(18 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical components and insertion procedure of a tracheostomy kit, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device provides temporary tracheal access for airway management rather than directly treating a disease or condition.
No
The device is indicated for providing percutaneous temporary tracheal access for airway management, and its description details a kit for inserting a tracheostomy tube. It does not mention diagnosing any condition.
No
The device description clearly details physical components such as a tracheostomy tube, inner cannula, and kit components, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing percutaneous temporary tracheal access for airway management." This describes a surgical/procedural device used directly on the patient's body for a therapeutic purpose (airway management).
- Device Description: The description details a physical device (tracheostomy tube, dilators, etc.) designed for insertion into the trachea. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool for creating and maintaining an airway.
N/A
Intended Use / Indications for Use
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
Product codes
73 JOH
Device Description
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheal, Stoma site
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
The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of the text "SMITHS INDUSTRIES" in bold, sans-serif font, with the words "Medical Systems" in a smaller, italicized font below. To the left of the text is a stylized graphic element, possibly representing the letters "SI".
SIMS Portex Inc.
10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703 FEB 2 4 1998
K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION
SIMS Portex Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY
February 4, 1998
TRADE NAME
PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula
COMMON NAME
Tracheostomy Tube with Disposable Inner Cannula
PRODUCT CLASS/CLASSIFICATION
Class II, 73 JOH, 21 CFR 868.5800.
PREDICATE DEVICE
Our current PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Our Current i EX-FFF - - Forstansous - e e cannula, K960429 and Cook Critical Care's Ciaglia Percutaneous Tracheostomy Introducer Set.
1
DESCRIPTION
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
INDICATIONS FOR USE
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
TECHNICAL CHARACTERISTICS
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula has the same technical characteristics as is currently marketed with our existing PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K960429 and Cook Critical Care's Ciaglia Percutaneous Tracheostomy Introducer Set. The "Dilator Stop" of the proposed modification is the same as the "Safety Ridge" of Cook Critical Care's guiding catheter.
CONCLUSION
The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.
Very truly yours,
SIMS Portex Inc.
Timothy J. Talaska
Timothy Talcott Manager, Regulatory Affairs
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1998
Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431
Re: K980466 PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula Regulatory Class: II (twō) Product Code: 73 JOH Dated: February 4, 1998 Received: February 6, 1998
Dear Mr. Talcott:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas L. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
B: INTENDED USE OF DEVICE
Page 1 of 1
510(k) Number (if known): Unknown
Device Name: PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula
Indications For Use:
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| M. Pazaral (Reviewer) |
| Prescription Use | X |
|---|---|
| OR | Over-The-Counter Use |
| (Division Sign Off) | |
|---|---|
| Division of | Vascular Respiratory, |
| and | Dental Devices |
| 510(k) Number | K980466 |