VANGUARD REPROCESSED PHACOEMULSIFICATION

K012698 · Vanguard Medical Concepts, Inc. · NKX · Nov 9, 2001 · Ophthalmic

Device Facts

• Record ID: K012698
• Device Name: VANGUARD REPROCESSED PHACOEMULSIFICATION
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NKX · Ophthalmic
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As an accessory device of a compatible phacoemulsification system, the phaco needle is intended for the breaking up of a cataractous lens nucleus with simultaneous irrigation and aspiration of the emulsified fragments.

Device Story

Phacoemulsification needle/tip; accessory to phacoemulsification system. Device uses ultrasonic energy (approx. 40,000 Hz) to vibrate hollow titanium tip; fragments cataractous lens nucleus; simultaneously irrigates and aspirates emulsified lens material. Used in ophthalmic surgery by surgeons. Vanguard Medical Concepts receives used OEM needles; cleans, inspects, tests, repackages, and sterilizes; returns to healthcare facility for reuse. Benefit: enables cataract removal through small incision.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization, and packaging efficacy studies, alongside functional performance testing to ensure the reprocessed needles maintain the same mechanical and operational characteristics as the original OEM devices.

Technological Characteristics

Titanium alloy hollow needle; piezoelectrically oscillated at ~40,000 Hz; various tip geometries (Round, Kelman, Epsilon, Flared); compatible with Alcon and Allergan phacoemulsification consoles; sterilized for reuse.

Indications for Use

Indicated for patients requiring cataract surgery; intended for breaking up cataractous lens nuclei via phacoemulsification with simultaneous irrigation and aspiration.

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 Legacy Series 20000 Phacoemulsification Tips
• Allergan AMO Proficient Phacoemulsification Tips

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2004

Vanguard Medical Concepts, Inc c/o Ms. Heather Crawford, RAC Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815

Re: K012698 - 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: 86 NKX Dated: August 13, 2001 Received: August 14, 2001

Dear Ms. Crawford:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 9, 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 - Ms. Heather Crawford, RAC

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,

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: Attachment 1- Catalog Model Numbers

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#### ATTACHMENT 1

#### K012698

#### ALCON Laboratories, Inc.'s Legacy Series 20000™ Phacoemulsification Tips TO BE REPROCESSED BY VANGUARD MEDICAL CONCEPTS

| 8065-740478 | 0.9mm MicroTip™, Purple | 0° Round |
|-------------|---------------------------------------------|---------------------|
| 30RTS | 0.9mm MicroTip™, Purple | 30° Round |
| 45RTS | 0.9mm MicroTip™, Purple | 45° Round |
| 30KTS | 0.9mm MicroTip™, Purple | 30° Kelman® |
| 45KTS | 0.9mm MicroTip™, Purple | 45° Kelman® |
| 8065790019 | 0.9mm ABS™ MicroTip™, Purple | 0° Round |
| 8065790020 | 0.9mm ABS™ MicroTip™, Purple | 30° Round |
| 8065790021 | 0.9mm ABS™ MicroTip™, Purple | 45° Round |
| 8065790022 | 0.9mm ABS™ MicroTip™, Purple | 30° Kelman® |
| 8065790023 | 0.9mm ABS™ MicroTip™, Purple | 45° Kelman® |
| 8065740836 | 0.9mm ABS™ MicroTip™, Purple | 0° Round, Flared |
| 8065740837 | 0.9mm ABS™ MicroTip™, Purple | 30° Round, Flared |
| 8065740838 | 0.9mm ABS™ MicroTip™, Purple | 45° Round, Flared |
| 8065740839 | 0.9mm ABS™ MicroTip™, Purple | 30° Kelman®, Flared |
| 8065740840 | 0.9mm ABS™ MicroTip™, Purple | 45° Kelman®, Flared |
| 8065740476 | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 0° Round |
| 15RT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 15° Round |
| 30RT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 30° Round |
| 45RT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 45° Round |
| 30KT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 30° Kelman® |
| 45KT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 45° Kelman® |
| 30ET | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 30° Epsilon® |
| 45ET | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 45° Epsilon® |
| 8065740791 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 0° Round |
| 8065740792 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Round |
| 8065740793 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Round |
| 8065740794 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Kelman® |
| 8065740795 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Kelman® |
| 8065740805 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 0° Round, Flared |
| 8065740806 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Round, Flared |
| 8065740807 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Round, Flared |
| 8065740808 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Kelman®, Flared |
| 8065740809 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Kelman®, Flared |

.

