(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 | 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.
§ 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.