Zeos Aqua Vision Pump and tube

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a circular seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in a bold, blue font, with the word "ADMINISTRATION" written in a smaller font below. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192921 Device Name ZEOS AQUA VISION PUMP ### Indications for Use (Describe) 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. 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) 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. 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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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 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. | Tubing | | | | | |------------------|-------------------------------------------------------|-------------|--|--| | Product Category | Model Designation | Part Number | | | | Tubing | ZEOS AQUA VISION EFFICIENT<br>CARE DAY TUBE | ZAVECDAY | | | | Tubing | ZEOS AQUA VISION EFFICIENT<br>CARE INFLOW/OUTFLOW SET | ZAVECSET | | | | Tubing | ZEOS AQUA VISION EFFICIENT<br>CARE INFLOW ONLY | ZAVECINF | | | | Tubing | ZEOS AQUA VISION EFFICIENT<br>CARE OUTFLOW ONLY | ZAVECOUT | | | | Tubing | ZEOS AQUA VISION PATIENT<br>CARE INFLOW/OUTFLOW SET | ZAVPCSET | | | | Tubing | ZEOS AQUA VISION PATIENT<br>CARE INFLOW ONLY | ZAVPCINF | | | | Tubing | ZEOS AQUA VISION PATIENT<br>CARE OUTFLOW ONLY | ZAVPCOUT | | | The pump has to be used with the following tube sets: # VI INDICATIONS FOR USE 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ 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. . {8}------------------------------------------------ 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 {9}------------------------------------------------ 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. {10}------------------------------------------------ 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 and<br>electromagnetic<br>compatibility<br>(EMC) | Testing in compliance<br>with the IEC 60601-1<br>and IEC 60601-1-2 | Evaluation and testing were<br>performed on the subject device<br>and demonstrated to be<br>substantially equivalent to the<br>predicate device. | | Biocompatibility<br>testing | Testing in compliance<br>with FDA Guidance<br>"Use of International<br>Standard ISO 10993,<br>Biological evaluation of<br>medical Devices Part 1"<br>and ISO 10993-1 | The following non clinical tests<br>were performed on the subject on<br>equivalent device: Cytotoxicity,<br>Sensitization, Irritation and Acute<br>systemic toxicity and<br>demonstrated to be substantially<br>equivalent to the predicate<br>device. | | Software Verification<br>and<br>Validation Testing | Software verification<br>testing in compliance<br>with FDA guidance<br>"General Principles of<br>Software Validation"<br>and IEC 62304 | Evaluation and testing were<br>performed on the subject device<br>and demonstrated substantially<br>equivalent performance to<br>identified predicate device | | Sterilization<br>Validation | The sterilization<br>validation was<br>performed according to<br>ISO 11135 and ISO<br>11135-1 Sterilization of<br>health care products -<br>Ethylene oxide - Part 1:<br>Requirements for the<br>development, validation<br>and routine control of a<br>sterilization<br>process for medical<br>devices; and<br>• ISO 10993-7 -<br>Biological evaluation of<br>medical devices – Part<br>7: Ethylene oxide<br>sterilization residuals. | Validation was performed on the<br>subject device and demonstrated<br>to be substantially equivalent to<br>the identified predicate devices. | | Bench Tests | The functional and<br>usability tests on ZEOS<br>AQUA Vision pump<br>system were performed<br>according to IEC 62366<br>- Medical Devices - | Evaluation and testing were<br>performed on the subject device<br>and demonstrated substantially<br>equivalent performance to<br>identified predicate device. | | | Part 1: Application of<br>Usability Engineering to<br>Medical to Medical<br>Devices. The functional<br>test included test on the<br>strength of the tubing<br>sets at to and following<br>three years and 3<br>months of accelerated<br>aging. | | | Animal studies | Not applicable | Not applicable | | Clinical Studies | Not applicable | Not applicable | {11}------------------------------------------------ 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.