The ALCON Enhanced UltraVit® Probe is a modified vitrectomy probe that will be added to the existing Alcon UltraVit® probe family. The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes used on the CONSTELLATION® System (Alcon Vision System, K063583). The ALCON Enhanced UltraVit® Probe will utilize existing packaging configurations and have the same shelf life as existing vitrectomy probes. It will be used with the CONSTELLATION® System. The differences between the enhanced and predicate versions are:

Increased maximum cut rate. .
. Software look-up table changes to accommodate RFID recognition of new probe.
Parylene N Coating on "O" ring seals. .

AI/ML Overview

Here's an analysis of the provided text regarding the Alcon Enhanced UltraVit Probe's acceptance criteria and studies:

Based on the provided 510(k) summary (K093305) for the ALCON Enhanced UltraVit Probe, please note that this device is a physical surgical instrument and not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions regarding AI device performance metrics like sensitivity, specificity, reader studies, ground truth establishment, and training sets are not applicable.

The approval for this device relies on demonstrating substantial equivalence to a predicate device (ALCON® Vision System (CONSTELLATION®) UltraVit Probes, K063583) and adherence to relevant biocompatibility, sterilization, and manufacturing standards.

Here's a breakdown of the requested information, with clarifications for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a vitrectomy probe, "acceptance criteria" relate to meeting safety and performance standards for its intended function, often compared to the predicate device.

Acceptance Criteria Category	Specific Criteria/Standard Met	Reported Device Performance/Evidence
Biocompatibility	Compliance with AAMI/ANSI/ISO 10993 series (Parts 1, 5, 7, 10, 11, 12) for materials in contact with patient/fluid path.	"Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:" (followed by a list of ISO 10993 series standards). This indicates the device met these standards.
Sterilization	Validation of Ethylene Oxide sterilization to a SAL of 10^-6^ per EN ISO 11135-1:2007.	"This product is Ethylene Oxide sterilized and the process has been validated to a SAL of 10^-6^ per FDA Recognized Consensus Standard - 'EN ISO 11135-1:2007...'"
Functional Performance	Functional requirements of a vitrectomy probe, including increased maximum cut rate compared to predicate.	"Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices." The device description explicitly states: "Increased maximum cut rate."
Manufacturing Quality	Compliance with 21 CFR 820 (Quality System Regulation) and ISO 14971:2003 (Risk Management).	"The ALCON® Enhanced UltraVit® Probe has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003."
Physical Characteristics	Same size, shape, and material as existing Alcon UltraVit® probes. Same packaging and shelf life.	"The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes... It will be used with the CONSTELLATION® System." Also, "utilize existing packaging configurations and have the same shelf life."
Software Changes	Software look-up table changes to accommodate RFID recognition of the new probe are functional.	Implied by general functional testing and substantial equivalence claim. Software changes are limited to RFID recognition.

For the following questions, please understand they are largely not applicable or directly answerable in the context of this 510(k) for a physical, non-AI medical device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in the traditional sense for an AI/SaMD. The "test set" here would refer to the samples used in non-clinical testing (e.g., material samples for biocompatibility, sterility test loads, functional performance tests on the device itself). Specific sample sizes for such tests are not detailed in this summary but are part of standard device validation protocols. There's no "patient data" test set or provenance mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. "Ground truth" in the context of an AI device refers to a definitively correct answer against which the AI's performance is measured. For a physical device, performance is measured against engineering specifications, validated test methods, and regulatory standards. Experts would be involved in designing and executing these validation tests, but not in establishing an "image interpretation ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review panels for ambiguous cases when establishing ground truth for diagnostic AI. This is not reported for a physical device's non-clinical testing.

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

Not Applicable. MRMC studies are designed to assess the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical instrument, not a diagnostic AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical device, not an algorithm. The "stand-alone" performance would refer to its functional capabilities (e.g., cutting rate, sterility) as assessed through engineering and bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable (or rather, the "ground truth" is defined by established engineering standards and regulatory requirements). The "truth" for this device's performance is determined by:
- Biocompatibility test results: Conformance to ISO 10993 standards.
- Sterilization validation: Achieving a specific sterility assurance level (SAL).
- Functional specifications: Meeting defined maximum cut rates and operational parameters.
- Materials specifications: Using specified and validated materials.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no AI training set, there is no ground truth for a training set.

