REPROCESSED PHACOEMUISIFICATION TIPS

K050518 · Alliance Medical, Inc. · NKX · Sep 23, 2005 · Ophthalmic

Device Facts

• Record ID: K050518
• Device Name: REPROCESSED PHACOEMUISIFICATION TIPS
• Applicant: Alliance Medical, Inc.
• Product Code: NKX · Ophthalmic
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures.

Device Story

Reprocessed phacoemulsification tips; used in ophthalmic microsurgical procedures to emulsify and excise cataract tissue. Device connects to ultrasonic handpiece of phacoemulsification system; vibrates at ultrasonic frequency to emulsify tissue; extracted tissue aspirated through hollow tip. Irrigation with saline solution maintains eye volume. Used by ophthalmic surgeons in clinical settings. Reprocessing by Alliance Medical Corporation involves removal of visible soil, decontamination, and functional testing of components prior to packaging/labeling.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, functional testing, and packaging validation to demonstrate safety and effectiveness.

Technological Characteristics

Mechanical phacofragmentation tip; ultrasonic vibration principle. Identical design, materials, and dimensions to predicate devices. Reprocessing includes cleaning and decontamination. Sterilization validation performed.

Indications for Use

Indicated for use to emulsify and excise cataract tissues in patients requiring eye 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 Series 20,000 Legacy (K911808)

Submission Summary (Full Text)

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K050518

## PART B: 510(k) SUMMARY

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Elizabeth Renken<br>Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f)<br>[e-mail] |
| Date of preparation: | February 25, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Phacoemulsification Tips<br>Classification Name: Phacofragmentation System |
| Predicate Device<br>K911808 | 510(k) Title<br>Alcon® Series 20,000® Legacy®<br>Manufacturer<br>Alcon® Surgical, Inc. |
| Device description: | Phacoemulsification Tips are used to emulsify and excise<br>cataract tissue in ophthalmic microsurgical procedures. When<br>connected to the ultrasonic handpiece of a phacoemulsification<br>system and activated, the Phacoemulsification Tip vibrates at an<br>ultrasonic frequency that emulsifies cataract tissue. The<br>extracted tissue is then aspirated away through the hollow tip.<br>Irrigation of the eye with a saline solution compensates for the<br>loss of volume in the eye when the cataract tissue is removed. |
| Intended use: | Reprocessed Phacoemulsification Tips are intended to emulsify<br>and excise cataract tissues in ophthalmic microsurgical<br>procedures. |
| Indications<br>statement: | Reprocessed Phacoemulsification Tips are indicated for use to<br>emulsify and excise cataract tissues in patients requiring eye<br>surgery. |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Phacoemulsification Tips are identical to the predicate devices.<br>The mechanism of action of Reprocessed Phacoemulsification<br>Tips is identical to the predicate devices in that the same<br>standard mechanical design, materials, and sizes are utilized.<br>There are no changes to the claims, intended use, clinical<br>applications, patient population, performance specifications, or<br>method of operation. In addition, Alliance Medical Corporation's<br>reprocessing of Phacoemulsification Tips includes removal of<br>adherent visible soil and decontamination. Each individual<br>Phacoemulsification Tip is tested for appropriate function of its<br>components prior to packaging and labeling operations. |

Alliance Medical Corporation Reprocessed Phacoemulsification Tips

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Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Phacoemulsification Tips. This included the following tests:

- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- . Packaging Validation

Performance testing demonstrates that Reprocessed Phacoemulsification Tips perform as originally intended.

Alliance Medical Corporation concludes that the modified Conclusion: devices (Reprocessed Phacoemulsification Tips) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of unity or interconnectedness.

SEP 2 3 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alliance Medical, Inc. c/o Ms. Elizabeth Renken Regulatory Specialist 10232 South 51st Street Phoenix. AZ 85044

Re: K050518

KU50518
Trade/Device Name: Alliance Reprocessed Phacofragmentation Needles
1778 Trade/Device Name: 178 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: NKX Dated: May 4, 2005 Received: August 29, 2005

