(106 days)
No
The device description and performance studies focus on the physical components and clinical performance of a percutaneous tracheostomy kit, with no mention of AI or ML technology.
No.
The device description and intended use focus on providing temporary access for airway management, acting as a means to maintain an airway rather than directly treating a medical condition or restoring a bodily function.
No
The device is designed for providing temporary tracheal access and inserting a tracheostomy tube for airway management, not for diagnosing a condition.
No
The device description clearly outlines physical components like a tracheostomy tube, inner cannula, and kit components, indicating it is a hardware medical device.
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 a patient for a physical intervention.
- Device Description: The description details a kit for inserting a tracheostomy tube, which is a physical device placed into the trachea.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a medical procedure.
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 (comma separated list FDA assigned to the subject device)
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. Consumers of the kit are provided with a single cannula Percutaneous Tracheostomy Tube, a disposable inner cannula, and the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation. The tracheostomy tube features a radiopaque blue line and is constructed of biocompatible polyvinylchloride material. It 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal access
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)
A side-by-side comparison of the proposed device to three legally marketed devices has been conducted, covering intended use, materials and design characteristics. A clinical user evaluation has been conducted at St. John's Mercy Medical Center with 28 subjects in the control group and 26 subjects in the two study groups.
The side-by-side comparison concluded that the proposed device is substantially equivalent to the predicate devices cited.
The clinical user evaluation concluded that the reduction in the incidence of occlusion of the tracheostomy tube with the proposed device was statistically highly significant. It was concluded that the proposed device is at least equivalent to the current device in these respects.
The evaluation also found that there was no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator. This provided useful support of the conclusion that the proposed device is equivalent to the predicate device(s) in these respects.
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.
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
JUL 1 8 2003
Image /page/0/Picture/2 description: The image shows a logo with the word "PORTEX" in white letters. The word is set against a black background. The background is a square with a curved bottom edge.
Portex, Inc.
- Bourna: Drive Kerse NH-13431-1772-05-A let o63 357 3812 www.puttershall.com
K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION
Portex, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Director, Regulatory Affairs
PREPARATION DATE OF SUMMARY
April 2, 2003
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 DEVICES
Predicate 1: Our current PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K980466[K960429]. This is the main predicate device, cited for materials/biocompatibility and for most design characteristics.
1
Predicate 2: Our DIC (Disposable Inner Cannula) Tracheostomy Tube, K934465[K903730]. This predicate device is cited, in conjunction with Predicate 1 above, for the tube/inner cannula shape and distal tip geometry.
Predicate 3: The Rusch 'PercuQuick® Dilatator Set', K011210. This predicate device is cited for the obturator angled tip.
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, K980466[K960429]. The device is being modified to increase the bevel and change to the anterior position, slightly modify the shape of the tube and inner cannula [increased arc of curvature, reduced length of straight portion resulting in an overall decrease in nominal length], provide an angled obturator/introducer, and add marking on the dilator stop on the guiding catheter. The Instructions for Use Physician's Clinical Guide are also revised to reflect these changes.
2
SUMMARY OF NONCLINICAL AND CLINICAL TESTS
A side-by-side comparison of the proposed device to three legally marketed devices has been conducted, covering intended use, materials and design characteristics. A clinical user evaluation has been conducted at St. John's Mercy Medical Center with 28 subjects in the control group and 26 subjects in the two study groups.
CONCLUSION OF NONCLINICAL AND CLINICAL TESTS
The side-by-side comparison concluded that the proposed device is substantially equivalent to the predicate devices cited.
The clinical user evaluation concluded that the reduction in the incidence of occlusion of the tracheostomy tube with the proposed device was statistically highly significant. It was concluded that the proposed device is at least equivalent to the current device in these respects.
The evaluation also found that there was no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator. This provided useful support of the conclusion that the proposed device is equivalent to the predicate device(s) in these respects.
CONCLUSION
The proposed device is safe and effective and is substantially equivalent to the predicate devices.
Portex, Inc.
Timothy Dalton
Timothy J. Paleott Director, Regulatory Affairs
3
Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird with three curved lines representing its body and wings. The bird is facing right. Encircling the bird is text that reads "HEALTH & HUMAN SERVICES USA". The text is arranged along the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Mr. Timothy J. Talcott Portex, Incorporated 10 Bowman Drive Keene, New Hampshire 03431
Re: K031057
Trade/Device Name: PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: April 2, 2003 Received: April 3, 2003
Dear Mr. Talcott:
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/tray. 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. Timothy J. Talcott
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 (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 the labeling regulation, please contact the Office of Compliance at (301) 594-4646. 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,
Kein Muly
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
B: INTENDED USE OF DEVICE
Page 1_of_1
510(k) Number (if known): KO3105 F
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)
Prescription Use
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031057
Concurrence of CDRH, Office of Device Evaluation (ODE)