The KING LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Device Description

Each device is constructed of medical grade elastomeric and thermoplastic materials. All fittings conform to ISO 5356-1/1996: Anesthetic and Respiratory Equipment - Conical Connectors; Part 1 Cones and Sockets. The device incorporates the following components or features:

. Bi-directional gas flow through a ventilation channel.
Inflatable bladders to assist in maintenance of placement and in sealing the . airway from the stomach and from the atmosphere
. Indicators for proper placement permanently printed on the tube
A rigid plastic connector complying with ISO standards for the 15mm connection . to the patient end of a breathing circuit.

AI/ML Overview

This document describes a premarket notification (510(k)) for the KING LT-D Disposable Oropharyngeal Airway, not an AI device. Therefore, many of the requested criteria (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, software validation) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a disposable version of an existing product. The acceptance criteria are related to material properties, design conformity, and intended use, rather than performance metrics of an AI algorithm.

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (based on predicate)	KING LT-D Performance (reported)
Intended Use: Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.	Yes	Yes
Design: Tube with two attached, inflatable balloons	Yes	Yes
Ventilation openings between the balloons	Yes	Yes
Sterile device indicated for single patient use.	No (for predicate)	Yes
ISO Standard 15 mm proximal connector for attachment to breathing circuit	Yes	Yes
Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream.	Yes	Yes
Connected to a Breathing Circuit	Yes	Yes
11.5 mm internal diameter	Yes	Yes
Weight (gm)	32.2 (predicate)	32.1
Prescription use only?	Yes	Yes
Inserted blindly?	Yes	Yes
Enters the trachea?	No	No
Seals the esophagus?	Yes	Yes
Cuffs are inflated with one inflation port?	Yes	Yes
Instructions that patient should have fasted before using the product?	Yes	Yes
Latex free product	Yes	Yes
Product classification	CAF (predicate)	CAE
Materials in conformity with voluntary standards (ISO 5356-1/1996, ASTM F1242-96, EN30993/ISO 10993)	Utilized in whole or in part	Yes (stated in text)
Biocompatibility	Equivalent to other medical devices	Yes (stated in text)
All verification and validation activities demonstrated that the predetermined acceptance criteria were met.	Yes	Yes (stated in text)
Conformance with design control procedure requirements as specified in 21 CFR 820.30	Yes	Yes (stated in text)

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a premarket notification (510(k)) submission demonstrating substantial equivalence to a legally marketed predicate device (King Systems Corporation KLT Oropharyngeal Airway, 510(k) #K021634).

The acceptance criteria are primarily met by:

Direct comparison of characteristics (e.g., intended use, design, dimensions, materials, sterile status) to the predicate device.
Compliance with recognized standards: ISO 5356-1/1996-12-15, ASTM F1242-96, and EN30993/ISO 10993 for biocompatibility.
Risk analysis and verification/validation activities: The document states that "the designated individual(s) performed all verification and validation activities and the results of the activities demonstrated that the predetermined acceptance criteria were met."
Conformance with design control procedures as per 21 CFR 820.30.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a medical device submission based on substantial equivalence to a predicate, not a study involving a test set of data in the context of an AI/software device. The product is manufactured in Malaysia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not software driven and does not involve AI or the establishment of ground truth by experts in the sense of diagnostic accuracy studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication process described for this device.

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

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The document explicitly states: "This device is not software driven. Software validation and verification is not applicable."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of an AI device. For this medical device, the "ground truth" or basis for acceptance is primarily the characteristics and performance of the legally marketed predicate device and compliance with established international and ASTM standards for design, materials, and intended use.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Section #7

PREMARKET SUMMARY (As Required By 21 CFR 807.93)

Alternate contact: Charles Burt

Contact person: Tom McGrail King Systems Corporation Establishment Registration Number: 1824226 15011 Herriman Boulevard Noblesville, IN 46060 Telephone: 317 776-6823

General Information

Proprietary or Trade Name: KING LT-D

KLT 203 Size 3 Small adult disposable oropharyngeal airwav

KLT 204 Size 4 Medium adult disposable oropharyngeal airway

KLT 205 Size 5 Large adult disposable oropharyngeal airway

Common/Usual Name: LT-D

Classification Name: Oropharyngeal airway; CAE (21 CFR 868.5110). Classification: Class I (New fundamental scientific technology exceeds limitations of exemptions found in 21 CFR 868.9.)

