DUAL PURPOSE CLOSED CATHETER

K982945 · Spirit Medical Systems, Inc. · BSY · Sep 22, 1998 · Anesthesiology

Device Facts

• Record ID: K982945
• Device Name: DUAL PURPOSE CLOSED CATHETER
• Applicant: Spirit Medical Systems, Inc.
• Product Code: BSY · Anesthesiology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

Device Story

Disposable sterile dual-purpose catheter; provides suctioning and oxygen delivery into patient trachea via endotracheal tube. Suction function removes airway secretions; oxygen function improves alveolar ventilation before and after suctioning. Used in clinical settings; operated by healthcare professionals. Device maintains airway sterility and patient safety during suctioning procedures.

Clinical Evidence

Bench testing only; performance testing conducted at HAUSER Laboratories confirmed substantial equivalence to the predicate device.

Technological Characteristics

Disposable sterile catheter; dual-lumen design for simultaneous or sequential suction and oxygen delivery. Class I device (21 CFR 868.6810).

Indications for Use

Indicated for patients requiring tracheobronchial suctioning and supplemental oxygen delivery via an endotracheal tube to improve alveolar ventilation.

Regulatory Classification

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Predicate Devices

• Jinotti™ Closed Suction/Oxygen Catheter (K833375)

Submission Summary (Full Text)

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# SEP 2 2 1998

DUAL PURPOSE CLOSED CATHETER 510(k) Premarket Notification Spirit Medical Systems, Inc.

# 510(k) SUMMARY

Kg82945

Date Summary was Prepared ____________________________________________________________________________________________________________________________________________________

Peter M. Fitzgerald Printed name of person required to submit 510(k) Signature of person required to sp omit 510(K) PRESIDENT

Title of person submitting 510(k)

Submitter:

SPIRIT MEDICAL SYSTEMS, INC. 16267 Whitestone Dr. Parker, CO. 80134 [phone]

#### Establishment Registration Number:

Spirit Medical Systems, Inc. is not currently registered with the FDA. Spirit Medical Systems, Inc. will submit form FDA-2891A (Initial Registration of Device Establishment), to the Food and Drug Administration prior to establishing a manufacturing facility.

| Proprietary Name: | DUAL PURPOSE CLOSED CATHETER |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Dual purpose oxygen/suction catheter |
| Classification Name: | Tracheobronchial Suction Catheter |
| Classification: | Dual purpose oxygen/suction catheter systems such as DUAL<br>PURPOSE CLOSED CATHETER falls under the classification of 21<br>CFR 868.6810 "Tracheobronchial suction catheter" regulatory Class<br>I. |
| Predicate device: | The predicate device is Jinotti™ Closed Suction/Oxygen Catheter,<br>(510(k) #K833375) manufactured and distributed by MedCare<br>Medical Group, Inc. |

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DUAL PURPOSE CLOSED CATHETER 510(k) Premarket Notification Spirit Medical Systems, Inc.

510(k) Summary - continued

Description of 510(k) submission device:

#### Product Description:

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

#### Intended use:

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

## Comparison to Predicate Device:

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER and the above named substantially equivalent device have the same intended use in that they are a disposable sterile dual purpose closed oxygen/suction catheters designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. Both the DUAL PURPOSE CLOSED CATHETER and the Jontti™ Closed Suction/Oxygen catheter provide maximum suction efficiency into the airway without compromising patient safety as well as additional gas flow into the airway for the purpose of improving alveolar ventilation, prior to and immediately following suctioning,

## Summary of Performance Testing:

Based on the results of performance testing conducted at HAUSER Laboratories the Spirit Medical Systems. Inc. DUAL PURPOSE CLOSED CATHETER is substantially equivalent to the Jinotti™ Closed Suction/Oxygen Catheter Systems manufactured and distributed by MedCare Medical Group, Inc.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

SEP 2 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey T. Sawyer Spirit Medical Systems, Inc. 16267 Whitestone Drive Parker, CO 80134

Re : K982945 Dual Purpose Closed Catheter Regulatory Class: I (one) Product Code: BSY Dated: August 17, 1998 Received: August 21, 1998

Dear Mr. Sawyer:

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 legally marketed predicate 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 QS 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. Jeffrey T. Sawyer

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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) NUMBER (IF KNOWN) : K98 29 S

DEVICE NAME :

#### INDICATIONS FOR USE:

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--------------------------------------------------|
| | OR |
| | Over-The-Counter-Use<br>(Optional Format 1-2-96) |

Page A-2

| (Division Sign-Off) | <i>Mark Kramer</i> |
|-------------------------------------------------------------------|--------------------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | <i>K982945</i> |