(51 days)
THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET IS USED TO MOVE FLUID FROM THE TOWER BAG TO THE PATIENT.
The Hydrotower® Arthroscopic Administration Tubing Set is designed to be used with the Nortech® Hydrotower® System. The device is comprised of pvc tubing, check valve, a pressure relief valve, and numerous polymer fittings.
The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Hydrotower® Arthroscopic Administration Tubing Set, which primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table or answer the questions related to the study design, sample sizes, expert qualifications, or comparative effectiveness.
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AUG 1 0 2001
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SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Arthroscope and Accessories |
|---|---|
| Proprietary Name: | Hydrotower® Arthroscopic Administration Tubing Set |
| Classification: | Class II |
Materials:
Materials used to manufacture the Nortech® Hydrotower® Arthroscopic Administration Tubing Set are non-toxic and have been previously used to manufacture other devices.
Description:
The Hydrotower® Arthroscopic Administration Tubing Set is designed to be used with the Nortech® Hydrotower® System. The device is comprised of pvc tubing, check valve, a pressure relief valve, and numerous polymer fittings.
Substantial Equivalence:
Northgate's Hydrotower® Arthroscopic Administration Tubing Set is a tubing set that is substantially equivalent in design materials, and intended use to numerous currently marketed devices. Northgate manufactures similar devices as indicated in Exhibits # 1/ # 2.
Intended Use:
The Nortech® Hydrotower® Arthroscopic Administration Tubing Set shall be used to move fluid from the tower bag to the patient.
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AUG 1 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road Elgin, Illinois 60123
Re: K011928
Roll 220
Trade/Device Name: The Hydrotower® Arthroscopic Administration Tubing Set Regulation Number: 880.5440, 876.1500 Regulatory Class: II Product Code: FPA, GCJ Dated: June 18, 2001 Received: June 20, 2001
Dear Mr. Kurek:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and we nave acteriment marketed predicate devices marketed in interstate commerce stated in the onerobare, to regardent date of the Medical Device Amendments, or to devices that provision as may 20, 1978, and with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (100). Totaliae) , accessors) , arovisions of the Act include requirements for annual provisions of the Free - rices.com 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 (1 remarket if pproval), 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 mspoonship 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.
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Page 2 - Mr. Casey Kurek
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,
Mark MMilhenson
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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Page 1 of 1
510 (k) Number (If known):
Device Name: THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET
KO11928
Indications For Use:
THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET IS USED TO MOVE FLUID FROM THE TOWER BAG TO THE PATIENT.
Casey Kurek
C. Kurek, Regulatory Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use
Mark N. Millhersen (Optional Format 1-2-96)
Division Sign Off
Division of General. Restorative and Neurological Devices
510(k) Number K011938
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.