(26 days)
No
The document describes a flexible endoscope with CMOS sensor technology and a Camera Control Unit for image processing and display. It explicitly states that the proposed device incorporates video sensor performance modifications but maintains the same principles of operation and uses the same CCU as the predicate device. There is no mention of AI, ML, or any related concepts like training or test sets for algorithms.
Yes
The "Intended Use / Indications for Use" section states that the device "can be used to perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures." Examination of body parts to identify abnormalities is a diagnostic function.
No
The device description explicitly details hardware components such as an endoscope with a CMOS sensor, wiring, PCB, LED light source, electrical cord, and a Camera Control Unit (CCU) containing PCBs, power supply, and power cables. While it mentions software in the CCU, the device is clearly a system incorporating significant hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney." This describes a device used in vivo (within the living body) for direct visualization and procedures.
- Device Description: The description details a flexible endoscope with a sensor at the tip, designed for insertion into the body. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or treatment. The description of this device does not involve the analysis of biological specimens outside the body.
Therefore, the Gyrus ACMI® Invisio® ICN (CystoNephroscope) System is an endoscopic imaging device used for in vivo examination and procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Gyrus ACMI® Invisio® ICN Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutancously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
The Gyrus ACMI® Invisio® ICN (CystoNephroscope) System (which includes the ICN Endoscope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
Product codes
FAJ
Device Description
Like the predicate ACMI® Invisio® ICN CystoNephroscope System, the Gyrus ACMI® Invisio® ICN is a flexible endoscope that incorporates CMOS ACMI® frivision territory is a noxiconi-conductor) sensor technology to generate an (collphillemary motived either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.
The ICN incorporates the same basic video imaging technology located in the The ICN moorporates and device. There is a miniature CMOS sensor located in the encosope as the proving through the endoscope shaft, a printed circuit board (PCB), a light-cmitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.
Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
This Special 510(k) proposes video sensor performance modifications to the ACMI® Invisio® ICN. The indications for use, labeling, principles of operation, materials and overall dimensions of the proposed Gyrus ACMI® Invisio® ICN remain the same as in the predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities, hollow organs and canals in the body, in the urinary tract, 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
Gyrus ACMI® Invisio® ICN Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Summary of S & E Mar 23, 2009
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® Invisio® ICN
Gyrus ACMI, Inc.
136 Turnpike Rd.
3003790304
Mar , 2009
Southborough, MA 01772-2104
Senior Regulatory Affairs Specialist
Graham A. L. Baillie, MS
pg 1 of 2
General Information
APR 2 0 2009
Manufacturer:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
Endoscope and accessories (21 CFR 876.1500), Class II Gastroenterology & Urology Panel Surgical camera and accessories General & Plastic surgery Panel (21 CFR 878.4160), Class I
Endoscope, Video Camera and accessories
Gyrus ACMI® Invisio® ICN
Trade Name:
Gencric/Common Name:
Predicate Device
ACMI® Invisio® ICN CystoNephroscope System
Intended Uses
The Gyrus ACMI® Invisio® ICN Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutancously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
1
Special 510(k) Notification Summary of S & E Statement Mar 23, 2009
Product Description
K1908,14
pg r of r
Like the predicate ACMI® Invisio® ICN CystoNephroscope System, the Gyrus ACMI® Invisio® ICN is a flexible endoscope that incorporates CMOS ACMI® frivision territory is a noxiconi-conductor) sensor technology to generate an (collphillemary motived either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.
The ICN incorporates the same basic video imaging technology located in the The ICN moorporates and device. There is a miniature CMOS sensor located in the encosope as the proving through the endoscope shaft, a printed circuit board (PCB), a light-cmitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.
Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
This Special 510(k) proposes video sensor performance modifications to the ACMI® Invisio® ICN. The indications for use, labeling, principles of operation, materials and overall dimensions of the proposed Gyrus ACMI® Invisio® ICN remain the same as in the predicate device.
Summary of Safety and Effectiveness
The proposed modifications for the Gyrus ACMI® Invisio® ICN, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
920
Ro
APR 2 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Graham A. L. Baillie, MS Senior Regulatory Affairs Specialist Gyrus ACMI, Inc. 136 Turnpike Road Southborough MA 01772
Re: K090814
Trade/Device Name: Gyrus ACMI® Invisio® ICN Regulation Number: 21 CFR 876.5130 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: March 23, 2009 Received: March 25, 2009
Dear Mr. Baillie:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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,
3
Page 2
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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gyrus ACMI® Invisio® ICN Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Intended Use Statement Mar 23, 2009
Indications for Use
510(k) Number: K 690814
Device Name: Gyrus ACMI® Invisio® ICN
Indications for Use:
The Gyrus ACMI® Invisio® ICN (CystoNephroscope) System (which includes the ICN Endoscope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
Prescription Use: X (Per 21 CFR 801:109)
AND/OR
Over-the-Counter Use: (21 CFR 801 Subpart C) ،
8
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Clemen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number