IRRIGATION SYRINGE KIT

K982435 · Sub-Q, Inc. · KYZ · Nov 6, 1998 · General Hospital

Device Facts

• Record ID: K982435
• Device Name: IRRIGATION SYRINGE KIT
• Applicant: Sub-Q, Inc.
• Product Code: KYZ · General Hospital
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6960
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

Device Story

Irrigation Syringe Kit used for delivery of saline or other FDA-cleared solutions to body cavities and wound sites. Device facilitates wound management; operated by clinicians or patients depending on setting. Simple mechanical syringe-based delivery system; provides controlled irrigation to assist in cleaning or treating wounds. Benefits include effective site irrigation and delivery of therapeutic fluids.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual irrigation syringe kit; components for fluid delivery; non-powered; mechanical operation.

Indications for Use

Indicated for irrigation of body cavities and wound sites and delivery of general wound management materials, including saline and other FDA-cleared solutions, in patients requiring wound care.

Regulatory Classification

Identification

An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

Mr. Vaughn P. Whalen Vice President and General Manager SUB-Q, Incorporated 1062-D Calle Negocio San Clemente, California 92673

K982435 Re : Irrigation Syringe Kit Trade Name: Requlatory Class: I Product Code: KYZ Dated: October 13, 1998 October 14, 1998 Received:

Dear Mr. Whalen:

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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. Whalen

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

Timothy 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): K982435 IRRIGATION SYRINGE KIT Device Name:

Indications for Use:

The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use -

C

Over the Counter Use _

(Per 21 CFR 801.109)

Nick Hubbard 6a Saturni Crescent.

(Division Sign-Off Division of Dental, Infection Control, and General Hospital Devices ×982435 510(k) Number_