(22 days)
No
The description mentions a "software filter function" and "instrument recognition feature" that measures resistance and regulates pressure. While this involves software and data processing, it does not describe the characteristics of AI or ML, such as learning from data or complex pattern recognition. The modifications are described as a filter and a measurement/regulation function, not an AI/ML algorithm.
No.
The device's intended use is for fluid distention of joint cavities during arthroscopic procedures, which is a supportive function during surgery rather than directly treating a disease or condition.
No
Explanation: The device is an arthroscopic pump intended for fluid distention of joint cavities during arthroscopic procedures. Its function is to distend ("inflate") the joint cavity for surgical access, not to diagnose a condition.
No
The device is described as a high flow arthroscopic pump, which is a hardware device. While it incorporates a software filter function and an optional cable remote control, these are features of a physical pump, not a standalone software device.
Based on the provided information, the Arthro-Surgimat-1500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures." This describes a device used in vivo (within the body) to facilitate a surgical procedure.
- Device Description: The description details a pump that regulates pressure and flow of fluid within a joint. This is a mechanical device used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Arthro-Surgimat-1500 does not perform any such analysis of biological specimens.
Therefore, the Arthro-Surgimat-1500 is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures.
Product codes
HRX
Device Description
The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended to distend joint cavities. The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114) manufactured by W.O.M. GmbH.
The Arthro-Surgimat-1500 incorporates the same design features and accessories as the Arthro-Surgimat (K962114). The following modifications have been performed:
-
- The device Arthro-Surgimat-1500 incorporates a software filter function referred to as the instrument recognition feature. The instrument recognition feature of the device measures the resistance of the tubing set and instrument being used and regulates the actual pressure accordingly. The instrument recognition feature of the device allows for a more accurate attainment of the desired intraarticular pressure.
-
- The device Arthro-Surgimat-1500 incorporates an optional cable remote control for the adjustment of device parameters. Only those parameter which may be adjusted utilizing the user-interface (front panel) and the foot pedal may be adjusted utilizing the cable remote control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, 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
Not Found
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
Summary of Safety and Effectiveness - 510(k) Summary L.
W.O.M. GmbH Michael McGrail, Manager, Regulatory Affairs Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany.
Proprietary Name: Arthro-Surgimat-1500 Arthroscopic Pump Common Name:
NOV 25 1998
The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended to distend joint cavities. The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114) manufactured by W.O.M. GmbH.
The Arthro-Surgimat-1500 incorporates the same design features and accessories as the Arthro-Surgimat (K962114). The following modifications have been performed:
-
- The device Arthro-Surgimat-1500 incorporates a software filter function referred to as the instrument recognition feature. The instrument recognition feature of the device measures the resistance of the tubing set and instrument being used and regulates the actual pressure accordingly. The instrument recognition feature of the device allows for a more accurate attainment of the desired intraarticular pressure.
-
- The device Arthro-Surgimat-1500 incorporates an optional cable remote control for the adjustment of device parameters. Only those parameter which may be adjusted utilizing the user-interface (front panel) and the foot pedal may be adjusted utilizing the cable remote control.
The utility and safety of arthroscopic techniques using modern electronic high flow pumps is discussed in the following literature, including the benefits and risks of such procedures and the importance of effective, well maintained instrumentation.
A Comprehensive discussion of the use of distention methods is presented in the book "Arthroscopie: Diagnostika und Therapie" (1) by Harald Hempfling, 1995, in which the development of arthroscopic procedures is reviewed, including objective comparisons of arthroscopy vs. traditional methods of treatment. This extensive analysis of the instrumentation in this field includes comments on the use of modern high flow pumps, the selection of the optimal distention medium and a summary of other instruments necessary for arthroscopic procedures. (Pg. 13-41).
3
1
Summary of Safety and Effectiveness - 510(k) Summary I.
W.O.M. GmbH Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany
Page -2- / -2-
This work is of particular interest due to the extensive review of arthroscopic techniques specific to various joints. This includes, but is not limited to, the knee, shoulder, wrist, and elbow.
"Operative Arthroscopy, Second Edition" (2), provides an in-depth review of the history, techniques and modern apparatus of arthroscopic procedures. Of special interest is the chapter . on advanced arthroscopic instrumentation (pg. 7-13), in which irrigation systems are also discussed in detail. Other references to irrigation systems include pg. 75 and pg. 256.
REFERENCES
-
Hempfling, Harald." Arthroscopie: Diagnostika und Therapie". Landsberg, Germany: Ecomed Verlagsgesellschaft AG + Co. KG, 1995, 375 pages.
-
McGinty, John B. "Operative Arthroscopy, Second Edition" Philadelphia: Lippincott-Raven Publishers, 1995, 1500 pages. See "Advanced Arthroscopic Instrumentation" on pages 7-13.
Signed:
.............................................................................................................................................................................. Major
Michael McGrail Agent for W.O.M. GmbH
28 October 1998
Date:
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle, with three lines representing the wings and head of the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1998
W.O.M. GmbH c/o Mr. Michael McGrail Manager, Regulatory Consultant 194 Branch Street Mansfield, Massachusetts 02048
Re: K983910 Trade Name: Arthro-Surgimat-1500 Regulatory Class: II Product Code: HRX Dated: October 28, 1998 Received: November 3, 1998
Dear Mr. McGrail:
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 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). 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 (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.
3
Page 2 - Mr. Michael McGrail
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 number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
A
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
4
STATEMENT OF INDICATIONS FOR USE
APPICANT:
W.O.M. GmbH
5 10(K) NUMBER (if known):
,
DEVICE NAME:
Arthro-Surgimat 1500
INDICATIONS FOR USE:
The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures.
( 21 C.F.R. & 888.1100).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
bcolls
Divisio Division of General Restorative D 510(k) Number
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