RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET

K972546 · Rusch Intl. · JOH · Apr 14, 1998 · Anesthesiology

Device Facts

• Record ID: K972546
• Device Name: RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
• Applicant: Rusch Intl.
• Product Code: JOH · Anesthesiology
• Decision Date: Apr 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Rusch Single Use Crystal Tracheostomy Tube is indicated for airway management of tracheostomized patients.

Device Story

The Rüsch Single Use Crystal Tracheostomy Tube set is a medical device designed for airway management in tracheostomized patients. The device consists of a polyvinyl chloride (PVC) tube featuring a radiopaque stripe, a flange, and a connector. It includes a high-volume cuff that is inflated via a luer-activated valve, pilot balloon, and inflation tube integrated into the main tube wall. The set may also include inner cannulas made of low-density polyethylene, which are designed for use with the tube and are available sterile-packed. The device is intended for clinical use by healthcare professionals to maintain patient airways. It is a single-use device, providing a sterile, disposable solution for tracheostomy care.

Clinical Evidence

Bench testing only. Compliance with appropriate sections of ISO 5366 was demonstrated through laboratory bench testing.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) tube with radiopaque stripe; low-density polyethylene inner cannulas. Design: Tracheostomy tube with high-volume cuff, luer-activated valve, pilot balloon, and inflation lumen. Sizes: 3.0 to 11.0 mm. Standards: Complies with ISO 5366. Sterilization: Sterile-packed.

Indications for Use

Indicated for airway management of tracheostomized patients.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Rüsch (Warne Surgical Products) Crystal Tracheostomy Tube (Preamendment)
• Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes (K934465)
• Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes (K913270, K914088)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters, specifically 'K972546'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The writing appears to be done with a dark ink or marker on a light background, providing good contrast and readability.

**RUSCH.**
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)

Tall Pines Park Jaffrey, NH 03452 [phone] FAX [phone] or 6108

# 510 (k) SUMARY

APR 1 4 1998

[As required by 21 CFR 807.92]

### 1. Submitter and Contact Person

James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452 Tel: [phone] Fax: [phone]

2. Device set Name

Trade Name:

Rüsch Single Use Crystal Tracheostomy Tube set

Common Name:

Tracheostomy Tube

Classification Name:

Tube, Tracheostomy, and Tube Cuff 73 JOH; 21 CFR 868.5800; Class II medical device

### 3. Comparison Devices

Rüsch (Warne Surgical Products) Crystal Tracheostomy Tube -Preamendment

Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465

Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088

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### 4. Description of Device Set

The Rusch Single Use Crystal Tracheostomy Tube set consists of a polyvinyl chloride tube with a radiopaque stripe, terminated with a flange and connector. The tube is fitted with a high volume cuff inflated through a luer-activated valve, pilot balloon, inflation tube and a lumen in the wall of the main tube.

Inner cannulas made of low density polyethylene and specifically designed for use with this tube are individually sterile packed. These cannulas may be boxed with the tracheostomy tube and will be available separately.

#### 5. Intended Use

The Rusch Single Use Crystal Tracheostomy Tube is indicated for airway management of tracheostomized patients.

#### Summary of Technological Characteristics 6.

The Rüsch Single Use Crystal Tracheostomy Tube Set has been developed from the Rüsch (formerly Warne Surgical Products) Crystal Tracheostomy Tube, which was in interstate commerce prior to May 28, 1976. The cumulative effect of developments, including modifications introduced to comply with the voluntary ISO 5366 standard, is thought to warrant this premarket notification.

The Rüsch Single Use Crystal Tracheostomy Tube Set will be available with and without an inner cannula, like the Smiths Industries (Portex) product and sizes from 3.0 to 11.0 mm.

#### 7. Summary of Performance Data

Laboratory bench testing has been completed to demonstrate compliance with appropriate sections of ISO 5366.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1998

Mr. James R. Whitney Rüsch International Tall Pines Park Jaffrey, NH 03452

Re : K972546 Rüsch Crystal Tracheostomy Tube Requlatory Class: II (two) Product Code: 73 JOH Dated: November 25, 1997 Received: January 15, 1998

Dear Mr. Whitney: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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, Druq, 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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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. James R. Whitney

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,

Thomas J. Callehan

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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Premarket Notification "Indications for Use" Statement

510(k) Number (if known):

K 972546

Device set Name:

Rüsch Single Use Crystal Tracheostomy Tube Set

Indications for Use:

The Rusch Single Use Crystal Tracheostomy Tube Set is indicated for airway management of tracheostomized patients.

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

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

OR

ﺳ

Thomas J. Callahor

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 6972546

510(k) Number.

Prescription Use
(Per 21 CFR 801.109) /

子

Over-the-Counter Use