(231 days)
The Arthrex Dual Wave Arthroscopy Fluid Management Device is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
The Arthrex Dual Wave Arthroscopy Fluid Management Device is a roller, peristaltic, arthroscopic pump designed with a universal input grade switching power supply. The Arthrex Dual Wave Arthroscopy Fluid Management Device senses the connection and use of the Arthrex Shaver Adapteur System (K932699) and provides an outflow function to support the same.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The document is a 510(k) summary for the Arthrex Dual Wave Arthroscopy Fluid Management Device, which primarily focuses on demonstrating substantial equivalence to predicate devices based on device description, intended use, and conformance to voluntary standards rather than performance studies with specific statistical outcomes or acceptance criteria.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, specific study details, sample sizes, expert ground truth, or adjudication methods. The document does not describe a clinical study or a performance study that measures specific outcomes against predefined acceptance criteria for the device itself. Instead, it refers to conformity to safety standards like EN-55011B and IEC-60601-1, which are general electrical and medical equipment safety standards, not performance-based acceptance criteria for the intended use.
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AUG Ó 8 2009
Arthroll Storex Dual Wave Arthroscopy Fluid Marea Public Maragement Device
11083707
510(k) Summary of Safety and Effectiveness
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| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
|---|---|
| 510(k) Contact | Sally FoustRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1251Fax: 239/598.5508Email: sfoust@arthrex.com |
| Trade Name | Arthrex Dual Wave Arthroscopy Fluid Management Device |
| Common Name | Pump |
| Product Code -Name -Reference | HRX - Arthroscope - CFR 888.1111 |
| Predicate Device | Arthrex Continuous Wave Arthroscopy Pump, K024291FMS DUO, K954465 |
| Device Description and IntendedUse | The Arthrex Dual Wave Arthroscopy Fluid ManagementDevice is a roller, peristaltic, arthroscopic pump designed witha universal input grade switching power supply. The ArthrexDual Wave Arthroscopy Fluid Management Device sensesthe connection and use of the Arthrex Shaver AdapteurSystem (K932699) and provides an outflow function tosupport the same.Arthrex Dual Wave Arthroscopy Fluid Management Device isintended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phasesof arthroscopic surgery. |
| Substantial Equivalence Summary | The Arthrex Dual Wave Arthroscopy Fluid ManagementDevice is substantially equivalent to the predicate devicesArthrex Continuous Wave III Arthroscopy Pump and the FMSDUO in which the basic features and intended uses are thesame or very similar. Any differences between the ArthrexDual Wave Arthroscopy Fluid Management Device and thepredicate devices Arthrex Continuous Wave III ArthroscopyPump and FMS DUO are considered minor and do not raisequestions conceming safety and effectiveness. Based on theinformation submitted, Arthrex, Inc. has determined that thenew Arthrex Dual Wave Arthroscopy Fluid ManagementDevice is substantially equivalent to the currently marketedpredicate devices. |
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Arthrex. TRADITIONAL 510(k): Arthrex Dual Wave Arthroscopy Fluid Management Device
dministrative Information
Manufacturer / Distributor/ Sponsor / Contact 4.1
4.1.1 Manufacturer/Distributor / Sponsor
Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 USA Establishment Registration Number: 1220246
4.1.2 Contact
Sally Foust Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 USA Telephone: 239/643.5553, extension 1251 Fax: 239/598.5508 Email: sfoust(@arthrex.com
4,2 Device Identification
4.2.1 Proprietary Name
Arthrex Dual Wave Arthroscopy Fluid Management System
4.2.2 Common Name
Pump
4.2.3 Classification Name and Reference
21 CFR 888.1111: Arthroscope
4.2.4 Regulatory Class
Based on the recommendation of the Orthopedic and Rehabilitation Device Panel, the FDA has classified this device as a Class II medical device.
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Arthrex. 8 TRADITIONAL 510(K): Arthrex Dual Wave Arthroscopy Fluid Management Device
4.2.5 Device Product Code
HRX o
Compliance with Special Controls 4,3
Sections 513 and 514 of the act, as amended under the Safe Medical Devices Act of 1990, do apply to this type of device.
Arthrex, Inc. is not aware of any requirements for post-market surveillance or other special controls for this device.
4.4 Conformance to Voluntary Standards
The Arthrex Dual Wave Arthroscopy Fluid Management Device will conform to the following voluntary standards:
EN -55011B (EMC 89/336/CEE): Emission Requirements
IEC-60601-1 (73/23/CEE): Medical electrical equipment, General Requirements for Safety
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ms. Sally Frost Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108
AUG 0 8 2009
Re: K083707
Trade/Device Name: Arthrex Dual Wave Arthroscopy Fluid Management Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 13, 2009 Received: July 15, 2009
Dear Ms. Forst:
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.
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 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 (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.
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Page 2 - Ms. Sally Frost
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Pedro R.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K08370?
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Arthrex TRADITIONAL 510(k): Arthrex Dual Wave Arthroscopy Fluid Management Device
Indications for Use
510(k) Number:
Device Name:
Arthrex Dual Wave Arthroscopy Fluid Management Device
The Arthrex Dual Wave Arthroscopy Fluid Management Device is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
Prescription Use_X_AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Neil K. Shahani Simpson
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083707
§ 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.