(176 days)
Not Found
Not Found
No
The summary describes a standard laparoscopic device and its MR compatibility testing, with no mention of AI or ML features.
No
The device is described as a laparoscope for viewing organs and performing diagnostic and surgical procedures, which are not considered therapeutic actions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "for the purpose of performing diagnostic and surgical procedures."
No
The device description explicitly states it is a "MR Compatible Laparoscope and Operating Laparoscopes" available in different sizes and angles, which are physical hardware components. The performance studies also focus on hardware-related testing like MR compatibility, magnetic attraction, torque, artifact, and RF heating.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures". This describes a device used in vivo (within a living organism) for visualization and intervention.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside the body.
- Device Description: The device is a laparoscope, which is a surgical instrument used to view the inside of the abdomen. This is consistent with in vivo use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on laboratory analysis.
Therefore, this device is a surgical instrument used for visualization and procedures within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For use to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscopes are available in standard and autoclavable 8.0mm, 10.0mm sizes, with 0°, 30° or 45° angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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. A Greatbatch Scientific MR Compatible 8.0mm endoscope was tested in conjunction with a 1.5 Tesla GE Signa Magnet for the presence of magnetic attractive and torque, artifact, and RF Heating. Based on intended use of the device and the results of extensive MR safety testing listed below, this device is MR Compatible.
Magnetic Attraction and Torque:
Static field strength: 1.5 Tesla / GE Signa 64 MHz MR System
Type of test: String deflection
Observed deflection: Very slight
Observed torque: 5 degrees
Artifact:
Static field strength: 1.5 Tesla / GE Signa 64 MHz MR System
Sequences: FSPGR axial plane ++, FSPGR sagittal plane ++
Amount of distortion: artifact same as the device
RF Heating:
Phantom: A 50 lb., fluid filled rectangular shaped plastic Plexiglas phantom
Type of RF Coil: Body coil
SAR applied: 2.1 W/kg
Length of time: 60 minutes
Maximum temperature rise observed: 0.5°C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Optus Laparoscope and Operating Laparoscope
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
.
DEC I I laar
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPE AND OPERATING LAPAROSCOPE
| 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: | 8 December, 1997 |
| Device Trade Name: | Greatbatch Scientific MR Compatible Laparoscope and Operating
Laparoscope |
| Device Common Name: | Laparoscope |
| Classification Name: | Laparoscope |
| Predicate Devices: | Optus Laparoscope and Operating Laparoscope |
| Device Description: | The Greatbatch Scientific MR Compatible Laparoscope and Operating
Laparoscopes are available in standard and autoclavable 8.0mm,
10.0mm sizes, with 0°, 30° or 45° angles. |
| Intended Use: | For use to permit direct viewing of the organs within the peritoneal
cavity for the purpose of performing diagnostic and surgical procedures
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 Laparoscope and Operating
Laparoscope as designed, can be used in a MR or an interventional MR
environment, not to exceed a 1.5 Tesla static magnetic field. |
1
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPE MR SAFETY TESTING SUMMARY
A Greatbatch Scientific MR Compatible 8.0mm endoscope was tested in conjunction with a 1.5 Tesla GE Signa Magnet for the presence of magnetic attractive and torque, artifact, and RF Heating. Based on intended use of the device and the results of extensive MR safety testing listed below, this device is MR Compatible.
Magnetic Attraction and Torque 1.
| Static field strength- | 1.5 Tesla / GE Signa 64 MHz MR System |
|---|---|
| Type of test- | String deflection |
| Observed deflection - | Very slight |
| Observed torque - | 5 degrees |
2. Artifact
1.5 Tesla / GE Signa 64 MHz MR System Static field strength -Sequences l Amount of distortion:
| Sequence | axial plane | sagittal plane |
|---|---|---|
| FSPGR | ++ | ++ |
artifact same as the device 44
3. Heating RF
Phantom: A .
| Type of phantom - | A 50 lb., fluid filled rectangular shaped
plastic Plexiglas phantom |
|----------------------------------------|------------------------------------------------------------------------|
| Type of RF Coil - | Body coil |
| SAR applied - | 2.1 W/kg |
| Length of time - | 60 minutes |
| Maximum temperature
rise observed - | 0.5°C |
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1997
Mr. Gary J. Sfeir, RAC Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence. New York 14031
Re: K972280
Trade Name: Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes Regulatory Class: II Product Code: GCJ Dated: September 10, 1997 Received: September 12, 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 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 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. 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.
3
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,
Styph Rhodes
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
4
.
DEC I I laar
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPE AND OPERATING LAPAROSCOPE
| 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: | 8 December, 1997 |
| Device Trade Name: | Greatbatch Scientific MR Compatible Laparoscope and Operating
Laparoscope |
| Device Common Name: | Laparoscope |
| Classification Name: | Laparoscope |
| Predicate Devices: | Optus Laparoscope and Operating Laparoscope |
| Device Description: | The Greatbatch Scientific MR Compatible Laparoscope and Operating
Laparoscopes are available in standard and autoclavable 8.0mm,
10.0mm sizes, with 0°, 30° or 45° angles. |
| Intended Use: | For use to permit direct viewing of the organs within the peritoneal
cavity for the purpose of performing diagnostic and surgical procedures
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 Laparoscope and Operating
Laparoscope as designed, can be used in a MR or an interventional MR
environment, not to exceed a 1.5 Tesla static magnetic field. |
5
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPE MR SAFETY TESTING SUMMARY
A Greatbatch Scientific MR Compatible 8.0mm endoscope was tested in conjunction with a A Greatoath Sciencific NA Companie of magnetic attraction and torque, artifact, and RF Heating. Based on intended use of the device and the results of extensive MR safety testing listed below, this device is MR Compatible.
Magnetic Attraction and Torque 1.
1.5 Tesla / GE Signa 64 MHz MR System Static field strength-.. String deflection Type of test-Very slight Observed deflection -Observed torque -5 degrees
2. Artifact
. .
1.5 Tesla / GE Signa 64 MHz MR System Static field strength -Sequences l Amount of distortion:
| Sequence | axial plane | sagittal plane |
|---|---|---|
| FSPGR | ++ | ++ |
artifact same as the device 44
3. RF Heating
Phantom: A .
| Type of phantom - | A 50 lb., fluid filled rectangular shaped
plastic Plexiglas phantom |
|----------------------------------------|------------------------------------------------------------------------|
| Type of RF Coil - | Body coil |
| SAR applied - | 2.1 W/kg |
| Length of time - | 60 minutes |
| Maximum temperature
rise observed - | 0.5°C |
6
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. 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
DEC 1 1997
Mr. Gary J. Sfeir, RAC Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence. New York 14031
Re: K972280
Trade Name: Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes Regulatory Class: II Product Code: GCJ Dated: September 10, 1997 Received: September 12, 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 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 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. 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.
7
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,
Stupt Rhodes
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
8
SECTION 4
INDICATIONS FOR USE
510 (k) Number (if known):
Device Name:
Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes
Indications For Use:
The Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes are used to permit viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures 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) | (OPTIONAL FORMAT 1-2-96) | |
|---|---|---|
| Division of General Restorative Devices | ||
| 510(k) Number | K972280 |