(191 days)
Not Found
No
The summary describes a physical arthroscope and its accessories, focusing on MR compatibility and physical characteristics. There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is described as being used by practitioners to "treat" various small joints, indicating a therapeutic purpose.
No
The device description indicates it is a surgical tool (arthroscope) used for treatment, not for diagnosis. Its intended use is to "treat the small joints," which implies intervention rather than assessment or identification of a condition.
No
The device description explicitly mentions physical components (arthroscopes in various sizes and angles) and performance studies related to MR compatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used by practitioners to treat patients in an MR environment. This is a therapeutic and interventional use, not a diagnostic test performed on samples outside the body.
- Device Description: The device is an arthroscope, which is a surgical instrument used for visualization and intervention within joints. This is not a device designed to analyze biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
"For use by practitioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal-mandibular joint in patients in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field."
"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."
Product codes
HRX
Device Description
"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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal-mandibular joint.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"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"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"The device was tested for MR Compatibility and was found to be acceptable for use in a 1.5 Tesla static magnet field."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optus Arthroscopes and Mini Arthroscopes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1971781
510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
NOV 2 1 1997
| Submitter Name: | Greatbatch Scientific
a division of Wilson Greatbatch Ltd. |
|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 4100 Barton Road
Clarence, 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 Joint
Arthroscopes |
| Device Common Name: | Arthroscope |
| Classification Name: | Arthroscope |
| Predicate Devices: | Optus Arthroscopes and Mini Arthroscopes |
| Device Description: | 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. |
| Intended Use: | For use by practitioners to treat the small joints of the wrist, knee,
ankles, elbow, shoulder, and the temporal-mandibular joint in patients
in a MR or an interventional MR environment, not to exceed a 1.5
Tesla static magnetic field. |
| Device Technological
Characteristics and
Comparison to
Predicate Devices(s): | The device technological characteristics are similar in design to the
predicate device. |
| Performance Data: | The device was tested for MR Compatibility and was found to be
acceptable for use in a 1.5 Tesla static magnet field. See attached MR
Safety Testing summary. |
| Conclusion: | The Greatbatch Scientific MR Compatible Arthroscopes, Small Joint
Arthroscopes, and the Accessories as designed, can be used in a MR or
an interventional MR environment, not to exceed a 1.5 Tesla static
magnetic field. |
1
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.
2
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
3
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/ |
|---|---|
| --------------- | ---------- |