(235 days)
Not Found
Not Found
No
The description focuses on the mechanical and optical components of a standard ureteroscope and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is described as being used with additional accessories "to perform various diagnostic and therapeutic procedures."
Yes
The device's intended use explicitly states "to perform various diagnostic and therapeutic procedures" in the urinary tract.
No
The device description explicitly states it is a telescope with fiber optical lenses and working channels within a semirigid shaft, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the examination and operation of the urinary tract and performing diagnostic and therapeutic procedures within the body. This is an in vivo use, not in vitro (outside the body).
- Device Description: The description details a telescope with fiber optics and working channels for inserting instruments into the urinary tract. This aligns with an in vivo surgical or diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside the body, which is the core function of an IVD.
Therefore, this device is a medical device used for procedures performed directly on the patient's urinary tract, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.
The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
78 FGB
Device Description
ACMI Circon's Semi-Rigid Ureteroscopes are substantially equivalent to other currently marketed ureteroscopes, referenced above. The Semi-Rigid Ureteroscopes and their predicate device(s) are all telescopes that incorporate fiber optical lenses and working channels within a semirigid shaft. The working channels of the Semi-Rigid Ureteroscopes and predicate device(s) allow the insertion of accessory instrumentation during urinary tract procedures. Both the Semi-Rigid Ureteroscopes and the predicate device(s) may be connected to an external light source to permit better illumination of the bladder surfaces.
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
qualified physicians
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.
ACMI Circon preamendment ureteroscope (circa, 1971)
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
APR - 9 2002
Pg 1 of r
11 012758
510(k) SUMMARY
ACMI Circon' SEMI-RIGID URETEROSCOPES
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
ACMI Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117
Phone: 805-961-3290 Fax: 805-968-7385
Mr. Wayne B. Sterner Contact Person: Corporate Director Regulatory Affairs
Date Prepared: February 8, 2002
Name of Device and Name/Address of Sponsor:
ACMI Circon's Semi-Rigid Ureteroscopes
ACMI Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117
Common or Usual Name:
Ureteroscopes
Classification Name and Classification Number:
Endoscope and accessories, 21 CFR Section 876.1500
Predicate Device(s):
The predicate device is an ACMI Circon preamendment ureteroscope (circa, 1971).
1
pg 2 of 2
Intended Use:
ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.
Technological Characteristics and Substantial Equivalence:
ACMI Circon's Semi-Rigid Ureteroscopes are substantially equivalent to other currently marketed ureteroscopes, referenced above. The Semi-Rigid Ureteroscopes and their predicate device(s) are all telescopes that incorporate fiber optical lenses and working channels within a semirigid shaft. The working channels of the Semi-Rigid Ureteroscopes and predicate device(s) allow the insertion of accessory instrumentation during urinary tract procedures. Both the Semi-Rigid Ureteroscopes and the predicate device(s) may be connected to an external light source to permit better illumination of the bladder surfaces.
The ACMI Circon's Semi-Rigid Ureteroscopes raise no new issues of safety or effectiveness.
7
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administra 200 Cornorate Boulevard Rockville MD 20850
Mr. Wayne B. Sterner Director, Regulatory Affairs ACMI Circon Corporation 6500 Hollister Avenue SANTA BARBARA CA 93117-3019
Re: K012758
Trade/Device Name: Semi-Rigid Ureteroscopes and Accessories Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB Dated: February 8, 2002 Received: February 11, 2002
Dear Mr. Sterner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abounding 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 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:
| 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" (21 CFR Part 807.97). 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 Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CIRCON CORPORATION CONFIDENTIAL
CIRCON CORPORATION Semi-Rigid Ureteroscopes and Accessories FDA Premarket Notification 510(k)
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Semi-Rigid Ureteroscopes and Accessories Device Name:
The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
David A. Bergerson