(89 days)
Not Found
No
The summary describes a traditional phacoemulsification system and a labeling change for reusable tips. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to assist in the phacoemulsification of a natural crystalline lens, which is a therapeutic intervention for cataracts.
No
The device is described as assisting in automated phacoemulsification and removing cataractous lens material from the eye, which is a therapeutic surgical procedure, not a diagnostic one.
No
The device description clearly outlines hardware components like a machine, handpiece, titanium needle/tip, and irrigation sleeve, which are integral to its function. The submission focuses on the reusability of a hardware component (the tip).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the automated phacoemulsification of a natural crystalline lens." This describes a surgical procedure performed directly on a patient's eye to remove a cataract.
- Device Description: The description details a system that uses ultrasonic energy to break up and remove lens material from the eye. This is a surgical instrument, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health status based on laboratory results.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
Product codes
86 HQC
Device Description
The Series 20000® Legacy® System and its predicate devices use ultrasonic energy to emulsify cataractous lens material and remove it from the eye (phacoemulsification). Electronic energy is generated in the machine, delivered to a handpiece and is finally converted to ultrasonic energy delivered through a hollow titanium needle, or tip. Irrigation fluid is delivered to the eye via the combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the handpiece/tip assembly. The handpieces are being routinely used repeatedly in multiple surgical procedures, while the tips marketed by Alcon have been labeled for single-use only. Other predicate devices have been labeled as reusable. The labeling modification which is the subject of this submission is that some of Alcon phacoemulsification tips can be used in up to 20 surgical procedures, provided they are carefully handled and inspected before and after each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
It has been demonstrated that repeated use of the phacoemulsification tips does not alter performance of the tips as to affect safety and efficacy of the device. Specifically, effects of fatigue, cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance.
Key Metrics
Not Found
Predicate Device(s)
K911808, K851210, K902876, K915456, K915457, K921460, K921758, K925631
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Jun 23 3 1998
March 20, 1998
510(K) SUMMARY
Submitted by:
Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)
Alcon Limited Reuse Ultrasonic Tip Trade Name: Alcon Limited Reuse Ultrasonic Tip Common Name Phacofragmentation System (per 21 CFR 886.4670) Classification Name
1
1. Predicate Device
We are claiming equivalence of the Alcon Limited Reuse tip to the phacoemulsification ultrasonic tips used in the following legally marketed devices:
| Predicate
| Devices | 510(k) Title | Manufacturer |
|---|---|---|
| K911808 | Alcon Series 20,000® Legacy® | Alcon Surgical |
| K851210 | United Sonics Phaco Module Model PF-35 | United Sonics, Inc. |
| K902876 | Phacotron Systems Plus III Phacoemulsifier Aspirator | Intraoptics Surgical |
| K915456 | United Sonics Phaco 3000 Linear | Innovative Medical Systems |
| K915457 | United Sonics Phaco 20/20 System I | “ |
| K921460 | Storz Premiere™/ Premiere™ Microvit® | Storz Instrument Company |
| K921758 | Storz Protege™ Ophthalmic Microsurgical System | “ |
| K925631 | Phacotron Gold™ Multifunction Ultrasonic Handpiece | Chiron IntraOptics |
2. Device Description
The Series 20000® Legacy® System and its predicate devices use ultrasonic energy to emulsify cataractous lens material and remove it from the eye (phacoemulsification). Electronic energy is generated in the machine, delivered to a handpiece and is finally converted to ultrasonic energy delivered through a hollow titanium needle, or tip. Irrigation fluid is delivered to the eye via the combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the handpiece/tip assembly. The handpieces are being routinely used repeatedly in multiple surgical procedures, while the tips marketed by Alcon have been labeled for single-use only. Other predicate devices have been labeled as reusable. The labeling modification which is the subject of this submission is that some of Alcon phacoemulsification tips can be used in up to 20 surgical procedures, provided they are carefully handled and inspected before and after each use.
3. Intended Use of the Device
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
4. Summary of the Technological Characteristics of the Device
The Alcon Limited Reuse Tips utilizes the same technology as the predicate devices. The tips are manufactured from a titanium alloy which exhibits excellent structural and chemical properties making it suitable for repeated use in surgical procedures.
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5. Summary of the Performance Data
It has been demonstrated that repeated use of the phacoemulsification tips does not alter performance of the tips as to affect safety and efficacy of the device. Specifically, effects of fatigue, cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance.
6. Conclusions
Therefore, based on the data provided in this Premarket notification, the Alcon Limited Reuse Phacoemulsification Ultrasonic Tip is proven to be substantially equivalent to the predicate devices described in Section 1 (above).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1998
Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132
Re: K981103 Trade Name: Turbosonics Limited Reuse Ultrasonic Tip Regulatory Class: II Product Code: 86 HQC Dated: March 20, 1998 Received: March 26, 1998
Dear Mr. Kaufman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Martin A. Kaufman
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Limited Reuse Ultrasonic Tips.
Indications For Use:
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED). Concurrence of CDRH, Office of Device Evaluation (ODE)
Bruce Drum
(Division Sign-Off) Division of Ophthalmic 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)