In summary: The provided 510(k) pertains to a hardware medical device. Its "acceptance criteria" are met through demonstrating compliance with recognized standards for biocompatibility, sterility, manufacturing quality, and functional equivalence to a predicate device through non-clinical testing. The concepts of AI-specific elements like reader studies, ground truth establishment, and training/test sets as typically discussed for SaMDs do not apply here.

Summary

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510 (k): K093305

APR - 2 2010

Image /page/0/Picture/2 description: The image shows the logo for Alcon Research, LTD. The logo is in black and white and features the word "Alcon" in large, outlined letters. Below the word "Alcon" is the phrase "RESEARCH, LTD." in smaller, outlined letters. The logo has a simple and clean design.

ALCON RESEARCH, LTD.
15800 ALTON PARKWAY
IRVINE, CA 92816
(949) 753-1393

Premarket Notification 510(K) Summary

This summary document is being prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Martin A. Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 15800 Alton Parkway Irvine, CA 92618 Phone: (949) 753-6250 Fax: (949) 753-6237

Device Subject to this 510(k):

Trade Name:	Enhanced UltraVit Probe
Common Name:	Vitrectomy Probe
Classification Name:	Vitreous aspiration and cutting instrument(886.4150)

Product Code: MLZ

Predicate Devices

The legally marketed devices(s) to which we are claiming equivalence to are:

510(k) Number	Device
K063583	ALCON® Vision System (CONSTELLATION®) UltraVitProbes

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Device Description

Increased maximum cut rate. .
. Software look-up table changes to accommodate RFID recognition of new probe.
Parylene N Coating on "O" ring seals. .

Indications for Use

The ALCON® Enhanced UltraVit® Probe is intended to be used to remove vitreous and dissect tissue in the eve.

Brief Summary of Non-clinical test and Results

Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:

Standard #	Title
10993-1: 2003 AAMI/ANSI/ISO	Biological Evaluation of Medical Devices --Part 1: Evaluation and testing
10993-5: 1999 AAMI/ANSI/ISO	Biological Evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity
10993-7:1995 AAMI/ANSI/ISO	Biological evaluation of medical devices - Part7: Ethylene oxide sterilization residuals
10993-10:2002/A1:2006 AAMI/ANSI/ISO	Biological Evaluation of Medical Devices --Part 10: Tests for irritation and delayed-typehypersensitivity - Including A1:2006
10993-11:2006 AAMI/ANSI/ISO	Biological Evaluation of Medical Devices --Part 11: Tests for systemic toxicity
10993-12:2007 AAMI/ANSI/ISO	Biological Evaluation of Medical Devices --Part 12: Sample Preparation and ReferenceMaterials

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The ALCON® Enhanced UltraVit Probe is provided sterile and intended for single use only. This product is Ethylene Oxide sterilized and the process has been validated to a SAL of 10to per FDA Recognized Consensus Standard - "EN ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

Technological characteristics affecting clinical performance are similar to those of predicate devices previously listed. The ALCON® Enhanced UltraVit® Probe has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003. Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices.

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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 consists of a stylized depiction of an eagle or bird-like figure with three overlapping lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

APR - 2 2010

Alcon Research, Ltd. c/o Mr. Martin A. Kaufman Director, Regulatory Affairs 15800 Alcon Parkway Irvine, CA 92816

Re: K093305

Trade/Device Name: Enhanced UltraVit Probe Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: II Product Code: MLZ Dated: February 5, 2010 Received: February 5, 2010

Dear Mr. Kaufman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 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 (PMA), it may be subject to 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 device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ALCON® Enhanced UltraVit® Probe Indications for Use:

The ALCON® Enhanced UltraVit® Probe is indicated to be used to remove vitreous and dissect tissues in the eye.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K013305

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.