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#### ALLERGAN, Inc.'s Phacoemulsification Tips TO BE REPROCESSED BY VANGUARD MEDICAL CONCEPTS

| OPOR0021G | 21-Gauge, AMO® Proficient™ | 0°, Round |
|------------|----------------------------|------------|
| OPOR1521G | 21-Gauge, AMO® Proficient™ | 15°, Round |
| OPOR3021G | 21-Gauge, AMO® Proficient™ | 30°, Round |
| OPOR4521G | 21-Gauge, AMO® Proficient™ | 45°, Round |
| OPOSR0019G | 19-Gauge, AMO® Proficient™ | 0°, Round |
| OPOSR1519G | 19-Gauge, AMO® Proficient™ | 15°, Round |
| OPOSR3019G | 19-Gauge, AMO® Proficient™ | 30°, Round |
| OPOSR4519G | 19-Gauge, AMO® Proficient™ | 45°, Round |

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NOV 0 9 2001

# K012698

#### Indications for Use

510(k) Number:

Device Name: Vanguard Reprocessed Phacoemusification Needles/Tips

Indications for Use:

As an accessory device of a compatible phacoemulsification system, the phaco needle is intended for the breaking up of a cataractous lens nucleus with simultaneous irrigation and aspiration of the emulsified fragments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

iv

0 2

MRB Nicholas

Division Sign-Off) Division of Ophthalmic Devices KC12698 510(k) Number.

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# 4012698

### NOV 0 9 2001

# 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Mike Sammon, Ph.D.<br>Director, Research and Development<br>[phone], extension 228<br>[phone] (facsimile)<br>[e-mail] |
| Date | August 13, 2001 |
| Device | Trade Names: Vanguard Reprocessed Phacoemulsification Needles/Tips ⇒ Alcon Laboratories Microtip™ and TurboSonics® Phacoemulsification Needles/Tips ⇒ Allergan AMO® Proficient® Phacoemulsification Needles/Tips Common Name: Phacoemulsification Needle/Tip, Phaco Needle/Tip Classification: 21 CFR 886.4670 – Class II - Phacofragmentation system Product Code HQC |
| Predicate<br>Devices | Respective Alcon Laboratories and Allergan legally marketed phaco needles<br>under various 510(k) premarket notifications. |
| Indications for<br>Use | As an accessory device of a compatible phacoemulsification system, the<br>phaco needle is intended for the breaking up of a cataractous lens nucleus<br>with simultaneous irrigation and aspiration of the emulsified fragments. |
| | Continued on next page |

ABS and Microtip are trademarks of Alcon Laboratories, Inc. TurboSonics, Alcon Series 20000 and LEGACY are registered trademarks of Alcon Laboratories, Inc. Mackool is a trademark of Richard J. Mackool, MD AMO and Proficient are registered trademarks of Allergan, Inc.

V - Page 1 of 2

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## 510(k) Summary of Safety & Effectiveness, Continued

| Device<br>Description | A phacoemulsification needle is a component of a phacoemulsification<br>system that utilizes ultrasound to disrupt and extract a cataract through a<br>small incision. Ultrasonic energy combined with the mechanical action of the<br>vibrating tip applicator (phaco tip) is applied to the cataractous lens of the<br>eye. The lens undergoes fragmentation and emusification and is rapidly<br>removed from the eye by aspiration. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The phaco tip is a hollow titanium needle located centrally in a handpiece<br>with is connected via an irrigation and/or aspiration line(s) to a console for<br>powering and controlling the functions of the phaco system. The tip is<br>piezoelectronically oscillated longitudinally at an ultrasonic frequency of<br>about 40,000 hertz. |
| | Vanguard receives previously used phaco needles (only) from healthcare<br>facilities; cleans, inspects, tests, repackages and sterilizes the devices; and<br>returns them to the healthcare facility. |
| Technological<br>Characteristics | The Vanguard reprocessed phaco needles are essentially identical to the<br>currently marketed OEM devices. No changes are made to the currently<br>marketed device's specifications and they possess the same technological<br>characteristics. Performance/functional testing demonstrate that the devices<br>are equivalent and continue to be safe and effective for their intended use. As<br>composite materials of all VMC reprocessed phaco needles are identical to<br>the currently marketed devices of Alcon and Allergan (titanium alloy),<br>biocompatibility testing was not performed. |
| Test Data | Cleaning, sterilization and packaging validations; and functional/performance<br>demonstrates that the reprocessed devices perform as intended and are safe<br>and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>reprocessed phacoemulsification needles/tips are substantially equivalent to<br>the predicate devices under the Federal Food, Drug and Cosmetic Act. |