(216 days)
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.
Tube with two attached, inflatable balloons. Ventilation openings between the balloons. Can be sterilized in an autoclave. Proximal ISO Standard 15mm connector for attachment to breathing circuit. Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream. Connected to a Breathing Circuit. Inserted blindly. Seals the esophagus. Cuffs are inflated with one inflation port. Instructions that patient should have fasted before using the product. Latex free product.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing this is a 510(k) premarket notification for a Class I device seeking substantial equivalence, not a detailed clinical trial report.
Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) submission seeking substantial equivalence to a predicate device (King Systems Corporation KLT Oropharyngeal Airway, 510(k) #K021634). For devices seeking substantial equivalence, the "acceptance criteria" are generally that the new device performs as well as or similarly to the predicate device, especially regarding performance characteristics relevant to its intended use and safety. The study provided here is primarily a comparison to the predicate device, demonstrating that the design and certain performance characteristics are "substantially equivalent."
Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the acceptance criteria are implicit: the new device's characteristics should match or be demonstrably similar to the predicate device. The "reported device performance" is the comparison data presented.
| Characteristic | Acceptance Criteria (from predicate) | KING LTSTM (New Device) Performance | Comparison |
|---|---|---|---|
| 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. | Same as predicate (Yes) | Meets criteria by being identical. |
| Design | Tube with two attached, inflatable balloons | Yes | Meets criteria by being identical. |
| Ventilation openings between the balloons | Yes | Yes | Meets criteria by being identical. |
| Can be sterilized in an autoclave | Yes | Yes | Meets criteria by being identical. |
| Proximal ISO Standard 15mm connector for attachment to breathing circuit | Yes | Yes | Meets criteria by being identical. |
| Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream | Yes | Identical to materials in predicate device | Meets criteria by being identical. |
| Summary of Features: Connected to a Breathing Circuit | Yes | Yes | Meets criteria by being identical. |
| Internal Volume (dead space) (ml)* | 9.0 | 8.7 | Difference: 0.3 ml. The submission implies this is proportionally, approximately equal. |
| Resistance cmH2O @ 30 L/min* | 1.3 | 1.6 | Difference: 0.3 cmH2O. The submission implies this is proportionally, approximately equal. |
| Weight (gm)* | 32.2 | 51.3 | Difference: 19.1 gm. This is a noticeable difference, but for a Class I device and the context of substantial equivalence, it's likely deemed acceptable if it doesn't impact safety or effectiveness. |
| Prescription use only? | Yes | Yes | Meets criteria by being identical. |
| Inserted blindly? | Yes | Yes | Meets criteria by being identical. |
| Enters the trachea? | No | No | Meets criteria by being identical. |
| Seals the esophagus? | Yes | Yes | Meets criteria by being identical. |
| Cuffs are inflated with one inflation port? | Yes | Yes | Meets criteria by being identical. |
| Instructions that patient should have fasted before using the product? | Yes | Yes | Meets criteria by being identical. |
| Latex free product | Yes | Yes | Meets criteria by being identical. |
| Product classification | CAE | CAE | Meets criteria by being identical. |
| *Comparison values are for Size 4. |
Study Information
The provided document is a 510(k) premarket notification for a Class I device establishing substantial equivalence to an existing predicate device. This type of submission, especially for Class I devices, typically relies on demonstrated comparability through engineering testing and material analysis rather than extensive human clinical trials.
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Sample size used for the test set and the data provenance:
- The "test set" in this context refers to the specific device characteristics measured for the KING LTS™ (new device) and compared to the KING LT™ (predicate device).
- Specific sample sizes for the measurements of internal volume, resistance, and weight are not explicitly stated (e.g., "n=X devices were tested for resistance"). However, the comparison is made on "Size 4 for both the KING LTS™ and the KING LT™," implying that at least one unit of each size 4 device was used for these measurements. It's likely that a small number of devices were tested per characteristic to ensure consistency.
- Data Provenance: The data appears to be from internal manufacturer testing ("Manufacturer's tests have shown the device to successfully withstand fifty or more cleaning and autoclave sterilization cycles."). The country of origin for the new product is Germany ("Product manufactured in Germany is new to U.S. market.").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of 510(k) submission. "Ground truth" for diagnostic or AI devices is typically established by multiple experts. For this device (an oropharyngeal airway), the "truth" is established by direct measurement of physical and performance characteristics, and by clinical consensus on its intended use and safety profile, which are aligned with the predicate. No expert panels for ground truth determination are described.
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Adjudication method for the test set:
- Not applicable. There is no expert adjudication described for the physical and performance measurements reported.
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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-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was conducted or described.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering measurements and specifications (e.g., internal volume, resistance, weight, material composition, sterilization capabilities) and alignment with established medical device standards (e.g., ISO 5356-1, ASTM F1242-96) and regulatory classifications (CAE - 21 CFR 868.5110). Clinical "ground truth" is implied by its similarity to an already legally marketed and accepted predicate device with a known safety and effectiveness profile.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As this is not an AI device, there is no training set or ground truth for such a set.
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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 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 (thissubmission) | K021634 |
| Intended UseVentilation during anesthesia during procedures ofshort duration. An oropharyngeal airway is a deviceinserted through the mouth to provide a patentairway. | Yes | Yes |
| DesignTube 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 connectorfor attachment to breathing circuit | Yes | Yes |
| Medical grade polymers or approved materials for allcomponents in contact with the anesthesia gas stream | Identical tomaterials inpredicatedevice | Yes |
| Summary of FeaturesConnected 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 beforeusing 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 (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
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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:
§ 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.