(266 days)
Not Found
No
The description focuses on computer-controlled fluid regulation and integrated shaver console, without mentioning AI or ML capabilities. The performance studies also do not indicate the use of AI/ML.
No
The device is used for fluid management and tissue debridement during arthroscopic surgery, which are surgical tools/procedures, not therapeutic treatments.
No
The device is described as a system for fluid management and tissue debridement during arthroscopic surgery, focusing on maintaining visibility and enabling tissue removal. It does not mention any function related to diagnosing diseases or conditions.
No
The device description explicitly mentions physical components like an "irrigation pump," "suction pump," and "integrated shaver console," indicating it is a hardware system with software control, not a software-only device.
Based on the provided information, the FMS VUE II Fluid Management and Tissue Debridement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a system used during surgical procedures (arthroscopic surgery) to manage fluid and debride tissue within the body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a pump system and shaver console designed to physically interact with the surgical field and tissue. This aligns with a surgical tool, not a device that analyzes samples like blood or tissue for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples, providing diagnostic information, or being used to determine a patient's condition or disease state.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The FMS VUE II does not perform this function.
N/A
Intended Use / Indications for 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.
Product codes
HRX
Device Description
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.
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)
FMS VUE™ II Fluid Management and Tissue Debridement System 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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's
Name and
Address | Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Project Lead
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3122
Facsimile: 508-977-6911
e-mail: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: FMS VUE™ II Fluid Management and Tissue
Debridement System
Classification Name: Arthroscope accessory
Class II, product code HRX, 21 CFR 888.1100
Common Name: Arthroscopic Pump |
| Substantial
Equivalence
Predicate
Devices | The FMS VUE™ II Fluid Management and Tissue
Debridement System is substantially equivalent to:
The FMS VUE™ Fluid Management and Tissue Debridement System (K130169)
(DePuy Mitek) |
| Device
Description | 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. |
| Indications for
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. |
| Technological
Characteristics
and
Performance | 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 FMS VUE™ II Fluid Management and Tissue Debridement System is similar to
the predicate DePuy Mitek's FMS VUE™ Fluid Management and Tissue Debridement
System (K130169) in that they share the same intended use, and contain inflow and
outflow pumps with an integrated shaver control. The FMS VUE™ II Fluid
Management and Tissue Debridement System contains updates in the software and
hardware, which include updated pressure and debridement settings, and an updated
pressure control with joint pressure estimation. |
| | FMS VUE™ II Fluid Management and Tissue Debridement System 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. 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 predicate
device, the FMS VUE™ II Fluid Management and Tissue Debridement System has
been shown to be substantially equivalent to the predicate device under the Federal
Food, Drug and Cosmetic Act. |
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