(251 days)
Not Found
Not Found
No
The provided text is a 510(k) summary for an irrigation device. It explicitly states "Mentions AI, DNN, or ML: Not Found" and the intended use and device description do not suggest the use of AI/ML.
No
The intended use explicitly states "For Irrigation of Medical Device Only" and "Not for Injection or Flushing of Skin Tissues," indicating it is for cleaning devices, not for treating patients.
No
Explanation: The device is intended for irrigation of medical devices, not for diagnosing medical conditions in patients. The statement "For Irrigation of Medical Device Only" directly indicates its function is maintenance of other medical devices.
Unknown
The provided text is a very incomplete 510(k) summary. It lacks a device description, which is crucial for determining if the device is software-only. The intended use mentions "Irrigation of Medical Device Only," which could potentially involve hardware components for irrigation. Without a device description, it's impossible to definitively classify it as software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For Irrigation of Medical Device Only". This clearly indicates the device is used on medical devices, not on biological samples (like blood, urine, tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
- For Irrigation of Medical Device Only.
- Not for Injection or Flushing of Skin Tissues.
Product codes
FOZ
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
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
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/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 an abstract symbol that resembles an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2000
Mr. Sam Lakhani Vice President, Research & Development Dumex Medical Surgical Products, Ltd. 104 Shorting Road Scarborough, Ontario M1S3S4 CANADA
Re : K992732 Sterile Water & Sterile 0.9% Sodium Chloride Trade Name: Requlatory Class: II Product Code: FOZ Dated: December 1, 1999 Received: February 4, 2000
Dear Mr. Lakhani:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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
1
Page 2 — Mr. Lakhani
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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 one royalation" (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,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use Form
510(k) Number (if known): __ K992732
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indication for Use:
- For Irrigation of Medical Device Only .
- Not for Injection or Flushing of Skin Tissues .
Wagner
April 17, 2003
Rebecca Cassista
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number _
PLEASE DO NOT WRITE BELLOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OI
Over-the-Counter Use (Optional Format 1-2-96)
Form B