KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205

K033186 · King Systems Corp. · CAE · Apr 14, 2004 · Anesthesiology

Device Facts

• Record ID: K033186
• Device Name: KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
• Applicant: King Systems Corp.
• Product Code: CAE · Anesthesiology
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5110
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

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 Story

KING LT-D is a disposable oropharyngeal airway for controlled ventilation during short-duration anesthesia. Device consists of a tube with two inflatable balloons and a 15mm proximal connector for breathing circuit attachment. Inserted blindly through the mouth; seals esophagus to provide patent airway; does not enter trachea. Used by clinicians in clinical settings. Output is a patent airway for gas delivery. Benefits include single-patient use to reduce cross-contamination risks compared to reusable predecessors. Device is non-software driven.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including compliance with ISO 5356-1 (connectors), ASTM F1242-96 (tracheal tubes), and ISO 10993 (biocompatibility).

Technological Characteristics

Constructed of medical-grade elastomeric and thermoplastic materials. Features bi-directional gas flow channel, two inflatable bladders, and 15mm rigid plastic connector. Conforms to ISO 5356-1 for connectors. Sterile, single-patient use. Non-software driven.

Indications for Use

Indicated for adult patients (>25 kg) requiring controlled ventilation during short-duration anesthesia procedures; contraindicated for patients at high risk of aspiration.

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)
• KING LT™ (K002458)

Submission Summary (Full Text)

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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: [phone]

### 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 (this<br>submission) | K002458 |
| Intended Use<br>Ventilation during anesthesia during<br>procedures of short duration. An<br>oropharyngeal airway is a device inserted<br>through the mouth to provide a patent airway. | Yes | Yes |
| Design<br>Tube 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 for<br>attachment to breathing circuit | Yes | Yes |
| Medical grade polymers or approved materials<br>for all components in contact with the<br>anesthesia 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 fasted<br>before using the product? | Yes | Yes |
| Latex free product | Yes | Yes |
| Product classification | CAE | CAF |

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#### 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.

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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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 [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 Division 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,

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:

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.

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:***_***_