(274 days)
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, bipolar coagulation and anterior vitrectomy.
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.
This FDA 510(k) summary document for the QUATERA 700 phacoemulsification system does not provide specific acceptance criteria or a detailed study report proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EVA Ophthalmic Surgical System K142877) through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various non-clinical tests performed and states that "Testing passed" or "Testing showed that the defined specifications [were met]". The "acceptance criteria" are implied to be the standards and specifications referenced for each test.
| Test Category | Implied Acceptance Criteria (Standards/Specifications) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-12, USP 34 <151> | Met specifications; Testing passed. |
| Sterility | ISO 11135:2014 (SAL of 10^-6), ISO 14644-2, ASTM F1608, ISO 11607-1, ASTM F1886-F1886M, ASTM F88/F88M, EN 868-5, ASTM F2096, AAMI TIR 30, AAMI TIR 12, AAMI TIR 34, AAMI TIR ST81, ISO 15883-1 | Achieved SAL of 10^-6; Testing passed. |
| Software | FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005), IEC 62304:2006+AC:2015, IEC 62366 | Testing passed. |
| Electrical Safety/EMC | IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2 | Testing passed. |
| Additional Bench Testing | Conformance to IEC 80601-2-58, IEC 60529 (for occlusion break response, fluidics, spring-eye model, emersion testing) | Testing passed. |
| Functional and System Level Testing | Defined specifications (not explicitly detailed) | Met defined specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for any of the non-clinical tests (e.g., how many units were tested for electrical safety, how many components for biocompatibility). The testing is described qualitatively.
- Data Provenance: The data provenance is primarily from non-clinical bench testing conducted by the manufacturer, Carl Zeiss Meditec AG, located in Germany. These are laboratory tests and do not involve human subjects or retrospective/prospective clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical engineering and laboratory testing, not a clinical study with human data requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above. The "ground truth" for the non-clinical tests is based on the adherence to established industry standards and internal specifications, not expert adjudication of clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not required since the system does not introduce a new methodology or new/expanded clinical claims." This indicates that the FDA deemed a clinical study unnecessary for this 510(k) submission, relying instead on substantial equivalence to the predicate device. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described (QUATERA 700) is a phacoemulsification surgical system, not an AI or algorithm-only device. Its performance is inherent in its electromechanical functions and safety features. Therefore, a standalone "algorithm only" performance assessment in the context of AI is not applicable. The software testing was for the device's internal control software, not a diagnostic algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" is established by:
- Industry standards and regulations: e.g., ISO, ASTM, IEC, USP.
- Manufacturer's defined specifications: These are the internal performance requirements for the device.
8. The Sample Size for the Training Set
This information is not applicable. The QUATERA 700 is a surgical hardware system with integrated software, not a machine learning or AI device that requires a "training set" in the conventional sense for deep learning models. The software testing mentioned is for the device's operational software.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above. There is no training set for an AI model.
In summary, the provided document focuses entirely on demonstrating the substantial equivalence of the QUATERA 700 to an existing predicate device through non-clinical bench testing, adhering to recognized standards for safety and performance (biocompatibility, sterility, software, electrical safety, etc.). It explicitly states that clinical studies were not required.
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April 19, 2022
Carl Zeiss Meditec AG % Maria Golovina Head of Regulatory Affairs - USA Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, California 94568
Re: K212241
Trade/Device Name: QUATERA 700 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE Dated: March 9, 2022 Received: March 10, 2022
Dear Maria Golovina:
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.
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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 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 (QS) 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 medical devices and radiation-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.
Anjana Jain, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212241
Device Name QUATERA 700
Indications for Use (Describe)
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, bipolar coagulation and anterior vitrectomy.
| 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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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 | Maria Golovina |
| Head of Regulatory Affairs - USA | |
| Carl Zeiss Meditec, Inc. | |
| 5300 Central Parkway Dublin, CA 94568 | |
| (925) 216-1078 Phone (925) 557-4259 Fax | |
| E-mail: maria.golovina@zeiss.com (preferred) |
Date Prepared:
April 18, 2022
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2. SUBJECT DEVICE
| Device Trade Name: | QUATERA 700 |
|---|---|
| Classification: | 21CFR886.4670 Phacofragmentation System |
| Regulatory Class: | II |
| Product Code: | HQC, HQE |
PREDICATE DEVICE AND REFERENCE DEVICE 3.
3.1. PREDICATE DEVICE
| Predicate Device: | EVA Ophthalmic Surgical System (K142877) |
|---|---|
| Classification: | 21 CFR 886.4670 Phacofragmentation System |
| Regulatory Class: | II |
| Product Code: | HQC, HQE, HQF |
3.2. REFERENCE DEVICE
| Predicate Device: | Visalis V500, Visalis S500 (K193376) |
|---|---|
| Classification: | 21 CFR 886.4670 Phacofragmentation System |
| Regulatory Class: | II |
| Product Code: | HQC |
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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.
INDICATIONS FOR USE న్.
QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the 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 Prescription Use (Rx) only.
SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.
