(124 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard surgical functions and control mechanisms.
Yes
The device is intended for the emulsification and removal of cataracts and anterior segment vitrectomy, which are medical procedures to treat a condition (cataracts) and perform surgical functions, thus making it a therapeutic device.
No
The device is described as a surgical system for the emulsification and removal of cataracts and anterior segment vitrectomy, providing capabilities for various surgical procedures. It does not perform diagnostic functions.
No
The device description explicitly mentions fluidic, ultrasound, and pneumatic modules, as well as a Foot Control Panel and various accessories, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the emulsification and removal of cataracts and anterior segment vitrectomy. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device description details a surgical system with functions like irrigation, aspiration, ultrasound, diathermy, and vitrectomy. These are all actions performed during surgery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze samples (like blood, tissue, or urine), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The QUATERA System is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.
This device is for Prescription Use (Rx) only.
Product codes
HQC, HQE
Device Description
QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation.
QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values.
QUATERA 700 has the following functions:
- · Irrigation and Aspiration
- · Ultrasound Capability
- · Diathermy
- · Anterior Vitrectomy
- Reflux
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, eye
Indicated Patient Age Range
Adults
Intended User / Care Setting
surgeon, clinic(s)/hospital(s)/surgical practice network.
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)
Non-Clinical Performance Testing
Biocompatibility
QUATERA 700 is not intended to come into contact with the patient. The materials used for the device console are common and widely used for ophthalmic and similar applications without reported heath concerns. ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12 standards have been followed for the accessories/ components, specifically regarding cytotoxicity, kligman maximization, and intracutaneous irritation and acute systemic toxicity testing.
Sterilization and Shelf Life
QUATERA 700 is a non-sterile system that has sterilized or reprocessed accessories. QUATERA 700 is not provided sterilized and is not intended to be sterilized during routine use.
Sterilization testing was performed on the appropriate components of the subject device. The testing aligns with current recognized standards and meets or exceeds testing performed for the predicate device.
Software Verification and Validation Testing
QUATERA 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005). In addition, the software testing also followed the Carl Zeiss Meditec internal software development procedure that follows the IEC 62304:2008 + AC:2015 - Medical device software life cycle processes. Validation has been conducted according to IEC 62366. Testing passed.
Electromagnetic compatibility (EMC) and Electrical Safety Testing Electrical safety and EMC testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2 standards. Testing passed.
(Bench) Performance Testing
Additional laboratory (bench) performance tests have been conducted for QUATERA 700 to demonstrate efficacy, safety and substantial equivalence to predicate devices including:
-Testing to ensure compliance to IEC 80601-2-58 " Medical electrical equipment, Part 2: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery"
-Testing to ensure compliance to IEC 60601-2-2 " Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories"
Animal/Clinical Performance Testing
Animal and Clinical testing was not conducted
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
July 31, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Carl Zeiss Meditec AG % Aditya Rao Regulatory Affairs Specialist- USA Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, California 94568
Re: K230858
Trade/Device Name: Quatera 700 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE Dated: June 26, 2023 Received: June 27, 2023
Dear Aditya Rao:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
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,
Elvin Y.)
for Claudine Krawczyk Acting 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
2
Indications for Use
510(k) Number (if known) K230858
Device Name QUATERA 700
Indications for Use (Describe)
QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.
This device is for Prescription Use (Rx) only
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
In accordance with 21 CFR 807.92 the 510(k) Summary for the QUATERA 700 is provided below.
1. SUBMITTER
| Applicant: | Carl Zeiss Meditec AG
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Aditya Rao
Regulatory Affairs Specialist - USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 549-9579 Phone (925) 557-4259 Fax
E-mail: aditya.rao@zeiss.com (preferred) |
| Secondary Correspondent | Anja Michelchen
Regulatory Affairs Manager
Carl Zeiss Meditec AG
Rudolf-Eber-Strasse 11 73447 Oberkochen, Germany
+49 7364 20 9963 Phone
E-mail: anja.michelchen@zeiss.com |
| Date Prepared: | July 31, 2023 |
4
2. DEVICE
| Device Trade Name: | QUATERA 700 (Software Version 1.1.4) |
|---|---|
| Classification: | 21CFR886.4670 Phacofragmentation System |
| Regulatory Class: | II |
| Product Code: | HQC, HQE |
3. PREDICATE DEVICE
Predicate Device: QUATERA 700 (Software Version 1.1.0) Classification: 21CFR886.4670 Phacofragmentation System Regulatory Class: II Product Code: HQC, HQE
DEVICE DESCRIPTION 4.
QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation.
QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values.
QUATERA 700 has the following functions:
- · Irrigation and Aspiration
- · Ultrasound Capability
- · Diathermy
- · Anterior Vitrectomy
- Reflux
QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.
INTENDED USE/INDICATIONS FOR USE న.
The intended use statement for the subject device is as follows:
QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment virrectomy. The device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation and anterior vitrectomy.
The Indications for Use (IFU) statement for the subject device is as follows:
5
QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.
This device is for Prescription Use (Rx) only.
SUBSTANTIAL EQUIVALENCE 6.
