(196 days)
Not Found
No
The device description and intended use focus on mechanical components and standard medical device features, with no mention of AI, ML, or related concepts.
Yes
The device is used for controlled ventilation during anesthesia, which is a therapeutic intervention.
No
The device is described as being for "controlled ventilation during anesthesia" and its components relate to maintaining an airway, not to diagnosing a condition.
No
The device description clearly outlines physical components made of elastomeric and thermoplastic materials, including inflatable bladders and a rigid plastic connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "controlled ventilation during anesthesia." This is a direct intervention on a patient's airway for respiratory support, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components and function of an airway management device (ventilation channel, inflatable bladders, connectors). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other typical components of an IVD.
Therefore, the KING LT-D is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAE
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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a date, "APR 14 2004". The month is April, the day is the 14th, and the year is 2004. The text is in a bold, sans-serif font.
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.
1
Comparison of the KING LT™ to the legally marketed predicate device:
| Characteristic | KING LT-D | KING LT™ |
|---|---|---|
| 510(k) Number | TBD (this | |
| submission) | K002458 | |
| 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. | Yes | No |
| 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 |
| 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 | ||
| before using the product? | Yes | Yes |
| Latex free product | Yes | Yes |
| Product classification | CAE | CAF |
2
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.
3
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.
4
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
5
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:__