The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.

Device Description

The ZEOS AQUA VISION pump is a micro-processor controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ZEOS AQUA VISION PUMP and tube, which is an arthroscopy pump system. The document focuses on demonstrating substantial equivalence to a predicate device (FMS VUE Fluid Management & Tissue Debridement System) through various non-clinical performance tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical performance study. Instead, it states compliance with recognized standards and guidelines as the acceptance criteria for each test category. The reported device performance is that the device meets these standards and demonstrated substantial equivalence to the predicate device.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Electrical safety and electromagnetic compatibility (EMC)	Compliance with IEC 60601-1 and IEC 60601-1-2 standards	Evaluation and testing demonstrated substantial equivalence to the predicate device.
Biocompatibility testing	Compliance with FDA Guidance "Use of International Standard ISO 10993, Biological evaluation of medical Devices Part 1" and ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11.	Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity tests were performed and demonstrated substantial equivalence to the predicate device.
Software Verification and Validation Testing	Compliance with FDA guidance "General Principles of Software Validation" and IEC 62304	Evaluation and testing demonstrated substantially equivalent performance to the identified predicate device.
Sterilization Validation	Compliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7 for sterilization and residuals.	Validation demonstrated substantial equivalence to the identified predicate devices. Residual ethylene oxide (EO) < 4 mg and ethylene chlorohydrin (ECH) < 5 mg after 3 days of aeration. Sterility Assurance Level (SAL) of 10^-6. Package and product integrity tested per ISO 11607-1 and ASTM-F-1980:2002.
Bench Tests (Functional and Usability)	Compliance with IEC 62366-1 (Usability Engineering), and functional/strength tests for tubing sets at t0 and after accelerated aging.	Evaluation and testing demonstrated substantially equivalent performance to the identified predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for the test sets in any of the mentioned tests (Electrical Safety, EMC, Biocompatibility, Software, Sterilization, Bench Tests). It refers to "evaluation and testing were performed on the subject device" or "on equivalent device" and "the tubing sets."

The data provenance is from non-clinical performance tests conducted by the manufacturer (Hemodia SAS) in support of the 510(k) submission. No country of origin for the data is explicitly stated, other than the manufacturer being based in France and the correspondent in Germany, implying these are likely the origins of the testing. The studies are by nature retrospective for the purpose of this submission, as they were conducted to support a premarket notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies performed are non-clinical, primarily engineering and laboratory-based tests comparing the device to standards and a predicate. Expert consensus for ground truth is typically relevant for clinical studies, which were not required or performed for this device.

4. Adjudication method for the test set

This information is not applicable as the studies are non-clinical performance tests against established standards and predicate device characteristics, not clinical studies requiring human adjudication of outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided and is not applicable. This device is an arthroscopy pump system, which assists in surgery by providing fluid management, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The ZEOS AQUA VISION PUMP is a medical device, not an algorithm, and is intended for human-in-the-loop use during arthroscopic procedures.

7. The type of ground truth used

For the non-clinical tests:

Electrical Safety and EMC: Ground truth is defined by the requirements of IEC 60601-1 and IEC 60601-1-2 standards.
Biocompatibility: Ground truth is defined by the requirements of ISO 10993 series standards.
Software Verification and Validation: Ground truth is defined by the software requirements, FDA guidance "General Principles of Software Validation," and IEC 62304 standard.
Sterilization Validation: Ground truth is defined by the requirements of ISO 11135, ISO 14937, ISO 10993-7, ISO11607-1, and ASTM-F-1980:2002 standards.
Bench Tests (Functional and Usability): Ground truth is defined by the functional specifications of the device, usability principles (IEC 62366-1), and the performance characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable. The ZEOS AQUA VISION PUMP is a hardware medical device; it does not involve machine learning or AI models that require training sets. The software mentioned (IEC 62304) focuses on software life cycle processes and validation, not on training data for an algorithm.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a machine learning model.

Summary

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October 9, 2020

Hemodia SAS % Arne Briest Managing Director VISAMED GmbH Kastellstr. 8 Karlsruhe, 76227 De

Re: K192921

Trade/Device Name: ZEOS AQUA VISION PUMP and tube Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 4, 2020 Received: September 8, 2020

Dear Arne Briest:

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

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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,

for

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K192921

Device Name ZEOS AQUA VISION PUMP

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/1 description: The image contains the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with the letter 'H' cut out in white. To the right of the leaf is the word 'hemodia' in a simple, sans-serif font. Below 'hemodia' are the words 'Medical Partner' in a smaller font size.

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.

