(83 days)
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No
The summary describes a pump with sensors and preselectable pressure levels, but there is no mention of AI, ML, or any learning or adaptive capabilities beyond reacting to pressure changes.
Yes.
Explanation: The device is described as a high-flow arthroscopic pump intended to distend joint cavities during arthroscopic procedures, which is a medical procedure for treatment.
No
Explanation: The device description states its purpose is to distend joint cavities and maintain constant intraarticular pressure during arthroscopic procedures, not to diagnose medical conditions.
No
The device description clearly states it is a "high flow arthroscopic pump" with physical components like a pump head, sensors, and a foot pedal, indicating it is a hardware device, not software-only.
Based on the provided information, the Arthro-Surgimat is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "distend joint cavities during arthroscopic procedures." This is a surgical procedure performed in vivo (within the living body), not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a pump designed to manage fluid flow and pressure within a joint during surgery. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Classification: The device is classified under 21 C.F.R. § 888.1100, which is for "Arthroscope and accessories." This classification is for surgical instruments, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Arthro-Surgimat does not fit this description.
N/A
Intended Use / Indications for Use
The Arthro-Surgimat is a high flow arthroscopic pump classified under 21 C.F.R. § 888.1100 intended to distend joint cavities during arthroscopic procedures. It has been designed to react very quickly to various influences, thereby maintaining constant intraarticular pressure.
Product codes
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Device Description
The Arthro-Surgimat is a high flow arthroscopic pump designed to distend joint cavities during arthroscopic procedures. It is designed to react quickly to maintain constant intraarticular pressure. Key features include pressure measurement through multiple sensors at the pump head, 3 optional preselectable pressure levels (0-1 mmHg for knee arthroscopy, 0-80 mmHg for shoulder arthroscopy, 0-60 mmHg for small joints), a max. flow rate of 1500 ml/min, and a foot pedal for temporary increase of preselected flow level for rinsing of joint after/during shaver use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Joint cavities, including knee, shoulder, wrist, and elbow.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The utility and safety of arthroscopic techniques using modern electronic high flow pumps is discussed in the following references, 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. (pp. 13-41)
- In perhaps the most comprehensive work on arthroscopy, "Operative Arthroscopy, Second Edition" (2), an in-depth review of the history, techniques and modern apparatus of arthroscopic procedures is provided. Of special interest is the chapter on advanced arthroscopic instrumentation (pp. 7-13), in which irrigation systems are also discussed in detail. Other references to irrigation systems appears at pp. 75 and 256.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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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
CON-IUti
AUG 22
510(k) Summarv W.O.M. GmbH Pascalstr. 11 D. 10587 Berlin Germany (030) 399 81 550
The Arthro-Surgimat is a high flow arthroscopic pump classified under 21 C.F.R. § 888.1100 intended to distend joint cavities during arthroscopic procedures. It has been designed to react very quickly to various influences, thereby maintaining constant intraarticular pressure.
The arthroscopic pump described in this notification is substantially equivalent in design and construction to the Linvatec Apex Universal Irrigation System, K933873, and the Smith & Nephew InteliJET Fluid Management System, K912453, and has similar indications for use to those devices. The principal differences lie in the following features:
- Pressure measurement through multiple sensors at the pump head. The Apex . device provides for pressure measurement through a single membrane at the end of an additional tube. The specific pressure measurement systems of the Smith & Nephew device are not known.
- 3 optional preselectable pressure levels (to be programmed by end-user): .
| Knee arthroscopy: | 0 - 1 mm Hg |
|---|---|
| Shoulder arthroscopy: | 0 - 80 mm Hg |
| Small Joints: | 0 - 60 mm Hg |
** (Please refer to specific pressure levels described in manual)
The Apex device contains no preselectable pressure levels; the Smith & Nephew device contains 4 preselectable pressure levels.
- Max. flow rate of 1500 ml/min. This is the same as the Smith & Nephew device: . Apex provides 2000 ml/min.
- Foot pedal for temporary increase of preselected flow level for rinsing of joint . after/during shaver use. The predicate devices offer an optional foot pedal having features that are not currently known.
The utility and safety of arthroscopic techniques using modern electronic high flow pumps is discussed in the following references, 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. (pp. 13-41)
1
CONFIDENTIAL
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.
- In perhaps the most comprehensive work on arthroscopy, "Operative Arthroscopy, . Second Edition" (2), an in-depth review of the history, techniques and modern apparatus of arthroscopic procedures is provided. Of special interest is the chapter on advanced arthroscopic instrumentation (pp. 7-13), in which irrigation systems are also discussed in detail. Other references to irrigation systems appears at pp. 75 and 256.
REFERENCES
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Hempfling, Harald, "Arthroscopie: Diagnostika and 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.
For W.O.M. GmbH: Michael J. McGrail Regulatory Affairs May 1996