K Number
K133562
Device Name
CATARHEX 3
Date Cleared
2014-08-12

(265 days)

Product Code
Regulation Number
886.4670
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The CataRhex 3 is medical electrical equipment to be used during eye surgery and is intended for ophthalmic anterior segment surgery. 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.
More Information

Not Found

No
The summary describes a surgical device with various functions (phaco, I/A, diathermy, vitrectomy, capsulotomy) controlled via a display, buttons, and a footswitch. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.

No.
The device is used for surgical interventions in the anterior eye segment to improve the patient's existing condition rather than for preventing or treating a disease, or affecting the structure or any function of the body.

No

This device is used for surgical interventions (therapeutic) and does not mention any diagnostic functions or capabilities.

No

The device description clearly states it is "medical electrical equipment" and includes physical components like a display, buttons, and a footswitch, indicating it is a hardware device with integrated software, not a software-only device.

Based on the provided information, the CataRhex 3 is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the device is used for "surgical interventions in the anterior eye segment." This involves direct surgical procedures on the patient's body.
  • Device Description: The description reinforces its use during "eye surgery" and its capabilities are all related to surgical procedures (phacoemulsification, irrigation/aspiration, etc.).
  • Anatomical Site: The device operates on the "anterior eye segment," which is a part of the living patient.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The CataRhex 3 does not perform any such analysis of specimens.

The CataRhex 3 is a surgical device used directly on the patient during an operation.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HQC, HQE, GEI

Device Description

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

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior eye segment

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081877, K101325

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

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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

1

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 AG
Hafnerwisenstrasse 4
CH-9442 Berneck
Switzerland |
|-----------------------------|------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Karin Rohr
Phone: +41 71 7474275
Fax: +41 71 7474290
Email: 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 Product
Code: | 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) NumberClearance DateDevice Description
K08187701/05/2009ASSOCIATE 2500 DUAL
AND COMPACT
SYSTEMS
K10132508/17/2010STELLARIS PC VISION
ENHANCEMENT
SYSTEM

Device Description

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

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.

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.