(97 days)
Not Found
No
The description focuses on software-controlled peristaltic pumps and integrated debridement functions, with no mention of AI or ML.
Yes.
The device is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery, making it a therapeutic device.
No
The device is described as a system for fluid management and tissue debridement during arthroscopic surgery, focusing on irrigation, aspiration, and controlled cutting/shaving of tissue and bone. Its purpose is to facilitate surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states the system consists of a pump, tube sets, and optional hardware accessories (Foot Pedal, Remote Control, Handpiece, FMS Connect Interface Cable). While software controls the pumps, the core device is a hardware system.
Based on the provided information, the DePuy Mitek FMS VUE Fluid Management and Tissue Debridement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system with pumps, tube sets, and accessories designed to manage fluid and perform tissue debridement within a joint cavity. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The FMS VUE is a surgical instrument used during a procedure on the patient.
N/A
Intended Use / Indications for Use
DePuy Mitek 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.
The FMS CONNECT Interface Cables are accessories to the DePuy Mitek FMS Fluid Management and Tissue Debridement Systems; they connect competitive shavers to FMS arthroscopy pumps.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The FMS VUE is DePuy Mitek's next generation of Fluid Management and Tissue Debridement System. The system consists of a pump, tube sets, and the following optional accessories Foot Pedal, Remote Control, Handpiece and FMS Connect Interface Cable.
As with its predicate devices, FMS DUO+ and FMS SOLO, this system utilizes pump technology designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control.
The FMS VUE provides irrigation (inflow) and aspiration (outflow) of fluid to and from joint cavities during arthroscopic procedures by way of 2 peristaltic roller pumps. Both roller pumps are software controlled to automatically manage fluid and intra-articular joint pressure based on default settings or adjusted setting chosen by the surgeon. Additionally, the pumps automatically manage shaver and cannula suction. By controlling both flow and pressure setting, the FMS VUE Fluid Management & Tissue Debridement System accurately requlates pressure and flow in the joint.
The FMS VUE can be used in either the DUO mode (default mode) which provides irrigation, shaver control and suction or the SOLO mode which provides irrigation and shaver control but not suction.
Like its predicates, the FMS VUE also incorporates an integrated debridement function for controlled shaving and burring of tissue and bone.
The FMS Connect Interface Cable allows the use of competitive shaver systems to interface with the FMS VUE. When the FMS Connect device is attached to the cable of a competitors hand piece and the hand piece is running, the FMS Connect sends a signal to the FMS VUE.
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)
Verification of the FMS VUE Fluid Management & Tissue Debridement System and accessories includes electrical, software and performance tests to show that the device meets its product specifications over a range of operating conditions. Validation testing for the FMS VUE includes testing to show the device meets user needs. Verification testing conform to the following Standards and Guidance documents: EN 60601-1:2005 Medical electrical equipment -- Part 1: General requirements for safety; EN60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests; IEC 62304:2006 Medical device software-software life cycle process; Guidance for the Content of Premarket Submission for Software Contained in Medical Devices: 2005; General Principles of Software Validation; Final Guidance for Industry and FDA Staff: 2002; Guidance Off-The-Shelf Software Use in Medical Devices: 1999.
No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The FMS VUE Fluid Management & Tissue Debridement System and FMS Connect Interface Cables do not differ from the predicate device in fundamental scientific technology or intended use.
Safety and performance testing have been executed to validate the performance and safety of the devices. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices. Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.
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.
Not Found
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 shows the logo for DePuy Mitek, a Johnson & Johnson company. The logo features a black circle followed by the company name in bold, stylized font. Below the company name is the text "a Johnson & Johnson company" in a smaller font. The text "K130169" is located below the company information.
510(k) SUMMARY
MAY 0 1 2013
Date Prepared January 22, 2013
| Submitter's Name and Address: | DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Susan Kagan
Project Manager, Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-880-8097
Facsimile: 508-977-6955
e-mail: skagan@its.jnj.com |
| Name of Medical Device | Classification Name: Arthroscope: 21 CFR 888.1100
Common: Pump
Trade Name: FMS VUE Fluid Management & Tissue Debridement System
FMS Connect Interface Cable
FDA Classification: II
FDA product code: HRX |
| Predicate Device(s) | The proposed FMS VUE Fluid Management & Tissue Debridement System, and FMS Connect Interface Cable are substantially equivalent to:
• K954465 FMS DUO (November 9, 1995)
• K002040 FMS SOLO (September 11, 2000) |
| Device Description | The FMS VUE is DePuy Mitek's next generation of Fluid Management and Tissue Debridement System. The system consists of a pump, tube sets, and the following optional accessories Foot Pedal, Remote Control, Handpiece and FMS Connect Interface Cable. |
.
