It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectomy and capsulotomy. The equipment has a display and buttons for selecting and activating the functions. With the equipment a footswitch is delivered for control by the surgeon.

AI/ML Overview

This document is a 510(k) Premarket Notification for the CataRhex 3 Cataract Surgery System. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria in a table format nor does it report detailed device performance metrics. Instead, it relies on a statement of substantial equivalence to predicate devices and adherence to general safety standards.

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

The document states: "No clinical studies were deemed necessary to determine the safety and effectiveness or substantial equivalence of CataRhex 3 to their predicate devices." This implies that there was no specific "test set" of patient data in the context of clinical performance evaluation. The evaluation was based on non-clinical testing.

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):

Since no clinical studies were performed, there was no test set with ground truth established by experts.

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

As no clinical studies were performed, no adjudication method was used for a test set.

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 device is a surgical system, not an imaging diagnostic AI tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed. There is no AI component mentioned that would assist human readers.

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

This device is a surgical system requiring human operation, not a standalone AI algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

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

Given the absence of clinical studies, no clinical "ground truth" (such as expert consensus, pathology, or outcomes data) was used. The evaluation was based on non-clinical testing to ensure the device performs as intended and meets safety standards, similar to its predicate devices.

8. The sample size for the training set:

The document states that no clinical studies were performed, and the evaluation was based on non-clinical testing. Therefore, there is no concept of a "training set" in the context of clinical data for this device.

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

As there was no training set for clinical data, no ground truth for a training set was established.

Summary of the Study and Acceptance Criteria Basis:

The document indicates that the CataRhex 3 Cataract Surgery System's safety and effectiveness are based on:

Substantial Equivalence: The device is considered substantially equivalent to the predicate devices:
- K081877 ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
- K101325 STELLARIS PC VISION ENHANCEMENT SYSTEM
Non-Clinical Testing: The device underwent non-clinical testing to ensure compliance with applicable safety standards and to demonstrate that it performs equivalently to the predicate devices.
Compliance with Quality Systems: The device will be manufactured in compliance with FDA and ISO quality systems requirements.
Validation and Verification: Functional requirements and specifications were met prior to commercial release, as shown through validation and verification processes.

Conclusion stated in the document: "The data presented from the nonclinical tests demonstrate that the device is safe and effective, and performs as safely and effectively as the legally marketed predicate devices. Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release."

In essence, the "acceptance criteria" here implicitly refer to meeting the performance, safety, and functional characteristics of the predicate devices through non-clinical testing and adherence to regulatory standards, rather than through a clinical study with defined performance metrics against a clinical ground truth.

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 features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines above them that resemble a bird's wing.

Public Health Service

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

August 12, 2014

Oertli Instrumente AG Ms. Karin Rohr Head of Quality Management & Regulatory Affairs Hafnerwisenstrasse 4 CH 9442 Berneck Switzerland

Re: K133562

Trade/Device Name: CataRhex 3 Cataract Surgery System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE Dated: July 9, 2014 Received: July 11, 2014

Dear Ms. Rohr:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, 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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Section 4: Indication for Use Statement

Indications for Use

510(k) Number (if known): K133562

Device Name: CataRhex 3

Indications for Use:

The CataRhex 3 is used for surgical interventions in the anterior eye segment.

Irrigation and aspiration (I/A function) ●
Ultrasound phaco (PHACO function)
Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function)
Diathermic capsulotomy (CAPS function)
. Operation of a vitrectomy instrument (VIT function)

The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.

Prescription Use X (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)

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Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the CataRhex 3 Premarket Notification.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the CataRhex 3 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device.

Applicant:	Oertli Instrumente AGHafnerwisenstrasse 4CH-9442 BerneckSwitzerland
Contact:	Ms. Karin RohrPhone: +41 71 7474275Fax: +41 71 7474290Email: karin.rohr@oertli-instruments.com
Date of Preparation:	November 16, 2013
Proprietary Name:	CataRhex 3
Common Name:	Phacofragmentation System
Classification Status:	Class II
Product Code:	HQC
Subsequent ProductCode:	HQE, GEI
Panel:	Ophthalmic Devices

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Predicate Device

Oertli's CataRhex 3 is substantially equivalent, for the purpose of this 510(k), to the following predicate devices.

510(k) Number	Clearance Date	Device Description
K081877	01/05/2009	ASSOCIATE 2500 DUALAND COMPACTSYSTEMS
K101325	08/17/2010	STELLARIS PC VISIONENHANCEMENTSYSTEM

Device Description

The CataRhex 3 is medical electrical equipment to be used during eye surgery and is intended for ophthalmic anterior segment surgery.

Intended Use

The CataRhex 3 is used for surgical interventions in the anterior eye segment.

Irrigation and aspiration
Ultrasound phaco ●
Bipolar diathermy for coagulation of bleeding during eye surgery ●
. Bipolar diathermic capsulotomy
o Operation of a vitrectomy instrument

The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.

Clinical and Non-Clinical testing

The CataRhex 3 has undergone testing and is in compliance with applicable safety standards. The subject device was found to perform equivalently to the predicate device. Therefore, the subject device and the predicate devices have similar safety, effectiveness, and performance profiles.

No clinical studies were deemed necessary to determine the safety and effectiveness or substantial equivalence of CataRhex 3 to their predicate devices.

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Conclusion

The technological characteristics that determine the functionality and performance of the CataRhex 3 are substantially equivalent to those of the predicate devices. The CataRhex 3 will be manufactured in compliance with FDA and ISO quality systems requirements. The data presented from the nonclinical tests demonstrate that the device is safe and effective, and performs as safely and effectively as the legally marketed predicate devices. Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release.

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.