(346 days)
Not Found
No
The description mentions "software controlled" and "automatically manage fluid and joint pressure based on settings chosen by the user," which indicates automation and control logic, but not necessarily AI/ML. There is no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used to provide irrigation/aspiration during arthroscopic surgical procedures. It is not used to treat a disease or condition, but rather to facilitate a surgical procedure.
No
The device is described as an irrigation/suction pump used during arthroscopic surgical procedures to manage fluid and joint pressure. Its function is operative (irrigation and aspiration), not diagnostic. It does not provide information about a patient's medical condition.
No
The device description clearly states it is a "combined irrigation and suction pump" and mentions hardware components like "roller pumps," a "footswitch," and "tubing." While the pumps are software-controlled, the device itself is a physical pump system, not solely software.
Based on the provided information, the Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for use during surgical procedures to provide irrigation and aspiration to the surgical site. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a pump system for managing fluid and pressure within a joint during surgery. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Karl Storz ARTHROPUMP POWER does not fit this description. It is a surgical device used to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.
Product codes
HRX
Device Description
The Karl Storz ARTHROPUMP POWER is a combined irrigation and suction pump for dilation and irrigation of joint capsules with a fluid. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on settings chosen by the user. If desired, both flow and manage hald and joint proodividually adjusted. The device is used as part of a system that includes the unit, a footswitch and tubing, and can support integrated use of a shaver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knees, ankle, elbow, wrist, and hip.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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
The KARL STORZ ARTHROPUMP POWER has been tested for function, performance and safety Test results show that all specifications have been met.
Key Metrics
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 the text "KARL STORZ - ENDOSKOPE" in a bold, sans-serif font. The text is white, and the background is dark and textured. The text appears to be a logo or title, possibly for a medical device company or product.
KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, California 90245
Toll Free 800 421 0837 Fax 800 321 1304
OCT 18 2010
ko9347)
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Submitter:
Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245-5017 Phone: (424) 218-8381 (424) 218-8519 Fax:
Contact Person:
Regulatory Affairs Specialist Email: cdizol@ksea.com
Crystal Dizol
Date Prepared: September 16, 2010
Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump Device Trade Name:
Common Name: . Arthroscopic pump
Classification Name: Arthroscope and accessories
Regulation Number: 21 CFR 884.1730
HRX Product Code:
Predicate Device(s):
Future Medical Systems, Inc .: FMS Duo (K954465) Karl Storz: Arthropump Plus (K971649)
Device Description:
The Karl Storz ARTHROPUMP POWER is a combined irrigation and suction pump for dilation and irrigation of joint capsules with a fluid. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on settings chosen by the user. If desired, both flow and manage hald and joint proodividually adjusted. The device is used as part of a system that includes the unit, a footswitch and tubing, and can support integrated use of a shaver.
Intended Use:
The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified The Ran Glorz An 11 in For only 1 Sweet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . the joints of the shoulder, knees, ankle, elbow, wrist, and hip.
Pape 3 of 3
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Technological Characteristics:
The KARL STORZ ARTHROPUMP POWER Irrigation Pump utilizes microprocessor controlled dual peristaltic pump technology to maintain user-set pressure and flow, and to also perform lavage and hemostasis as necessary.
Non-Clinical Performance Data:
The KARL STORZ ARTHROPUMP POWER has been tested for function, performance and safety Test results show that all specifications have been met.
Determination of Substantial Equivalence:
The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is substantially equivalent to the predicate devices since the basic features, design, and intended use are similar. The minor differences between the Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the function or intended use of the devices. Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness.
Conclusions:
The Karl Storz ARTHROPUMP POWER is substantially equivalent to the identified predicate devices and does not raise any new issues of safety and efficacy.
Att: Substantial Equivalence Table for Karl Storz ARTHROPUMP POWEF
2023 02 15
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Karl Storz Endoscopy-America, Inc. % Ms. Crystal Dizol Regulatory Affairs Specialist 2151 East Grand Avenue El Segundo, California 90245-5017
OCT 1 8 2010
Re: K093471
Trade/Device Name: Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 16, 2010 Received: September 20, 2010
Dear Ms. Dizol:
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
3
Page 2 - Ms. Crystal Dizol
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 (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
for Peter D
Mark N. Melkerson
DEP Dir
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
OCT 1 8 2010
510(k) Number (if known): K093471
Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump Device Name:
Indications for Use: The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.
× Prescription Use: (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)
Nittededen for nxa
sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K093471