(22 days)
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.
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: 1. 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. 2. 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 provided text is a 510(k) Summary for a medical device (Arthro-Surgimat-1500 arthroscopic pump) seeking substantial equivalence to a predicate device. It primarily discusses the device's function, modifications, and references existing literature on arthroscopic techniques. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets those criteria, as this information is not present in the provided document.
The document states:
- The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114).
- Modifications include a software filter for instrument recognition and an optional cable remote control.
- The utility and safety of arthroscopic techniques using modern electronic high flow pumps are discussed in referenced literature.
The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and indications for use, rather than conducting new performance studies that would involve acceptance criteria, test sets, experts, or ground truth as described in your request. Clinical performance studies with defined endpoints and statistical analyses are generally reserved for Pre-Market Approval (PMA) applications or when substantial equivalence cannot be demonstrated through non-clinical means.
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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).
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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
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Hempfling, Harald." Arthroscopie: Diagnostika und Therapie". Landsberg, Germany: Ecomed Verlagsgesellschaft AG + Co. KG, 1995, 375 pages.
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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:
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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.
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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
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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).
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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)
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Divisio Division of General Restorative D 510(k) Number
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§ 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.