KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305

K033189 · King Systems Corp. · CAE · May 4, 2004 · Anesthesiology

Device Facts

• Record ID: K033189
• Device Name: KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
• Applicant: King Systems Corp.
• Product Code: CAE · Anesthesiology
• Decision Date: May 4, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5110
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The KING LTS is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration oonlour vehilation is considered to have a low risk of aspiration of stomach contents.

Device Story

KING LTS is a reusable oropharyngeal airway device designed for airway management during anesthesia. It consists of a tube with two inflatable balloons and ventilation openings positioned between them. The device is inserted blindly through the mouth to seal the esophagus and provide a patent airway without entering the trachea. It features a proximal 15mm ISO standard connector for attachment to a breathing circuit. The device is operated by clinicians in a clinical setting. It is supplied non-sterile and is compatible with autoclave sterilization. By sealing the esophagus and facilitating ventilation, it assists in maintaining patient oxygenation during short procedures. The device is prescription-only and intended for patients who have fasted.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological comparison to the predicate device.

Technological Characteristics

Reusable oropharyngeal airway; medical-grade polymers; two inflatable balloons; 15mm ISO 5356-1 conical connector; ASTM F1242-96 compliant; autoclave-sterilizable; non-sterile distribution.

Indications for Use

Indicated for adult patients (>25 kg) requiring controlled ventilation during short-duration anesthesia procedures where aspiration risk is low.

Regulatory Classification

Identification

An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Predicate Devices

• King Systems Corporation KLT Oropharyngeal Airway (K021634)

Submission Summary (Full Text)

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K033189

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: [phone]

## General Information

Proprietary or Trade Name:

KING LTS ™

KLT 303 Size 3 Small adult oropharyngeal airway

KLT 304 Size 4 Medium adult oropharyngeal airway

KLT 305 Size 5 Large adult oropharyngeal airway

Common/Usual Name: LTS

Oropharyngeal airway; CAE (21 CFR 868.5110). Classification Name: 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: Product manufactured in Germany is new to U.S. market.

The intended device is similar in intended use, material, safety and effectiveness in similar applications 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 non-sterile, clean. Sterilization information is provided as part of the instructions for use. Manufacturer's tests have shown the device to successfully withstand fifty or more cleaning and autoclave sterilization cycles.

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.

The materials in the device are identical to materials used in the identified predicate device.

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| Characteristic | KING LTSTM | KING LTTM |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------|
| 510(k) Number | TBD (this<br>submission) | K021634 |
| Intended Use<br>Ventilation during anesthesia during procedures of<br>short duration. An oropharyngeal airway is a device<br>inserted through the mouth to provide a patent<br>airway. | Yes | Yes |
| Design<br>Tube with two attached, inflatable balloons | Yes | Yes |
| Ventilation openings between the balloons | Yes | Yes |
| Can be sterilized in an autoclave | Yes | Yes |
| Proximal ISO Standard 15mm connector<br>for attachment to breathing circuit | Yes | Yes |
| Medical grade polymers or approved materials for all<br>components in contact with the anesthesia gas stream | Identical to<br>materials in<br>predicate<br>device | Yes |
| Summary of Features<br>Connected to a Breathing Circuit | Yes | Yes |
| Internal Volume (dead space) (ml) * | 8.7 | 9.0 |
| Resistance cmH2O @ 30 L/min* | 1.6 | 1.3 |
| Weight (gm) * | 51.3 | 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 fasted before<br>using the product? | Yes | Yes |
| Latex free product | Yes | Yes |
| Product classification | CAE | CAE |

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

*Size 4 for both the KING LTS™ and the KING LT™ is used for this comparison of weight, dead space, and
resistance. Size 4 is the middle size for both product lines, and vari expected to be proportionally, approximately equal.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three horizontal lines curving upwards, often interpreted as representing human aspiration and progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2004

Tom McGrail Director, R & D King Systems Corporation 15011 Herriman Blvd. Noblesville, IN 46060

Re: K033189

Trade/Device Name: King LTS Reusable Oropharyngeal Airway with Drain/Suction Regulation Number: 21 CFR 868.5110 Regulation Name: Regulatory Class: I Product Code: CAE Dated: April 2, 2004 Received: April 5, 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 rcquirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

lf 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.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements

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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Fet of all , I outh 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 and flouing (21 CF CF 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) Fills letter notification. The FDA finding of substantial equivalence of your device to a premits total of the 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), r you demte the Office of Compliance at [phone]. 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 maj ookan of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clair Lin, Ph. D.

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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## Indications for Use

510(k) number: K033189

Device name:

KLTS 303 Size 3 Small adult KING LTS oropharyngeal airway KLTS 304 Size 4 Medium adult KING LTS oropharyngeal airway KLTS 305 Size 5 Large adult KING LTS oropharyngeal airway

Indications for Use:

The KING LTS is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration oonlour vehilation is considered to have a low risk of aspiration of stomach contents.

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)

Quy Sileom

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

510(k) Number: