RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS

K023918 · Rusch Intl. · JOH · Mar 28, 2003 · Anesthesiology

Device Facts

• Record ID: K023918
• Device Name: RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
• Applicant: Rusch Intl.
• Product Code: JOH · Anesthesiology
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

Device Story

The Rüsch Crystal Clear Tracheostomy Sets are medical devices designed for airway management in tracheostomized patients. The sets are available in cuffed and cuffless versions, constructed primarily of polyvinylchloride (PVC) with a Nylon 15mm swivel connector and a polyethylene obturator. The cuffed version includes a high-volume/low-pressure cuff and pilot balloon. The device is inserted into the trachea to maintain an open airway. It is intended for use by healthcare professionals in clinical settings. The device is provided sterile and is for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical materials and design to the predicate device.

Technological Characteristics

Materials: Polyvinylchloride (PVC), Nylon, Polyethylene. Components: Tracheostomy tube, swivel connector, obturator, pilot balloon (cuffed version). Sizes: 3.5mm to 10.5mm (0.5mm increments). Sterilization: Gamma Irradiation or Ethylene Oxide. Packaging: Blister pack with Tyvek seal.

Indications for Use

Indicated for airway management in 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 Crystal Tracheostomy Set (K972546)

Submission Summary (Full Text)

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MAR 2 8 2003

Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs. The word "RUSCH" is in large, bold, black letters at the top of the image. Below that, in smaller letters, is "INTERNATIONAL Group Regulatory Affairs". At the bottom of the image, it says "A Subsidiary of Teleflex Incorporated (USA)".

Tall Pines Park affrey, NH 03452 603) 532-7706 FAX [phone] or 6108

K023918

### 510 (k) Summary

- Submitter Name, Address, and Date of Submission: 1.
Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone Number: [phone] Fax Number: [phone]

[e-mail] E-Mail:

Same as above Contact:

- Name of the Device, Common, Proprietary (if known), and 2. Classification:
Classification Name: Tube, Tracheostomy (W/WO Connector)

Common Name: Tracheostomy Tube

Rüsch Crystal Clear Tracheostomy Proprietary Name: Set, Cuffed Rüsch Crystal Clear Tracheostomy Set, Cuffless

#### 3. Identification of the legally marketed device to which the submitter claims equivalence:

Rüsch Crystal Clear Tracheostomy Sets are substantially The equivalent in design and materials to:

Rüsch Crystal Tracheostomy Set - K972546

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#### 4 . Description of the Device:

TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows:

The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are:

### Rüsch Crystal Clear Tracheostomy Set, Cuffed:

The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.

This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

### Rüsch Crystal Clear Tracheostomy Set, Cuffless:

The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.

This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

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Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless provided sterile, by either Gamma Irradiation or will be Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility Each pack will be individually labeled. The device barrier. will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.

#### Intended Use of the Device: 5.

The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

#### ୧ . Summary of Technological Characteristics:

Rüsch Crystal Clear Tracheostomy Sets are identical The in materials and sizes to the 510(k) # K972546, Rüsch Crystal Tracheostomy Set, which was determined to be substantially equivalent on April 14, 1998. The 3.0mm and 11.0mm sizes indicated in K972546 have been removed from the current product line.

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Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Mr. Rick Lykins Group RA Manager Rüsch International 50 Plantation Drive Jaffrey, New Hampshire 03452

Re: K023918

Trade/Device Name: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: 73 JOH Dated: November 21, 2002 Received: November 25, 2002

Dear Mr. Lykins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lykins

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of 1

# 510(k) Number (if known): ¥023918

Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Device Name: Cuffless

#### Indications for Use:

The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless intended for airway management of tracheostomized are patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Ransor

(Division Sign-Off) Division of Anesthesiolo Infection Control. De

510(k) Number: