The phaco tip is a component of the phacoemulsification system. The tip is attached to an ultrasonic transducer. When properly stimulated, the transducer lengthens and shortens, causing the tip to oscillate at a specific frequency usually between 27 to 64 kHz. Phacofragmentation of the cataractous lens is accomplished by the action of the phaco tip, a hollow needle located centrally in the device handpiece. When the device is used in the phacofragmentation mode both irrigation and aspiration occur simultaneously. The irrigating solution enters the eye via a collinear axial lumen, which encircles the phaco tip. The fragmentation process is the result of combined mechanical and ultrasonic action induced by the oscillating phaco tip. The cataractous lens and its fragments are disrupted by the phaco tip during the procedure and removed due to the pump suction at the phaco tip orifice. This submission is for the phaco tip only.

AI/ML Overview

The provided document describes the FDA clearance for SterilMed, Inc.'s reprocessed phaco tips (K012579). The key information regarding acceptance criteria and the supporting study is found in the "Functional and Safety Testing" section and the comparison table.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with specific numerical thresholds. Instead, it broadly states that "Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."

However, we can infer some performance characteristics from the comparison table (Table 1: Comparison of Subject Devices' and Predicate Devices' Characteristics) which implicitly serve as acceptance criteria for reprocessing, aiming for substantial equivalence to predicate devices.

Acceptance Criteria (Inferred from Predicate Device Characteristics)	Reported Device Performance (SterilMed's Reprocessed Phaco Tips)
Device Description: Cylindrical, metal tip connected to phaco handpiece.	The phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece.
Intended Use: Assist in automated phacoemulsification of natural crystalline lens.	The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
Principles of Operation: Fragmentation of crystalline lens via ultrasonic handpiece, irrigation, and aspiration.	The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens. Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.
Needle Tip Bevel Angle: Range of 0°-60° (Round, Oval, Kelman types)	0°-45° Round, 30°-60° Oval, 30° or 45° Kelman (Matches or falls within the combined ranges of predicate devices)
Shaft Shape: Straight or curved	Straight or curved
Outer Diameter: 19-20 Gage	19-20 Gage
Materials: Titanium alloy tip	Same* (Referencing "Same materials as Alcon Phaco Tips, Tri-Star Phaco Tips, Surgin Phaco Tips or previously approved devices," indicating titanium alloy tip).
Sterility: Sterility Assurance Level (SAL) of 10⁻⁶ via EtO.	EtO SAL 10⁻⁶
Product Code: HQC	HQC
Functional Characteristics: Appropriate functioning (mentioned in summary)	"Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics." (No specific numerical results provided in this summary.)
Cleaning and Sterilization: Validated procedures (mentioned in summary)	"Process validation testing was done to validate the cleaning and sterilization procedures." (No specific numerical results provided in this summary, but implies successful validation to achieve SAL 10⁻⁶.)
Packaging: Validated packaging (mentioned in summary)	"Process validation testing was done to validate... the device's packaging." (No specific details provided in this summary.)
Visual and Functional Testing: Performed on all products (mentioned in summary)	"the manufacturing process includes visual and functional testing of all products produced." (Confirms ongoing quality control, but no specific results for this submission.)

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

Sample Size: The document mentions "Representative samples of phaco tips underwent bench testing." However, it does not specify the exact sample size used for the functional and safety testing.
Data Provenance: The nature of reprocessing (SterilMed, Inc. reprocessing devices from OEMs like Alcon, Allergan, AMO, and OPTIKON) implies that the devices themselves are from various manufacturers. The testing was conducted by SterilMed, Inc., which is located in Minneapolis, MN, USA. The data would therefore be retrospective in the sense that the devices were initially manufactured and used, then reprocessed and tested. The testing itself is prospective in relation to the reprocessing process.

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

This document describes a 510(k) submission for a reprocessed medical device, focusing on functional and safety equivalence rather than diagnostic performance or interpretation. Therefore:

No "ground truth" established by experts in the context of disease diagnosis or image interpretation.
The "truth" is established by comparing the physical and functional characteristics of the reprocessed devices to those of new, legally marketed predicate devices, and demonstrating that reprocessing maintains safety and effectiveness. This is typically done through engineering and microbiology testing, not expert clinical review of test data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations. The "adjudication" in this context would be the internal review and approval by SterilMed's R&D team and the FDA's regulatory review of the submitted data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a reprocessed medical device, not a diagnostic AI device requiring an MRMC study. There is no human reader component that would be "assisted by AI" in this context.

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

Yes, in a sense. The bench testing and process validation for the reprocessed phaco tips are standalone performance evaluations of the device itself and the reprocessing procedures. The performance is assessed based on predefined engineering and sterility parameters, without a human "in-the-loop" for interpretation or decision-making beyond operating the test equipment.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the established performance and safety characteristics of the original, new predicate devices (Alcon Limited Reuse Ultrasonic Tip, Tri-Star Ophthalmic Phaco Tip, Surgin High Efficiency Phaco Tip). SterilMed's reprocessed devices are deemed substantially equivalent if they meet these established benchmarks through functional, material, and sterility testing.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm development study, so there is no concept of a "training set" in the traditional sense. The "training" for the reprocessing procedures would have been done during the initial process development and validation, but this refers to process optimization, not a data-driven training set for an algorithm.

