(90 days)
Not Found
No
The description focuses on standard imaging technology (CMOS sensor, LEDs, PCBs, software for processing and display) and does not mention any AI/ML terms or capabilities.
No
The device is primarily intended for "close visualization" (diagnostic) and enables the use of "additional accessories ... to perform various diagnostic and therapeutic procedures," but the device itself is not described as performing a therapeutic function.
Yes
The device is described as being for "close visualization" and states that "Additional accessories can be used to perform various diagnostic and therapeutic procedures," implying that the base device itself has a diagnostic function.
No
The device description explicitly details hardware components such as a rigid endoscope, CMOS sensor, wiring, PCB, LED light source, electrical cord, and a Camera Control Unit (CCU) containing PCBs, power supply, and power cables. While software is mentioned as part of the CCU, the device is clearly a system with significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System is a rigid endoscope used for direct visualization of internal anatomical structures (urinary bladder, renal pelvis, major calyces). It captures images of these structures in vivo (within the living body).
- Lack of Specimen Examination: The device does not examine specimens (like blood, urine, or tissue) in vitro (outside the body). Its function is to provide visual information directly from within the patient's body.
Therefore, the device's intended use and description clearly indicate it is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
FGA, FEC, FED
Device 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS sensor technology
Anatomical Site
urinary bladder, renal pelvis, major calyces, kidney
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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. #: 508-804-2738 | |
| Fax #: 508-804-2624 | |
| 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
1
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.
2
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
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