GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM

K072594 · Gyrus Acmi, Inc. · FGA · Dec 13, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072594
• Device Name: GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
• Applicant: Gyrus Acmi, Inc.
• Product Code: FGA · Gastroenterology, Urology
• Decision Date: Dec 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® Smith™ Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

Device Story

Rigid endoscope system for urological visualization; utilizes distal-tip CMOS sensor to capture images; transmits signals via internal wiring to IDC-1500 Camera Control Unit (CCU). CCU processes signals using internal PCBs and software to display images on external monitor. Used in clinical settings by physicians for diagnostic and therapeutic procedures in urinary bladder, renal pelvis, and major calyces. Introduced percutaneously into kidney or via urethra into bladder. Provides real-time visualization to assist physician in performing procedures; benefits patient by enabling minimally invasive access to renal and bladder structures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Rigid endoscope with distal-tip CMOS sensor, LED light source in handle, and electrical connectivity to CCU. Construction materials similar to predicate MRO-20 and MR-6A/MR-6LA. System includes IPN-2505 endoscope and IDC-1500 CCU containing PCBs, power supply, and software for image processing.

Indications for Use

Indicated for visualization of the urinary bladder, renal pelvis, and major calyces in patients requiring diagnostic or therapeutic urological procedures via percutaneous or urethral access.

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

• ACMI® DUR-Digital Ureteroscope and Choledochoscope System (K060269)
• ACMI® MROTM -20 Rigid Percutaneous Nephroscopes (K791182)
• ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (K052044)

Submission Summary (Full Text)

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#### 07259 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System

# General Information

DEC 1. 3 2007

| Manufacturer: | Gyrus ACMI, Inc. |
|-----------------------------------------------------------|-----------------------------------------|
| | 136 Turnpike Rd. |
| | Southborough, MA 01772-2104 |
| Contact Person: | Graham A.L. Baillie |
| | Senior Regulatory Specialist |
| | Tel. #: [phone] |
| | Fax #: [phone] |
| Date Prepared: | September 10, 2007 |
| Device Description | |
| Classification Name: | Endoscope and accessories |
| | (21 CFR 876.1500), Class II |
| | Surgical camera and accessories |
| | (21 CFR 878.4160), Class I |
| Trade Name: | Gyrus ACMI® IPN-2505, Invisio® |
| | Smith™ Percutaneous Nephroscope |
| | System |
| Generic/Common Name: | Endoscope, Video Camera and accessories |
| Predicate Devices | |
| ACMI® DUR-Digital Ureteroscope and Choledochoscope System | K060269 |
| ACMI® MROTM -20 Rigid Percutaneous Nephroscopes | K791182 |
| ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes | K052044 |

## Intended Uses

The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® Smith™ Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of

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Traditional 510(k) Notification 0(k) Summarv

K072594 Pg A22

the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

### Product Description

The Gyrus ACMI® IPN-2505. Invisio® Smith™ Percutaneous Nephroscope (referred to hereafter as the IPN-2505) is a rigid endoscope that incorporates CMOS (complimentary metal oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the IDC-1500 Camera Control Unit (CCU).

The IPN-2505 can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The IPN-2505 uses an IDC-1500 CCU that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

#### Technological Characteristics and Substantial Equivalence

The IPN-2505, utilizes features incorporated into the following legally marketed predicate devices:

The IPN-2505 incorporates the same basic CMOS video imaging technology located in the endoscope as the predicate ACMI® DUR-Digital Ureteroscope and Choledochoscope System (K060269).

The IPN-2505 shaft is dimensionally similar to its predicate ACMI® MRO-20 Rigid Percutaneous Nephroscope (K791182), having the same working channel diameter, similar lengths and diameters. The IPN-2505 utilizes similar materials in its construction as the predicate MRO-20 (K791182) and the predicate MR-6A/MR-6LA Autoclavable Ureteroscope (K052044).

Like the predicate MRO-20 the IPN-2505 is indicated to allow close visualization of the renal pelvis and major calyces through a percutaneous tract.

In summary, the Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2007

Mr. Graham A.L. Baillie Sr. Regulatory Specialist Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772-2104

K072594 Re:

> Trade/Device Name: Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System

Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FGA, FEC and FED Dated: September 12, 2007 Received: September 14, 2007

Dear Mr. Baille:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C Brogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System

510(k) Number: Ko72594

Intended Use:

The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® Smith™ Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

## (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: _

(Per 21 CFR 801.109)

Lom Mwhan
(Division Sign Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number