(77 days)
None
Not Found
No
The document describes a disposable tubing set for an irrigation system used in arthroscopic surgery. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
Explanation: The device is used to infuse sterile irrigant solution during arthroscopic procedures, which is a supportive function rather than directly treating or preventing a disease or condition.
No
Explanation: The device is described as a tubing set for infusing sterile irrigant solution during arthroscopic surgical procedures, which is a therapeutic rather than a diagnostic function. It does not mention any role in identifying, monitoring, or predicting diseases or conditions.
No
The device description explicitly states it is a "Disposable Tubing Set" made of physical materials (PVC, silicone, polyolefin, and Makrolon), indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures. This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a tubing set for delivering fluid during surgery. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.
The MTP Arthropump Disposable Tubing Set is intended to be utilized with the Karl Storz Arthropump Irrigation System for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.
Product codes
HRX
Device Description
The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joints
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)
Not Found
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 is a logo for MTP, which stands for Technical Medical Promotion. The letters "mtp" are stacked vertically, with the "t" in white and the "m" and "p" in black. Below the letters are the words "technical medical promotion" in a smaller font. The logo is set against a gray background.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 MTP's knowledge.
| Applicant: | mtp medical technical promotion gmbh
p.o. box 4529 • d-78510 tuttlingen
tel.: +49/7461/96630 - 0
fax: +49/7461/96630 - 25 |
|------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan |
(310) 410-2769
Common Name: Device Identification: Irrigation Tubing Set
Trade Name: (optional) MTP Arthropump Disposable Tubing Set
Indication: The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.
Device Description: The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
Substantial Equivalence: The MTP Arthropump Disposable Tubing Set is substantially equivalent to the predicate device since the basic features, design and intended uses are the same.
Signed:
JUN
3
Kevin Kennan
Image /page/0/Picture/11 description: The image shows the number 000025. The first four digits are zeros, followed by the number 25. The numbers are in a bold, sans-serif font and are black in color. There is a line going through the number 5.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
MTP Medical Technical Promotion GmbH c/o Mr. Kevin A. Kennan P.O. Box 1954 Culver City, California 90232
K990911 Re: Trade Name: MTP Arthropump Disposable Tubing Set Regulatory Class: II Product Code: HRX Dated: February 26, 1999 Received: March 18, 1999
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 requirement, as set forth in the Quality System Regulation (QS) 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.
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.
2
Page 2 - Mr. Kevin A. Kennan
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 number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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 a logo for a company called MTP, which stands for Medical Technical Promotion. The logo is in black and white and features the letters "mtp" in a stylized font. The words "technical medical promotion" are written below the letters. The logo is set against a dark background.
510(k) Number (if known):
Device Name: Arthropump Disposable Tubing Set
Indications for Use: The MTP Arthropump Disposable Tubing Set is intended to be utilized with the Karl Storz Arthropump Irrigation System for the infusion of sterile irrigant solution into joints 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)
| Prescription Use:
| (Per 21 CFR 801.109) | X |
|---|---|
| OR Over-The-Counter Use: |
(Optional Format 1-2-96)
(Division of)
Division Restorative Devices
| 510(k) Number | K990911 |
|---|---|
| --------------- | --------- |
000003