(176 days)
Not Found
Not Found
No
The summary describes a roller pump for irrigation and aspiration, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device facilitates surgical procedures by providing irrigation and aspiration, but it does not directly treat a disease or condition itself.
No
This device is described as an irrigation/aspiration pump used during arthroscopic surgical procedures. Its function is to provide fluid management at the surgical site, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "roller type irrigation/aspiration pump," which is a hardware device.
Based on the provided information, the Karl Storz Arthropump Plus system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation and aspiration during surgical procedures. This is a function performed on the patient during surgery, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details a pump system for managing fluids during surgery. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological samples.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Karl Storz Arthropump Plus system's function is entirely focused on facilitating the surgical procedure itself.
N/A
Intended Use / Indications for Use
The Karl Storz Arthropump Plus system is designed to provide irrigation and aspiration of the surgical site during arthroscopic surgical procedures.
These instruments are intended for use by qualified surgeons and provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Karl Storz Arthropump Plus and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction underpressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
K971649
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
2 9 1997 OCT -
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 is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Suction/irrigation Pump |
| | Trade Name: (optional) |
Indication: The Karl Storz Arthropump Plus system is designed to provide irrigation and aspiration of the surgical site during arthroscopic surgical procedures.
Karl Storz Arthropump Plus
Device Description: The Karl Storz Arthropump Plus and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction underpressure.
Substantial Equivalence: The Karl Storz Arthropump Plus system is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Arthropump Plus and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed: Blin Blanett
Kevin Kennan Regulatory Affairs Specialist
000130
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Kennan Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, California 90230-7600
OCT 2 9 1997
Re: K971649 Trade Name: Arthropump Plus Regulatory Class: II Product Code: HRX Dated: July 21, 1997 Received: August 14, 1997
Dear Mr. Kennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Kevin Kennan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free would number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fcolle
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "Karl Storz Endoscopy" in a smaller font. The logo is simple and easy to read.
510(k) Number (if known): Not yet assigned
Device Name: Arthropump Plus
Indications for Use: These instruments are intended for use by qualified surgeons and provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971649 |
| Prescription Use:
| (Per 21 CFR 801.109) | X | OR Over-The-Counter Use: |
|---|---|---|
| ------------------------------------------- | --- | -------------------------- |
(Optional Format 1-2-96)000003