(268 days)
Not Found
No
The document describes a surgical system with various functions (irrigation, aspiration, ultrasound phaco, diathermy, vitrectomy) controlled by a surgeon via a foot pedal and control panel. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance studies.
Yes.
The device is used for surgical interventions to treat cataractous lenses and perform vitrectomy, which are therapeutic procedures aimed at restoring or improving health.
No
The Faros is a surgical system used for treatment (lens fragmentation, aspiration) and ancillary functions (vitreous cutting, diathermy) during cataract surgery, not for diagnosis.
No
The device description clearly outlines a physical system including a main unit, infusion pole, foot pedal, tubing system, and surgical handpieces, indicating it is a hardware-based medical device with integrated software for control.
Based on the provided information, the Faros Surgery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Faros is a "surgery system used by ophthalmologists during cataract surgery." It describes surgical procedures performed on the patient's eye (anterior segment).
- Device Description: The description details a surgical system with handpieces and functions for performing procedures like lens fragmentation, irrigation, aspiration, diathermy, and vitrectomy. These are all surgical interventions performed directly on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Faros does not perform any such analysis of specimens.
The Faros is a surgical device used for performing procedures in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.
Faros is used for these surgical interventions in the anterior eye segment:
- Irrigation and aspiration (I/Afunction)
- Ultrasound phaco (PHACO function)
- Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
- Bipolar diathermic capsulotomy (CAPS function)
- Operation of a vitrectomy instrument (VIT function)
The device may only be used with the instruments recommended and supplied by Oertli.
Product codes (comma separated list FDA assigned to the subject device)
HQC, HQE, GEI
Device Description
The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens, which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery.
The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.
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
Used by ophthalmologists during cataract surgery. Prescription Use.
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 Faros Surgery System and the predicate device. CataRhex 3. have similar safety, effectiveness, and performance profiles. Technological characteristics affecting surgical performance are similar to those of the predicate CataRhex 3. Non-clinical testing has demonstrated that the Faros Surgery System complies with specifications and requirements established for the Faros Surgery System and the proposed subject device is substantially equivalent to the predicate device.
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.
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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June 27, 2024
Oertli Instrumente AG % Meagan Fagan Principal Consultant, CardioMed Device Consultants LLC CardioMed Device Consultants LLC 1783 Forest Drive Suite 254 Annapolis, Maryland 21401
Re: K233398
Trade/Device Name: Faros Surgical System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE, GEI Dated: May 28, 2024 Received: May 28, 2024
Dear Meagan Fagan:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Claudine H. Krawczyk -S
Claudine Krawczyk Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233398
Device Name Faros Surgical System
Indications for Use (Describe)
The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.
Faros is used for these surgical interventions in the anterior eye segment:
- Irrigation and aspiration (I/Afunction)
- Ultrasound phaco (PHACO function)
- Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
- Bipolar diathermic capsulotomy (CAPS function)
- Operation of a vitrectomy instrument (VIT function)
The device may only be used with the instruments recommended and supplied by Oertli.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
(as required by 21 CFR 807.92)
Faros Surgical System
510(k) K233398
| Date Prepared | June 20th, 2024 |
|---|---|
| Applicant | Oertli Instrumente AG |
| Hafnerwisenstrasse 4 | |
| 9442 Berneck | |
| Switzerland | |
| Contact Name: | Ms. Marianne Kesseli |
| Title: | Regulatory Affairs Manager |
| Email: | marianne.kesseli@oertli-instruments.com |
| Telephone: | +41 71 747 42 74 |
| Name of the Device | Faros Surgical System |
| Common Name | Phacofragementation Unit |
| Classification Name | Phacofragmentation System (21 CFR 886.4670) |
| Regulatory Class | II |
| Product Code | HQC |
| Subsequent Product Codes | HQE, GEI |
| Predicate Device | CataRhex 3 Cataract Surgery System (K133562) |
Intended Use/Indications for Use:
The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.
Faros is used for these surgical interventions in the anterior eye segment:
- . Irrigation and aspiration (I/A function)
- . Ultrasound phaco (PHACO function)
- . Bipolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
- Bipolar diathermic capsulotomy (CAPS function) ●
- . Operation of a vitrectomy instrument (VIT function)
The device may only be used with the instruments recommended and supplied by Oertli.
Device Description
The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens,
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which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery.
The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.
Comparison with Predicate Device
Comparison of the Faros Surgery System and the predicate device shows that the technological characteristics of the subject device (Faros Surgery System) such as the software and operating principle are similar to the currently marketed predicate device. The intended use of the subject device and the predicate are the same.
| Subject Device - Faros | Predicate Device - CataRhex 3 | |
|---|---|---|
| Manufacturer | Oertli Instrumente AG | Oertli Instrumente AG |
| 510(k) | K233398 | K133562 |
| Indication for | ||
| Use/Intended Use | The Faros Surgery System is used by | |
| ophthalmologists during cataract surgery. It is | ||
| designed for use in anterior segment | ||
| procedures that require simultaneous lens | ||
| fragmentation, irrigation, and aspiration, as | ||
| well as ancillary functions such as vitreous | ||
| cutting along with bipolar diathermy. |
The Faros Surgery System is used for these
surgical interventions in the anterior eye
segment:
Irrigation and aspiration (I/A function) Ultrasound phaco (PHACO function) Biopolar diathermy for hemostasis and
coaptation of the conjunctiva (DIA
function) Bipolar 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. | The CataRhex 3 is a surgery system used by
ophthalmologists during cataract surgery. It is
designed for use in anterior segment procedures
that require simultaneous lens fragmentation,
irrigation and aspiration, as well as ancillary
functions such as vitreous cutting along with bipolar
diathermy.
