------------|
| 20130MM | 8065740633 |
| 20130MV | 8065740634 |
| 20130S | 8065740635 |
| 20145 | 8065749847 |
| 20145MM | 8065740848 |
| 20145MV | 8065740849 |
| 20145S | 8065740850 |
| 20130K | 8065740887 |
| 20130KMM | 8065740888 |
| 20130KMV | 8065740889 |
| 20130KS | 8065740890 |

## AMO Titan™ Tips

OM342302E OM342302A OM342302B OM342302C

#### OPTIKON

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## Indications for Use

510(k) Number (if known):

K012579

Device Name:

Reprocessed Phaco Tip

Indications For Use:

The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dr. Callaway
(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devises

**510(k) Number** K012579

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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## NOV 0 8 2001

# SECTION 2. SUMMARY AND CERTIFICATION

#### A. 510(k) Summary

| Submitter: | SterilMed, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Fleischhacker<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 763-488-3400<br>Fax: [phone] |
| Date Prepared: | August 7, 2001 |
| Trade Name: | Reprocessed Phaco Tips |
| Classification Name:<br>and Number: | Phacofragmentation Needle<br>Class II, 21 CFR 886.4670 |
| Product Code: | HQC |
| Predicate Device(s): | The reprocessed phaco tip is substantially equivalent to:<br>Alcon Limited Reuse Ultrasonic Tip (K981103),<br>manufactured by Alcon; Phaco Tip (K914229),<br>manufactured by Tri-Star Ophthalmic; Surgin High<br>Efficiency Phaco Tip (K943102), manufactured by Surgin;<br>and the counterpart devices from the original<br>manufacturer. |
| Device Description: | The phaco tip is a component of the phacoemulsification<br>system. The tip is attached to an ultrasonic transducer.<br>When properly stimulated, the transducer lengthens and<br>shortens, causing the tip to oscillate at a specific frequency<br>usually between 27 to 64 kHz. Phacofragmentation of the<br>cataractous lens is accomplished by the action of the phaco<br>tip, a hollow needle located centrally in the device<br>handpiece. When the device is used in the<br>phacofragmentation mode both irrigation and aspiration<br>occur simultaneously. The irrigating solution enters the eye<br>via a collinear axial lumen, which encircles the phaco tip.<br>The fragmentation process is the result of combined<br>mechanical and ultrasonic action induced by the oscillating<br>phaco tip. The cataractous lens and its fragments are<br>disrupted by the phaco tip during the procedure and<br>removed due to the pump suction at the phaco tip orifice.<br>This submission is for the phaco tip only. |

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Intended Use:

Functional and Safety Testing:

Conclusion:

The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

The reprocessed phaco tips are substantially equivalent to the Alcon Limited Reuse Ultrasonic Tip (K981103), manufactured by Alcon; Phaco Tip (K914229), manufactured by Tri-Star Ophthalmic; Surgin High Efficiency Phaco Tip (K943102), manufactured by Surgin and the counterpart devices from the original manufacturer.

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| Device<br>Characteristics | SterilMed's Reprocessed Phaco<br>Tips | Alcon Limited Reuse<br>Ultrasonic Tip<br>(K981103) | Tri-Star Ophthalmic<br>Phaco Tip (K914229) | Surgin High<br>Efficiency<br>(K943102) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------|----------------------------------------|
| Device<br>Description | The phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. | Same | Same | Same |
| Intended Use | The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens. | Same | Same | Same |
| Principles of<br>Operation | The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens.<br>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. | Same | Same | Same |
| Needle Tip Bevel<br>Angle | 0°-45° Round<br>30°-60°Oval<br>30° or 45° Kelman | 15-45° Round<br>30° or 45° Oval | 30° or 45° Round<br>30° or 45° Oval | 15-45° Round<br>30° or 45° Oval |
| Shaft Shape | Straight or curved | Same | Same | Same |
| Outer Diameter | 19-20 Gage | 19-20 Gage | Unknown | 19-20 Gage |
| Materials | Same* | Titanium alloy tip | Titanium alloy tip | Titanium alloy<br>tip |
| Sterility | EtO SAL 10⁻⁶ | EtO Sterilization or<br>Radiation Sterilization | Radiation Sterilization | Unknown |
| Product Code | HOC | Same | Same | Same |

## Table 1: Comparison of Subject Devices' and Predicate Devices' Characteristics

*Same materials as Alcon Phaco Tips, Tri-Star Phaco Tips, Surgin Phaco Tips or previously approved devices.