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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Parker Flex-Tip Endotracheal Tube:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device and safety/efficacy through non-clinical and clinical data, rather than explicit, quantifiable acceptance criteria with pass/fail thresholds. However, based on the text detailing compliance and deviations from the ASTM standard, and the outcomes of the clinical study, we can infer the following as the implicit acceptance criteria and the device's performance against them:

Acceptance Criteria (Inferred from ASTM F1242-96 and study goals)	Reported Device Performance
Material Composition, Biocompatibility, Packaging, Sterilization: Identical to predicate device.	Identified as identical to predicate device.
Mechanical Design - Distal Tip: Semi-rigid, side-beveled tip (ASTM 6.4.1).	Deviation: Flexible, slightly rounded, rear-beveled distal tip tapering centrally.
Mechanical Design - Murphy Eye: Single, lateral Murphy eye opposite the bevel (ASTM 6.5).	Deviation: Two, facing Murphy eyes flanking the bevel.
Mechanical Design - Radiopaque Stripe/Cuff Inflation Circuit Position: Radiopaque stripe on greater curvature, cuff inflation circuit on lesser curvature.	Deviation: Positions reversed on Parker tube.
Mechanical Design - Patient End: Rounded without sharp points or rough edges (ASTM 4.2.1).	Compliance: Although tapered, its point is rounded (not sharp) and edges are rounded (not rough).
Clinical Safety & Efficacy (compared to standard tracheal tubes): - Not adversely affect safety or efficacy. - Be at least as safe and efficacious for orotracheal intubation. - (Implicit) Reduce trauma during intubation.	Clinical safety/efficacy found to be at least as safe and efficacious as standard tracheal tubes. Appeared clearly and consistently less traumatic to the nose, larynx, and trachea during intubation (cadaver study).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Comparative Study): 66 adult patients (31 intubated with standard tracheal tube, 35 with Parker tracheal tube).
Data Provenance: The text does not explicitly state the country of origin. It mentions an "IRB approval and informed consent," suggesting a prospective clinical study in human subjects. Given the manufacturer's location in the US (Cincinnati, Ohio), it's highly probable the study was conducted in the US. The study appears to be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not detail the specific "ground truth" establishment for the clinical study beyond the outcomes observed during intubation and patient follow-up. It doesn't mention expert readers or adjudicators for "ground truth" in the traditional sense of image analysis. The "ground truth" here is the observed clinical outcome during intubation and subsequent patient status, as assessed by the medical professionals performing the procedures and patient care. No specific number or qualification of experts establishing a separate ground truth is mentioned.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is mentioned. The clinical study describes intubations being "watched through a videoscope, and some were recorded," and conclusions drawn from this direct observation and patient outcomes. It implies direct assessment by the medical staff involved in the study rather than a separate adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is a physical medical device (endotracheal tube), not an AI/software device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

As this is a physical medical device, not an algorithm, a standalone performance study in the context of AI is not applicable and was not done.

7. The Type of Ground Truth Used

Cadaver Study: Direct visual observation via videoscope of the intubation process and its immediate effects on the nose, larynx, and trachea. The ground truth was the observed trauma.
Clinical Study: The ground truth was the observed safety and efficacy during and after orotracheal intubation in adult patients for surgery. This would typically involve assessments of intubation success, ease of intubation, presence of complications (e.g., vocal cord damage, airway trauma), and adequacy of ventilation. This is essentially outcomes data from a clinical setting.

8. The Sample Size for the Training Set

No training set is mentioned as this is a physical medical device. The "training" or development would have been through engineering, materials testing, and iterative design, not through a data-driven machine learning approach.

9. How the Ground Truth for the Training Set Was Established

As no training set (in the AI/machine learning sense) was used, this question is not applicable. The "ground truth" for the device's design and non-clinical development would have been established through engineering specifications, material performance standards, and manufacturing quality control.

Summary

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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)

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510(k) Summary Page 2

Product Description:

(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.

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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.

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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.

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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

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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)

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

Regulation Number and Section

§ 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).