STERILE WATER & STERILE 0.9% SODIUM CHLORIDE by DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

The provided text is a 510(k) summary from the FDA for a medical device (Sterile Water & Sterile 0.9% Sodium Chloride) and does not describe a study or specific acceptance criteria and performance related to an AI/ML powered device. The document is a clearance letter indicating the device is substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information. The document does not contain details about:

Acceptance criteria or device performance data.
Sample sizes for test or training sets.
Data provenance.
Expert qualifications or the number of experts.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone performance.
Type of ground truth.
How ground truth was established for training data.

Summary

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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

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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

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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)

Over-the-Counter Use (Optional Format 1-2-96)

Form B

Regulation Number and Section

§ 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).