(111 days)
Not Found
No
The summary describes a standard video endoscope system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "can be used to perform various diagnostic and therapeutic procedures."
Yes
The intended use explicitly states that the system can be 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; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures." The examination of body cavities and organs is a diagnostic function, and the direct mention of "diagnostic procedures" confirms its diagnostic capability.
No
The device description explicitly states it consists of an endoscope, CMOS video sensor, light source, and a Controller unit, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the examination of body cavities, hollow organs, and canals within the body (in vivo). It also mentions diagnostic and therapeutic procedures performed on the patient.
- Device Description: The device description details a flexible endoscope used for internal visualization and procedures.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body. IVDs are specifically designed for testing samples taken from the body.
The device is clearly an endoscopic system for direct visualization and intervention within the patient's body, which falls under the category of surgical or diagnostic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system 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 (comma separated list FDA assigned to the subject device)
78 FAJ, FGA, 80 FWF
Device Description
The ECN Video Cystonephroscope is a flexible endoscope that incorporates video sensor technology to capture the endoscopic image, replacing the fiber optic image bundle typically used in most endoscopes. The ECN Video Cystonephroscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K904797, K012951, K010489, K020174, K951191
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Premarket Notification ECN Video Cystonephroscope
JUL 16 2003
SECTION 10
K 030960 pg 1 of 2
510(k) SUMMARY ACMI ECN Video Cystonephroscope
-
- ACMI Corporation Sponsor: 136 Turnpike Road Southborough, MA 01771-2104
Contact: Frank J. Fucile. Telephone: 508-804-2632 Date: March 25, 2003
- ACMI Corporation Sponsor: 136 Turnpike Road Southborough, MA 01771-2104
-
- Device Name:
Proprietary Name: Common/Usual Name: Classification Name:
- Device Name:
ACMI ECN Video CystoNephroscope System Endoscope, Video Camera and accessories Endoscope, Surgical Camera and accessories
-
- Predicate Devices:
ACMI USA Series™ ACN™-2 Flexible CystoNephroscope (K904797)
- Predicate Devices:
ACMI USA Series™ APN™ -2 Flexible Choledochoscope (K012951)
Dyonics Vision 111 Mobile Video Unit, Smith & Nephew, Inc., (K010489)
Visera Cystovideoscope, Olympus (K020174)
Pentax ECY-1530 Video Choledoconephroscope, Pentax America, (probably covered under K951191 and internal letter to file adding video)
-
Device Description: 3.
The ECN Video Cystonephroscope is a flexible endoscope that incorporates video sensor technology to capture the endoscopic image, replacing the fiber optic image bundle typically used in most endoscopes. The ECN Video Cystonephroscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney -
- Intended Use:
The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope with a CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system 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
- Intended Use:
1
K 0309 60
pg 2 of 2
Technological Characteristics and Substantial Equivalence: న.
The ECN Flexible Video Cystonenhroscope is substantially equivalent to features incorporated into the following legally marketed predicate devices:
The ECN Flexible Video Cystonephroscope utilizes the flexible endoscope technology (design and materials) of the following ACMI flexible endoscopes:
-
ACMI USA Series™ ACN-2 Flexible CystoNephroscope (K904797)
- l ACMI USA Series™ APN -2 Flexible Choledochoscope (K012951)
The ECN Flexible Video Cystonephroscope incorporates the video sensor technology located in the distal tip of the endoscope similar to that utilized in the following devices:
- Visera Cystovideoscope CYF Type V/VA, Olympus America, Inc., (K021074) 해
- 1 Pentax ECY-1530 Video Choledoconephroscope, Pentax America, (probably covered under K951191 and internal letter to file adding video)
The ECN Flexible Video Cystonephroscope incorporates the CMOS sensor technology similar to that used in the Dyonics Vision 111 Mobile Video Unit, Smith & Nephew, Inc., (K010489).
Finally, the ECN Flexible Video Cystonephroscope uses video processing technology (hardware and software) similar to that used in the ACMI MicroDigital® IP 6.2 Controller (510K exempt).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 2003
Mr. John A. DeLucia VP. OA/RA/CA ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772
Re: K030960
Trade/Device Name: ACMP Electronic Video CystoNephroscope (ECN) System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Codes: 78 FAJ and FGA Regulation Number: 21 CFR §878.4160 Regulation Name: Surgical camera and accessories Product Code: 80 FWF Dated: June 25, 2003 Received: June 27, 2003
Dear Mr. DeLucia:
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 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.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
4
SECTION 8
Indications for Use Statement
030960 510(k) Number (if known):
Device Name: ACMI® Electronic Video CystoNephroscope (ECN) System
Indications For Use:
The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number R030760