(102 days)
The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, 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 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, and flow during arthroscopic procedures. The system integrates a tissue debridement for controlled cutting, burring, shaving and abrading of bone and soft tissue.
The FMS VUE 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 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.
The FMS VUE Fluid Management and Tissue Debridement System is designed to work with the existing FMS VUE platform accessories including: foot pedal, remote hand control, shaver handpieces, FMS connect cable, tubing sets, blades, and burrs.
The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors.
The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm.
The provided document is a 510(k) summary for the DePuy Mitek, Inc. FMS VUE™ Fluid Management and Tissue Debridement System, seeking substantial equivalence to a previously cleared predicate device (K130169). The submission highlights hardware updates and a software modification (an additional shaver oscillation profile algorithm).
Crucially, this document is for a medical device (arthroscopic pump and debridement system) and not an AI/ML powered device that would typically have the acceptance criteria and study information you're asking for related to AI model performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to the hardware and software changes for a physical medical device, demonstrating that the modified device remains as safe and effective as its predicate.
Therefore, many of the requested points in your prompt are not applicable to the information contained in this 510(k) summary. I will address the applicable points based on the document's content.
Acceptance Criteria and Device Performance (Non-AI/ML Context)
The acceptance criteria here are focused on demonstrating that the updated FMS VUE system maintains its functional performance, electrical safety, electromagnetic compatibility, and software integrity, proving it is substantially equivalent to the predicate device despite hardware and minor software changes.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria (General Area) | Reported Device Performance (Summary from Document) |
|---|---|
| Functional Performance | - Pressure Transducer Test: Performed. Results not detailed but implied to be acceptable for intended use.- Pressure Security Test (Low & High Pressure Fault Checks): Performed. Results not detailed but implied to be acceptable.- DUO (Inflow/Outflow) Performance: Performed. Results not detailed but implied to be acceptable.- SOLO (Inflow) Performance: Performed. Results not detailed but implied to be acceptable.- RFID Capability Functional Testing with existing electrical accessories (Foot Pedal, Remote Hand Control, Shaver Handpieces, FMS Connect Cable): Performed. Results not detailed but implied to be acceptable.- Backflow-Prevention Valve Testing (Dye Leak Testing): Performed. Results not detailed but implied to be acceptable.- Microbial and Viral Ingress Testing: Performed. Results not detailed but implied to be acceptable.Overall: "Results of functional performance testing were compared to the predicate device and have demonstrated that the proposed device is suitable for its intended use." |
| Software Verification & Validation | - Software verification and validation (V&V) testing was conducted. Documentation provided as per FDA guidance "Content of Premarket Submission for Device Software Functions" (Basic Documentation level).- "The software development process for the subject FMS VUE Fluid Management and Tissue Debridement System software conforms to all clauses of IEC 62304 standard." (IEC 62304 is a standard for medical device software life cycle processes). |
| Electrical Safety & EMC | - "The subject FMS VUE Fluid Management and Tissue Debridement System complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC." (These are international standards for medical electrical equipment safety and electromagnetic compatibility). |
Study Information (as applicable to this non-AI/ML medical device submission)
-
Sample size used for the test set and the data provenance:
- The document describes "functional performance testing" of the physical device. This doesn't involve "test sets" of patient data in the way an AI/ML model would. Instead, it refers to testing the physical device and its components (e.g., pressure transducers, pumps, software algorithms for fluid control, electrical safety tests).
- The provenance of data is from laboratory testing and verification conducted by the manufacturer, DePuy Mitek, Inc. (a Johnson & Johnson company). It is implicitly prospective testing for the design verification and validation of the modified device. No specific patient data or geographic origin is relevant here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. "Ground truth" in the context of an AI/ML model's diagnostic or predictive performance is not relevant for the functional performance testing of a fluid management and tissue debridement system. The "ground truth" here is the engineering specifications and performance requirements established by the manufacturer, verified through standard test methods and adherence to regulatory standards (e.g., IEC 60601-1, IEC 62304).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple expert readers in imaging studies. This is a functional and safety verification of a physical device.
-
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 question is not applicable. The device is a physical arthroscopic fluid management and tissue debridement system, not an AI/ML-powered diagnostic or assistive tool for human readers. No MRMC study was performed or required. The document explicitly states: "No human clinical testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device has an integrated shaver console with an "additional shaver oscillation profile algorithm." The software verification and validation would have tested this algorithm's performance within the system, which can be seen as a form of standalone testing for the algorithm's functional correctness. The document states: "Software verification and validation testing was conducted..." and "The software development process... conforms to all clauses of IEC 62304 standard." This implicitly covers testing of the algorithm without a human-in-the-loop, to ensure it performs as programmed.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This question is not applicable in the typical sense for AI/ML. The "ground truth" for the device's functional performance are the engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., pressure output accuracy, flow rates, software logic, electrical safety limits).
