GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES

K972280 · Wilson Greatbatch Technologies, Inc. · GCJ · Dec 11, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972280
• Device Name: GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
• Applicant: Wilson Greatbatch Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Laparoscope and operating laparoscope designed for use in MR or interventional MR environments; static magnetic field limit 1.5 Tesla. Device provides direct visualization of peritoneal cavity organs during diagnostic and surgical procedures. Operated by physicians in clinical/surgical settings. MR compatibility verified via testing for magnetic attraction, torque, and RF heating. Benefits include enabling surgical visualization during MR-guided interventions.

Clinical Evidence

Bench testing only. MR safety testing performed using a 1.5 Tesla GE Signa 64 MHz system. Results: very slight string deflection, 5 degrees torque, and 0.5°C maximum temperature rise during 60 minutes of RF exposure at 2.1 W/kg SAR. Artifact distortion levels were assessed.

Technological Characteristics

Rigid laparoscope available in 8.0mm and 10.0mm diameters with 0°, 30°, or 45° angles. Autoclavable. Designed for MR compatibility in static fields up to 1.5 Tesla.

Indications for Use

Indicated for patients requiring diagnostic or surgical procedures within the peritoneal cavity where direct visualization is necessary in an MR or interventional MR environment (up to 1.5 Tesla).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Optus Laparoscope and Operating Laparoscope

Submission Summary (Full Text)

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K972280

| Submitter Name: | Greatbatch Scientific<br>a division of Wilson Greatbatch Ltd. |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 4100 Barton Road<br>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<br>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<br>Laparoscopes are available in standard and autoclavable 8.0mm,<br>10.0mm sizes, with 0°, 30° or 45° angles. |
| Intended Use: | For use to permit direct viewing of the organs within the peritoneal<br>cavity for the purpose of performing diagnostic and surgical procedures<br>in a MR or an interventional MR environment, not to exceed a 1.5<br>Tesla static magnetic field. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Devices(s): | The device technological characteristics are similar in design to the<br>predicate device. |
| Performance Data: | The device was tested for MR Compatibility and was found to be<br>acceptable for use in a 1.5 Tesla static magnet field. See attached MR<br>Safety Testing summary. |
| Conclusion: | The Greatbatch Scientific MR Compatible Laparoscope and Operating<br>Laparoscope as designed, can be used in a MR or an interventional MR<br>environment, not to exceed a 1.5 Tesla static magnetic field. |

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## 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<br>plastic Plexiglas phantom |
|----------------------------------------|------------------------------------------------------------------------|
| Type of RF Coil - | Body coil |
| SAR applied - | 2.1 W/kg |
| Length of time - | 60 minutes |
| Maximum temperature<br>rise observed - | 0.5°C |

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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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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.

# DEC I I laar

## - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPE AND OPERATING LAPAROSCOPE

K972280

| Submitter Name: | Greatbatch Scientific<br>a division of Wilson Greatbatch Ltd. |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 4100 Barton Road<br>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<br>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<br>Laparoscopes are available in standard and autoclavable 8.0mm,<br>10.0mm sizes, with 0°, 30° or 45° angles. |
| Intended Use: | For use to permit direct viewing of the organs within the peritoneal<br>cavity for the purpose of performing diagnostic and surgical procedures<br>in a MR or an interventional MR environment, not to exceed a 1.5<br>Tesla static magnetic field. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Devices(s): | The device technological characteristics are similar in design to the<br>predicate device. |
| Performance Data: | The device was tested for MR Compatibility and was found to be<br>acceptable for use in a 1.5 Tesla static magnet field. See attached MR<br>Safety Testing summary. |
| Conclusion: | The Greatbatch Scientific MR Compatible Laparoscope and Operating<br>Laparoscope as designed, can be used in a MR or an interventional MR<br>environment, not to exceed a 1.5 Tesla static magnetic field. |

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## 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<br>plastic Plexiglas phantom |
|----------------------------------------|------------------------------------------------------------------------|
| Type of RF Coil - | Body coil |
| SAR applied - | 2.1 W/kg |
| Length of time - | 60 minutes |
| Maximum temperature<br>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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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 | |