(121 days)
Not Found
No
The description details a microprocessor-controlled peristaltic pump with pressure monitoring and control, which are standard functions for this type of medical device and do not indicate the use of AI or ML.
No.
The device is intended to provide fluid distension and irrigation during arthroscopic procedures, which are supportive functions for a medical procedure rather than directly treating a disease or condition.
No
Explanation: The device is described as an "Arthroscopy Pump" intended to provide "fluid distension and irrigation" during arthroscopic procedures. Its function involves continuous pressure measurement and regulation to maintain a pre-set pressure in the joint cavity, but it does not perform any diagnostic analysis or provide diagnostic information itself. It is a surgical tool that facilitates diagnostic and operative procedures.
No
The device description clearly outlines multiple hardware components including a casing, power supply, battery pack, touch screen display, roller-wheel stand, cartridge tube set, and optional remote control. While it mentions software control for pressure management and alarms, it is fundamentally a hardware device with integrated software.
Based on the provided information, the FLOSIMPLE Arthroscopy Pump A120 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing fluid distension and irrigation within the joint cavities during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood, urine, or tissue).
- Device Description: The description details a pump system for delivering fluid and managing pressure within the joint. This aligns with a surgical device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the FLOSIMPLE Arthroscopy Pump A120 is a surgical device used during arthroscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
Product codes
HRX
Device Description
The FLOSIMPLE Arthroscopy Pump A120 (the “A120”) is a microprocessor controlled single roller pump, which functions according to the peristaltic system. The device incorporates the following major components and features: a casing, a world power supply, a rechargeable battery pack. The A120 performs a continuous pressure measurement to ensure that the actual pressure in the joint cavity complies with the pre-set nominal pressure. In addition, a software controlled active pressure reduction mechanism is activated if the actual pressure measured in the joint cavity exceeds the preset nominal pressure value. The device is also designed with several alarms to inform the operator in case of an overpressure. For user convenience, the device is equipped with a touch screen display. The A120 is to be mounted on a roller-wheel stand and is to be used with a specially designed cartridge tube set and with an optional remote control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, 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)
K030402, K000153, K983910, K990732
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
$\kappa\alpha62380$
510(k) SUMMARY
| DEC 14 2006 | ||
|---|---|---|
| Submitter: | W.O.M. WORLD OF MEDICNE AG | |
| Alte Poststraße 11 | ||
| 96337 Ludwigsstadt | ||
| Germany | ||
| Phone: +49 9263 877 131 | ||
| Fax: +49 9263 877 137 | ||
| Official | ||
| Correspondent: | Susanne Raab | |
| Regulatory Affairs Consultant | ||
| 1480 Cambridge Street | ||
| Cambridge, MA 02139 | ||
| Phone: 617 547 0628 | ||
| Fax: 617 520 2136 | ||
| e-mail: sbraab@comcast.net | ||
| Trade Name: | FLOSIMPLE Arthroscopy Pump A120 | |
| Common Name: | Arthroscopic Pump, Tubing Sets and Accessory | |
| Classification | ||
| Name: | Arthroscope, 21 C.F.R. 888.1100 | |
| Regulatory Class: | II | |
| Product Code: | HRX | |
| Predicate Devices: | 1. Arthroscopy Pump A107 (K030402) |
- Arthro-Surgimat-A103 (K000153)
- Arthro-Surgimat-1500 (K983910)
- Lap-Wave 3000 (K990732) | |
| Device Description: | The FLOSIMPLE Arthroscopy Pump A120 (the “A120”) is
a microprocessor controlled single roller pump, which
functions according to the peristaltic system. The device
incorporates the following major components and features: a
casing, a world power supply, a rechargeable battery pack, a | |
.
1
The A120 performs a continuous pressure measurement to ensure that the actual pressure in the joint cavity complies with the pre-set nominal pressure. In addition, a software controlled active pressure reduction mechanism is activated if the actual pressure measured in the joint cavity exceeds the preset nominal pressure value. The device is also designed with several alarms to inform the operator in case of an overpressure. For user convenience, the device is equipped with a touch screen display. The A120 is to be mounted on a roller-wheel stand and is to be used with a specially designed cartridge tube set and with an optional remote control.
- The FLOSIMPLE Arthroscopy Pump A120 is intended to Intended Use / provide fluid distension and irrigation of knee, shoulder, hip, Indication for Use: elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
The A120 is substantially equivalent to the Arthroscopy Substantial Pump A107 (K030402) (the "A107") manufactured by Equivalence: W.O.M. WORLD OF MEDICINE AG. Both the A120 and the A107 have the same intended use, function according to the peristaltic system and have a maximum flow performance of 3 1/min. The technological differences between the A120 and the A107 are minor and primarily related to the modification of the casing to allow for mounting of the A120 on a roller-wheel stand, the development of a new cartridge tube set, the offering of preselectable pressure and flow levels (knee, shoulder, small joints), the incorporation of a rechargeable power pack and of a touch screen. Unlike the A107, the A120 is a single roller pump that does not allow for the aspiration of liquids out of joint cavities. Finally, the A120 incorporates only one pressure sensor in place of the redundant pressure measurement of the A107.
Furthermore, the A120 is substantially equivalent to the Arthro-Surgimat-A103 (K000153) (the "A103"), the Arthro-Surgimat-1500 (K983910) (the "Arthro-Surgimat") and the Lap-Wave 3000 (K990732) (the "Lap-Wave"), all three manufactured by W.O.M. WORLD OF MEDICINE AG. Specifically, the A120 and the predicate devices A103 and Arthro-Surgimat have the same intended use, are designed as a single roller pump and function according to the peristaltic system. In addition, like the A103, the A120 incorporates a single ceramic sensor to perform actual pressure measurements.
2
Furthermore, both the A120 and the Arthro-Surgimat are designed with preselectable pressure levels (knee, shoulder, small joint) that can be programmed by the user. Finally, the A120 is substantial equivalent to the laparoscopic pump Lap-Wave with regards to the casing. Both devices are designed with a smaller casing that is to be mounted on a roller wheel stand. In sum, the technological differences between the A120 and the predicate devices are minor and raise no new questions of safety and effectiveness.
August 10, 2006 Date Prepared:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2006
World of Medicine AG % Ms. Susanne Raab Regulatory Affairs Consultant 1480 Cambridge Street Cambridge, Massachusetts 02139
Re: K062380
Trade/Device Name: FLOSIMPLE Arthroscopy Pump A120 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 29, 2006 Received: December 5, 2006
Dear Ms. Raab:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Susanne Raab
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will anon your to be one finding of substantial equivalence of your device to a legally promaties motive 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), please it you t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K062380
Device Name: FLOSIMPLE Arthroscopy Pump A120
Indications for Use:
The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_