(15 days)
No
The description focuses on mechanical and interface modifications (serial interface, increased flow) and does not mention any AI or ML capabilities. The "voice-activation control" is a standard feature and not indicative of AI/ML in this context.
No
The device is described as an arthroscopic pump intended for fluid distention of joint cavities during arthroscopic procedures, not for treating a disease or condition.
No
Explanation: The device is an arthroscopic pump intended for fluid distention of joint cavities during arthroscopic procedures, not for diagnostic purposes.
No
The device description clearly states it is a high flow arthroscopic pump, which is a hardware device. While it incorporates a serial interface for external control (potentially involving software), the core device is a physical pump.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- Intended Use: The intended use of the Arthro-Surgimat-2000 ECU is for "fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities... during arthroscopic procedures." This is a procedure performed inside the body (in vivo) to facilitate visualization and manipulation during surgery.
- Device Description: The device description clearly states it's a "high flow arthroscopic pump intended to distend joint cavities." This function is related to surgical procedures, not laboratory testing of samples.
The device is a surgical pump used during arthroscopic procedures, which are performed directly on the patient's body. It does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control during arthroscopic procedures. (21 C.F.R. & 888.1100).
Product codes
HRX
Device Description
The ARTHRO-SURGIMAT-2000 ECU is a high flow arthroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. GmbH.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
L
Summary of Safety and Effectiveness - 510(k) Summary
W.O.M. GmbH Michael McGrail, Agent Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany.
Proprietary Name: Common Name:
Arthro-Surgimat-2000 ECU Arthroscopic Pump
The ARTHRO-SURGIMAT-2000 ECU is a high flow arthroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Inrigation System (K933873).
With the exception of the following modifications, the ARTHRO-SURGIMAT-2000 ECU incorporates the same design features and accessories as the Arthro-Surgimat-1500 (K983910):
- A serial interface has been incorporated in the device to allow for surgeon selection of device settings ● utilizing the HERMES Operating Room Control Center (K980787). The external adjustment capability of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Surgiflator-20 ECU (K981859) manufactured by W.O.M. GmbH
- The maximum flow performance of the device has been increased from 1,5 Vmin. to 2 Vmin. The . flow performance of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Apex Universal Irrigation System (K933873) manufactured by Linvatec Corp.
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).
This work is of particular interest due to the extensive review of arthroscopic techniques specific to various ioints. 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.
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-
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: M. McDuail
Michael McGrail Agent, W.O.M. GmbH
Feb. 8, 1999
Date: 02/08/99
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 1999
W.O.M. GmbH c/o Michael McGrail Regulatory Consultant 194 Branch Street Mansfield, Massachusetts 02048
K990443 Re: R970445
Trade Name: ARTHRO-SURGIMAT-2000 ECU Regulatory Class: II Product Code: HRX Dated: February 8, 1999 Received: February 11, 1999
Dear Mr. McGrail:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notificantes to invalent (for the indications for above and we have determined this case to the researce commerce prior to use stated in the enclosure) to device manatical Device Amendments, or to devices that May 28, 1976, the ellacinem date of the Mocions of the Federal Food, Drug, and have been reclassified in accordance wrer the device, subject to the general controls Cosment Act (Act. "Tournaly, therefere) is provisions of the Act include requirements for provisions of the Act. The generales, 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 (Frematice Approval), it may of sacreer to sal in the Code of Federal Regulations, Title 21, It guilance and out a vite equivalent determination assumes compliance with the I arts 600 to 695. I Fouction Practice requirement, as set forth in the Quality System Carrent Good Managed Devices: General regulation (21 CFR Part 820) and that, Regulation (QS) inspections, the Food and Drug Administration (FDA) will verify through perrodio (QB) inspecies.is) with the GMP regulation may result in regulatory such assumptions. Funal to compy with further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does I cachi Rogister. Trease you might have under sections 531 through 542 of the Act for not affect any obligation you magazet 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/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
4
STATEMENT OF INDICATIONS FOR USE
APPICANT:
W.O.M. GmbH
510(K) NUMBER (if known):
ARTHRO-SURGIMAT 2000 ECU, for optional use DEVICE NAME: with the HERMES Operating Room Control Center
INDICATIONS FOR USE:
The Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control 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)
.