BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING

K974295 · Byron Medical · KGZ · Feb 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974295
• Device Name: BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
• Applicant: Byron Medical
• Product Code: KGZ · General, Plastic Surgery
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1

Intended Use

General surgical aspiration and fluid irrigation/ infiltration.

Device Story

Device consists of aspiration and infiltration/irrigation tubing sets acting as a fluid pathway between an operative site and an external aspiration or irrigation source. Used in general surgical settings to facilitate fluid delivery or the removal of soft tissue and general aspirate. Operated by healthcare professionals during surgical procedures. Device functions as a passive conduit; no active electronic or mechanical components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Passive surgical tubing sets. Materials and dimensions consistent with standard surgical tubing for fluid/tissue transport. Non-powered, standalone device. Sterilization method not specified.

Indications for Use

Indicated for general surgical aspiration and fluid irrigation/infiltration in patients requiring such procedures.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• VCI Suction and Irrigation Tubing Sets (K93482)
• Irrigation and Aspiration Tubing (K923201)
• Ackrad Fluid Connecting Set (K820937)
• Disposable Tubing (Wells Johnson Company)

Submission Summary (Full Text)

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Byron Medical Confidential - TRADE SECRET

FEB 10 1998

### 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: ك 97429 ك

Submitted by:

Steve Bollinger V.P. Research and Development Byron Medical, Inc. 3280 East Hemisphere Loop Tucson, AZ 85706

Telephone #: [phone] Facsimile #: [phone]

Date Prepared:

ત્વપ્ર

12 November 1997

Establishment Registration Number: Byron Medical is located at 3280 East Hemisphere Loop, Tucson, AZ 85706. We are registered with the Food and Drug Administration as Establishment Number 2025576.

Classification Name:

Catheter, Irrigation 21 CFR § 878.4200 (1997)

Tubing, Non-Invasive 21 CFR § 884.1720 (1997)

Common/Usual Name:

Aspiration and Irrigation Tubing

Byron Medical Aspiration (HI-VAC) and Infiltration / Irrigation (LAM)Tubing

Indication for Use:

Proprietary Name:

General surgical aspiration and fluid irrigation/ infiltration.

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## Byron Medical Confidential - TRADE SECRET

## 510(k) SUMMARY (cont.)

Device Description:

The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery.

#### Substantial Equivalence Claim:

The principles of operation and technology incorporated in the Tubing are similar to other tubing devices with the function to deliver fluids or remove soft tissue and general aspirate which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below.

VCI Suction and Irrigation Tubing Sets Product: Vital Concepts Manufacturer: 510(k) Number: K93482 Substantial Equivalence Date: 01 February 1994

Irrigation and Aspiration Tubing Product: Manufacturer: ARMM. Inc. K923201 510(k) Number: Substantial Equivalence Date: Unknown

Ackrad Fluid Connecting Set Product: Ackrad Laboratories, Inc. Manufacturer: 510(k) Number: K820937 Substantial Equivalence Date: 26 April 1982 Substantial Equivalence Letter is presented as Exhibit N.

Disposable Tubing Product: Wells Johnson Company. Manufacturer: Unknown 510(k) Number: Substantial Equivalence Date: Unknown

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Bollinger Vice President Research and Development Byron Medical, Incorporated 3280 East Hemisphere Loop Tucson, Arizona 85706

FEB 1 0 1998

Re: K974295 Trade Name: Byron Medical Aspiration and Infiltration/Irrigation Tubing Regulatory Class: II Product Code: KGZ Dated: November 12, 1997 Received: November 14, 1997

Dear Mr. Bollinger:

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 requirements , 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

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Page 2 - Mr. Bollinger

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

tocoell

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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K974295 510(k) Number (if known): _

Device Name: Byron Medical Aspiration and Infiltration/IrrigationTubing

Indications for Use:

The Tubing Indications for use are general surgical fluid, exudate, rne Tubing me aspiration and general surgical fluid irrigation/infiltration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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**Division Sign-Off**

(Division Sign-OM)
Division of General Restorative Devices K4 74245
510(k) Number

Prescription Use
(Per 21 CFR 801.109

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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