REPROCESSED PHACOEMULSIFICATION TIPS

K060648 · Alliance Medical Corp. · NKX · Mar 19, 2007 · Ophthalmic

Device Facts

• Record ID: K060648
• Device Name: REPROCESSED PHACOEMULSIFICATION TIPS
• Applicant: Alliance Medical Corp.
• Product Code: NKX · Ophthalmic
• Decision Date: Mar 19, 2007
• 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. Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Device Story

Reprocessed Phacoemulsification Tips are used in ophthalmic microsurgical procedures to remove cataract tissue. The device connects to an ultrasonic handpiece; when activated, the tip vibrates at ultrasonic frequencies to emulsify cataract tissue. The hollow tip allows for aspiration of the emulsified tissue, while saline irrigation maintains eye volume. The device is intended for use by surgeons in clinical settings. Reprocessing involves cleaning, decontamination, and functional testing of previously used tips to restore them to a state equivalent to the original predicate device.

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 phacoemulsification tip; ultrasonic vibration principle; identical materials and design to predicate; sterilized via validated process; no software or electronic components.

Indications for Use

Indicated for emulsification and excision of 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 Laboratories ALCON SERIES 20000 LEGACY MACKOOL SYSTEM Phacoemulsification Tips (K955789)

Submission Summary (Full Text)

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## PART B: 510(k) SUMMARY MAR 1 9 2007 Ascent Healthcare Solutions Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Katie Bray Contact: Requlatory Affairs Engineer [phone] (o) [phone] (f) [e-mail] March 9, 2007 Date of preparation: Trade/Proprietary Name: Reprocessed Phacoemulsification Tips Name of device: (Mackool) Classification Name: Needle, Phacoemulsification, Reprocessed Manufacturer 510(k) Title Predicate Device Alcon Laboratories ALCON SERIES 20000 LEGACY K955789 MACKOOL SYSTEM Phacoemulsification Tips are used to emulsify and excise Device description: cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed. Intended use: Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures. Reprocessed Phacoemulsification Tips are indicated for use to Indications emulsify and excise cataract tissues in patients requiring eye statement: surgery. The design, materials, and intended use of Reprocessed Technological Phacoemulsification Tips are identical to the predicate devices. characteristics: The mechanism of action of Reprocessed Phacoemulsification Tips is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Alliance Medical Corporation's reprocessing of Phacoemulsification Tips includes removal of adherent visible soil and decontamination. Each individual Phacoemulsification Tip is tested for appropriate function of its

Ascent Healthcare Solutions Reprocessed Phacoemulsification Tips Traditional 510(k)

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components prior to packaging and labeling operations.

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.

## Conclusion:

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

Ascent Healthcare Solutions Reprocessed Phacoemulsification Tips Traditional 510(k)

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the left and its wings outstretched. The eagle is composed of three curved lines that create a sense of movement and dynamism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044

Re: K060648

Trade/Device Name: Ascent Reprocessed Phacoemulsification Tips Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: NKX Dated: March 9, 2007 Received: March 12, 2007

Dear Ms. Bray:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 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 (PMA), 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 898. In addition, FDA may 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 that FDA has made a determination that your device complies 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 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.

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## Page 2 - Ms. Katie Bray

This letter will allow you to begin marketing your device as described in your Section 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), 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/industry/support/index.html.

Sincerely yours,

M.B. Egelman M.D.

Malvina B. Evdelman, 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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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.

Prescription Use __ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MRRB Nicholas

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

510(k) Number K060648

CONFIDENTIAL

Alliance Medical Corporation Reprocessed Phacoemulsification Tips Traditional 510(k)