6.1. Primary Predicate
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| Subject Device | Predicate Device (K212241) | Equivalency Analysis |
|---|---|---|
| QUATERA 700 is intended for | ||
| the emulsification and removal | ||
| of cataracts, anterior and | ||
| posterior segment vitrectomy. | ||
| The device is designed for use | ||
| in anterior and posterior | ||
| segment surgeries. It provides | ||
| capabilities for | ||
| phacoemulsification, coaxial | ||
| and bimanual irrigation/ | ||
| aspiration, bipolar coagulation, | ||
| anterior vitrectomy, viscous | ||
| fluid injection/ removal and | ||
| air/fluid exchange operations. | QUATERA 700 is intended for | |
| the emulsification and removal | ||
| of cataracts, anterior and | ||
| posterior segment vitrectomy. | ||
| The device is designed for use | ||
| in anterior and posterior | ||
| segment surgeries. It provides | ||
| capabilities for | ||
| phacoemulsification, coaxial | ||
| and bimanual irrigation/ | ||
| aspiration, bipolar coagulation, | ||
| anterior vitrectomy, viscous | ||
| fluid injection/ removal and | ||
| air/fluid exchange operations. | The indications | |
| for use are | ||
| equivalent as | ||
| basis of the | ||
| medical context. |
| Attribute | Subject Device | Primary Predicate
Device (K212241) | Equivalency
Analysis |
|---------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------|
| Device name | QUATERA System
(QUATERA 700 (SW V1.1.4)) | QUATERA System
(QUATERA 700 (SW V1.1.0)) | N/A |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| 510(k) | K230858 | K212241 | N/A |
| Classification Product
Code | HQC, HQE | HQC, HQE | Identical |
| Regulation # | 21CFR886.4670 | 21CFR886.4670 | Identical |
| Attribute | Subject Device | Primary Predicate
Device (K212241) | Equivalency
Analysis |
| Application | Phacofragmentation
System
Ophthalmic Surgery | Phacofragmentation
System
Ophthalmic Surgery | Identical |
| Combination Device | No | No | Identical |
| Patient Population | Adults | Adults | Identical |
| System Procedures | Irrigation / Aspiration
Ultrasound
Diathermy
Anterior
Vitrectomy | Irrigation / Aspiration
Ultrasound
Diathermy
Anterior
Vitrectomy | Identical |
| Accessories Provided
Sterile | Yes | Yes | Identical |
| Method of
Sterilization | Ethylene Oxide | Ethylene Oxide | Identical |
| User Interface | Foot Control Panel,
Graphical User
Interface, Handpiece | Foot Control Panel,
Graphical User
Interface, Handpiece | Identical |
| IRRIGATION AND ASPIRATION | | | |
| Aspiration Pump Type | Flow Control &
Vacuum
ControlQuattro Pump | Flow Control &
Vacuum Control
Quattro Pump | Identical |
| Irrigation | Yes | Yes | Identical |
| Adjustable pump
ramp | Yes | Yes | Identical |
| Continuous Irrigation | Yes | Yes | Identical |
| PHACOEMULSIFICATION | | | |
| Handpiece type | Piezoelectrical | Piezoelectrical | Identical |
| Range of frequency | 40 kHz | 40 kHz | Identical |
| Control | fixed or linear | fixed or linear | Identical |
| Tip stroke | up to 100µm | up to 100µm | Identical |
| Incision type Co-Mix | 1.8mm | 1.8mm | Identical |
| Pulse Mode/Duration | 0 - 250 pps | 0 - 250 pps | Identical |
| Phaco Tip Movement | longitudinal | longitudinal | Identical |
| DIATHERMY | | | |
| Operating Frequency | 2 MHz (± 20%) | 2 MHz (± 20%) | Identical |
| Foot Control Panel | Yes | Yes | Identical |
| ANTERIOR VITRECTOMY | | | |
| Pneumatic | Yes | Yes | Identical |
| Cutting mode | Back and Forth | Back and Forth | Identical |
| Cutter control | Linear or fixed | Linear or fixed | Identical |
| Single Cut | Yes | Yes | Identical |
6
7
SUMMARY OF STUDIES 7.
Non-Clinical Performance Testing
Biocompatibility
QUATERA 700 is not intended to come into contact with the patient. The materials used for the device console are common and widely used for ophthalmic and similar applications without reported heath concerns. ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12 standards have been followed for the accessories/ components, specifically regarding cytotoxicity, kligman maximization, and intracutaneous irritation and acute systemic toxicity testing.
Sterilization and Shelf Life
QUATERA 700 is a non-sterile system that has sterilized or reprocessed accessories. QUATERA 700 is not provided sterilized and is not intended to be sterilized during routine use.
Sterilization testing was performed on the appropriate components of the subject device. The testing aligns with current recognized standards and meets or exceeds testing performed for the predicate device.
Software Verification and Validation Testing
QUATERA 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005). In addition, the software testing also followed the Carl Zeiss Meditec internal software development procedure that follows the IEC 62304:2008 + AC:2015 - Medical device software life cycle processes. Validation has been conducted according to IEC 62366. Testing passed.
Electromagnetic compatibility (EMC) and Electrical Safety Testing Electrical safety and EMC testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2 standards. Testing passed.
(Bench) Performance Testing
Additional laboratory (bench) performance tests have been conducted for QUATERA 700 to demonstrate efficacy, safety and substantial equivalence to predicate devices including:
-Testing to ensure compliance to IEC 80601-2-58 " Medical electrical equipment, Part 2: Particular requirements for the basic safety and essential performance of lens
removal devices and vitrectomy devices for ophthalmic surgery"
-Testing to ensure compliance to IEC 60601-2-2 " Medical electrical equipment Part 2:
Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories"
Animal/Clinical Performance Testing
Animal and Clinical testing was not conducted
8
8. REASONS FOR 510(k)
The subject device qualifies as a class II medical device and is therefore subject to a premarket notification. Changes to K212241 include:
- Minor Software changes
- Minor changes to the QUATTRO CASSETTE that do not affect Sterilization and Biocompatibility
- · Extension of shelf-life
• Changes to components and parts on the QUATERA 700 due to obsolescence reasons, minor improvements and small changes to the label.
9. CONCLUSION
The indications for use are equivalent to the indications for use of the predicate device and therefore, are deemed to be equivalent.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device.
Therefore, the subject device meets the requirements for substantial equivalence as compared to the proposed predicate device.