Dear Ms. Renken:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(tx) prematic is substantially equivalent (for the indications
referenced above and have determined the device is subscripted in interstate referenced above and nave detellinited the arreted predicate devices marketed in interstate for use stated in the enclosure) to tegally manced te of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the engagions of the Federal Food. commerce prior to May 28, 1970, the encomence with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance whatest approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act The and Cosmetic Act (Act) that do not require appear of the general controls provisions of the Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of general controls provisions of the receined required.
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 (PMA), it If your device is classified (see adver) mo entirely significal sifecting your device can
may be subject to such additional controls. Existing major regulations affective FD may be subject to such additional controlist Existing insults 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 899 be found in the Code of Federal Regarates.
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a substitution on the requirements of the Act
that FDA has made a determination that your device accepains. You must that HDA has made a delermination inal your areas by other Federal agencies. You must
or any Federal statutes and regulations administered to: registration and listin or any Federal statures and regilances and unities and linited to: registration and listing (21)
comply with all the Act's requirements, including, but not securements as set comply with an the Act S requirements, monanagements practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good if emplicable, the electronic CFR Part 807); labeling (21 CFR 1 at 607); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000, 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Ms. Elizabeth Renken

This letter will allow you to begin marketing your device as described in your Section 510(k)
the same of the many of a first of a least of souvelenee of your device to a le This letter will allow you to begin marketing your article as assisteme of your device to a legally
premarket notification. The FDA finding of substantial end this permits v premarket notification. The FDA inding of substanted by 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), please
rs the same of the same and as a the same of a regulation entitled If you desire specific advice for your device on our acoming the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note of the Mourmay ob contact the Office of Computation in (301) 027 07 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by relerence to prematics nontheaton" < Pos Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-20 other general information on your responsionities and its toll-free number [phone] or Manufacturers, International and Consumer Assistance at to votes himdustry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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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### ATTACHEMENT I

#### K050518

# The Alcon Phacoemulsification Tip Models

to be

Reprocessed by Alliance Medical Corporation:

| Reprocessed by Alliance Medical Corp. | |
|-----------------------------------------|------------|
| MicroTip (0.9MM OD) | 8065740478 |
| MicroTip (0.9MM OD) | 30RTS |
| MicroTip (0.9MM OD) | 45RTS |
| MicroTip (0.9MM OD) | 30KTS |
| MicroTip (0.9MM OD) | 45KTS |
| ABS MicroTip (0.9MM OD) | 8065790019 |
| ABS MicroTip (0.9MM OD) | 8065790020 |
| ABS MicroTip (0.9MM OD) | 8065790021 |
| ABS MicroTip (0.9MM OD) | 8065790022 |
| ABS MicroTip (0.9MM OD) | 8065790023 |
| Flared ABS MicroTip (0.9MM OD) | 8065740836 |
| Flared ABS MicroTip (0.9MM OD) | 8065740837 |
| Flared ABS MicroTip (0.9MM OD) | 8065740838 |
| Flared ABS MicroTip (0.9MM OD) | 8065740839 |
| Flared ABS MicroTip (0.9MM OD) | 8065740840 |
| TurboSONICS Standard U/S Tip (1.1mm OD) | 8065740476 |
| TurboSONICS Standard U/S Tip (1.1mm OD) | 15RT |
| TurboSONICS Standard U/S Tip (1.1mm OD) | 30RT |
| TurboSONICS Standard U/S Tip (1.1mm OD) | 45RT |
| TurboSONICS Standard U/S Tip (1.1mm OD) | 30KT |
| TurboSONICS Standard U/S Tip (1.1mm OD) | 45KT |
| TurboSONICS Standard ABS Tip (1.1mm OD) | 8065740791 |
| TurboSONICS Standard ABS Tip (1.1mm OD) | 8065740792 |
| TurboSONICS Standard ABS Tip (1.1mm OD) | 8065740793 |
| TurboSONICS Standard ABS Tip (1.1mm OD) | 8065740794 |
| TurboSONICS Standard ABS Tip (1.1mm OD) | 8065740795 |

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| TurboSONICS Standard ABS Flared Tip (1.1mm OD) | 8065740805 |
|------------------------------------------------|------------|
| TurboSONICS Standard ABS Flared Tip (1.1mm OD) | 8065740806 |
| TurboSONICS Standard ABS Flared Tip (1.1mm OD) | 8065740807 |
| TurboSONICS Standard ABS Flared Tip (1.1mm OD) | 8065740808 |
| TurboSONICS Standard ABS Flared Tip (1.1mm OD) | 8065740809 |

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#### Indications for Use Statement 2.

#### 510(k) Number (if known):

Device Name: Reprocessed Phacoemulsification Tips

Indications for Use: Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Jivision Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K050518

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Alliance Medical Corporation Reprocessed Phacoemulsification Tips Traditional 510(k)

or