(58 days)
Not Found
No
The summary describes a digital endoscope system with image processing capabilities but does not mention any AI or ML components, algorithms, or functions.
Yes
The intended use statement explicitly indicates that the device, using additional accessories, "can be used to perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used to perform various diagnostic and therapeutic procedures."
No
The device description explicitly details hardware components such as a flexible 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 and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System is a flexible endoscope used to directly visualize internal body cavities, organs, and canals. It uses a CMOS sensor to capture images of the inside of the body.
- Intended Use: The intended use is for examination of body cavities, hollow organs, and canals, and for performing diagnostic and therapeutic procedures within the body. This is an in vivo (within the living body) application, not in vitro (outside the living body).
- Lack of Specimen Analysis: The device does not analyze specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. It provides visual information directly from within the body.
Therefore, the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System falls under the category of an endoscope used for direct visualization and intervention within the body, which is not an IVD.
N/A
Intended Use / Indications for Use
The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy 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.
The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Product codes
FBN, FGB
Device Description
The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) 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 Camera Control Unit.
The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a 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.
Mentions image processing
Not Found
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, interior of the kidney, bile ducts
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)
During design verification, the performance of the DUR®-D was compared against the physical performance characteristics of the predicate DUR®-8E and the digital visualization characteristics of the predicate Invisio™ ICN. Testing demonstrated that the performance requirements were met, and that the DUR®-D exhibited comparable performance characteristics to both the predicate DUR®-8E and predicate Invisio™ ICN.
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
ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road MAR 3 1 2006 Southborough, MA 01772
Traditional 510(k) Notification 510(k) Summary January 30, 2006
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® DUR-Digital Ureteroscope and Choledochoscope S
General Information
| Manufacturer: | ACMI Corporation
136 Turnpike Rd.
Southborough, MA 01772-2104 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Terrence E. Sullivan
Director, Regulatory Affairs
Tel. #: 508-804-2739
Fax #: 508-804-2624 |
| Date Prepared: | January 30, 2006 |
| 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: | ACMI® DUR-Digital Ureteroscope and
Choledochoscope System (DUR®-D) |
| Generic/Common Name: | Endoscope, Video Camera and accessories |
| Predicate Devices | |
| ACMI® Invisio™ ICN
ACMI DUR®-8E | K042225
K012925 and K023358 |
Intended Uses
The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-1)) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy 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.
1
ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification 510(k) Summary January 30, 2006
K ci.0269 pg 2 of 3
The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Product Description
The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) 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 Camera Control Unit.
The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a 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.
Technological Characteristics and Substantial Equivalence
The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System, utilizes features incorporated into the following legally marketed predicate devices:
The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System utilizes the same flexible endoscope technology design as those used in the predicate DUR®-8E device (K012925 and K023358).
The DUR®- Digital Ureteroscope and Choledochoscope is dimensionally similar to the predicate DUR®-8E, having the same working channel diameter and length, and utilizes the same materials in its construction as the predicate DUR®-8E.
The DUR®-Digital Ureteroscope and Choledochoscope incorporates the same basic video imaging technology located in the endoscope as the predicate ACMI® Invisio™ ICN System (K042225).
Like the predicate DUR®-8E, the ACMI® DUR®-Digital Ureteroscope and Choledochoscope (DUR®-D) System is indicated for use in therapeutic and diagnostic procedures in the entire intrarenal collecting system, and may also be used to manage biliary calculi.
2
ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification 510(k) Summary January 30, 2006
K060269 Pg 3 of 3
During design verification, the performance of the DUR®-D was compared against the physical performance characteristics of the predicate DUR®-8E and the digital visualization characteristics of the predicate Invisio™ ICN. Testing demonstrated that the performance requirements were met, and that the DUR®-D exhibited comparable performance characteristics to both the predicate DUR®-8E and predicate Invisio™ ICN.
In summary, the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is depicted with three curved lines representing its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
MAR 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terrence E. Sullivan Director, Regulatory Affairs ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772
Re: K060269
Trade/Device Name: ACMI® DUR-Digital Ureteroscope and Choledochoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FBN and FGB Dated: January 30, 2006 Received: February 1, 2006
Dear Mr. Sullivan:
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 (Premarket Approval), 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.
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.
4
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 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" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
5
Traditional 510(k) Notification Statement of Intended Use January 30, 2006
Device Name: ACMI® DUR-Digital Ureteroscope and Choledochoscope System
510(k) Number: K
Indications for use:
The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System Flexible Ureteroscope includes the DUR-Digital Invisio™ and (which Choledochoscope and IDC Invisio™ 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.
The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ____________________________________________________________________________________________________________________________________________________________
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
David A. Lygum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number