(87 days)
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.
A phacoemulsification needle is a component of a phacoemulsification system that utilizes ultrasound to disrupt and extract a cataract through a small incision. Ultrasonic energy combined with the mechanical action of the vibrating tip applicator (phaco tip) is applied to the cataractous lens of the eye. The lens undergoes fragmentation and emusification and is rapidly removed from the eye by aspiration.
The phaco tip is a hollow titanium needle located centrally in a handpiece with is connected via an irrigation and/or aspiration line(s) to a console for powering and controlling the functions of the phaco system. The tip is piezoelectronically oscillated longitudinally at an ultrasonic frequency of about 40,000 hertz.
Vanguard receives previously used phaco needles (only) from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
The provided document is a 510(k) summary for reprocessed phacoemulsification needles/tips by Vanguard Medical Concepts. It details their substantial equivalence to legally marketed predicate devices.
However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics presented in a quantitative manner (e.g., sensitivity, specificity, accuracy, precision, recall) that are typically associated with AI/ML device validation. It focuses on demonstrating that the reprocessed devices are functionally equivalent to new devices.
Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, or standalone algorithm performance) because these details are not present in the provided text.
The document states:
- "Performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use."
- "Cleaning, sterilization and packaging validations; and functional/performance demonstrates that the reprocessed devices perform as intended and are safe and effective."
This indicates that functional testing was performed for the reprocessed devices, but the specific acceptance criteria (e.g., maximum allowable deviation in ultrasonic frequency, aspiration rate, tip integrity) and the results against these criteria are not detailed in this summary. The information provided is high-level and focused on regulatory clearance for reprocessed medical devices, not the in-depth performance validation of an AI/ML algorithm.
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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Mr. Mike Sammon, Ph.D.Director, Research and Development(863) 683-8680, extension 228(801) 327-3339 (facsimile)mikes@safe-reuse.com |
| 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 |
| PredicateDevices | Respective Alcon Laboratories and Allergan legally marketed phaco needlesunder various 510(k) premarket notifications. |
| Indications forUse | As an accessory device of a compatible phacoemulsification system, thephaco needle is intended for the breaking up of a cataractous lens nucleuswith 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
| DeviceDescription | A phacoemulsification needle is a component of a phacoemulsificationsystem that utilizes ultrasound to disrupt and extract a cataract through asmall incision. Ultrasonic energy combined with the mechanical action of thevibrating tip applicator (phaco tip) is applied to the cataractous lens of theeye. The lens undergoes fragmentation and emusification and is rapidlyremoved from the eye by aspiration. |
|---|---|
| The phaco tip is a hollow titanium needle located centrally in a handpiecewith is connected via an irrigation and/or aspiration line(s) to a console forpowering and controlling the functions of the phaco system. The tip ispiezoelectronically oscillated longitudinally at an ultrasonic frequency ofabout 40,000 hertz. | |
| Vanguard receives previously used phaco needles (only) from healthcarefacilities; cleans, inspects, tests, repackages and sterilizes the devices; andreturns them to the healthcare facility. | |
| TechnologicalCharacteristics | The Vanguard reprocessed phaco needles are essentially identical to thecurrently marketed OEM devices. No changes are made to the currentlymarketed device's specifications and they possess the same technologicalcharacteristics. Performance/functional testing demonstrate that the devicesare equivalent and continue to be safe and effective for their intended use. Ascomposite materials of all VMC reprocessed phaco needles are identical tothe currently marketed devices of Alcon and Allergan (titanium alloy),biocompatibility testing was not performed. |
| Test Data | Cleaning, sterilization and packaging validations; and functional/performancedemonstrates that the reprocessed devices perform as intended and are safeand effective. |
| Conclusion | Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the Vanguardreprocessed phacoemulsification needles/tips are substantially equivalent tothe predicate devices under the Federal Food, Drug and Cosmetic Act. |
§ 886.4670 Phacofragmentation system.
(a)
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.(b)
Classification. Class II.