POWERPUMP ARTHROSCOPY SYSTEM

K093409 · Medical Vision AB · HRX · Feb 24, 2010 · Orthopedic

Device Facts

• Record ID: K093409
• Device Name: POWERPUMP ARTHROSCOPY SYSTEM
• Applicant: Medical Vision AB
• Product Code: HRX · Orthopedic
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

Device Story

PowerPump is a dual-roller pump system for arthroscopic procedures. It provides fluid distension, irrigation, and suction for knee, shoulder, hip, elbow, ankle, and wrist joints. The system includes a main unit, foot control, power cord, and sterile disposable cassettes/tubing. Software controls both roller pumps to automatically manage fluid flow and joint pressure based on user-selected settings; settings are adjustable. The device features 'SmartVision' optical detection to monitor for blood and debris. Used in clinical settings by surgeons/staff during arthroscopy. The system maintains joint visibility and distension, facilitating surgical access and potentially improving procedural outcomes.

Clinical Evidence

Bench testing only. The device underwent functional, performance, and safety testing. Results confirmed that all specifications were met.

Technological Characteristics

Dual-roller pump system; software-controlled fluid management; includes sterile disposable cassettes and irrigation tubing. Features SmartVision optical detection for blood/debris monitoring. Operates via electrical power. Designed for arthroscopic joint distension and irrigation.

Indications for Use

Indicated for patients undergoing diagnostic or operative arthroscopic procedures of the knee, shoulder, hip, elbow, ankle, or wrist joint cavities requiring fluid distension, irrigation, and suction.

Regulatory Classification

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.

Predicate Devices

• Future Medical Systems FMS DUO (K954465)

Reference Devices

• Gambro Dialysis Machine (K771227)
• Baxter Altratouch system 1000 dialysis machine (K954987)

Submission Summary (Full Text)

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## 510(k) Summary

Submitter: Medical Vision Nacka, Sweden

FEB 2 4 2010

Contact Information: C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridley, MN 55432

Submission Date: October 29, 2009

Device Name and Classification: Power Pump® Arthroscopy System, Class II Product Code: HRX

### Equivalent Device Identification:

Device: Future Medical Systems FMS DUO, K954465 Smart Vision® Feature: Gambro Dialysis Machine, K771227 and Baxter Altratouch system 1000 dialysis machine. K954987

#### Device Description:

The PowerPump provides liquid irrigation and aspiration for arthroscopic procedures in one unit through two individual roller pumps. Both roller pumps are software controlled and automatically manage fluid and ioint pressure based on procedure settings chosen by the user. If needed, both flow and pressure settings can be individually adjusted. By controlling both inflow and outflow, the PowerPump accurately regulates pressure and flow in the joint. The PowerPump also provides suction when used in conjunction with a shaver. The PowerPump consists of the following articles:

- 1. PowerPump Unit
- 2. Non-sterile Foot Control
- 3. Non-sterile Power Cord
- 4. Disposable, sterile Patient Cassette
- 5. Disposable, sterile Day Cassette
- 6. Disposable, sterile PowerPump Irrigation Tubing

## Intended Use:

The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

Summary of Testing: The PowerPump has been tested for function, performance and safety. Test results show that all specifications have been met.

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## Conclusion:

The PowerPump arthroscopy pump and the predicate device FMS DUO are substantially equivalent. Both pumps are intended to be used for providing distention pressure of body joints by pressurizing irrigation liquid, and to aspirate the liquid from the joint. Differences that exist between the devices are minor and do not affect the safety and effectiveness of the PowerPump.

The optical detection (SmartVision) feature is equivalent to blood and debris detection features used with dialysis machines. The addition of this well-known technology to the PowerPump does not affect the safe and effective intended use of the device as an Arthroscopy pump.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 2 4 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Medical Vision AB % C. G. Bundy Associates, Inc. Constance G. Bundy 435 Rice Creek Terrace Fridley, Minnesota 55432

Re: K093409

Trade/Device Name: PowerPump® Arthroscopy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 17, 2010 Received: February 22, 2010

Dear Constance G. Bundy:

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

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Page 2 - Constance G. Bundy

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

yours,

Melkerson

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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# Indications for Use

510(k) Number: K093409

Device Name: PowerPump® Arthroscopy System

Indications For Use:

The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluirds motion during diagnostic and operative arthroscopic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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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| (Division Sign-Off |
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| Division of Surgica Orthopedic, |
| and Restorative Devices |

| 510(k) Number | K093409 |
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