(216 days)
No
The summary describes a mechanical airway device with no mention of software, algorithms, or any features indicative of AI/ML.
Yes
The device is described as affecting the body directly by facilitating controlled ventilation during anesthesia, which aligns with the definition of a therapeutic device.
No
The device description indicates it is used for controlled ventilation during anesthesia, and its components describe an airway device. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly outlines a physical tube with inflatable balloons, connectors, and materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for controlled ventilation during anesthesia. This is a direct intervention on a patient's respiratory system, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical airway device with balloons and connectors for a breathing circuit. This aligns with a medical device used for airway management, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, the KING LTS is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
CAE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharyngeal
Indicated Patient Age Range
adult patients (in excess of 25 kg)
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 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.
1
Characteristic | KING LTSTM | KING LTTM |
---|---|---|
510(k) Number | TBD (this | |
submission) | K021634 | |
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 |
Can be sterilized in an autoclave | Yes | Yes |
Proximal ISO Standard 15mm connector | ||
for attachment to breathing circuit | Yes | Yes |
Medical grade polymers or approved materials for all | ||
components in contact with the anesthesia gas stream | Identical to | |
materials in | ||
predicate | ||
device | Yes | |
Summary of Features | ||
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 | ||
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.
2
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
3
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 (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 maj ookan 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,
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
4
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: