FMS VUE II Fluid Management and Tissue Debridement System

K171237 · Medos International SARL · HRX · Jan 18, 2018 · Orthopedic

Device Facts

• Record ID: K171237
• Device Name: FMS VUE II Fluid Management and Tissue Debridement System
• Applicant: Medos International SARL
• Product Code: HRX · Orthopedic
• Decision Date: Jan 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FMS VUE II Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

Device Story

Arthroscopic pump system; provides controlled fluid distention and suction; includes integrated shaver console for cutting, burring, shaving, and abrading bone/tissue. Used in OR by surgeons during arthroscopic procedures. System consists of irrigation pump (controls joint pressure) and suction pump (removes saline/waste). Features computer-controlled fluid regulation; includes updated pressure control with joint pressure estimation. Provides optimal surgical field visibility; assists in tissue debridement. Benefits patient by maintaining stable joint pressure and facilitating efficient tissue removal during minimally invasive surgery.

Clinical Evidence

Bench testing only. Included functional performance testing, joint pressure estimation and control validation, and software verification/validation. Tubing accessory testing included dye leak, microbial, and viral ingress testing. Compliance with IEC 60601-1 and IEC 60601-1-2 demonstrated.

Technological Characteristics

System includes irrigation pump, suction pump, and integrated shaver console. Features computer-controlled fluid regulation and joint pressure estimation. Connectivity/form factor not specified. Sterilization: Re-usable tubing set-up includes one-way valve. Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients undergoing arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist, or hip joints requiring fluid distention, suction, and tissue debridement.

Regulatory Classification

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.

Predicate Devices

• FMS VUE Fluid Management and Tissue Debridement System (K130169)

Submission Summary (Full Text)

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January 18, 2018

Medos International SARL % Tatyana Korsunsky Regulatory Affairs Project Lead DePuy Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K171237

Trade/Device Name: FMS VUE II Fluid Management and Tissue Debridement System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 12, 2017 Received: December 14, 2017

Dear Tatyana Korsunsky:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

The FMS VUE™ II Fluid Management and Tissue Debridement System

Indications for Use (Describe)

The FMS VUE II Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

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

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY FMS VUE™ II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM

Date Prepared: 1/17/2018

| Submitter's<br>Name and<br>Address | Medos International SARL<br>Chemin-Blanc 38, Le Locle Neuchatel<br>CH 2400, Switzerland |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky<br>Regulatory Affairs Project Lead<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: FMS VUE™ II Fluid Management and Tissue<br>Debridement System<br>Classification Name: Arthroscope accessory<br>Class II, product code HRX, 21 CFR 888.1100<br>Common Name: Arthroscopic Pump |
| Substantial<br>Equivalence<br>Predicate<br>Devices | The FMS VUE™ II Fluid Management and Tissue<br>Debridement System is substantially equivalent to:<br>The FMS VUE™ Fluid Management and Tissue Debridement System (K130169)<br>(DePuy Mitek) |
| Device<br>Description | The FMS VUE™ II Fluid Management and Tissue Debridement System is an<br>arthroscopic pump system designed to provide optimal visibility of the surgical field<br>by computer-controlled fluid regulation of intra-articular pressure during arthroscopic<br>procedures.<br><br>The FMS VUE™ II Fluid Management and Tissue Debridement System consists of<br>irrigation pump, which controls joint pressure, and the suction pump, which controls<br>the flow of saline and waste from the joint.<br><br>The FMS VUE™ II Fluid Management and Tissue Debridement System includes an<br>integrated shaver console, intended to provide controlled cutting, burring, shaving and<br>abrading of bone and soft tissue. |
| Indications for<br>Use | The FMS VUE™ II Fluid Management and Tissue Debridement System is intended to<br>provide controlled fluid distention and suction, controlled cutting, burring, shaving and<br>abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee,<br>ankle, elbow, wrist and hip joints. |
| Technological<br>Characteristics<br>and<br>Performance | The determination of substantial equivalence for this device was based on a detailed<br>device description, performance data, and conformance to consensus and voluntary<br>standards.<br>The FMS VUE™ II Fluid Management and Tissue Debridement System is similar to<br>the predicate DePuy Mitek's FMS VUE™ Fluid Management and Tissue Debridement<br>System (K130169) in that they share the same intended use, and contain inflow and<br>outflow pumps with an integrated shaver control. The FMS VUE™ II Fluid<br>Management and Tissue Debridement System contains updates in the software and<br>hardware, which include updated pressure and debridement settings, and an updated<br>pressure control with joint pressure estimation. |
| | FMS VUE™ II Fluid Management and Tissue Debridement System testing included<br>functional performance, joint pressure estimation and control, software verification and validation and testing per IEC 60601-1 and IEC 60601-1-2 standards. Results of functional performance testing were compared to the predicate device and have demonstrated that the proposed device is suitable for its intended use.<br>The testing of re-usable set-up of tubing accessory containing one-way valve included the dye leak testing, and microbial and viral ingress testing. |
| Conclusion | Based on similarities in the intended use, technological characteristics, IEC 60601-1/<br>IEC 60601-2 compliance and functional performance in comparison to the predicate<br>device, the FMS VUE™ II Fluid Management and Tissue Debridement System has<br>been shown to be substantially equivalent to the predicate device under the Federal<br>Food, Drug and Cosmetic Act. |

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