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.

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

QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a medical device called QUATERA 700. It asserts the device's substantial equivalence to a predicate device (also a QUATERA 700, but with older software) rather than presenting a performance study against specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable or not present in this document.

The document focuses on non-clinical performance testing and substantial equivalence to an existing device, primarily due to minor software changes and component updates. There is no mention of an AI/machine learning component that would require the rigorous performance evaluation typically outlined by the questions.

However, I can extract and infer information relevant to the types of "acceptance criteria" and "study" that were performed to demonstrate substantial equivalence, based on the provided text, even if not in the AI-specific format you requested.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative performance metrics against specific predefined acceptance criteria in the way one would for an AI algorithm's diagnostic accuracy. Instead, the "acceptance criteria" for this 510(k) are essentially the demonstration of compliance with established medical device standards and the maintenance of equivalence to the predicate device. The "performance" is a statement of compliance or "passed."

Acceptance Criteria Category/Standard	Reported Device Performance
Biocompatibility (for accessories/components coming into patient contact)	"Standards have been followed for the accessories/components, specifically regarding cytotoxicity, kligman maximization, and intracutaneous irritation and acute systemic toxicity testing." (Implies compliance/acceptance)
Sterilization and Shelf Life (for reprocessed accessories)	"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." (Implies compliance/acceptance)
Software Verification and Validation (Software Version 1.1.4)	"Testing passed." (According to FDA Guidance May 2005, IEC 62304:2008 + AC:2015, IEC 62366)
Electromagnetic Compatibility (EMC) and Electrical Safety	"Testing passed." (In accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2 standards)
Bench Performance Testing (Efficacy, Safety, Substantial Equivalence)	"Additional laboratory (bench) performance tests have been conducted... to demonstrate efficacy, safety and substantial equivalence to predicate devices." (Specifically: IEC 80601-2-58, IEC 60601-2-2). [Implies compliance/acceptance, but no specific metrics are given.]
Functionality Equivalence to Predicate (e.g., Irrigation/Aspiration, Ultrasound, etc.)	"Identical" for all listed functional attributes (see comparison tables on page 5-6).
Intended Use/Indications for Use Equivalence to Predicate	"The indications for use are equivalent as basis of the medical context." (See table on page 5).
Technological Characteristics and Risk Profile Equivalence to Predicate	"The technological characteristics and risk profile of the subject device are equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in the context of an AI model's performance on a dataset. The "tests" performed here are primarily engineering verification and validation (e.g., software testing, electrical safety, bench testing for performance against standards). The document does not specify "sample sizes" for these types of tests (e.g., how many times an electrical test was run, or how many components were tested for sterility).
Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The "data" here refers to test results from engineering and lab assessments.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The "ground truth" for this filing is compliance with engineering standards, functional equivalence to a predicate device, and successful verification/validation testing. This is typically established through documented test procedures and adherence to regulatory guidelines, not clinical expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of discrepancies in expert readings for clinical test sets.

5. MRMC Comparative Effectiveness Study:

No. The document explicitly states: "Animal and Clinical testing was not conducted." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone Performance:

Not applicable in the context of an AI algorithm's standalone performance. The device itself (QUATERA 700) performs specific surgical functions. Its "performance" is demonstrated through engineering tests and comparison to a predicate device, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

Compliance with recognized international and national standards (e.g., ISO, IEC, FDA guidance documents).
Successful completion of verification and validation testing protocols.
Functional equivalence to the legally marketed predicate device, demonstrated through comparative tables of specifications.

8. Sample Size for the Training Set:

Not applicable. This device is a phacofragmentation system, not an AI/machine learning model that undergoes a "training" phase on a dataset of clinical cases.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI model.

In summary: The K230858 clearance for QUATERA 700 is for a surgical device that has undergone minor software and component changes. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating continued safety, efficacy, and substantial equivalence to an existing predicate device through engineering verification and validation, rather than a clinical performance study of a novel AI component.

Summary

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July 31, 2023

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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

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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

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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)

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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 AGGoeschwizer Strasse 51-52D-07745 JenaGermany
Primary Correspondent	Aditya RaoRegulatory Affairs Specialist - USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 549-9579 Phone (925) 557-4259 FaxE-mail: aditya.rao@zeiss.com (preferred)
Secondary Correspondent	Anja MichelchenRegulatory Affairs ManagerCarl Zeiss Meditec AGRudolf-Eber-Strasse 11 73447 Oberkochen, Germany+49 7364 20 9963 Phone E-mail: anja.michelchen@zeiss.com
Date Prepared:	July 31, 2023

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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 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:

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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 forthe emulsification and removalof cataracts, anterior andposterior segment vitrectomy.The device is designed for usein anterior and posteriorsegment surgeries. It providescapabilities forphacoemulsification, coaxialand bimanual irrigation/aspiration, bipolar coagulation,anterior vitrectomy, viscousfluid injection/ removal andair/fluid exchange operations.	QUATERA 700 is intended forthe emulsification and removalof cataracts, anterior andposterior segment vitrectomy.The device is designed for usein anterior and posteriorsegment surgeries. It providescapabilities forphacoemulsification, coaxialand bimanual irrigation/aspiration, bipolar coagulation,anterior vitrectomy, viscousfluid injection/ removal andair/fluid exchange operations.	The indicationsfor use areequivalent asbasis of themedical context.

Attribute	Subject Device	Primary PredicateDevice (K212241)	EquivalencyAnalysis
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 ProductCode	HQC, HQE	HQC, HQE	Identical
Regulation #	21CFR886.4670	21CFR886.4670	Identical
Attribute	Subject Device	Primary PredicateDevice (K212241)	EquivalencyAnalysis
Application	PhacofragmentationSystemOphthalmic Surgery	PhacofragmentationSystemOphthalmic Surgery	Identical
Combination Device	No	No	Identical
Patient Population	Adults	Adults	Identical
System Procedures	Irrigation / AspirationUltrasoundDiathermyAnteriorVitrectomy	Irrigation / AspirationUltrasoundDiathermyAnteriorVitrectomy	Identical
Accessories ProvidedSterile	Yes	Yes	Identical
Method ofSterilization	Ethylene Oxide	Ethylene Oxide	Identical
User Interface	Foot Control Panel,Graphical UserInterface, Handpiece	Foot Control Panel,Graphical UserInterface, Handpiece	Identical
IRRIGATION AND ASPIRATION
Aspiration Pump Type	Flow Control &VacuumControlQuattro Pump	Flow Control &Vacuum ControlQuattro Pump	Identical
Irrigation	Yes	Yes	Identical
Adjustable pumpramp	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

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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

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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.

Regulation Number and Section

§ 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.