(256 days)
No
The device description lists standard mechanical components and there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes.
The device is used to create a tracheostomy stoma for subsequent insertion of a tracheostomy tube, which is a medical procedure aimed at managing the patient's airway. This directly addresses a medical condition or aims to improve a health function.
No
The device is used to create a tracheostomy, which is a surgical procedure for airway management, not for diagnosing a condition.
No
The device description explicitly lists physical components like a scalpel, gauze, needles, syringes, guidewires, and dilators, indicating it is a kit containing hardware, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management." This describes a surgical procedure performed directly on a patient's body for therapeutic purposes (airway management).
- Device Description: The description details components used for a surgical procedure (scalpel, gauze, needle, syringe, guidewire, dilators, etc.) to create an opening in the trachea.
- Lack of IVD Characteristics: IVD devices are 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.
Therefore, this device is a surgical instrument/kit used for a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management."
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube.
The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
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)
The testing performed and comparison to predicate devices demonstrate that the proposed device is safe and effective and substantially equivalent to the predicate devices.
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.
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.
K983830, R027050, K852444, K963320, K932946, K962175, K032047
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
§ 868.5800 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.
0
510k SUMMARY
MAR 2 1 2003
COMPANY INFORMATION:
Portex Ltd, Hythe,Kent. England CT21 6DB 1022212
Contact: Steve Ogilvie Regulatory and Scientific Affairs Director
PREPARATION DATE OF SUMMARY:
10th February 2003
TRADE NAME
Percutaneous Dilation Tracheostomy Kit with Serial Dilators/Introducers for 7, 8 and 9mm tubes only, without Tracheostomy Tube (REF 100/566/000)
COMMON NAME
Percutaneous Tracheostomy Kit
PRODUCT CLASS/CLASSIFICATION
Class II 73 JOH, 21 CFR 868.5800
1
510k SUMMARY
PREDICATE DEVICES
Main Product Predicates:
- Rusch "PercuQuick Set" Percutaneous Tracheostomy Kit." Legally marketed in ● the USA under K011210
- Portex "Per-Fit Percutaneous Tracheostomy Kit" Legally marketed in the USA . under K936133
| Kit Component/Element Predicates: | |||
|---|---|---|---|
| -- | ----------------------------------- | -- | -- |
| Component/Element | Predicate |
|---|---|
| Hydrophilic coating for | |
| Serial Dilators/Introducers | Mallinckrodt “Finch” and “Copperhead” Percutaneous |
| Transluminal Angioplasty Catheters already marketed in | |
| the USA under K983830 | |
| Scalpel | Maersk/Paragon Single Use Scalpel already sold into |
| USA under device listing R027050. | |
| Syringe | ASIK ‘ONCE’ Syringe already marketed in the USA |
| under K852444 | |
| Guidewire materials | TFX guidewire already marketed in the USA under |
| K963320 | |
| 14G Needle and Cannula | |
| materials | Wallace IV Cannula already marketed in the USA under |
| K932946 | |
| 14Fr Pre-dilator materials | Base Polymer - Portex Adjustable Flange Tracheostomy |
| tube already marketed in the USA under K962175. | |
| Colourant - Portex Y-Cann already marketed in the USA | |
| under K032047 |
DESCRIPTION:
The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube.
The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.
2
510k SUMMARY
INDICATIONS FOR USE:
"To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management."
TECHNICAL CHARACTERISTICS:
Percutaneous Dilation Tracheostomy Kit with Serial Dilators/Introducers for 7, 8 and 9mm tubes only, without Tracheostomy Tube (REF 100/566/000) has the same technical characteristics as the currently marketed Rusch "PercuQuick Set" Percutaneous Tracheostomy Kit." K011210. Where necessary, the Portex "Per-Fit Percutaneous Tracheostomy Kit'' K936133 is used as a predicate for specific features and/or characteristics.
CONCLUSION
The testing performed and comparison to predicate devices demonstrate that the proposed device is safe and effective and substantially equivalent to the predicate devices.
For Portex Ltd.
Suara
Steve Ogilvie
Regulatory and Scientific Affairs Director
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are abstract and flowing, creating a sense of unity and connection. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
MAR 21 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Ogilvie Regulatory and Science Affairs Director Portex. Limited Military Road Hythe. Kent United Kingdom CT21 6DB
Re: K022212
Trade/Device Name: Percutaneous Dilation Tracheostomy Kit (Serial Dilators) Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: February 13, 2003 Received: February 24, 2003
Dear Mr. Ogilvie:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
4
Page 2 - Mr. Steve Ogilvie
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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 the labeling regulation, please contact the Office of Compliance at (301) 594- . . Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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,
Susan Runner, DDS, MA
Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K022212
Device Name: Portex Percutaneous Dilatiational Tracheostomy Kit
Indications for Use:
To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.
Approved: su 12/feb/03
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sai C. Hino 3/28/2003
510(k) Number: K022212