(80 days)
Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market.
Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle
The provided text is a 510(k) premarket notification letter from the FDA regarding "Hydrox Sterile Water." This document does not describe an AI/ML medical device, nor does it contain any information related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods for such a device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not contain this type of information. It is a regulatory clearance letter for a sterile water product, not an AI/ML device study report.
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Mr. Kappana Ramanandan ·President Hydrox Laboratories 825 B Tollgate Road Elgin, Illinois 60123
Re : K974758 Hydrox Saterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle Regulatory Class: II Product Code: JOL Dated: December 12, 1997 December 19, 1997 Received:
Dear Mr. Ramanandan:
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 89500 Association substantially equivalent determination 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Ramanandan
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 requlations.
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) 594-4618. 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,
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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510(k) Number (if known): _ K 9 74758
Device Name: Sterile Water
Indications For Usc:
Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market. Refer to Orion Sterile Water K943828, Kit Pak Sterile Water K843 166 and Medline Industries Sterile Water K825510A.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrica Cicconetti
Division Sig: Off)
Division of Dental, Infection and General Hospital Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
5
Over-The-Counter Use
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.