(81 days)
The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
Here's a breakdown of the acceptance criteria and the study details for the Truphatek Tru-MR™ Laryngoscope set, based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ASTM F2052-02 (MR Safety Testing) | In 3.0 Tesla < 45 degree string deflection (magnetic force) |
| Usable in a Magnetic Resonance (MR) environment up to 3.0 Tesla | Successfully tested in a 3.0 Tesla environment |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes physical testing of the device for MR compatibility, not a study involving human or clinical data. Therefore, the concept of "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" as it refers to patient data is not applicable.
The "test set" for this device was the Truphatek Tru-MR™ Laryngoscope set itself (handle, battery, and blades). The testing was performed on the device to verify its MR Conditional properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The "ground truth" for MR compatibility of a medical device is established by standardized testing protocols (e.g., ASTM F2052-02), not through expert consensus or interpretation of clinical data in the same way an AI algorithm's output might be evaluated. The result (e.g., < 45 degree string deflection) is a direct, measurable physical outcome.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. For physical device testing, the results are objectively measured according to the specified standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI systems in a clinical setting, often comparing human readers with and without AI assistance. The Truphatek Tru-MR™ is a physical medical device (laryngoscope) and not an AI system.
6. Standalone Performance Study (Algorithm Only)
No, a standalone (algorithm only) performance study was not done. This is not an AI-powered device. The "performance" described is the physical device's MR compatibility.
7. Type of Ground Truth Used
The "ground truth" used for this device was based on physical measurements and adherence to an industry standard: ASTM F2052-02. The acceptance criterion of "< 45 degree string deflection" in a 3.0 Tesla environment serves as the objective measure of its MR compatibility, which is the key performance aspect for this device's intended use.
8. Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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Premarket Notification 510(k) Section 5 – 510(k) Summary
Truphatek Tru-MR™
5 510(k) Summary
| Non-Confidential Summary of Safety and Effectiveness |
|---|
| Page 1 of 2 |
| Page 1 of 225-Aug-06 | NOV 17 2006 | |
|---|---|---|
| Truphatck International Ltd.Park Poleg-C, Sapir Industrial zoneNetanya, 42504 ISRAEL | Tel - 011-972-9-885-1155Fax - 011-972-9-885-1212 | |
| Official Contact: | David Grey, CEO | |
| Proprietary or Trade Name: | Tru-MR™ Laryngoscope set - MR Conditional | |
| Common/Usual Name: | Laryngoscope handle and blades - MR conditional | |
| Classification Name: | Rigid Laryngoscope | |
| Device: | Tru-MR™ | |
| Predicate Devices: | Minrad MR tested laryngoscope - K041852 | |
| Device Description: |
The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
| Indications for Use: | |
|---|---|
| Indicated Use -- | The Tru-MR ™ laryngoscope set is used to facilitate andaid in tracheal intubation in a Magnetic Resonance (MR)environment, not to exceed a 3.0 Tesla static magneticfield. |
| Patient Population -- | No limitations |
| Environment of Use -- | Magnetic resonance (MR) environment up to 3.0 Tesla |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 25-Aug-06
| Device Attributes: | |
|---|---|
| Design | |
| Configurations offered | Handles, many blades, i.e. Miller, Mac, etc. |
| Cleaning | Cold solution, autoclave |
| Testing |
| ASTM F2052-02------------------------------------------------------------------------------------------------------------------------------------------------------------------------------For Person Research Parcel of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A . A | In 3.0 Tesla < 45 degree string deflectionwhile and the first and of the program and the comments of the comments of the first and the first andComments of Concession of Children Company of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Differences Between Other Legally Marketed Predicate Devices
The Tru-MR™ laryngoscope set viewed as substantially equivalent to the following predicate device -- Minrad -- K041852.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Truphatek International, Limited C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creck Court, #102 Bonita Springs, Florida 34134
NOV 1 7 2006
Re: K062523
Trade/Device Name: Tru MRTM Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Larvngoscope Regulatory Class: I Product Code: CCW Dated: August 25, 2006 Received: August 29, 2006
Dear Mr. Dryden:
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. Dryden
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Onete y.m., @lice Omd
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 Statement 4
Page 1 of 1
| 510(k) Number: | K 062523 (To be assigned) |
|---|---|
| Device Name: | Tru MRTM |
| Indications for Use: | The Tru-MR TM laryngoscope set is used to facilitate andaid in tracheal intubation in a Magnetic Resonance (MR)environment, not to exceed a 3.0 Tesla static magneticfield. |
Prescription Use XX (Part 21 CFR 801 Subpart D)
01
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)
Smite y. Michael ons
ni Sign-Citi) on of Anesthesiology, General Hospital, don Control. Dental
Number: K062523
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(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