(102 days)
No reference devices were used in this submission.
No
The description mentions "computer-controlled fluid regulation" and a "shaver oscillation profile algorithm," which are indicative of automated control and software, but not explicitly AI or ML. There is no mention of learning, adaptation, or data-driven decision making beyond pre-programmed algorithms.
Yes
The device is described as assisting in arthroscopic surgery by controlling fluid distention and suction, and providing controlled cutting, shaving, and abrading of bone and tissue, which are direct interventions for treating conditions within joints.
No
This device is described as an arthroscopic pump system for fluid management and tissue debridement during surgery, not for diagnosing conditions.
No
The device description explicitly states it includes hardware components such as irrigation and suction pumps, an integrated shaver console, and updates in hardware components. While it mentions software modifications, it is clearly a system with significant hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for surgical procedures (arthroscopic surgery) involving fluid management and tissue debridement within the body.
- Device Description: The description details a pump system and integrated shaver console designed for physical manipulation of tissue and fluid during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVD devices typically involve analyzing biological samples like blood, urine, or tissue.
The FMS VUE Fluid Management and Tissue Debridement System is a surgical device used during a procedure, not for analyzing samples before or after a procedure for diagnostic purposes.
N/A
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, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knee, ankle, elbow, wrist and hip joints.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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
- Shaver Handpieces
- FMS Connect Cable
- Backflow-Prevention Valve Testing (Dye Leak Testing)
- Microbial and Viral Ingress Testing
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 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.
No animal testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System.
No human clinical testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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"
1
(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
2
Enclosure
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 Name
and Address | DePuy Mitek, Inc.
325 Paramount Drive
Raynham, MA 02767, USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Pol Fort Grèbol
Project Manager Regulatory Affairs
DePuy Synthes
a Johnson & Johnson company
Phone: +34 672 672 579
Email: pfortgre@its.jnj.com |
| Date Prepared | February 22, 2023 |
| Proprietary Name | FMS VUE™ Fluid Management and Tissue Debridement System |
| Common or Usual
Name | 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 Description
Summary | 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. |
5
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 Use | |||
| Comparison | The proposed device has the same indications for use as the predicate device. | ||
| Comparison of | |||
| Technological | |||
| Characteristics with | |||
| the 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 Device | ||
| FMS VUE Fluid | |||
| Management and | |||
| Tissue Debridement | |||
| System | Predicate Device | ||
| FMS VUE Fluid | |||
| Management and | |||
| Tissue Debridement | |||
| System (K130169) | |||
| Product Code | Same as the predicate device. | HRX | |
| Intended | |||
| Use/Indications for Use | |||
| Statement | Same as the predicate device. | 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. | |||
| Contraindications | Same as the predicate device. | The FMS VUE System | |
| is contraindicated in | |||
| any non-arthroscopic | |||
| surgical procedure and | |||
| is for use with saline | |||
| irrigation only. The | |||
| system is not | |||
| appropriate for patients | |||
| for whom an | |||
| arthroscopic procedure | |||
| is contraindicated for | |||
| any reason. | |||
| • DO NOT use the | |||
| FMS VUE in | |||
| instances where | |||
| capsular integrity is | |||
| suspect. | |||
| • DO NOT use the | |||
| FMS VUE with a | |||
| gas distension | |||
| medium. Use only | |||
| with sterile | |||
| irrigation solution | |||
| for distension of | |||
| the operative site. | |||
| • DO NOT use the | |||
| FMS VUE to | |||
| administer drugs, | |||
| IV-fluids, blood or | |||
| blood substitutes. | |||
| Principles of Operation | Same as the predicate | ||
| device. | The device is | ||
| controlled by software | |||
| and microelectronics | |||
| that execute control | |||
| algorithms that ensure | |||
| the set pump pressure | |||
| is being achieved. | |||
| Energy Source | Same as the predicate | ||
| device. | Supply voltage | ||
| provided to the console | |||
| is that of a typical | |||
| business or hospital | |||
| environment | |||
| Pump Mechanism | Same as the predicate | ||
| device. | Two peristaltic pumps: | ||
| 1 inflow and 1 outflow | |||
| Functional Mode | Same as the predicate | ||
| device. | • DUO Mode | ||
| (Inflow/Outflow) | |||
| • SOLO Mode | |||
| (Inflow only) | |||
| Roller Wheel | Same as the predicate | ||
| device. | The device has | ||
| internally mounted | |||
| roller wheels that | |||
| interface with | |||
| disposable tubing sets. | |||
| Non-clinical and | |||
| Clinical | |||
| Performance 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 and | |||
| Electromagnetic | |||
| Compatibility | Same as the predicate device. | IEC 60601-1 | |
| IEC 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 Testing | |||
| Functional 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 |
6
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.
7
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.
8
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. | |
| Substantial | |
| Equivalence | 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 |
9
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. |