(41 days)
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Not Found
No
The summary describes a pump system for aspiration and does not mention any AI or ML components or functionalities.
No
The device is described as an aspiration pump system for the suction or aspiration of fluids and tissue during surgical procedures, which is a surgical tool rather than a device intended to directly treat or cure a medical condition.
No
The device is described as an aspiration pump system for the suction or aspiration of fluids and tissue during surgical procedures, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a "tabletop unit or as part of an integrated Operative Workstation," indicating it is a hardware system, not software only.
Based on the provided information, the LySonix Aspiration Pump System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "suction or aspiration of fluids and tissue during surgical procedures." This describes a device used on a patient during a surgical procedure, not a device used to test samples outside of the body (in vitro).
- Device Description: The description reinforces its use as a surgical aspiration system, either standalone or integrated into a workstation.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue samples in vitro), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the LySonix Aspiration Pump System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
Product codes
BTA, JCX
Device Description
The LySonix Aspiration Pump System is a stand-alone version of the aspiration component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
510(k) SUMMARY
MAR 1 8 1900
· his 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
| Submitted by: | Ronald F. Lagerquist
Regulatory Affairs Manager
LySonix Inc.
1170 Mark Avenue
Carpinteria, CA 93013
Telephone: (805) 684-0409 |
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
FAX:
February 4, 1998 Date Prepared:
Device Name:
・・
Proprietary Name: LySonix Aspiration Pump System
Common Name: Aspiration Pump
Indication for Use:
The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
(805) 684-0170
Device Description:
The LySonix Aspiration Pump System is a stand-alone version of the aspiration component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
Substantial Equivalence:
· The LySonix Aspiration Pump System is equivalent to the aspiration component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance.
1
Image /page/1/Picture/1 description: The image shows the seal of the United States Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads, representing health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
$$\mathbf{a}$$
Mr. Ronald F. Lagerquist Regulatory Affairs Manager LySonix, Inc. 1170 Mark Avenue Carpinteria, California 93013
Re: K980454 LySonix Aspiration Pump System Trade Name: Requlatory Class: II Product Code: BTA and JCX Dated: February 4, 1998 Received: February 5, 1998
Dear Mr. Lagerquist:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent dețermination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in requlatory 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.
2
Page 2 - Mr. Lagerquist
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,
R. Slyter Rhodes
Galen M. Witter, Ph.D.
M. Witten, Ph.D., M.D. irector ivision of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
Applicant:
LySonix, Inc.
510(k) Number:
LySonix Aspiration Pump System Device Name:
Indications For Use:
The LySonix Aspiration System is intended for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a standalone aspiration system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Atat Eluolia
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. studying the image, I see that it is a text block. I will reproduce the text in markdown format. The text is: (Division Sign-Off) Division of General Restorative Devices 510(k) Number. K980454
Prescription Use X Per 21 CFR 801.109
OR
Over-the-Counter