(266 days)
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.
The FMS VUE™ II Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure during arthroscopic procedures.
The FMS VUE™ II Fluid Management and Tissue Debridement System consists of irrigation pump, which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint.
The FMS VUE™ II Fluid Management and Tissue Debridement System includes an integrated shaver console, intended to provide controlled cutting, burring, shaving and abrading of bone and soft tissue.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. Specifically, the document is a 510(k) summary for a medical device (FMS VUE II Fluid Management and Tissue Debridement System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description with acceptance criteria and performance data in the format you requested.
Here's what I can extract and what's missing:
What is available in the document:
- Device Name: FMS VUE™ II Fluid Management and Tissue Debridement System
- 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."
- Predicate Device: The FMS VUE™ Fluid Management and Tissue Debridement System (K130169) (DePuy Mitek)
- Testing Mentioned: The document generally states that testing included "functional performance, joint pressure estimation and control, software verification and validation and testing per IEC 60601-1 and IEC 60601-1-2 standards." It also mentions "dye leak testing, and microbial and viral ingress testing" for a re-usable tubing accessory.
- Conclusion: The device has been shown to be substantially equivalent to the predicate device based on similarities in intended use, technological characteristics, IEC 60601-1/IEC 60601-2 compliance, and functional performance.
What is NOT available in the document (and therefore cannot be provided in the table or detailed answers):
- Specific Acceptance Criteria: The document mentions "functional performance" and "joint pressure estimation and control" but does not explicitly state numerical acceptance criteria (e.g., specific pressure ranges, flow rates, debridement efficacy metrics).
- Reported Device Performance: While it states that results "have demonstrated that the proposed device is suitable for its intended use," it does not provide the actual performance metrics or data against any criteria.
- Sample Size for Test Set: Not specified.
- Data Provenance (country, retrospective/prospective): Not specified.
- Number of Experts and Qualifications: Not applicable as this is a fluid management and tissue debridement system, not an AI diagnostic device requiring expert interpretation for ground truth.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable to this type of device.
- Standalone Performance: Not applicable in the context of an AI algorithm. The device's "standalone" performance would be its functional performance, which is generally described but not quantified.
- Type of Ground Truth Used: Not applicable in the context of expert consensus or pathology for a fluid management system. Ground truth would be based on engineering specifications and performance testing.
- Sample Size for Training Set: Not applicable as this is not an AI/machine learning device with a training set.
- How Ground Truth for Training Set was Established: Not applicable.
Based on the provided text, I cannot complete your request in the specified format for acceptance criteria and study details. The document is a regulatory submission summary that attests to equivalence and suitability for intended use, rather than a detailed scientific study report.
If this were an AI/ML device, the regulatory submission would typically include a separate section with a detailed clinical validation study that addresses these points.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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'sName andAddress | Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland |
|---|---|
| Contact Person | Tatyana KorsunskyRegulatory Affairs Project LeadDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3122Facsimile: 508-977-6911e-mail: tkorsuns@its.jnj.com |
| Name ofMedical Device | Proprietary Name: FMS VUE™ II Fluid Management and TissueDebridement SystemClassification Name: Arthroscope accessoryClass II, product code HRX, 21 CFR 888.1100Common Name: Arthroscopic Pump |
| SubstantialEquivalencePredicateDevices | The FMS VUE™ II Fluid Management and TissueDebridement System is substantially equivalent to:The FMS VUE™ Fluid Management and Tissue Debridement System (K130169)(DePuy Mitek) |
| DeviceDescription | The FMS VUE™ II Fluid Management and Tissue Debridement System is anarthroscopic pump system designed to provide optimal visibility of the surgical fieldby computer-controlled fluid regulation of intra-articular pressure during arthroscopicprocedures.The FMS VUE™ II Fluid Management and Tissue Debridement System consists ofirrigation pump, which controls joint pressure, and the suction pump, which controlsthe flow of saline and waste from the joint.The FMS VUE™ II Fluid Management and Tissue Debridement System includes anintegrated shaver console, intended to provide controlled cutting, burring, shaving andabrading of bone and soft tissue. |
| Indications forUse | The FMS VUE™ II Fluid Management and Tissue Debridement System is intended toprovide controlled fluid distention and suction, controlled cutting, burring, shaving andabrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee,ankle, elbow, wrist and hip joints. |
| TechnologicalCharacteristicsandPerformance | The determination of substantial equivalence for this device was based on a detaileddevice description, performance data, and conformance to consensus and voluntarystandards.The FMS VUE™ II Fluid Management and Tissue Debridement System is similar tothe predicate DePuy Mitek's FMS VUE™ Fluid Management and Tissue DebridementSystem (K130169) in that they share the same intended use, and contain inflow andoutflow pumps with an integrated shaver control. The FMS VUE™ II FluidManagement and Tissue Debridement System contains updates in the software andhardware, which include updated pressure and debridement settings, and an updatedpressure control with joint pressure estimation. |
| FMS VUE™ II Fluid Management and Tissue Debridement System testing includedfunctional 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.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/IEC 60601-2 compliance and functional performance in comparison to the predicatedevice, the FMS VUE™ II Fluid Management and Tissue Debridement System hasbeen shown to be substantially equivalent to the predicate device under the FederalFood, Drug and Cosmetic Act. |
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§ 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.