(206 days)
Not Found
No
The 510(k) summary describes a mechanical medical device (tracheal tube) with design modifications. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is used for airway management and mechanical ventilation, which are therapeutic interventions. Additionally, the performance studies discuss less traumatic intubation, indicating a therapeutic benefit.
No
Explanation: The device is a tracheal tube used for airway management and mechanical ventilation, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly describes a physical tracheal tube with specific material composition, structural features, and sizes. The performance studies involve intubation procedures on cadavers and human patients, which are physical interactions with a tangible device. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "tracheal tube" designed for "oral intubation" and indicated for "airway management" in "anesthesia and emergent and respiratory care where mechanical ventilation is required." This involves physically inserting the device into the airway.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.
The device is a physical tool used for a medical procedure (intubation) to manage a patient's airway, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Parker tracheal tubes are designed for oral intubation and are indicated for airway management.
Product codes (comma separated list FDA assigned to the subject device)
73 BTR
Device Description
The Parker tracheal tubes are sterile, single use devices, for use in anesthesia and emergent and respiratory care where mechanical ventilation is required. The tube will be made in four sizes: 6.5, 7.0, 7.5, and 8.0 mm ID. It is identical to the predicate device in material composition, biocompatibility, packaging, sterilization, and in all structural respects, except for the following features:
- (1) Instead of a semi-rigid, side-beveled distal tip, the Parker tube has a flexible, slightly rounded, rear-beveled distal tip which tapers centrally toward the midline of the lesser curvature of the tube.
- (2) Instead of a single, lateral Murphy eye opposite the bevel, the Parker tube has two, facing Murphy eyes flanking the bevel.
- (3) Instead of a radiopaque stripe on the greater curvature of the tube and a cuff inflation circuit on the lesser curvature of the tube, the positions of these two features are reversed on the Parker tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Anesthesia and emergent and respiratory care
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)
Non-clinical Performance Data: ASTM F1242-96 is widely regarded as a performance standard written to be applicable to "standard" tracheal tubes, such as the predicate device, but not necessarily to all aspects of specialized tubes, such as the Parker tube. Nevertheless, Parker tracheal tubes comply with ASTM F1242-96 in all respects except for the following:
- (1) Clause 6.4.1 provides for a tip which is beveled laterally. The predicate device meets this requirement. The Parker tube tip, by design, is beveled posteriorly, toward the greater curvature of the tube, rather than laterally.
- (2) Clause 6.5 provides for a Murphy eye on the side of the tube opposite the bevel. The predicate device meets this requirement. The Parker tube tip, by design, has two Murphy eyes, rather than one, and they are placed lateral to, rather than opposite, the bevel.
Clause 4.2.1 provides that the patient end of the tube shall be Note: "rounded without sharp points or rough edges." The predicate device meets this requirement. Although the Parker tube tip is tapered, its point is rounded, rather than sharp, and its edges are also rounded, rather than rough.
Clinical Performance Data: To determine whether the unique tip design of the Parker tracheal tube would adversely affect its safety or efficacy, both orotracheal and nasotracheal intubations were carried out in adult human cadavers with standard tracheal tubes and with Parker tracheal tubes. These intubations were watched through a videoscope, and some were recorded. In this study, the tip of the Parker tracheal tube appeared to be clearly and consistently less traumatic to the nose, larynx, and trachea than standard tracheal tubes, including the predicate device.
A comparative clinical study of intubation was also carried out with IRB approval and informed consent on 66 adult patients orotracheally intubated for surgery. 31 of those patients were intubated with a standard tracheal tube and 35 were intubated with a Parker tracheal tube. The conclusion drawn from this study was that the Parker tracheal tube is at least as safe and efficacious for orotracheal intubation as standard tracheal tubes.
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.
