(120 days)
Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.
The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cricothyroid membrane. The airway tube is provided pre-assembled onto a dilator with a Veress needle located in the centre. The kit employs two well-established and understood techniques: Firstly: The use of a Veress needle to provide visual indication of entry into a body cavity. (the trachea). (This can be confirmed by aspiration through the needle as with the predicate Cook Melker product ref. IFU in Attachment B(i)) The Veress needle is usually used for insufflation of the abdomen. It has a central sprung-loaded protective core to the needle that guards the cutting point and gives a visual indication via a "flag" at the hub end of the needle tip is passing through tissues. When the needle tip passes through into the abdominal cavity, or tractica, passure in ough assucer ------------------------------------------------------------------------------------------------------------------------------------------------------ Secondly: the use of a dilator/introducer to enlarge a stomal opening and place an airway tube within the traches. The pre-assembled needle/dilator/tube is inserted through the cricothyroid whill the tracether and the tube is then slid off the dilator fully into the trachea. This is the same principle employed by the Cook Melker Cricothyroidotomy sct. As well as the airway tube assembly, the kit provides the user with scalpel for skin incision, syringe for aspiration to confirm location of the needle in the trachea, sutures and neck-strap to secure the airway tube and a heat and moisture exchanger to reduce patient energy loss and protect the airway from blockage. These are all items that will be well understood by the user. Packaging comprises a rigid hinged blister pack for protection and a polythene/Tyvek welded pouch as the sterile barrier. pouch as ale sterilised and individually packed in a carton together with the directions for use.
The provided text is a 510(k) summary for the Portex Emergency Cricothyroidotomy Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with quantitative metrics like sensitivity or specificity.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's a breakdown of why the requested information is absent based on the provided text:
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Table of acceptance criteria and reported device performance: Not present. The document focuses on comparing the new device's technical characteristics and indications for use to those of legally marketed predicate devices to establish substantial equivalence, not to demonstrate performance against pre-defined acceptance criteria.
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Sample sized used for the test set and data provenance: No test set or associated sample size is mentioned. Clinical studies to evaluate performance against acceptance criteria are not typically required for a 510(k) submission where substantial equivalence is being claimed. The document primarily describes the device and its operational principle.
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Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no test set or ground truth establishment is described.
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Adjudication method for the test set: Not applicable, as no test set or adjudication process is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical medical instrument, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance of AI or imaging interpretations.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established or discussed in the context of performance evaluation. The "ground truth" for a 510(k) in this context is typically the established safety and effectiveness of the predicate device.
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The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided 510(k) text is a regulatory document seeking market clearance based on substantial equivalence to existing devices. It does not include the detailed performance study information requested, which would be typical for a PMA submission or a de novo classification, or for devices with novel technology requiring specific quantitative performance metrics.
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MAY 2 6 2005
Portex Emergency Cricothyroidotomy Kit 510(k) Notification
Section 7: Summary of Safety and Effectiveness (k)510 Summary
510k SUMMARY:
COMPANY INFORMATION:
Smiths Medical International, Hythe, Kent. England CT21 6DB
CONTACT: Barry Smith Regulatory Affairs Manager
PREPARATION DATE OF SUMMARY: 21/01/2005
TRADE NAME Portex Emergency Cricothyroidotomy Kit
COMMON NAME Emergency Airway Needle
PRODUCT CLASS/CLASSIFICATION Class II 73, 21 CFR 868.5090
PREDICATE DEVICES
Cook Melker Emergency Cricothyroidotomy Sets. Portex Blue Line Ultra Tracheostomy Tube Portex Blue Line Directional Tracheal Tube Portex Per-fit Percutaneous Tracheostomy Kit Mectra Labs Pneumoperitoneum Insufflation Needle Portex Steri-Cath
(k)013916 & (k)010016 (k)030381 (k)931735 (k)031057 (k)021247 (k)923559
DESCRIPTION:
The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cricothyroid membrane. The airway tube is provided pre-assembled onto a dilator with a Veress needle located in the centre.
The kit employs two well-established and understood techniques:
Firstly: The use of a Veress needle to provide visual indication of entry into a body cavity. (the trachea). (This can be confirmed by aspiration through the needle as with the predicate Cook Melker product ref. IFU in Attachment B(i)) The Veress needle is usually used for insufflation of the abdomen. It has a central sprung-loaded protective core to the needle that guards the cutting point and gives a visual indication via a "flag" at the hub end of the needle tip is
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Portex Emergency Cricothyroidotomy Kit 510(k) Notification
Section 7: Summary of Safety and Effectiveness (k)510 Summary
passing through tissues. When the needle tip passes through into the abdominal cavity, or tractica, passure in ough assucer ------------------------------------------------------------------------------------------------------------------------------------------------------
Secondly: the use of a dilator/introducer to enlarge a stomal opening and place an airway tube within the traches. The pre-assembled needle/dilator/tube is inserted through the cricothyroid whill the tracether and the tube is then slid off the dilator fully into the trachea. This is the same principle employed by the Cook Melker Cricothyroidotomy sct.
As well as the airway tube assembly, the kit provides the user with scalpel for skin incision, syringe for aspiration to confirm location of the needle in the trachea, sutures and neck-strap to secure the airway tube and a heat and moisture exchanger to reduce patient energy loss and protect the airway from blockage. These are all items that will be well understood by the user.
Packaging comprises a rigid hinged blister pack for protection and a polythene/Tyvek welded pouch as the sterile barrier.
pouch as ale sterilised and individually packed in a carton together with the directions for use.
INDICATIONS FOR USE:
Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.
TECHNICAL CHARACTERISTICS:
The Portex Emergency Cricothyroidotomy Kit comprises of components and materials that have predicates in similar medical devices currently being legally marketed in the USA.
CONCLUSION
The data provided and comparison to the predicate devices demonstrate that the proposed device is safe and effective and substantially equivalent to the predicate device/s.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is in a sans-serif font.
Public Health Service
MAY 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher Turnbull Senior Development Manager Smiths Medical International Hythe, Kent ENGLAND CT21 6DB
Re: K050166
Trade/Device Name: Portex Emergency Cricothyroidotomy Kit Regulation Number: 21 CFR 868.5090 Regulation Name: Emergency Airway Needle Regulatory Class: II Product Code: BWC Dated: April 12, 2005 Received: April 15, 2005
Dear Mr. Turnbull:
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 (1 ml ), ice 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. Turnbull
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Chih-Lin, Ph.D.
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
r
050166 510(k) Number (if known):
Portex Emergency Cricothyroidotomy Kit Device Name:
Indications For Use:
Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.
Yes Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
No Over-The-Counter Use (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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Sision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number K050166
Page 1 of 1
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).