The CataRhex 3 is used for surgical interventions in
the anterior eye segment:
Irrigation and aspiration (I/A function) Ultrasound phaco (PHACO function) Biopolar diathermy for hemostasis and
coaptation of the conjunctiva (DIA function) Bipolar 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. |
| Hardware Design | Main unit, tower-like device
Transportable: mobile
Foot pedal with additional switches
Control panel with backlit keys, with
additional keys
Automated irrigation pole
Colour coded ports for hand pieces
Voltage indicator LED
Fluidic system
Optional instrument table | Main unit, compact console
Transportable: portable
Foot pedal
Control panel with backlit keys
Manual irrigation pole
Colour coded ports for hand pieces
Fluidic system |
| Software | Software features:
continuous state of device monitoring control signals generation interfacing the parts of the device | Software features:
continuous state of device monitoring control signals generation interfacing the parts of the device |
| Electrical data | Mains voltage: 100 - 240 VAC
Mains frequency: 50 - 60 Hz
Power consumption: 150 VA
Operating mode: continuous | Mains voltage: 100 - 240 VAC
Mains frequency: 50/60 Hz
Power consumption: 280 VA
Operating mode: continuous |
| Irrigation / Aspiration | Gravity feed irrigation | Gravity feed irrigation |
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| Subject Device - Faros | Predicate Device - CataRhex 3 | |
|---|---|---|
| Function | I/A pump principle: peristaltic | |
| I/A modes | I/A pump principle: peristaltic | |
| I/A modes | ||
| Phaco Function | Ultrasonic emulsification | |
| Oscillation: longitudinal | ||
| Operating frequency: 28 kHz | ||
| Phaco modes | ||
| Preset aspiration mode called SPEEP | Ultrasonic emulsification | |
| Oscillation: longitudinal | ||
| Operating frequency: 28 kHz | ||
| Phaco modes | ||
| Preset aspiration mode called CORTEX | ||
| Diathermy Function | Bipolar diathermy | |
| Capsulotomy | ||
| Diathermy modes | ||
| Operating frequency: 500 kHz | Bipolar diathermy | |
| Capsulotomy | ||
| Diathermy modes | ||
| Operating frequency: 500 kHz | ||
| Vitrectomy Function | Cutting principle: pneumatic | |
| Push and pull movement | ||
| Cutting design: guillotine | Cutting principle: pneumatic | |
| Push and pull movement | ||
| Cutting design: guillotine |
Summary of Performance Data
The Faros Surgery System and the predicate device. CataRhex 3. have similar safety, effectiveness, and performance profiles. Technological characteristics affecting surgical performance are similar to those of the predicate CataRhex 3. Non-clinical testing has demonstrated that the Faros Surgery System complies with specifications and requirements established for the Faros Surgery System and the proposed subject device is substantially equivalent to the predicate device.
Electrical safety and electromagnetic compatibility (EMC)
The Faros Surgery System electrical safety and electromagnetic compatibility has been evaluated and found to be in compliance with:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012. C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- . FDA Guidance Electromagnetic Compatibility (EMC) of Medical Devices, 2022-06
- . IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- . IEC 80601-2-58 Edition 2.0 2014-09 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
Software
The Faros Surgery System software has been evaluated and found to be in compliance with:
- FDA Guidance, Content of Premarket Submissions for Device Software Functions, 2023-06 .
- . IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
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Cybersecurity
The Faros Surgery System cybersecurity has been evaluated and found to be in compliance with:
- . FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, 2023-09
- . FDA Guidance for Post-market Management of Cybersecurity in Medical Devices, 2016-12-28
- AAMI TIR57:2016 . Principles for medical device security - Risk management
- . AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
- . ANSI AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
- . IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety effectiveness and security - Part 5-1: Security -Activities in the product life cycle
- . ISO/IEC 29147:2018-10 Information technology - Security techniques - Vulnerability disclosure
- . ISO/IEC 30111:2019-10 Information technology - Security techniques - Vulnerability handling processes
- . FIRST CVSS v3.X Common Vulnerability Scoring System version 3.X
Usability
The Faros Surgery System usability has been evaluated and found to be in compliance with:
- FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices, 2016-02
- . IEC 62366-1 Edition 1.1 2020-06 Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
- . IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Biocompatibility
The biocompatibility of the Faros Surgery System and its components and accessories was found to be in compliance with:
- FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical ● devices - Part 1: Evaluation and testing within a risk management process, 2023-09
- ISO 10993-1 Fifth edition 2018-08 ● Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
8
- . ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Processing of Reusable Accessories (Moist Heat)
The reusable accessories of Faros Surgery System were found to be in compliance with:
- . ISO 17664-1 Second edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
Sterility of Accessories
The sterile accessories of Faros Surgery System were found to be in compliance with:
- . FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, 2024-01
Conclusion
The Faros surgery system has the same intended use, similar design and functional features as the predicate device. Conclusions drawn from the non-clinical tests demonstrate that the Faros Surgery System is substantially equivalent to the predicate device.