(88 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest AI/ML functionality.
No.
Explanation: The device is intended for aspiration and surgical suction, which are procedural functions rather than direct therapeutic interventions for a specific disease or condition.
No
The device is described as an aspiration and suction device used during flexible endoscopy. Its intended use is for fluid removal, not for diagnosing conditions.
No
The 510(k) summary describes a device for aspiration and suction, which are physical processes requiring hardware components (e.g., a pump, tubing, collection container). The summary does not mention any software-specific functions or components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for aspiration and suction during medical procedures (flexible endoscopy, general/surgical suction). This is a physical process performed on or within the patient's body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- 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, etc.)
- Detecting or measuring substances within those samples
- Providing diagnostic or monitoring information based on sample analysis
The device is clearly intended for a procedural function within a healthcare setting.
N/A
Intended Use / Indications for Use
For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.
Product codes
JCX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care establishment
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 3 1 2001
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle or other bird-like figure with three wing-like shapes extending from its body. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger Gray Head of Quality Assurance and Regulatory Affairs KeyMed (Medical & Industrial Equipment) Ltd. KeyMed House Stock Road, Southend-on-Sea Essex SS2 5OH United Kingdom
Re: K011725
Trade/Device Name: Olympus Suction Pump Model KV-5 Regulation Number: 878.4780 Regulatory Class: II Product Code: JCX Dated: May 21, 2001 Received: June 4, 2001
Dear Mr. Gray:
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.
1
Page 2 - Mr. Roger Gray
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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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,
Lisa Wlmefr
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): צוגרונס או א Unknown
Olympus Suction Pump model KV-5 Device Name:
Indications For Use:
For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011725
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use