(180 days)
Not Found
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description and intended use do not suggest AI/ML functionality.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to "perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" states "to perform various diagnostic and therapeutic procedures".
No
The device description explicitly states "Ureteroscopes," which are physical medical devices used for examination and operation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "examination/operation of the urinary tract" and performing "various diagnostic and therapeutic procedures" within the body. This describes an in vivo (within a living organism) procedure, not an in vitro (outside the body, typically on samples) diagnostic test.
- Device Description: Ureteroscopes are instruments used to visualize and manipulate the urinary tract directly. This is a surgical/endoscopic device, not a device used to analyze biological samples.
- Lack of IVD Indicators: The description does not mention analyzing biological samples (like urine, blood, or tissue), performing tests on these samples, or providing diagnostic information based on the analysis of these samples.
Therefore, the Circon ™ MR Series Ureteroscopes are not IVD devices. They are medical devices used for direct visualization and intervention within the urinary tract.
N/A
Intended Use / Indications for Use
The intended use for these Ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures. This device is a reusable device; methods for cleaning, reprocessing are located in later sections of this submission under Section 5, "Sterility Information."
Product codes
78 FGB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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.
Not Found
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
Image /page/0/Picture/13 description: The image shows a logo with a stylized bird in flight, rendered in black lines. The bird's body is formed by three curved lines that suggest movement and feathers. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement around the bird. The text is in a smaller font size compared to the bird, and it follows the curve of the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2001
Mr. Wayne Sterner Director, Regulatory Affairs ACMI Circon Corporation 6500 Hollister Avenue SANTA BARBARA CA 93117 Re: K011849
Trade/Device Name: Micro-6, MRO-6, MRO-7, MRO-7A Series Ureterscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: 78 FGB Dated: September 12, 2001 Received: September 18, 2001
Dear Mr. Sterner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered province that 10, 1978) the 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 I ou may, dicrororo, mans 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 (2) 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.
1
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to ocgin marketing , quivalence of your device to a legally marketed noutication. The I Dr I mailing of Scation 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 If you desire specific acrise at one of the following numbers, based on the regulation number at the top of this 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 Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Office of Compilance at (301) 597-1857 Part 807.97). Other general information on by release to premainer nombarday (be obtained from the Division of Small Manufacturers, your responsional 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. Griggin
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CIRCON CORPORATION CONFIDENTIAL
CIRCON CORPORATION
Circon ™ MR Series Ureteroscopes FDA Premarket Notification 510(k)
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K011849
Device Name: Circon ™ MR Series Ureteroscopes
The intended use for these Ureteroscopes is for examination/operation of the urinary tract The intended use for these ories, to perform various diagnostic and therapeutic and, using additional accessuring as a reusable device; methods for cleaning, procedures. This deliver is a look in latter sections of this submission under Section 5, "Sterility Information."
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
Flancy Bragdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number
Prescription Use