K Number
K012929
Device Name
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
Manufacturer
Date Cleared
2001-11-19

(80 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.
Device Description
USA Series™ AUR™ 735 Flexible Pediatric Cystoureteroscope
More Information

Not Found

Not Found

No
The summary describes a flexible cystoureteroscope for pediatric use and does not mention any AI or ML capabilities.

Yes
The device is described as being used to "perform various diagnostic and therapeutic procedures on pediatric patients," indicating its use for treatment purposes.

Yes
The device is used to "examine the urinary tract of pediatric patients," which is a diagnostic function to assess the condition or identify issues within the urinary tract. Additionally, it states it can "perform various diagnostic ... procedures."

No

The device description explicitly states it is a "Flexible Pediatric Cystoureteroscope," which is a physical medical device used for examination and procedures. This is not a software-only device.

Based on the provided information, the AUR-735 Flexible Pediatric Cystoureteroscope is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to examine the urinary tract and perform procedures on pediatric patients. This is a direct interaction with the patient's body for diagnostic and therapeutic purposes.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The device itself does not analyze these samples.
  • Device Description: The description is for a flexible scope, which is a medical device used for visualization and intervention within the body.

The AUR-735 is a medical device used for internal examination and procedures, not for analyzing samples outside the body.

N/A

Intended Use / Indications for Use

The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.

Product codes

78 FAJ

Device Description

USA Series™ AUR™-735 Flexible Pediatric Cystoureteroscope

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

pediatric patients

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2001

Mr. Wayne B. Sterner Director of Regulatory Affairs Circon Corporation 6500 Hollister Avenue SANTA BARBARA CA 93117 Re: K012929

Trade/Device Name: USA Series™ AURTM 735 Flexible Pediatric Cystoureteroscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FAJ Dated: August 29, 2001 Received: August 31, 2001

Dear Mr. Sterner:

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.

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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 nredicate 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 C Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 9 2001

CIRCON CORPORATION

K012929

FDA Premarket Notification 510(k)

USA Series™ AUR™-735 Flexible Pediatric Cystoureteroscope

INDICATIONS FOR USE STATEMENT

(if known) K012929 510(k) Number: USA Series™ AUR™-735 Flexible Pediatric Cystoureteroscope Device Name:

The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CRDH, Office of Device Evaluation (ODE)

Nancy Hogdon

Prescription Use

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