QS DELIVERY SYSTEM

K991254 · Sub-Q, Inc. · KYZ · Aug 23, 1999 · General Hospital

Device Facts

• Record ID: K991254
• Device Name: QS DELIVERY SYSTEM
• Applicant: Sub-Q, Inc.
• Product Code: KYZ · General Hospital
• Decision Date: Aug 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6960
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The QS Delivery System is intended for the delivery of hemostatic agents that can be mechanically mixed and delivered to bleeding sites.

Device Story

The QS Delivery System is a mechanical device designed for the preparation and application of hemostatic agents. It functions by mechanically mixing hemostatic materials and delivering them directly to bleeding sites during surgical or clinical procedures. Operated by healthcare professionals, the device facilitates the controlled application of hemostatic agents to manage bleeding. By providing a consistent delivery mechanism, the system assists clinicians in achieving hemostasis, potentially improving patient outcomes by ensuring accurate and efficient placement of the therapeutic agent at the site of injury.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical delivery system for hemostatic agents. Device utilizes manual mechanical mixing and delivery mechanisms. No electronic components, software, or energy sources described.

Indications for Use

Indicated for the delivery of hemostatic agents to bleeding sites in patients requiring mechanical mixing and application of such agents.

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/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 23 1999

Mr. Dan W. Miller Director of Regulatory Affairs and Quality Assurance SUB-O. Inc. 1062-D Calle Negocio

San Clemente, California 92673

K991254 Re: Trade Name: OS Delivery System Regulatory Class: I Product Code: KYZ Dated: June 28, 1999 Received: June 30, 1999

Dear Mr. Miller:

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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. A 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with 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. Dan W. Miller

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 [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,

Sincerely, yours,

Neil R.P. Ogle

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(K) Number (if known): K991254

Device Name: QS Delivery System

The QS Delivery System is intended for the delivery of hemostatic Indications for Use: agents that can be mechanically mixed and delivered to bleeding sites.

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Revised: August 10, 1999

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------------------|
| NRO | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K991254 |
| Prescription Use | OR |
| (Per 21 CFR 801.109) | Over-The-Counter Use __________ |