Table 1. Subject to Predicate Device Comparison Table - Indications for Use
| Subject Device | Primary Predicate Device(K142877) | Equivalency Analysis |
|---|---|---|
| QUATERA 700 is intended for theemulsification and removal of cataracts andanterior segment vitrectomy. In combinationwith various required components and | The EVA Ophthalmic SurgicalSystem is indicated for bothanterior segment (i.e.) | The indications for use areequivalent as basis of themedical context. Thedifferent wording leads to |
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| Subject Device | Primary Predicate Device(K142877) | Equivalency Analysis |
|---|---|---|
| accessories, the device is designed for use inanterior segment surgery. It providescapabilities for phacoemulsification, coaxialand bimanual irrigation/aspiration, bipolarcoagulation and anterior vitrectomy. | phacoemulsification andremoval of cataracts) andposterior segment (i.e.,vitreoretinal)ophthalmic surgery. | equivalent therapy options,however the indicationsprovided by QUATERA700 is clearer. |
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
| Attribute | Subject Device | Primary Predicate Device(K142877) | EquivalencyAnalysis |
|---|---|---|---|
| Device name | QUATERA System(QUATERA 700) | EVA Ophthalmic SurgicalSystem | N/A |
| Manufacturer | Carl Zeiss Meditec AG | D.O.R.C. Dutch OphthalmicResearch Center (International)B.V. | N/A |
| 510(k) | K212241 | K142877 | N/A |
| Classification ProductCode | HQC, HQE | HQC, HQE, HQF | Equivalent |
| Regulation # | 21CFR886.4670 | 21CFR886.4670 | Identical |
| Application | Phacofragmentation SystemOphthalmic Surgery | Phacofragmentation SystemOphthalmic Surgery | Identical |
| Combination Device | No | No | Identical |
| Patient Population | Adults | Adults | Identical |
| System Procedures | - Irrigation / Aspiration- Ultrasound- Diathermy- Anterior Vitrectomy | - Irrigation / Aspiration- Ultrasound- Diathermy- Vitrectomy- Illumination- Air tamponade- Silicone tamponade- Laser | Identical,narrower scope |
| 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, GraphicalUser Interface, Handpiece | Identical |
| IRRIGATION and ASPIRATION | |||
| Aspiration Pump Type | Flow Control & VacuumControlQuattro Pump | Peristaltic | Different |
| Irrigation | Yes | Yes | Identical |
| Attribute | Subject Device | Primary Predicate Device(K142877) | EquivalencyAnalysis |
| 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 | 100 µm | Equivalent |
| Incision type Co-Mix | 1.8mm | 1.8 mm | Identical |
| Pulse Mode/Duration | 0 - 250 pps | 0 - 250 pps | Identical |
| Phaco Tip Movement | longitudinal | longitudinal | Identical |
| DIATHERMY | |||
| Operating Frequency | 2 MHz (± 20%) | 1MHz ± 10% | Equivalent |
| 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 |
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7. SUMMARY OF STUDIES
Non-Clinical Performance Testing
Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the defined specifications. Substantial equivalence was additionally demonstrated by using equivalent testing methods applied during testing of the subject device (such as biocompatibility, sterility, software, electrical safety, and software) as compared to the reference device. The totality of the performance data provided supports substantial equivalence and is summarized below.
Biocompatibility & Animal Testing
Biocompatibility assessments and testing for patient contacting components/accessories was performed in accordance with the following standards: ISO 10993-1, ISO 10993-7, ISO 10993-10, ISO 10993-11, and ISO 10993-12, USP 34 <151>. Specifications regarding intracutaneous reactivity or acute ocular irritation tested in rabbits (ISO 10993-10), material mediated pyrogenicity tested in rabbits (USP 34 <151>), acute systemic cytotoxicity tested in mice (ISO 10993-11), kligman maximization (i.e., skin sensitization) tested in guinea pigs (ISO 10993-10) have been met.
Additionally, patient contacting components referenced in this 510(k) are identical to the device components referenced in K193376. These components are I/A HANDPIECE 21G ANGLED 45°, VA HANDPIECE 21G CURVED. IRR & ASP HANDPIECE BIMANUAL FRONT. IRR & ASP HANDPIECE BIMANUAL. PHACO SET PLUS 21G BICONICAL 15°, PHACO SET PLUS 21G FLARED 30°, PHACO SET PLUS 21G BICONICAL 30°, tips for PHACO SET (flared tip 30°, biconical tip 15°, biconical tip 30°) Sleeve, test chamber set plus 21G, DIATHERMY FORCEPS.
Sterility Testing
The sterilization cycle B-01 /B-01x was validated to achieve a sterility assurance level (SAL) of 10 9 according to ISO 11135:2014. Additionally, visual inspection, micro-biological dusting, seal strength, dye penetration and bubble leak testing was performed to ensure micro-biological barrier function met specifications. Testing passed.
Additionally, after the sterilization process was completed, testing on the patient contacting components for the accessories to measure ethylene oxide (EO) and ethylene chlorohydrin residual (ECH) levels, as well as Limulus Amebocyte Lysate (LAL) levels was conducted. Testing passed.
The following standards were followed: ISO 11135, ISO 14644-2, ASTM F1608, ISO 11607-1, ASTM F1886F1886M, ASTM F88/F88M and EN 868-5, ASTM F2096, AAMI TIR 30, AAMI TIR 12, AAMI TIR 34, AAMI TIR ST81, ISO 15883-1.
Software Testing
Subject Device 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 62304:2006+AC:2015 - Medical device software - Software life cycle processes. Validation has been conducted according to IEC 62366. Testing passed.
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Electrical Safety/EMC Testing
Electrical, Thermal, EMC testing was conducted in accordance with IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2 standards. Testing passed.
Additional Bench Testing
In addition to testing mentioned above, conformance to IEC 80601-2-58 and IEC 60529 was demonstrated by testing for occlusion break response, fluidics assessments, spring-eye model, and emersion testing was performed. Testing passed.
Clinical Performance Testing
Clinical studies were not required since the system does not introduce a new methodology or new/expanded clinical claims.
CONCLUSION 8.
The indications for use are equivalent to the indications for use of the predicate device; are deemed to be substantially equivalent.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are deemed to be substantially equivalent.
Testing methods are equivalent to those of the predicate device and reference device; and therefore, are deemed to be substantially equivalent.
Therefore, the subject device meets the requirements for substantial equivalence as compared to the proposed predicate device.
§ 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.