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
JUL 15 1999
K984528 Premarket Notification
510(k) Summary
Submitted by:
Parker Medical
2121 Herrick Ave. Cincinnati, Ohio 45208 Tel. 513-321-1097 Fax: 513-321-2097
109 Inverness Drive East, Suite J Englewood, CO 80112-5105 Tel. 303-799-1990 Fax: 303-799-1996
Contact person: Dr. Jeffrey D. Parker
Contact telephone: 513-321-1097
Date of Summary: March 18, 1999
Name of the Device
Trade names: Parker Flex-Tip Endotracheal Tube Parker FlexEMS Endotracheal Tube
Common name: Cuffed tracheal tube
Classification name: Tracheal tube
Classification:
Class II, 21 CFR 868.5730
Predicate device:
Kendall Sheridan CF Tracheal Tube (K822082)
1
510(k) Summary Page 2
Product Description:
The Parker tracheal tubes are sterile, single use devices, for use in anesthesia and emergent and respiratory care where mechanical ventilation is required. The tube will be made in four sizes: 6.5, 7.0, 7.5, and 8.0 mm ID. It is identical to the predicate device in material composition, biocompatibility, packaging, sterilization, and in all structural respects, except for the following features:
- (1) Instead of a semi-rigid, side-beveled distal tip, the Parker tube has a flexible, slightly rounded, rear-beveled distal tip which tapers centrally toward the midline of the lesser curvature of the tube.
- (2) Instead of a single, lateral Murphy eye opposite the bevel, the Parker tube has two, facing Murphy eyes flanking the bevel.
- (3) Instead of a radiopaque stripe on the greater curvature of the tube and a cuff inflation circuit on the lesser curvature of the tube, the positions of these two features are reversed on the Parker tube.
Indications and Usage:
Parker tracheal tubes are designed for oral intubation and are indicated for airway management. Other, reinforced tracheal tubes should be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is to be required following intubation.
Non-clinical Performance Data:
ASTM F1242-96 is widely regarded as a performance standard written to be applicable to "standard" fracheal tubes, such as the predicate device, but not necessarily to all aspects of specialized tubes, such as the Parker tube. Nevertheless, Parker tracheal tubes comply with ASTM F1242-96 in all respects except for the following:
- (1) Clause 6.4.1 provides for a tip which is beveled laterally. The predicate device meets this requirement. The Parker tube tip, by design, is beveled posteriorly, toward the greater curvature of the tube, rather than laterally.
2
510(k) Summary Page 3
- (2) Clause 6.5 provides for a Murphy eye on the side of the tube opposite the bevel. The predicate device meets this requirement. The Parker tube tip, by design, has two Murphy eyes, rather than one, and they are placed lateral to, rather than opposite, the bevel.
Clause 4.2.1 provides that the patient end of the tube shall be Note: "rounded without sharp points or rough edges." The predicate device meets this requirement. Although the Parker tube tip is tapered, its point is rounded, rather than sharp, and its edges are also rounded, rather than rough.
Clinical Performance Data:
To determine whether the unique tip design of the Parker tracheal tube would adversely affect its safety or efficacy, both orotracheal and nasotracheal intubations were carried out in adult human cadavers with standard tracheal tubes and with Parker tracheal tubes. These intubations were watched through a videoscope, and some were recorded. In this study, the tip of the Parker tracheal tube appeared to be clearly and consistently less traumatic to the nose, larynx, and trachea than standard tracheal tubes, including the predicate device.
A comparative clinical study of intubation was also carried out with IRB approval and informed consent on 66 adult patients orotracheally intubated for surgery. 31 of those patients were intubated with a standard tracheal tube and 35 were intubated with a Parker tracheal tube. The conclusion drawn from this study was that the Parker tracheal tube is at least as safe and efficacious for orotracheal intubation as standard tracheal tubes.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Jeffrey D. Parker, M.D. Parker Medical 109 Inverness Drive East, Suite J Englewood, CO 80112-5105
Re: K984528 Parker Flex-Tip Tracheal Tube and Parker FlexEMS Tracheal Tube Requlatory Class: II (two) Product Code: 73 BTR Dated: April 22, 1999 April 22, 1999 Received:
Dear Dr. Parker:
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 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. 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 regulations 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 Failure to comply with the GMP regulation may result in assumptions. 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 regulations.
4
Page 2 - Jeffrey D. Parker, M.D.
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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page A4
510(k) NUMBER: K984528
DEVICE NAMES: PARKER FLEX-TIP TRACHEAL TUBE and PARKER FlexEMS TRACHEAL TUBE
"INDICATIONS AND USAGE"
Parker cuffed tubes are designed for oral intubation and are indicated for airway management.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Office of Device Evaluation (ODE) Concurrence of CDRH,
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter-Use (Optional Format 1-2-96)
M. R
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
TOTAL P.02