(114 days)
Not Found
No
The description mentions "software controlled" and "automatically manage fluid and joint pressure based on procedure settings chosen by the user," which indicates automated control based on pre-programmed logic, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
No
The device provides fluid distension, irrigation, and suction during arthroscopic procedures. It is used to maintain visibility during surgery and does not directly treat a disease or condition.
No
The device is described as providing fluid distension, irrigation, and suction during diagnostic and operative arthroscopic procedures, but it does not perform the diagnostic function itself. It supports diagnostic procedures by managing the fluid environment.
No
The device description explicitly lists multiple hardware components, including the "PowerPump Unit," "Non-sterile Foot Control," and "Non-sterile Power Cord," in addition to disposable components. While the pumps are software-controlled, the device itself is a physical system with hardware.
Based on the provided information, the PowerPump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the PowerPump is for providing fluid distension, irrigation, and suction during diagnostic and operative arthroscopic procedures within joint cavities. This is a direct interaction with the patient's body during a medical procedure.
- Device Description: The description details a system of pumps, controls, and tubing designed to manage fluid flow and pressure within a joint. This is a mechanical and fluid management system used in vivo (within a living organism).
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The PowerPump does not perform any analysis of biological specimens.
The PowerPump is a medical device used for surgical and diagnostic procedures performed directly on the patient.
N/A
Intended Use / 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 fluid suction during diagnostic and operative arthroscopic procedures.
Product codes
HRX
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:
-
- PowerPump Unit
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- Non-sterile Foot Control
-
- Non-sterile Power Cord
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- Disposable, sterile Patient Cassette
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- Disposable, sterile Day Cassette
-
- Disposable, sterile PowerPump Irrigation Tubing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, elbow, ankle and wrist joint cavities
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)
The PowerPump has been tested for function, performance and safety. Test results show that all specifications have been met.
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.
0
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the numbers '093409'. The handwriting is cursive and the numbers are written in a connected manner.
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:
-
- PowerPump Unit
-
- Non-sterile Foot Control
-
- Non-sterile Power Cord
-
- Disposable, sterile Patient Cassette
-
- Disposable, sterile Day Cassette
-
- 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.
1
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird, possibly an eagle, with its wings spread, symbolizing protection and care.
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 (800) 638-2041 or (301) 796-7100 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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