-SUBMISSION SPONSOR and APPLICATION CORRESPONDANT

A. SUBMISSION SPONSOR

HEMODIDA SAS

85 rue du Chêne vert 31670 Labège - France www.hemodia.com Tel +33 (0) 5 61 00 03 50

Contact Person :

Adeline Théron Regulatory Affairs Engineer adeline.theron@hemodia.com

B. APPLICATION CORRESPONDANT

VISAMED GmbH

Kastellstr. 8 D-76227 Karlsruhe-Germany www.visamed.com Tel +49 (0)721-476 4847

Contact Person : Arne Briest CEO arne.briest@visamed.com

II. Dated prepared: October 11, 2019

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Image /page/4/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with the letter 'H' embedded within it. To the right of the leaf is the word 'hemodia' in a simple, sans-serif font, and below that, in smaller letters, are the words 'Medical Partner'.

DEVICE IDENTIFICATION ��

Name of Device:	ZEOS AQUA VISION PUMP and tube
Common Name:	Pump (Arthroscopy pump)
Classification Name:	Arthroscope (21 CFR § 888.1100)
Classification Panel:	Orthopedic
Regulatory Class:	II
Product Code:	HRX
510k #:	TBD

IV PREDICATE DEVICE

K130169 FMS VUE Fluid Management & Tissue Debridement System; . FMS Connect Interface Cable

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Image /page/5/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green shape resembling a leaf or a drop, with the letter 'H' embedded within it. To the right of the green shape, the word 'hemodia' is written in a lowercase, sans-serif font. Below 'hemodia', the words 'Medical Partner' are written in a smaller, sans-serif font.

V. DEVICE DESCRIPTION

The pump can be connected to various shaver systems.

Tubing
Product Category	Model Designation	Part Number
Tubing	ZEOS AQUA VISION EFFICIENTCARE DAY TUBE	ZAVECDAY
Tubing	ZEOS AQUA VISION EFFICIENTCARE INFLOW/OUTFLOW SET	ZAVECSET
Tubing	ZEOS AQUA VISION EFFICIENTCARE INFLOW ONLY	ZAVECINF
Tubing	ZEOS AQUA VISION EFFICIENTCARE OUTFLOW ONLY	ZAVECOUT
Tubing	ZEOS AQUA VISION PATIENTCARE INFLOW/OUTFLOW SET	ZAVPCSET
Tubing	ZEOS AQUA VISION PATIENTCARE INFLOW ONLY	ZAVPCINF
Tubing	ZEOS AQUA VISION PATIENTCARE OUTFLOW ONLY	ZAVPCOUT

The pump has to be used with the following tube sets:

VI INDICATIONS FOR USE

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Image /page/6/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a green abstract shape resembling a stylized letter 'H' with a leaf-like extension at the top. To the right of the symbol is the word "hemodia" in a lowercase, sans-serif font. Below "hemodia" are the words "Medical Partner" in a smaller font size.

VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The FMS VUE Fluid Management & Tissue Debridement System is the predicate device for the ZEOS AQUA VISION pump and tubing sets.

Both pump systems are designed, developed and manufactured using the same general design principles and similar mechanical and electrical components. They have the same intended use and incorporate the same basic design. Specifically, both the FMS VUE Fluid Management & Tissue Debridement System and the ZEOS AQUA VISION pump and tubing sets are pumps for use during arthroscopic procedures to provide fluid irrigation and aspiration. They are both roller pumps that function according to the peristaltic principle and are to be used with specially designed tube sets.

The differences in the technological characteristics of both the proposed device FMS VUE Fluid Management & Tissue Debridement System and the ZEOS AQUA VISION pump and tubing sets are minor and do not raise new questions of safety and effectiveness.

Both the FMS VUE Fluid Management & Tissue Debridement System and the ZEOS AQUA VISION pump and tubing sets are designed to be used with compatible shaver systems.

VIII PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Software

The software was developed, tested, and verified in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the following standard:

· IEC62304- Medical Device Software - Software Life Cycle Processes.

Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical

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K192921

Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:

Unit test reports
Integration test reports
· System test reports
· Overall software test report
· Verification test reports
· Overall software validation report

The software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirement according to the Software Verification Plan.

Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ZEOS AQUA VISION pump device.

Design verification testing of the ZEOS AQUA VISION pump demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.

Electrical safety and electromagnetic compatibility

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the ZEOS AQUA VISION pump.

The device complies with recognized electrical safety standards:

. IEC 60601-1 standard for electrical safety
IEC 60601-1-2 standard for electromagnetic compatibility. .

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Image /page/8/Picture/0 description: The image shows the logo for Hemodia, a medical partner. The logo features a stylized green leaf shape with the letter 'H' cut out in white. To the right of the leaf is the word 'hemodia' in a smaller, sans-serif font. Below 'hemodia' are the words 'Medical Partner' in an even smaller font, indicating the company's focus within the healthcare sector.

