(120 days)
(k)013916 & (k)010016, (k)030381, (k)931735, (k)031057, (k)021247, (k)923559
Not Found
No
The device description focuses on mechanical components and established medical techniques (Veress needle, dilator) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
No.
The device is used for emergency airway access, which is a life-saving intervention and not a therapeutic treatment for curing a disease or condition.
No
The device is described as an emergency airway access kit used for percutaneous insertion of a cricothyroidotomy tube. Its primary function is therapeutic (to establish an airway), not diagnostic. While it includes a method to confirm entry into the trachea (aspiration through a needle), this is a procedural step to ensure correct placement for a therapeutic intervention, not a diagnostic function in itself.
No
The device description clearly outlines a physical kit containing multiple hardware components (airway tube, dilator, Veress needle, scalpel, syringe, sutures, neck-strap, heat and moisture exchanger, packaging). There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for emergency airway access by percutaneous insertion of a tube through the cricothyroid membrane. This is a surgical/procedural device used directly on the patient's body for a therapeutic purpose (establishing an airway).
- Device Description: The description details the physical components and how they are used to perform the procedure. It involves inserting a needle, dilator, and tube into the trachea.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not involve the analysis of such specimens.
The device is clearly intended for a medical procedure performed directly on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.
Product codes (comma separated list FDA assigned to the subject device)
BWC
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cricothyroid membrane / trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
(k)013916 & (k)010016, (k)030381, (k)931735, (k)031057, (k)021247, (k)923559
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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.
3
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
4
Image /page/4/Picture/0 description: The image shows the words "ATTACHMENT 12" in bold, black font. The words are all capitalized and are arranged on a single line. The text appears to be part of a document or report, indicating that the following content is an attachment numbered 12.
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
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