PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

K041348 · Smiths Medical · JOH · Jul 13, 2004 · Anesthesiology

Device Facts

• Record ID: K041348
• Device Name: PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
• Applicant: Smiths Medical
• Product Code: JOH · Anesthesiology
• Decision Date: Jul 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Portex "Ultra Perc" Perculaneous Dilation Trachcostomy kit with Serial Dilators or Single Stage Dilator. The Line Ultra Tracheostomy Tube and Introducer are indicated to create a percutaneous difiational tracheostomy using guidewire dilators and components of this kit that allow for tracheal access for airway management.

Device Story

Kit facilitates percutaneous dilatational tracheostomy via Seldinger guidewire technique; includes Blue Line Ultra Tracheostomy Tube, introducer, and serial or single-stage dilators. Used in controlled clinical settings (ICU/OR) by two trained operators: one manages airway/anesthesia/vitals, one performs procedure. Introducer assists placement of tracheostomy tube into trachea. Provides tracheal access for airway management; benefits patient by establishing secure airway.

Clinical Evidence

Clinical data provided in Appendix 2; specific study results not detailed in summary. Substantial equivalence supported by performance testing (Section 8.0) and comparison to legally marketed predicate devices.

Technological Characteristics

Kit includes tracheostomy tube, introducer, and dilators. Available in 7.0, 8.0, and 9.0mm sizes. Utilizes Seldinger guidewire technique for percutaneous dilation. Mechanical device; no software or electronic components.

Indications for Use

Indicated for adult patients requiring percutaneous dilatational tracheostomy for airway management. Use restricted to controlled settings (ICU or OR) by trained personnel.

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

• Portex Percutaneous Dilation Tracheostomy Kit with Serial Dilators (K022212)
• Portex Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator (K040014)
• Blue Line Ultra Tracheostomy Tube kits (K030381)
• Portex Percutaneous Dilatory Tracheostomy Kit with Speciality tracheostomy Tube (Perfit) (K980466)
• Rusch Percuquick set for percutaneous dilation tracheostomy (K011210)
• Shiley Low Pressure Cuffed tracheostomy tube (K880247)

Submission Summary (Full Text)

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Smiths Medical: Portex Percutaneous Dilation Tracheostomy kit with Secial Dilators or Single Stage Dilators, Blue Line Ultra Tracheostomy Tube and Introducer 510(K) Notification

# KD41348

#### JUL 1 3 2004 SECTION 5.0 : 510K SUMMARY

#### DATE SUBMITTED: 6th May 2004

| SUBMITTER: | Smiths Medical |
|------------|-------------------|
| | Hythe |
| | Kent |
| | England, CT21 6JL |

#### CONTACT PERSON:

Mr Barry Smith Regulatory Affairs Manager Smiths Medical, Hythe, Kent, England. CT21 5BN Phone [phone] Fax [phone] e-mail: barry.smith(@smiths-medical.com

#### DEVICE NAME:

Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer.

#### COMMON NAME AND CLASSIFICATION:

Percutaneous Dilation Tracheostomy kit with Serial Dilators. Class II BTO, 21 CFR 868.5800

#### PREDICATE DEVICES:

- Portex Ltd: Portex Perculaneous Dilation Trachcostomy Kit with Scrial Dilators. already marketed in the 1. USA under K022212
- Portex Ltd: Portex Perculancous Dilation Trachcostomy Kit with Single Stage Dilator already marketed in 2. the USA under K040014
- Portex Ltd: Blue Line Ultra Tracheostomy Tube kits, already marketed in the USA under K030381 ﻢ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
- Portex Inc. Perculaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube (Perfit) already 4. marketed in the USA under K980466
- Rusch Percuquick set for percutaneous dilation tracheostomy already marketed in the USA under K011210 5.
- Shiley Low Pressure Cuffed tracheostomy tube already marketed in the USA under K8802+7 ().

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#### Smiths Medical: Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilators, Blue Line Ultra Trachcostomy Tube and Introducer 510(K) Notification

#### SECTION 5.0 : 510K SUMMARY

#### DEVICE DESCRIPTION:

The Portex "Ultra Perc" single use Percutancous Dilation Trachcostomy Kits allow the perculancous insertion of I he Police Sublic Fere "Single discriptions of the stage) circumferencial dilatational Seldinger guidewire technique.

Kits are supplied with a Portex Blue Line Ultra Tracheostomy Tube and introducer.

The kits are intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel. A minimum of 2 operators are required - one to maintain the patient's airway, anaesthesia, breathing and circulation, and the other to perform the procedure.

The Portex Perculaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra The Forex Forealizer, are available in sizes 7.0, 8.0 and 9.0mm only.

#### INTENDED USE:

The Portex "Ultra Perc" Perculaneous Dilation Trachcostomy kit with Serial Dilators or Single Stage Dilator. The Line Ultra Tracheostomy Tube and Introducer are indicated to create a percutaneous difiational tracheostomy using guidewire dilators and components of this kit that allow for tracheal access for airway management.

## TECHNOLOGICAL CHARICTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:

- The proposed device is equivalent to Predicate devices 1 & 2- Portex Ltd: Portex Percutaneous Dilation . Tracheostomy Kits already marketed in the USA under K022212 and K040014 and Predicate 3 - Portex Ltd. I racheostomy Tube kits already marketed in the USA under K03038 lin all aspects except for the following:
- Tracheostomy tube Introducer. The proposed device has a Tracheostomy tube Introducer that o allows for the placement of the Blue Line Ultra Tracheostomy tube into the patients trachea. The curvature and materials of the Introducer will be compared with the Single Stage Dilator of Predicate 2 and the obturator of Predicate 3. The handle will be compared to he Single Stage Dilator of Predicate 2 and the Obturator/Introducer of Predicate 4

#### PERFORMANCE / CLINICAL DATA:

Performance data for the proposed device is shown in section 8.0 Performance. Clinical data is provided in Appendix 2

#### CONCLUSION:

Comparison of the proposed device to the predicate devices supports the conclusion that the proposed device is substantially equivalent in safety and effectiveness in its intended use to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 3 2004

Mr. Barry Smith Regulatory Affairs Manager Smiths Medical, International Limited Military Road Hythe, Kent, CT21 5BN ENGLAND

Re: K041348

Trade/Device Name: Portex "Ultraperc" Percutaneous Dilation Tracheostomy Kit Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: May 6, 2004 Received: May 20, 2004

Dear Mr. Smith:

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. Smith

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 (QS) 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Clus

Chiu Lin, Ph.D. 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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#### Smiths Medical : Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single al : Fortex Ferentaneous Ultra Tracheostomy Tube and Introducer 510(K) Notification

## SECTION 4.0: STATEMENT OF INDICATIONS FOR USE

Document 1

#### DEVICE NAME:

Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer.

#### INDICATIONS OF USE:

The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue The Forex Ferentaneous Dhatton Tracheostenly mindicated to create a percuraneous dillational Lifte Unia Tractievslonly Tube and introducer and components of these kits that allow for tracheal access for airway management for use in adults only.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Syberot

(Division Sign-Division of Anesthesiology, General Hospital, Infection Control, De

510(k) Number