(191 days)
The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal- mandibular joint of patients in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes are available in standard and autoclavable 1.7mm, 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the core acceptance criterion is related to MR compatibility.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| MR Compatibility in a 1.5 Tesla static magnetic field environment | "The device was tested for MR Compatibility and was found to be acceptable for use in a 1.5 Tesla static magnet field." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the MR compatibility testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in the detailed test report, which is not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to a device like an arthroscope, which is evaluated for physical performance characteristics (like MR compatibility) rather than for diagnostic accuracy based on expert interpretation of images or other data. The "ground truth" for MR compatibility would be established through engineering tests and measurements, often against established standards.
4. Adjudication Method for the Test Set
This concept is not applicable to the type of performance data presented here. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., of medical images) where there might be disagreement among experts. For physical device testing, the results are usually objective measurements, not subject to adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved in interpreting output. The Greatbatch Scientific MR Compatible Arthroscopes are physical medical devices, not AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study in the context of an algorithm or AI performance was not done. This device is a physical instrument, not an algorithm. The testing performed was related to the physical properties of the device itself (MR compatibility).
7. The Type of Ground Truth Used
The "ground truth" for this study was established through engineering and performance testing related to MR compatibility. This would involve objective measurements of electromagnetic interference, heating, and other physical interactions with an MRI environment, likely against predefined limits (e.g., as per ASTM standards for MR safety). It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This concept is not applicable. The device is a physical arthroscope, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for a physical medical device like this arthroscope.
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1971781
510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
NOV 2 1 1997
| 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: | 30 October, 1997 |
| Device Trade Name: | Greatbatch Scientific MR Compatible Arthroscopes and Small JointArthroscopes |
| Device Common Name: | Arthroscope |
| Classification Name: | Arthroscope |
| Predicate Devices: | Optus Arthroscopes and Mini Arthroscopes |
| Device Description: | The Greatbatch Scientific MR Compatible Arthroscopes and SmallJoint Arthroscopes are available in standard and autoclavable 1.7mm,2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles. |
| Intended Use: | For use by practitioners to treat the small joints of the wrist, knee,ankles, elbow, shoulder, and the temporal-mandibular joint in patientsin a MR or an interventional MR environment, not to exceed a 1.5Tesla 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 magnet field. See attached MRSafety Testing summary. |
| Conclusion: | The Greatbatch Scientific MR Compatible Arthroscopes, Small JointArthroscopes, and the Accessories as designed, can be used in a MR oran interventional MR environment, not to exceed a 1.5 Tesla staticmagnetic field. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an inner symbol. The inner symbol features a stylized eagle or bird-like figure, with its wings forming a protective shape. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 1997
Mr. Gary J. Sfeir, RAC Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence, New York 14031
Re: K971781
Trade Name: Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes --- . . . . . . . . . . . . - Regulatory Class: II Product Code: HRX Dated: September 5, 1997 Received: September 8, 1997
Dear Mr. Sfeir:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indieations 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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, RAC
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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):
97i781
Device Name:
Greatbatch Scientific MR Compatible Arthroscopes and Small_Joint Arthroscopes and Accessories
Indications For Use:
The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal- mandibular joint of patients 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 | X | OR... | OVER-THE-COUNTER USE |
|---|---|---|---|
| ------------------ | ----------------------------------------- | ------- | ---------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | 1497178/ |
|---|---|
| --------------- | ---------- |
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.