Biocompatibility testing

The biocompatibility evaluation for ZEOS AQUA VISION tube sets has been conducted in accordance with FDA Guidance Document: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1 -"Biological evaluation of medical devices - Evaluation and testing within a risk management system". The evaluation reveals that biocompatibility requirements are met by the ZEOS AQUA VISION tube sets.

Biocompatibility testing was performed on the tube sets in accordance with:

• ISO 10993-1 - Biological evaluation of medical devices- Evaluation and testing within a risk management system;

• ISO 10993-5 - Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity; and

• ISO 10993-10 - Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;

· ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.

Sterilization Validation

In addition, the sterilization validation on the tube sets has been performed in accordance with:

· ISO 11135 Sterilization of health care products Ethylene Oxide -Requirements for the development, validation and routine control of a sterilization process for medical device
ISO 11135-1 Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
· ISO 14937 Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; and
ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 3 days of aeration (gas release) that remain on the tube set will not be exceeded. The sterility assurance level (SAL) was 10-6. Package and product integrity of the tube sets were tested in

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Image /page/9/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green leaf shape with the letter 'H' cut out in white. To the right of the leaf is the word 'hemodia' in a sans-serif font, and below that, in smaller letters, are the words 'Medical Partner'.

accordance with ISO11607-1 - Packaging for terminally sterilized medical devices and ASTM-F- 1980:2002 - Standard for accelerated aging of sterile medical device packages.

Performance Testing - Bench

The following performance tests were conducted:

Functional tests of the ZEOS AQUA Vision pump ●
Functional tests of the ZEOS AQUA Vision pump accessories ●
Usability Tests of the ZEOS AQUA Vision pump system .
. Functional tests of the tubing sets at to and after 3 years and 3 months of accelerated aging
. Leak and Tensile (Strength) tests of the tubing sets at to and after 3 years and 3 months of accelerated aging

Animal studies

Data from animal studies were not required to support the safety and effectiveness of the ZEOS AQUA VISION PUMP.

Clinical Studies

Clinical data were not required to support the safety and effectiveness of the ZEOS AQUA VISION PUMP. All validation was performed based on non-clinical performance tests.

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Image /page/10/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a green, stylized shape resembling a drop or leaf, with the letter 'H' formed within it. To the right of the shape is the word 'hemodia' in a smaller, sans-serif font, and below that, the words 'Medical Partner' in an even smaller font size.

IX SUMMARY OF NON CLINICAL PERFORMANCE TESTING - Bench

Test	Test Method Summary	Results
Electrical safety andelectromagneticcompatibility(EMC)	Testing in compliancewith the IEC 60601-1and IEC 60601-1-2	Evaluation and testing wereperformed on the subject deviceand demonstrated to besubstantially equivalent to thepredicate device.
Biocompatibilitytesting	Testing in compliancewith FDA Guidance"Use of InternationalStandard ISO 10993,Biological evaluation ofmedical Devices Part 1"and ISO 10993-1	The following non clinical testswere performed on the subject onequivalent device: Cytotoxicity,Sensitization, Irritation and Acutesystemic toxicity anddemonstrated to be substantiallyequivalent to the predicatedevice.
Software VerificationandValidation Testing	Software verificationtesting in compliancewith FDA guidance"General Principles ofSoftware Validation"and IEC 62304	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performance toidentified predicate device
SterilizationValidation	The sterilizationvalidation wasperformed according toISO 11135 and ISO11135-1 Sterilization ofhealth care products -Ethylene oxide - Part 1:Requirements for thedevelopment, validationand routine control of asterilizationprocess for medicaldevices; and• ISO 10993-7 -Biological evaluation ofmedical devices – Part7: Ethylene oxidesterilization residuals.	Validation was performed on thesubject device and demonstratedto be substantially equivalent tothe identified predicate devices.
Bench Tests	The functional andusability tests on ZEOSAQUA Vision pumpsystem were performedaccording to IEC 62366- Medical Devices -	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performance toidentified predicate device.
	Part 1: Application ofUsability Engineering toMedical to MedicalDevices. The functionaltest included test on thestrength of the tubingsets at to and followingthree years and 3months of acceleratedaging.
Animal studies	Not applicable	Not applicable
Clinical Studies	Not applicable	Not applicable

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Image /page/11/Picture/0 description: The image shows the logo for Hemodia Medical Partner. The logo features a stylized green letter "H" that is connected to a green musical note-like shape. To the right of the "H" is the word "hemodia" in a lowercase, sans-serif font. Below "hemodia" are the words "Medical Partner" in a smaller, sans-serif font.

CONCLUSIONS x

Based on the similar intended use, the same basic technological characteristics and performance testing, the ZEOS AQUA VISION PUMP is substantially equivalent to the predicate device FMS VUE Fluid Management & Tissue Debridement System (K130169). The differences between the proposed device and the predicate device do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.