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

Not applicable, as there is no training set mentioned or implied for an AI algorithm. If "training set" were interpreted as the data used to validate the reprocessing process, then the ground truth for that validation would be the specifications and requirements for a safe and effective reprocessed device, derived from regulatory standards, material science, and the characteristics of the predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three bars above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed, Inc. % Dr. Bruce Lester Vice President Research and Development 11400 73td Avenue, North Minneapolis, MN 55369

1 2004 NOV

Re: K012579 - 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: NKX Dated: October 15, 2001 Received: October 22, 2001

Dear Dr. Lester:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 8, 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 - Dr. Bruce Lester

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,

David Whipple

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

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ENCLOSURE

The following OEM models are covered under SVS for Phaco Tips (K012579):

ALCON

ALLERGAN, INC.

Small-Incision™ Phaco Tip 20 Gauge (0.9 mm)

54158 5430S 54458 5430H05 5430H20
Fluid-Dynamic™ Phaco Tip 19 Gauge (1.0 mm)
5115 2115F 2130 5130F 5145 5145F 6130 6130F 6145F
Turbosonics 20000 Legacy

20130M	8065740632
20130MM	8065740633
20130MV	8065740634
20130S	8065740635
20145	8065749847
20145MM	8065740848
20145MV	8065740849
20145S	8065740850
20130K	8065740887
20130KMM	8065740888
20130KMV	8065740889
20130KS	8065740890

AMO Titan™ Tips

OM342302E OM342302A OM342302B OM342302C

OPTIKON

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Indications for Use

510(k) Number (if known):

K012579

Device Name:

Reprocessed Phaco Tip

Indications For Use:

The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dr. Callaway
(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K012579

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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NOV 0 8 2001

SECTION 2. SUMMARY AND CERTIFICATION

A. 510(k) Summary

Submitter:	SterilMed, Inc.
Contact Person:	Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3400Fax: 763-488-3350
Date Prepared:	August 7, 2001
Trade Name:	Reprocessed Phaco Tips
Classification Name:and Number:	Phacofragmentation NeedleClass II, 21 CFR 886.4670
Product Code:	HQC
Predicate Device(s):	The reprocessed phaco tip is substantially equivalent to:Alcon Limited Reuse Ultrasonic Tip (K981103),manufactured by Alcon; Phaco Tip (K914229),manufactured by Tri-Star Ophthalmic; Surgin HighEfficiency Phaco Tip (K943102), manufactured by Surgin;and the counterpart devices from the originalmanufacturer.
Device Description:	The phaco tip is a component of the phacoemulsificationsystem. The tip is attached to an ultrasonic transducer.When properly stimulated, the transducer lengthens andshortens, causing the tip to oscillate at a specific frequencyusually between 27 to 64 kHz. Phacofragmentation of thecataractous lens is accomplished by the action of the phacotip, a hollow needle located centrally in the devicehandpiece. When the device is used in thephacofragmentation mode both irrigation and aspirationoccur simultaneously. The irrigating solution enters the eyevia a collinear axial lumen, which encircles the phaco tip.The fragmentation process is the result of combinedmechanical and ultrasonic action induced by the oscillatingphaco tip. The cataractous lens and its fragments aredisrupted by the phaco tip during the procedure andremoved due to the pump suction at the phaco tip orifice.This submission is for the phaco tip only.

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Intended Use:

Functional and Safety Testing:

Conclusion:

The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

The reprocessed phaco tips are substantially equivalent to the Alcon Limited Reuse Ultrasonic Tip (K981103), manufactured by Alcon; Phaco Tip (K914229), manufactured by Tri-Star Ophthalmic; Surgin High Efficiency Phaco Tip (K943102), manufactured by Surgin and the counterpart devices from the original manufacturer.

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DeviceCharacteristics	SterilMed's Reprocessed PhacoTips	Alcon Limited ReuseUltrasonic Tip(K981103)	Tri-Star OphthalmicPhaco Tip (K914229)	Surgin HighEfficiency(K943102)
DeviceDescription	The phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece.	Same	Same	Same
Intended Use	The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.	Same	Same	Same
Principles ofOperation	The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens.Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.	Same	Same	Same
Needle Tip BevelAngle	0°-45° Round30°-60°Oval30° or 45° Kelman	15-45° Round30° or 45° Oval	30° or 45° Round30° or 45° Oval	15-45° Round30° or 45° Oval
Shaft Shape	Straight or curved	Same	Same	Same
Outer Diameter	19-20 Gage	19-20 Gage	Unknown	19-20 Gage
Materials	Same*	Titanium alloy tip	Titanium alloy tip	Titanium alloytip
Sterility	EtO SAL 10⁻⁶	EtO Sterilization orRadiation Sterilization	Radiation Sterilization	Unknown
Product Code	HOC	Same	Same	Same

Table 1: Comparison of Subject Devices' and Predicate Devices' Characteristics

*Same materials as Alcon Phaco Tips, Tri-Star Phaco Tips, Surgin Phaco Tips or previously approved devices.

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.