HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE

K974758 · Hydrox Laboratories · JOL · Mar 9, 1998 · General Hospital

Device Facts

• Record ID: K974758
• Device Name: HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
• Applicant: Hydrox Laboratories
• Product Code: JOL · General Hospital
• Decision Date: Mar 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2

Indications for Use

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.

Device Story

Hydrox Sterile Water is a sterile, non-pyrogenic water solution provided in 100 ml bottles or 120 ml (4 oz) cups. Used in clinical settings for suction catheter procedures, device lubrication, moistening, and flushing. Device is non-injectable. Healthcare providers use the solution to maintain equipment functionality and patient comfort during suctioning. Benefits include providing a sterile medium for procedural maintenance, reducing friction during catheter use, and preventing equipment clogging.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile water solution; non-pyrogenic; provided in 100 ml bottle or 120 ml cup form factors. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for suction catheter procedures, device lubrication, moistening, and flushing. Contraindicated for wound irrigation, IV, or IM administration. Not for injection.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Orion Sterile Water (K943828)
• Kit Pak Sterile Water (K843166)
• Medline Industries Sterile Water (K825510A)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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