(274 days)
The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal . - intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.
The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.
The provided document describes the 510(k) premarket notification for the "MR Fiber Optic Intubating Laryngoscope Handle." This is a medical device submission, and the focus of the testing and acceptance criteria is on demonstrating the device's substantial equivalence to existing predicate devices, particularly its safety for use in an MRI environment.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test | Specified Limit/Target | Reported Device Performance |
|---|---|---|
| Artifact Level in 1.5 Tesla Static Magnetic Field (tested in the center of the field) | Not explicitly stated as a numerical limit, but implied acceptable. | "The device displayed an artifact level of twice the size of the device." (This is presented as a characteristic, not a pass/fail against a specific numerical limit, but considered acceptable within the context of substantial equivalence.) |
| RF Heating in 1.5 Tesla Static Magnetic Field | < 1° C (less than 1 degree Celsius) | "< 1° C of RF Heating" (The device exhibited less than 1° C of RF Heating, meeting the specified criteria.) |
| Attraction to Magnet (Angle of Attraction at center of 1.5 Tesla field) | Not explicitly stated as a numerical limit, but implied acceptable. | "a 4° angle of attraction." (This is presented as a characteristic, not a pass/fail against a specific numerical limit, but considered acceptable within the context of substantial equivalence.) |
| Attraction to Magnet (Angle of Attraction at portal and 15cm outside the magnet) | 0° (zero degrees) | "The device exhibited a 0° angle of attraction at the portal and at 15cm outside the magnet, which is the area of intended use." (Meets the 0° criteria in the intended use areas.) |
| Compliance with ASTM Standards (General Safety/Performance) | ASTM F965 and F1185 compliance | "This device has been tested according to ASTM Standards F 965 and F 1185 and MR safety testing" (Implies compliance with these standards.) |
| Substantial Equivalence to Predicate Devices | Similar design and intended use to predicate devices | "The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope Handle is substantially equivalent in design and intended use to the predicate devices listed above. The only difference is that the Greatbatch Scientific MR Fiber Optic Laryngoscope can be safely used in a MRI or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of multiple devices being tested. It refers to "The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope" (singular) being tested. This suggests that at least one representative sample of the device was subjected to the described tests.
- Sample Size: A limited number of device samples (likely one or a few for verification) were tested. The text refers to "The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope" as the subject of the tests, implying a focus on the device model rather than a large statistical sample.
- Data Provenance: The study was conducted by the submitter, Greatbatch Scientific. The testing likely occurred at their facilities or a contracted testing lab. The document does not specify a country of origin for the data beyond that. The nature of the testing (device performance, not clinical) means it's not "retrospective or prospective" in the sense of patient data. It's a technical performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission (510(k) for a basic medical device like a laryngoscope handle, particularly for MR compatibility) typically does not involve human "experts" establishing a clinical ground truth for a test set in the way a diagnostic AI algorithm would.
- Experts: Not applicable in the context of clinical ground truth for a test set. The validation relies on engineering and physics principles relevant to MRI compatibility.
- Qualifications of Experts: Not applicable. The "expert" evaluation would be the engineering and testing personnel who conducted the MR safety tests and interpreted ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. This is a technical performance test, not an evaluation where human adjudicators reconcile differences in medical assessments. The results are objective measurements (e.g., temperature rise, angle of attraction, artifact size).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not a diagnostic device or an AI-assisted tool requiring a MRMC study. The device is a physical instrument for intubation, and the study focuses on its physical properties and safety in an MRI environment.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm or software device. It's a physical medical instrument.
7. The Type of Ground Truth Used
The "ground truth" here is based on accepted engineering standards and physical principles for MRI compatibility and safety.
- MRI Safety Ground Truth: The physical laws governing magnetic attraction, RF heating, and artifact generation in an MRI environment, as well as the established safety limits (e.g., temperature rise, attraction limits).
- ASTM Standards Ground Truth: The requirements defined in ASTM F965 (Standard Guide for Care and Handling of Anesthesia and Respiratory Equipment for Tissue Banks) and F1185 (Standard Specification for Anesthetic and Respiratory Equipment - Laryngoscopes). These are consensus standards representing accepted safe performance.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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510(k) SUMMARY MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE
| Submitter Name: | Greatbatch Scientifica division of Wilson Greatbatch Ltd. |
|---|---|
| Submitter Address: | 4100 Barton RoadClarence, New York 14031NOV 19 1997 |
| Contact Person: | Gary J. Sfeir, RAC |
| Phone Number: | 716.759.5277 |
| Facsimile Number: | 716.759.5280 |
| Date Prepared: | 6 October, 1997 |
| Device Trade Name: | MR Fiber Optic Intubating Laryngoscope Handle |
| Device Common Name:Classification Name: | LaryngoscopeRigid Laryngoscope |
| Predicate Devices: | Fiber Optic LaryngoscopeWelch Allyn, Inc.Sun Lite™ LaryngoscopeSun Med, Inc.Heine Fiber Optic LaryngoscopeHeine USA Ltd. |
| Device Description: | The MR Fiber Optic Intubating Laryngoscope consists of a handlewhich is manufactured from brass and is chrome plated. The cellused to provide the light source energy is a proprietary "c" sizecell. |
| Intended Use: | The MR Fiber Optic Intubating Laryngoscope Handle when used withthe laryngoscope blades stated in the package insert will be used tofacilitate and aid in tracheal intubation in a MRI or aninterventional MR environment, not to exceed a 1.5 Tesla staticmagnet field. |
| Device Technological | The technological characteristics of all of the devices are similar indesign. The Greatbatch Scientific MR Fiber Optic IntubatingLaryngoscope was tested in the center of a 1.5 Tesla static magneticfield, to assess artifact, RF Heating and the presence of attraction tothe magnet. The device displayed an artifact level of twice the sizeof the device, less than 1° C of RF Heating, and a 4° angle ofattraction. The device exhibited a 0° angle of attraction at theportal and at 15cm outside the magnet, which is the area of intendeduse. |
| Predicate Devices(s):Performance Data: | This device has been tested according to ASTMStandards F 965 and F 1185 and MR safety testing |
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The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope Conclusion: Handle is substantially equivalent in design and intended use to the predicate devices listed above. The only difference is that the Greatbatch Scientific MR Fiber Optic Laryngoscope can be safely used in a MRI or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 19 1997
Mr. Gary J. Sfeir Greatbatch Scientific, Inc. 4100 Barton Road 14031 Clarence, New York
K970619 Re: MR Fiber Optic Laryngoscope Handle Regulatory Class: I (one) Product Code: 73 CCW October 6, 1997 Dated: October 8, 1997 Received:
Dear Mr. Sfeir:
.. .
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gary J. Sfeir
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callhhan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Greatbacch Scientific Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle 510(K) Premarket Notification
SECTION 4
INDICATIONS FOR USE
510 (k) Number (if known):
Device Name:
Greatbatch Scientific MR Fiber Optic Laryngoscope Handle
Indications For Use:
The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal . - intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic
Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE)
| PRESCRIPTION USE | OR... | OVER-THE-COUNTER USE | |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------- | ---------------------- |
| Christy Forman (OPTIONAL FORMAT 1-2-96) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices |
§ 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