-
The sample size for the training set:
- This question is not applicable. This is not an AI/ML system that requires a "training set" of data in the manner of deep learning models. The software algorithms are likely rule-based or control-loop algorithms, not learned from large datasets.
-
How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 7.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 26, 2024
DePuy Mitek, Inc. Pol Fort Grebol Project Manager Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K233675
Trade/Device Name: FMS VUE™ Fluid Management and Tissue Debridement System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 16, 2023 Received: January 23, 2024
Dear Pol Fort Grebol:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Jesse Muir -S Digitally signed by Jesse Muir
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
FMS VUE™ Fluid Management and Tissue Debridement System
Indications for Use (Describe)
The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, 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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Image /page/4/Picture/2 description: The image shows the logo for DePuy Synthes, which is a company that specializes in orthopedics. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font. The words "Johnson & Johnson" are in red.
510(k) Summary
| Submitter's Nameand Address | DePuy Mitek, Inc.325 Paramount DriveRaynham, MA 02767, USA |
|---|---|
| Contact Person | Pol Fort GrèbolProject Manager Regulatory AffairsDePuy Synthesa Johnson & Johnson companyPhone: +34 672 672 579Email: pfortgre@its.jnj.com |
| Date Prepared | February 22, 2023 |
| Proprietary Name | FMS VUE™ Fluid Management and Tissue Debridement System |
| Common or UsualName | Arthroscopic Pump, Tubing Sets and Accessories |
| Regulation Number | 21 CFR § 888.1100 (Arthroscope) |
| Regulatory Class | Class II |
| Product Code | HRX |
| Predicate Device | The FMS VUE Fluid Management and Tissue Debridement System(K130169)No reference devices were used in this submission. |
| Device DescriptionSummary | The FMS VUE Fluid Management and Tissue Debridement System is anarthroscopic pump system designed to provide optimal visibility of thesurgical field by computer-controlled fluid regulation of intra-articularpressure, and flow during arthroscopic procedures. The system integrates atissue debridement for controlled cutting, burring, shaving and abrading ofbone and soft tissue.The FMS VUE Fluid Management and Tissue Debridement System consistsof irrigation pump, which controls joint pressure, and the suction pump, whichcontrols the flow of saline and waste from the joint.The FMS VUE Fluid Management and Tissue Debridement System includesan integrated shaver console, intended to provide controlled cutting, burring,shaving and abrading of bone and soft tissue.The FMS VUE Fluid Management and Tissue Debridement System isdesigned to work with the existing FMS VUE platform accessories including:foot pedal, remote hand control, shaver handpieces, FMS connect cable,tubing sets, blades, and burrs. |
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Image /page/5/Picture/1 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font. The symbol on the left is a stylized representation of a bone or joint.
| The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors.The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm. | |||
|---|---|---|---|
| Intended Use /Indications for Use | The FMS VUE 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. | ||
| Indications for UseComparison | The proposed device has the same indications for use as the predicate device. | ||
| Comparison ofTechnologicalCharacteristics withthe Predicate Device | Device comparison demonstrated that the subject FMS VUE Fluid Management and Tissue Debridement System is substantially equivalent to the previously cleared FMS VUE Fluid Management and Tissue Debridement System (K130169) regarding intended use, indications for use, technological characteristics (design features and performance) as well as operating principle. | ||
| Characteristic | Subject DeviceFMS VUE FluidManagement andTissue DebridementSystem | Predicate DeviceFMS VUE FluidManagement andTissue DebridementSystem (K130169) | |
| Product Code | Same as the predicate device. | HRX | |
| IntendedUse/Indications for UseStatement | Same as the predicate device. | The FMS VUE FluidManagement andTissue DebridementSystem is intended toprovide controlled fluiddistention and suction,controlled cutting,burring, shaving andabrading of bone andtissue for use inarthroscopic surgery ofthe shoulder, knee,ankle, elbow, wrist andhip joints. | |
| Contraindications | Same as the predicate device. | The FMS VUE Systemis contraindicated inany non-arthroscopicsurgical procedure andis for use with salineirrigation only. Thesystem is not | |
| appropriate for patientsfor whom anarthroscopic procedureis contraindicated forany reason. | |||
| • DO NOT use theFMS VUE ininstances wherecapsular integrity issuspect. | |||
| • DO NOT use theFMS VUE with agas distensionmedium. Use onlywith sterileirrigation solutionfor distension ofthe operative site. | |||
| • DO NOT use theFMS VUE toadminister drugs,IV-fluids, blood orblood substitutes. | |||
| Principles of Operation | Same as the predicatedevice. | The device iscontrolled by softwareand microelectronicsthat execute controlalgorithms that ensurethe set pump pressureis being achieved. | |
| Energy Source | Same as the predicatedevice. | Supply voltageprovided to the consoleis that of a typicalbusiness or hospitalenvironment | |
