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.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device, specifically an Alcon Limited Reuse Ultrasonic Tip. It is not an AI/ML device, so much of the requested information (like AI/ML specific criteria, ground truth, and training sets) is not applicable.

However, I can extract information related to the device's performance claims and supporting evidence described in the document.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable table format as might be expected for modern AI/ML device submissions. Instead, it refers to the performance relative to predicate devices and the absence of certain negative effects after repeated use.

Acceptance Criteria (Inferred from regulatory requirements and claims)	Reported Device Performance
Safety: Performance of tips does not compromise safety during repeated use.	"It has been demonstrated that repeated use of the phacoemulsification tips does not alter performance of the tips as to affect safety..." Specifically, "effects of fatigue, cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance."
Efficacy: Performance of tips during repeated use remains effective for the intended purpose.	"... 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." The device "utilizes the same technology as the predicate devices."
Structural Integrity: Maintains structural integrity after repeated use (e.g., no significant fatigue).	"effects of fatigue... have been shown to have no significant effect on tip performance." The tips are manufactured from a "titanium alloy which exhibits excellent structural... properties making it suitable for repeated use."
Material Degradation: No significant cavitation erosion or chemical reactions that degrade performance or safety.	"cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance."
Equivalence to Predicate Devices: Performance is substantially equivalent to legally marketed predicate devices.	"the Alcon Limited Reuse Phacoemulsification Ultrasonic Tip is proven to be substantially equivalent to the predicate devices described in Section 1 (above)." The device "utilizes the same technology as the predicate devices." The predicate devices are listed and are reusable. Alcon's tips are now labeled for 20 uses.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not provide a specific "sample size" for a test set in the conventional sense of a clinical trial or algorithm validation. The "study" mentioned is more akin to engineering and materials testing to assess the effects of repeated use on the tip's physical properties and performance.

Sample Size: Not explicitly stated in terms of number of tips or number of uses observed in a "test set." The document generally refers to "repeated use."
Data Provenance: Not specified (e.g., country of origin). The testing would have been conducted by Alcon Laboratories, Inc.
Retrospective or Prospective: Unclear, but likely a combination of prospective laboratory testing (e.g., accelerated aging, fatigue testing) and potentially retrospective analysis of predicate device performance or materials science. It's not a clinical study on patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This concept is not directly applicable to this device submission. "Ground truth" in the context of expert consensus is typically for diagnostic interpretation. Here, the "ground truth" relates to the physical and functional integrity of a mechanical device after repeated use. This would be established through:

Engineers/Material Scientists: Experts in fatigue analysis, material science, and mechanical testing.
Manufacturing Quality Control: Personnel performing inspections and performance checks.
Surgeons/Ophthalmologists: Providing input on clinical performance parameters and observations during use.

The document does not detail the specific number or qualifications of these individuals involved in assessing the testing results.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepant expert interpretations are resolved, which isn't relevant for mechanical device testing results. The "adjudication" would be based on established engineering standards and performance benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

This is explicitly not applicable. This is a physical ultrasonic tip, not an AI/ML device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is explicitly not applicable. This is a physical ultrasonic tip, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance would be derived from:

Engineering/Material Science Testing Data: Measurements of material degradation (e.g., fatigue cracking, erosion), functional output (e.g., ultrasonic power, tip integrity), and structural analysis.
Bench Testing: Performance against established specifications and predicate device performance in controlled environments.
Clinical Performance Observations (indirect): Ensuring no adverse events or performance degradation when used in a surgical context (though direct patient outcomes from a trial are not reported here).
Regulatory Standards: Adherence to relevant FDA guidance and industry standards for medical device materials and reuse.

8. The Sample Size for the Training Set:

This is explicitly not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This is explicitly not applicable. As it's not an AI/ML model, there is no "training set" or "ground truth for the training set."

Summary

{0}------------------------------------------------

K981103

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:

PredicateDevices	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

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.

{2}------------------------------------------------

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).

{3}------------------------------------------------

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 .

{4}------------------------------------------------

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

{5}------------------------------------------------

K981103

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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.