(141 days)
The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the anesthesia machine after insertion into the patient. It is intended that the user will be able to inflate the device cuff and ventilate the patient.
The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking of the tube when movement of the head or neck is required following intubation.
The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery. The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the spring prevent kinking or occlusion of the tube. The cuff is intended to provide a seal against the trachea, ensuring that Inspiratory and expiratory gasses are directed through the tube and not allowed to escape to the patients "upper" airway, thus preventing loss of ventilation and aspirated stomach contents from entering the lungs. This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, and it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ SU and LMA CTrach Airways.
This document is a 510(k) summary for the LMA Fastrach™ ETT SU, a reinforced tracheal tube. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving their fulfillment:
Crucially, the provided text DOES NOT contain specific acceptance criteria with quantifiable metrics or a detailed study designed to demonstrate the device meets such criteria.
Instead, this is a Premarket Notification (510(k)) summary, which is a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating equivalence in design, materials, intended use, and performance characteristics, often through bench testing and comparison to predicate devices, rather than a full-scale clinical trial with pre-defined acceptance criteria and efficacy/safety outcomes.
Here's how to address your points based on the available information, highlighting what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantifiable performance metrics for the LMA Fastrach™ ETT SU itself. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to predicate devices in areas like material composition, design, and intended use, and by ensuring the device meets relevant recognized standards (which are not detailed here).
- Reported Device Performance: The document states, "Clinical evaluation data is shown in Section 6." However, Section 6 is not provided in the input text. Therefore, specific reported device performance metrics against any acceptance criteria are unknown.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Missing, but inferred activities) |
|---|---|
| Substantial Equivalence to Predicate Devices: | |
| - Material equivalence to specific predicate ETTs | Claimed: Identical in material to Sheridan Spiral-Flex ETT, Rusch Reinforced ETT, Portex reinforced ETT. |
| - Design equivalence for cuff material and design | Claimed: Identical in material and design to Sheridan Spiral-Flex ETT cuff. |
| - Sterility (single-use) | Claimed: Sterile single use device, similar to Portex reinforced ETT and Sheridan Spiral-Flex ETT. |
| - Intended Use (oral intubation for airway management) | Claimed: Intended use is identical to predicate devices. |
| - Kink resistance (due to wire reinforcement) | Claimed: Metal wire spiral reinforcement provides kink-resistance. "The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the ophing crevent kinking or occlusion of the tube." (No quantitative data on kink resistance provided) |
| - Cuff seal integrity and ventilation | Claimed: Cuff intended to provide seal, ensuring inspiratory/expiratory gases are directed through tube and preventing aspiration. (No quantitative data on seal pressure/leakage provided) |
| Compliance with General Controls: | Assumed to be met for 510(k) clearance. |
| - Annual registration, listing, GMP, labeling, etc. | Not discussed in the provided text, but required for marketing. |
| Performance/Clinical Data (as mentioned in text): | Specific data is missing (referenced Section 6 not provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Unknown. The document references "Clinical evaluation data is shown in Section 6," but Section 6 is not provided. Without this section, detailed information about any test set's sample size is unavailable.
- Data Provenance: Unknown, as the specific data or studies are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Unknown. This type of detail is typically associated with studies involving subjective interpretation (e.g., imaging, pathology reviews). For a device like a tracheal tube seeking 510(k) clearance, the "ground truth" for demonstrating substantial equivalence is usually based on engineering specifications, material testing data, and functional performance benchmarks (e.g., flow rates, pressure integrity, kink resistance) compared to predicate devices, rather than expert consensus on diagnostic images.
- If a clinical study was indeed performed and involved expert assessment (e.g., ease of intubation, lack of complications), this information is not in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Unknown. As explained above, an adjudication method like 2+1/3+1 is typically used in studies involving multiple readers for subjective assessments. This is not relevant to the information presented for this device.
5. 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 a medical device (tracheal tube), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) hinges on demonstrating substantial equivalence to the predicate devices. This typically involves:
- Material composition analysis: Comparing the chemical/physical properties of materials used to those in predicate devices.
- Design verification: Ensuring dimensional, structural, and functional aspects match or are appropriately justified against predicate devices.
- Performance testing: Bench testing (e.g., kink resistance, cuff inflation/deflation characteristics, flow dynamics, tensile strength) to show performance is equivalent or better than predicates and meets relevant standards.
- Biocompatibility testing: Ensuring materials are safe for patient contact.