1
2002 : 0 YAM
As with its predicate devices, FMS DUO+ and FMS SOLO, this system utilizes pump technology designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control.
The FMS VUE provides irrigation (inflow) and aspiration (outflow) of fluid to and from joint cavities during arthroscopic procedures by way of 2 peristaltic roller pumps. Both roller pumps are software controlled to automatically manage fluid and intra-articular joint pressure based on default settings or adjusted setting chosen by the surgeon. Additionally, the pumps automatically manage shaver and cannula suction. By controlling both flow and pressure setting, the FMS VUE Fluid Management & Tissue Debridement System accurately requlates pressure and flow in the joint.
The FMS VUE can be used in either the DUO mode (default mode) which provides irrigation, shaver control and suction or the SOLO mode which provides irrigation and shaver control but not suction.
Like its predicates, the FMS VUE also incorporates an integrated debridement function for controlled shaving and burring of tissue and bone.
The FMS Connect Interface Cable allows the use of competitive shaver systems to interface with the FMS VUE. When the FMS Connect device is attached to the cable of a competitors hand piece and the hand piece is running, the FMS Connect sends a signal to the FMS VUE.
Indications for Use
DePuy Mitek 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.
The FMS CONNECT Interface Cables are accessories to the DePuy Mitek FMS Fluid Management and Tissue Debridement Systems; they connect competitive shavers to FMS arthroscopy pumps.
2
Comparison to Predicate Device
This submission is intended to demonstrate that the FMS VUE and FMS Connect Interface Cable are substantially equivalent to their legally marketed devices: FMS DUO+ (K954465) and FMS SOLO (K002040).
The FMS VUE Fluid Management & Tissue Debridement System and FMS Connect Interface Cable have been carefully compared to legally marketed devices with respect to intended use, essential components and material, performance specifications and technology characteristics. They have the same Indications for Use and technology characteristics.
- Enhancements on the FMS VUE include: .
- o Incorporating DUO+ and SOLO mode functionality in one pump system
- o Measurement displayed in mmHg
- FMS Connect Interface Cable has a different mode of connecting to completive shavers and is powered for a wall source rather that the pump.
Safety and Performance
Verification of the FMS VUE Fluid Management & Tissue Debridement System and accessories includes electrical, software and performance tests to show that the device meets its product specifications over a range of operating conditions. Validation testing for the FMS VUE includes testing to show the device meets user needs. Verification testing conform to the following Standards and Guidance documents:
| Standard/
| Guidance | Description |
|---|---|
| EN 60601- | |
| 1:2005 | Medical electrical equipment -- Part 1: General |
| requirements for safety | |
| EN60601-1- | |
| 2:2007 | Medical electrical equipment -- Part 1-2: General |
| requirements for safety - Collateral standard: | |
| Electromagnetic compatibility - Requirements and tests. | |
| IEC | |
| 62304:2006 | Medical device software-software life cycle process |
| Guidance for the Content of Premarket Submission for Software | |
| Contained in Medical Devices: 2005 | |
| General Principles of Software Validation; Final Guidance for Industry and | |
| FDA Staff: 2002 | |
| Guidance Off-The-Shelf Software Use in Medical Devices: 1999 |
TABLE 1 Standards & Guidance Documents
3
Clinical No clinical studies are required to demonstrate safety and efficacy of Testing the device in support of an application for premarket clearance. The FMS VUE Fluid Management & Tissue Debridement System and FMS Connect Interface Cables do not differ from the predicate device in fundamental scientific technology or intended use.
Safety and performance testing have been executed to validate the Conclusion performance and safety of the devices. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices. Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.
Based on the indications for use, fundamental scientific technology, and comparison to the predicate devices, the FMS VUE Fluid Management & Tissue Debridement System, and FMS Connect Interface Cable are shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes intertwined around a staff.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 1. 2013
DePuy Mitek, Inc. % Ms. Susan Kagan Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K130169
Trade/Device Name: FMS VUE Fluid Management & Tissue Debridement System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 22, 2013 Received: February 07, 2013
Dear Ms. Kagan:
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 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.
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
5
Page 2 - Ms. Susan Kagan
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter DERRumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K130169
FMS VUE™ Fluid Management and Tissue Debridement System Device Name:
Indications for Use:
DePuy Mitek 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C.
Nipper -S
(Division Sign-Off)
For
Division of Surgical Devices
510(k) Number_K130169
Page 1 of 1
7
Indications for Use
510(k) Number (if known): K130169
FMS™ Connect Interface Cable Device Name:
Indications for Use:
The FMS CONNECT Interface Cables are accessories to the DePuy Mitek FMS Fluid Management and Tissue Debridement Systems; they connect competitive shavers to FMS arthroscopy pumps.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Joshua C.
Nipper -S
For
(Division Sign-Off)
Division of Surgical Devices
K130169 510(k) Number_