(312 days)
Portex ® UniPerc™ single use Percutaneous Dilation Tracheostomy (PDT) Kits allows the controlled, elective subcricoid perculaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldings guidewire dilation technique in patients with a large neck and manimum of 50mm of pre-tracheal soft tissue in to the trachea) where standard (up to a maximum of S0mm of pre-tracheal soft tissue anterior to the trached on go noon anatomy (up to a maximum of pre-traches to the trachea) where standard length flange tracheostomy tubes are too short.
Tracheostomy tube maximum period of use 29 days.
The UniPerc™ device has been designed to facilitate percutaneous tracheostomy in patients with a large neck mass and a consequently large skin to anterior trachea depth. The UniPerc™ device is centered on an extra length, wire reinforced, pre-curved, cuffed or uncuffed, tracheostomy tube mounted with an adjustable flange. The tube is supplied with an inner cannula, which can be used to line the internal surface of the tube. Obturators, dilators and other parts are supplied with the various kits.
The UniPerc™ device is designed for insertion using existing, dilating percutaneous or surgical insertion techniques. Care of the device whilst in use also follows existing standards techniques.
The graduated single stage dilator has a lubricious hydrophilic coating when wetted, to improve its ease of insertion.
The provided text does not describe acceptance criteria for a device, nor does it contain a study that proves a device meets those criteria.
Instead, the documents are a 510(k) summary and an FDA clearance letter for the Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit. This type of regulatory submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance against pre-defined acceptance criteria through a specific study.
Therefore, I cannot extract the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) from the provided text.
The key points from the provided text are:
- Device: Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit
- Purpose: To facilitate percutaneous tracheostomy in patients with a large neck mass and large skin to anterior trachea depth, where standard tracheostomy tubes are too short.
- Regulatory Mechanism: 510(k) submission, seeking substantial equivalence to predicate devices (other Portex tracheostomy kits and tubes).
- Basis of Substantial Equivalence: Comparison of technological characteristics, intended use, and materials of composition with predicate devices.
- Intended Use: In a controlled setting (ICU/operating room) with trained personnel, requiring a minimum of two operators. Specifically for patients with a minimum of 50mm of pre-tracheal soft tissue anterior to the trachea. Maximum period of use is 29 days.
- FDA Clearance: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
In summary, the provided content is a regulatory submission for device clearance based on substantial equivalence, not a performance study against acceptance criteria.
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R083031
SECTION 5: 510(k) SUMMARY
.
| SECTION 5:510(k) SUMMARY | AUG 1 8 2009 | |
|---|---|---|
| Trade Name: | Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit | |
| Common Name: | Percutaneous Tracheostomy Kit | |
| Classification Name: | Tracheostomy tube and tube cuff (21 CFR 888.5800, Product Code JOH) | |
| Contact Person: | John TulletRegulatory Affairs Manager (International)Smiths Medical | |
| Tel.: +44 (0) 1303 236 815 (ex3202)Fax: +44 (0) 1303 264679 | ||
| Equivalent to: | Portex® Percutaneous Dilation Tracheostomy Kit with Serial Dilators(K040014)Portex® Percutaneous (GWDF) Tracheostomy Kit (K060945)Portex® UltraPerc Tracheostomy kits (K041348)Smiths Point-Lok Device (K946289)Portex® Blue Line Ultra Tracheostomy tubes (K030381)Portex® Adjustable Flange Tracheostomy Tube (K962175)Portex® Reinforced Tracheal Tubes Cuffed and Uncuffed (K032112)Kapitex Inner Cannula Cleaning Swabs (Class 1 exempt) | |
| Device Description: | The UniPerc™ device has been designed to facilitate percutaneoustracheostomy in patients with a large neck mass and a consequently largeskin to anterior trachea depth. The UniPerc™ device is centered on an extralength, wire reinforced, pre-curved, cuffed or uncuffed, tracheostomy tubemounted with an adjustable flange. The tube is supplied with an innercannula, which can be used to line the internal surface of the tube.Obturators, dilators and other parts are supplied with the various kits.The UniPerc™ device is designed for insertion using existing, dilatingpercutaneous or surgical insertion techniques. Care of the device whilst inuse also follows existing standards techniques. | |
| Intended Use: | The kits are intended for use in a controlled setting such as an IntensiveCare Unit or operating room with the assistance of trained personnel. Aminimum of 2 operators are required – one to maintain the patient'sairway, anaesthesia, fibreoptic bronchoscopy, breathing and circulation,and one to perform the procedure. |
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The graduated single stage dilator has a lubricious hydrophilic coating when wetted, to improve its ease of insertion.
Substantial Equivalence:
The Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit has the same intended use as the Portex UltraPerc Tracheostomy Kits.
The Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit is composed essentially of the same materials as the predicate Portex Limited kits and tubes listed in the predicate device section. The Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit incorporates a number of design and performance characteristics from the Portex® UltraPerc™ Tracheostomy Kits, the Portex® Percutaneous Tracheostomy Tube kits and the Portex® Adjustable Flange Tracheostomy Tube, including similar sterilization and packaging processes.
The determination of substantial equivalence of the Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit to the predicate devices was based on a comparison of device technological characteristics, intended use and materials of composition.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Smiths Medical ASD, Incorporated C/O Mr. John Tullet Regulatory Affairs Manager Smiths Medical International, Limited Boundary Road Hythe, Kent UNITED KINGDOM CT216JN
AUG 1 8 2009
Re: K083031
Trade/Device Name: Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit
Regulation Number: 21 CEFR 868 5800 Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: August 7, 2009 Received: August 14, 2009
Dear Mr. Tullett:
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 to market 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 Devices marks.
Amendments, or to devices that have been health and 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 provisions of
approval application (PMA) . You moveth . . . . . . . . . . . . . . . . . . . . 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 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. Tullett
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 Fequirement 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrb/imdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Pinner
Susan Runner, D.D.S., M.A. Acting Division 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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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): |< 0 8 3 0 3 |
Device Name:
Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit.
Indication For Use: Portex ® UniPerc™ single use Percutaneous Dilation Tracheostomy (PDT) Kits allows the controlled, elective subcricoid perculaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldings guidewire dilation technique in patients with a large neck and manimum of 50mm of pre-tracheal soft tissue in
to the trachea) where standard (up to a maximum of S0mm of pre-tracheal soft tissue anterior to the trached on go noon anatomy (up to a maximum of pre-traches
to the trachea) where standard length flange tracheostomy tubes are too short.
Tracheostomy tube maximum period of use 29 days.
L. Schutte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083031
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/ OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
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.(b)
Classification. Class II.