| Pump Mechanism | Same as the predicatedevice. | Two peristaltic pumps:1 inflow and 1 outflow | |
| Functional Mode | Same as the predicatedevice. | • DUO Mode(Inflow/Outflow) | |
| • SOLO Mode(Inflow only) | |||
| Roller Wheel | Same as the predicatedevice. | The device hasinternally mountedroller wheels thatinterface withdisposable tubing sets. | |
| Non-clinical andClinicalPerformance Data | Design | Same as the predicate device. | Pump consists of the following main components:Console housing Power supply Two peristaltic pumps Tubing pinch valve Display panel |
| Software Development | Same as the predicate device. | IEC 62304 | |
| Electrical Safety andElectromagneticCompatibility | Same as the predicate device. | IEC 60601-1IEC 60601-1-2 | |
| The core functionality of the predicate FMS VUE Fluid Management and Tissue Debridement System K130169, as cleared per K130169, remains unchanged. Similarly, the indications for use and intended use remain unchanged.The changes described in this premarket notification are related to hardware and software upgrades. | |||
| Design verification and validation testing were performed on the subject FMS VUE Fluid Management and Tissue Debridement System as a result of the risk analysis and product requirements.Proposed FMS VUE Fluid Management and Tissue Debridement System testing included functional performance, 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. | |||
| Functional Performance TestingFunctional performance testing was conducted to ensure the device design meets user needs in the environment of use: | |||
| Pressure Transducer Test Pressure Security Test (Low Pressure Fault Checks and High Pressure Fault Checks) DUO (Inflow/Outflow) Performance SOLO (Inflow) Performance RFID Capability Functional Testing with existing electrical accessories: Foot Pedal Remote Hand Control |
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Image /page/6/Picture/1 description: The image shows the logo for DePuy Synthes, which is a company that specializes in orthopedics. The logo consists of a red symbol on the left, followed by the company name in gray text. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font size.
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Image /page/7/Picture/1 description: The image shows the DePuy Synthes logo. The logo features a red abstract symbol on the left, followed by the words "DePuy Synthes" in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font size, with "Johnson & Johnson" in red.
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Image /page/8/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a stylized red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson-Johnson" in a smaller font.
| Ο Shaver Handpieces Ο FMS Connect Cable • Backflow-Prevention Valve Testing (Dye Leak Testing) • Microbial and Viral Ingress Testing | |
|---|---|
| Software Verification and Validation | |
| Software verification and validation testing was conducted, and documentation was provided as recommended by Guidance for Industry and FDA Staff "Content of Premarket Submission for Device Software Functions" issued on June 14, 2023. Based on the cited FDA guidance document, the most appropriate documentation level for the subject FMS VUE software is Basic Documentation. The software development process for the subject FMS VUE Fluid Management and Tissue Debridement System software conforms to all clauses of IEC 62304 standard. | |
| Electrical Safety and Electromagnetic Compatibility (EMC) | |
| Electrical safety and EMC testing were conducted on the predicate FMS VUE Fluid Management and Tissue Debridement System and results provided as part of the original 510(k) submission, K130169. The subject FMS VUE Fluid Management and Tissue Debridement System complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. | |
| Animal Study | |
| No animal testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System. | |
| Clinical Studies | |
| No human clinical testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System. | |
| SubstantialEquivalence | The determination of substantial equivalence for this device was based on a detailed device description, performance data, and conformance to consensus and voluntary standards.The testing included in this submission demonstrates that: Any differences in technological characteristics of the predicate devices do not raise any new questions of safety or effectiveness. The proposed devices are at least as safe and effective as the predicate devices. |
| Conclusion | The intended use, design principles, and fundamental technology of the subject FMS VUE Fluid Management and Tissue Debridement System remains unchanged and therefore is substantially equivalent to the predicate device – the FMS VUE Fluid Management and Tissue Debridement System (K130169). The proposed hardware and software modifications do not raise new questions of safety or effectiveness of the subject FMS VUE Fluid Management and Tissue Debridement System. The results of the non-clinical |
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Image /page/9/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo consists of a red graphic to the left of the company name, which is written in gray. Below the company name is the text "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson."
| demonstrates that proposed FMS VUE performs as intended in the specified |
|---|
| use conditions. |
§ 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.