PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
Device Facts
| Record ID | K040014 |
|---|---|
| Device Name | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY |
| Applicant | Portex , Ltd. |
| Product Code | JOH · Anesthesiology |
| Decision Date | Feb 13, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
To create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management.
Device Story
Kit facilitates percutaneous creation of tracheostomy stoma and subsequent insertion of size 7, 8, or 9mm tracheostomy tubes; utilizes Seldinger guidewire technique. Components include scalpel, needle, cannula, syringe, guidewire, guiding catheter, gauze, short pre-dilator, single-stage tapered dilator, and tube introducers. Used in clinical settings by healthcare professionals. Single-stage dilator replaces multiple serial dilators found in predicate kits. Device provides mechanical dilation of stoma to allow airway access; benefits patient by enabling controlled, minimally invasive tracheostomy placement.
Clinical Evidence
No clinical data provided; substantial equivalence based on design, intended use, and technological characteristics compared to predicate devices.
Technological Characteristics
Kit includes scalpel, needle, cannula, syringe, guidewire, guiding catheter, gauze, pre-dilator, single-stage tapered dilator, and tube introducers. Employs Seldinger over-the-wire technique. EO sterilized. Packaging consists of outer blister with inner tray organized by order of use.
Indications for Use
Indicated for patients requiring tracheal access for airway management via percutaneous dilational tracheostomy.
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 for Sizes 7, 8 & 9mm tubes only, without Tracheostomy Tube (k022212)
Reference Devices
- Portex Per-fit™ kit (k980466)
Submission Summary (Full Text)
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# ATTACHMENT F: SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 1 3 2004
K640014
## 510k SUMMARY:
# COMPANY INFORMATION:
Portex Ltd, Hythe,Kent. England CT21 6DB
CONTACT: Barry Smith Regulatory Affairs Manager
PREPARATION DATE OF SUMMARY: 16/12/03
#### TRADE NAME
Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator, and Soft Introducers for Sizes 7. 8 & 9mm tubes only, without Tracheostomy Tube
#### COMMON NAME
Percutaneous Tracheostomy Kit
# PRODUCT CLASS/CLASSIFICATION
Class II 73 JOH, 21 CFR 868.5800
#### PREDICATE DEVICES
The proposed device, the "Portex Percutaneous Dilation Tracheostomy Kit with Serial Dilators for Sizes 7, 8 & 9mm tubes only, without Tracheostomy Tube" (k022212)
### DESCRIPTION:
The new kit is designed to permit percutaneous creation of a tracheostomy stoma and subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. It employs the well understood and established procedure for dilating a stoma and introducing the tracheostomy tube using the Seldinger over a guide wire system. (Ref Portex Per-fit™ kit k980466 and Portex UltraPerc serial dilator kit k022212.
The kit contains all of the standard components to which the user are accustomed: scalpel, needle and cannula, syringe, guidewire, guiding catheter, Gauze pads, short pre-dilator, dilator system, and tracheostomy tube introducers.
The kit differs from the above two kits in that it employs a single tapered dilator to replace the multiple serial dilators.
The packaging is the same as that used in k022212. It is designed with an outer blister, which contains an inner tray. The tray layout is designed to present the user with the components in the order of use.
Each pack is EO sterilised and individually packed in a carton together with the directions for use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Mr. Barry Smith Portex Limited Regulatory Affairs Manager Hythe, Kent ENGLAND CT21 6DB
Re: K040014
Trade/Device Name: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator, and Soft Introducer for Sizes 7, 8 & 9mm Tubes Only, without Tracheostomy Tubes Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: December 16, 2003 Received: January 23, 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 mean that 1 27 mas muss statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bate a requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as betronic 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) I mis letter will and in Jo 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), n you deeme speelling at Compliance at (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susa Ruano
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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# Indications for Use
510(k) Number (if known): Not known
Device Name: "Portex Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator, and Soft Introducers for Sizes 7, 8 and 9mm tubes only. Without Tracheostomy Tube"
Indications for Use: "To create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management."
Prescription Use YES (Part 21 CFR 801 Subpart D)
NO Over The Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:
Concurrence of CDRH, Office of Device Evaluation (ODE)
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