Classification Panel: Anesthesiology Review Committee

Reason for Premarket Notification: A disposable version of an existing reusable device is intended for introduction into the US market.

The KING LT-D is similar in intended use, material, safety and effectiveness to: King Systems Corporation KLT Oropharyngeal Airway (510(k) #K021634). The intended use and indications of the modified device, as described in its labeling, are the same as those for the unmodified predicate device. The modification has not altered the fundamental technology of the predicate device.

The device is to be distributed by King Systems as sterile, for single patient use.

The following voluntary standards are utilized in whole or in part: ISO 5356-1/1996-12-15, Anesthetic and Respiratory Equipment-conical Connectors, Part 1- cones and sockets; ASTM F1242-96 Standard Specifications for Cuffed and Uncuffed Tracheal Tubes; EN30993/ISO 10993, Biocompatibility Evaluation of Medical Devices.

The materials in the device are identical to materials used in other medical devices that have the same level of patient contact.

This device is not software driven. Software validation and verification is not applicable.

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Comparison of the KING LT™ to the legally marketed predicate device:

Characteristic	KING LT-D	KING LT™
510(k) Number	TBD (thissubmission)	K002458
Intended UseVentilation during anesthesia duringprocedures of short duration. Anoropharyngeal airway is a device insertedthrough the mouth to provide a patent airway.	Yes	Yes
DesignTube with two attached, inflatable balloons	Yes	Yes
Ventilation openings between the balloons	Yes	Yes
Sterile device indicated for single patient use.	Yes	No
ISO Standard 15 mm proximal connector forattachment to breathing circuit	Yes	Yes
Medical grade polymers or approved materialsfor all components in contact with theanesthesia gas stream.	Yes	Yes
Summary of Features
Connected to a Breathing Circuit	Yes	Yes
11.5 mm internal diameter	Yes	Yes
Weight (gm)	32.1	32.2
Prescription use only?	Yes	Yes
Inserted blindly?	Yes	Yes
Enters the trachea?	No	No
Seals the esophagus?	Yes	Yes
Cuffs are inflated with one inflation port?	Yes	Yes
Instructions that patient should have fastedbefore using the product?	Yes	Yes
Latex free product	Yes	Yes
Product classification	CAE	CAF

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Device Description

. Bi-directional gas flow through a ventilation channel.
Inflatable bladders to assist in maintenance of placement and in sealing the . airway from the stomach and from the atmosphere
. Indicators for proper placement permanently printed on the tube
A rigid plastic connector complying with ISO standards for the 15mm connection . to the patient end of a breathing circuit.

King Systems Corporation (establishment registration number 1824226) will be the exclusive U.S. distributor for this line of oropharyngeal ainways. The product is manufactured in Malaysia.

Each device is distributed as an individually packaged sterile device for single patient use.

As required by the risk analysis performed for the KING LT-D, the designated individual(s) performed all verification and validation activities and the results of the activities demonstrated that the predetermined acceptance criteria were met. King Systems Corporation is in conformance with the design control procedure requirements as specified in 21 CFR 820.30, and the records are available for review.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular border.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

Mr. Tom McGrail Director, Research & Development King System, Corporation 15011 Herriman Boulevard Noblesville, Indiana 46060

Re: K033186

Trade/Device Name: KING LT-D Disposable Oropharyngeal Airway Models KLT 203 Regulation Number: 868.5110 Regulation Name: Oropharyngeal Airway Regulatory Class: I Product Code: CAE Dated: March 17, 2004 Received: March 18, 2004

Dear Mr. McGrail:

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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mcgrail

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 and 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 our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment I

Indications for Use

510(k) number: K033186

Device name:

KLT 203 Size 3 Small adult disposable oropharyngeal airway KLT 204 Size 4 Medium adult disposable oropharyngeal airway KLT 205 Size 5 Large adult disposable oropharyngeal airway

Indications for Use:

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

HWth

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:__

Regulation Number and Section

§ 868.5110 Oropharyngeal airway.

(a)
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.