(200 days)
The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
Here's a breakdown of the acceptance criteria and study information for the Greatbatch Scientific MR Compatible Sinuscope, based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| MR Compatibility | Acceptable for use in a 1.5 Tesla static magnetic field | Found to be acceptable for use in a 1.5 Tesla static magnetic field. The device can be used in an MR or interventional MR environment not to exceed a 1.5 Tesla static magnetic field. |
| Magnetic Attraction | No observed string deflection | None |
| Magnetic Torque | No observed torque | None |
| Artifact | Not explicitly specified, but implied to be minimal | For T1 spin echo, artifact was the same size as the device (1). For FSPGR and T1 fast spin echo, artifact was slightly larger than the device (444 for FSPGR, ++ for T1 fast spin echo). The specific numeric values (e.g., 444) for artifact size are not fully explained but indicate a relatively small field of distortion. No absolute maximum artifact size is given. |
| RF Heating | Maximum temperature rise < 1.1°C (Phantom) | <1.1°C (Phantom test with 1.1 W/kg SAR for 26 minutes) |
| Maximum temperature rise (Clinical) | 7°C (Clinical test with 0.971 W/kg SAR for 15 minutes, 22 seconds) | |
| Gradient Induced Voltage | No adverse effects observed | No adverse effects were observed in clinical tests (maximum gradient strength of 10 mT/m, risetime of 600 mSec). |
Study Information
-
Sample size used for the test set and the data provenance:
- Magnetic Attraction & Torque: The testing involved a single device (the Greatbatch Scientific MR Compatible Sinuscope). The data provenance is laboratory testing conducted by Greatbatch Scientific, likely in the USA.
- Artifact: The testing involved a single device. Data provenance is laboratory testing by Greatbatch Scientific.
- RF Heating (Phantom): A single phantom was used. Data provenance is laboratory testing by Greatbatch Scientific.
- RF Heating (Clinical): The document states "Clinical" but does not specify the number of subjects or the methodology, only the SAR applied and duration. This suggests an in-vivo test, but the exact sample size is not provided. Data provenance is implied to be clinical testing arranged by Greatbatch Scientific.
- Gradient Induced Voltage (Clinical): The document states "Clinical" results without specifying the number of subjects or methodology. Data provenance is implied to be clinical testing arranged by Greatbatch Scientific.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a physical instrument, not an AI or diagnostic system. Therefore, "ground truth" as typically understood in AI/diagnostic studies (e.g., expert consensus on images or pathology) is not applicable here. The "truth" is established by direct physical measurement against predefined engineering and safety standards for MR compatibility. The experts would be the engineers and scientists conducting the MR safety tests. Their specific qualifications are not detailed but are assumed to be competent in MR safety testing.
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Adjudication method for the test set:
- Not applicable. This is a physical device performance test (MR compatibility), not a diagnostic assessment requiring adjudication of interpretations. The measurements are objective.
-
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:
- No, this is not an AI or diagnostic device. This type of study is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a physical medical device, not an algorithm. Standalone performance as an algorithm is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for MR compatibility is based on objective physical measurements against established safety standards for magnetic attraction, torque, artifact generation, RF heating, and gradient-induced voltage. These standards dictate acceptable limits for safe use in an MR environment.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."
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How the ground truth for the training set was established:
- Not applicable as there is no training set for a physical device.
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510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
| Submitter Name: | Greatbatch Scientifica division of Wilson Greatbatch Ltd. |
|---|---|
| Submitter Address: | 4100 Barton RoadClarence, New York 14031 |
| Contact Person: | Gary J. Sfeir, RAC |
| Phone Number: | 716.759.5277 |
| Facsimile Number: | 716.759.5280 |
| Date Prepared: | 17 October, 1997 |
| Device Trade Name: | Greatbatch Scientific MR Compatible Sinuscope |
| Device Common Name: | Sinuscope |
| Classification Name: | Nasopharyngoscope |
| Predicate Devices: | Optus Sinuscope and Accessories |
| Device Description: | The Greatbatch Scientific MR Compatible Sinuscope isavailable in standard and autoclavable 2.7mm and 4.0mm sizes, with0°, 30° or 70° angles. |
| Intended Use: | For use by practitioners to examine and treat a patient's nasal cavity andnasal pharynx in a MR or an interventional MR environment, not toexceed a 1.5 Tesla static magnetic field. |
| Device TechnologicalCharacteristics andComparison toPredicate Devices(s): | The device technological characteristics are similar in design to thepredicate device. |
| Performance Data: | The device was tested for MR Compatibility and was found to beacceptable for use in a 1.5 Tesla static magnetic field. See attached MRSafety Testing Summary. |
| Conclusion: | The Greatbatch Scientific MR Compatible Sinuscope and Accessoriesas designed can be used in a MR or an interventional MR environmentnot to exceed a 1.5 Tesla static magnetic field. |
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MR COMPATIBLE SINUSCOPE MR SAFETY TESTING SUMMARY
Magnetic Attraction and Torque 1 .
| Static field strength- | 1.5 Tesla / GE Signa 64 MHz MR System |
|---|---|
| Type of test- | String deflection |
| Observed deflection - | None |
| Observed torque - | None |
2. Artifact
Static field strength -1.5 Tesla / GE Signa 64 MHz MR System 3 Sequences -Amount of distortion:
| Sequence | axial_plane | sagittal plane |
|---|---|---|
| FSPGR | 444 | ++++ |
| T1 spin echo | 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| T1 fast spin echo | ++ | ++ |
- artifact same as the device ++ artifact slightly larger than size of the device ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
Heating 3. RF
Phantom: A .
| Type of phantom - | A rectangular-shaped plastic Plexiglasphantom filled with 45 liters of physiologicsaline |
|---|---|
| Type of RF Coil - | Body coil |
| SAR applied - | 1.1 W/kg |
| Length of time - | 26 minutes |
| Maximum temperaturerise observed - | <1.1°C |
B. Clinical:
| Type of RF coil - | Head |
|---|---|
| SAR applied - | 0.971 W/kg |
| Length of time - | 15 minutes, 22 seconds |
| Maximum temperature - | |
| rise observed | 7°C |
Gradient Induced 4. Voltage
- Phantom No phantom tests were conducted. A .
- B. No adverse effects were observed in clinical Clinical tests conducted at a maximum gradient strength of 10 mT/m and risetime of 600 mSec.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gary J. Sfeir Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence, New York 14031
OCT 3 1 1997
Re:
K971375 Greatbatch Scientific MR Compatible Sinuscope Dated: September 26, 1997 Received: September 29, 1997 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB
Dear Mr. Steir:
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 stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
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 marketd 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 viro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
h.Jliau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4
INDICATIONS FOR USE
510 (k) Number (if known):
Device Name:
Greatbatch Scientific MR Compatible Sinuscope
Indications For Use:
The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE) PRESCRIPTION USE V OR... OVER-THE-COUNTER USE (OPTIONAL FORMAT 1-2-96)
ﻥ ﻓ
Ehard C. Rejman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971375
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.