- While the document mentions "Clinical evaluation data is shown in Section 6," without that section, we don't know if outcomes data (e.g., intubation success rates, complication rates) from a clinical study were used as part of the ground truth. However, for a 510(k) of this nature, detailed clinical outcomes are often not required if substantial equivalence can be shown through non-clinical means.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set is relevant here.
In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices for a reinforced tracheal tube. It does not contain the level of detail regarding acceptance criteria, study methodologies, sample sizes, or expert involvement that would be present in a comprehensive clinical study report for proving device performance against specific, quantifiable endpoints. The key missing piece of information is "Section 6: Clinical evaluation data," which might have provided some of the requested performance details.
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DEC 1 3 2005
2051993
The Laryngeal Mask Company Limited
LMA Fastrach™ ETT SU
510(K) SUMMARY
Submitter:
The Laryngeal Mask Company Limited PO Box 221, Mahe, Seychelles
US Agent for Submission And Contact Person:
Mr. Foster Boop LMA North America, Inc. 4660 La Jolla Village Drive Suite 900 San Diego, CA 92122 Phone: 858-587-4025
Date Prepared:
04 July 2005
Trade Name:
LMA Fastrach™ETT SU
Reinforced Tracheal Tube (Cuffed)
Common Name:
Device Type and Class:
Reinforced Tracheal Tube. Class II BTR, 21 CFR 868.5730
Predicate Device:
- Predicate 1: LMA Fastrach™ ETT already marketed in the USA under . K991580
- Predicate 2: Sheridan Spiral-Flex ETT already marketed in the USA under . K860105
- Predicate 3: Rusch Reinforced ETT already marketed in USA under . K990619
- Predicate 4: Portex reinforced ETT already marketed in the USA under ● K032112
Device Description:
The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery.
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LMA Fastrach™ ETT SU
The Laryngeal Mask Company Limited
510(K) SUMMARY
The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the ophing crevent kinking or occlusion of the tube.
The cuff is intended to provide a seal against the trachea, ensuring that The Cull 1s Intended to provied through the tube and not allowed to Inspiratory and expiratory gasses are atthus preventing loss of ventiation / escape to the patients "upper" direct" and aspirated stomach contents from entering the lungs.
This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, This reinforced trached tube is available in size of other fract and as the comment.
And it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ And it is coolig. LMA CTrach Airways.
Intended Use:
The LMA Fastrach™ ETT SU is intended to be used for oral intubation for arway management during anaesthesia. The product maybe used where the patient's management uunny anaesthoolar 11c froo atient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Technological Characteristics of the Proposed Versus Prodicate Devices:
The proposed device is substantially equivalent to predicate 1 – LMA Fastrach™ ETT, in all aspects except the followings:
- Material. The proposed device is identical in material to the tubing . Material: The propossa Sheridan Spiral-Flex ETT, Predicate 3: Rusch Reinforced ETT and Predicate 4: Portex reinforced ETT.
- Sterile. The proposed device is a sterile single use device which is . Sterfic. The Predicate 4- Portex reinforced ETT and Predicate 2-Sheridan Spiral-Flex ETT.
- Cuff. The proposed device is identical in material and design to that of 1 Predicate 2- Sheridan Spiral-Flex ETT.
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The Laryngeal Mask Company Limited
LMA Fastrach™ ETT SU
:
510(K) SUMMARY
Performance / Clinical Data:
Clinical evaluation data is shown in Section 6.
Conclusion:
Comparison of the proposed device to the predicate devices supports the Companson of the proposed device is substantially equivalent in safety and conclusion that the proposed - to existing legally marketed devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
DEC 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Laryngeal Mask Company Limited C/O Mr. Foster Boop Director, Technical Affairs LMA North America, Incorporated 9360 Towne Centre Drive San Diego, California 92121
Re: K051993
Trade/Device Name: LMA Fastrach™ ETT Single Use Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: December 2, 2005 Received: December 5, 2005
Dear Mr. Boop:
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. Boop
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 (240) 276-0120. 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/industry/support/index.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
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Indications for Use
510(k) Number (if known): K051993
LMA Fastrach™ ETT Single Use
The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the modif into the traction after insertion into the patient. It is intended andootherio machine the user will be able to inflate the device cuff and ventilate the patient.
Indications for Use:
Device Name:
The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for intubation of the traonomist of the head or neck is required following intubation.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cune Egleom
Page 1 of 1
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).