(97 days)
Not Found
No
The summary describes mechanical working elements, guiding tubes, and injection cannulas for urological procedures, with no mention of AI or ML capabilities.
Yes
The Intended Use / Indications for Use section explicitly states that the devices are intended to "perform various diagnostic and therapeutic procedures in the urological tract."
Yes
Explanation: The "Intended Use / Indications for Use" states that the devices are "intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract."
No
The device description lists physical components (working element, guiding tube, injection cannula) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes examining and performing diagnostic and therapeutic procedures in the urological tract. This involves direct interaction with the patient's body for diagnosis and treatment, not the analysis of samples in vitro (outside the body).
- Device Description: The devices are described as working elements, guiding tubes, and injection cannulas. These are instruments used for accessing and manipulating within the body, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue), using reagents, or performing tests in vitro.
Therefore, the description clearly points to a device used for in vivo procedures within the urological tract, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.
Product codes (comma separated list FDA assigned to the subject device)
78 FDC
Device Description
Subject Devices:
Model A2765 - Working element, for probes
Model A0561 - Guiding tube, for probes, with retractor
Model A0562 - Guiding tube, for probes
Model A2891 - Injection cannula, 1,2 mm x 420 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological 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.
K790071, K904939, K904939, K904939, K790071
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/1 description: The image shows the logo for Olympus Winter & IBE. Below the logo is the business address, which is Kuehnstr. 61, D-22045 Hamburg. The mailing address is Postfach 70 17 09, D-22017 Hamburg. The telephone number is (040) 6 69 66-0, and the telefax number is (040) 6 68 15 91.
992141 Pri of 2
510(k) SUMMER
OLYMPUS WORKING ELEMENT FOR PROBES
This summery of 510(k) safety and effectivness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Device Name: | Olympus Working Element for Probes | |
|---|---|---|
| Common/Usual Name: | Working Element | |
| Classification Name: | ENDOSCOPE AND/OR ACCESSORIES | |
| Classification: | CFR 876.1500 | Class II |
Subject Devices:
| Model | Description |
|---|---|
| A2765 | Working element, for probes |
| A0561 | Guiding tube, for probes, with retractor |
| A0562 | Guiding tube, for probes |
| A2891 | Injection cannula, 1,2 mm x 420 mm |
Predicate Devices:
| Manufacturer | Description | 510(k) |
|---|---|---|
| Richard Wolf | Working element with open handle and probe guide channel | |
| Type 8654.281 | unknown | |
| Richard Wolf | Injection cannula flexible, 4.5 Fr | |
| Type 8654.951 | unknown | |
| Olympus | Working element | |
| O3523 | K790071 | |
| Olympus | Working element, V-spring type | |
| A3573 | K904939 | |
| Olympus | Working element, V-spring type | |
| A2496 | K904939 | |
| Olympus | Knife, semi circular, 3 Fr. channel, for A2496 | K904939 |
| Olympus | Stricture scalpel hollow, for use of a 5 Fr. guide catheter | K790071 |
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| Prepared & Submitted By:
(Contact Person) | Mrs. Laura Storms-Tyler
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, NY 11747-3157
Phone: 516-844-5688
FAX: 516-844-5416 | K992141
Pg 208? |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Summary Preparation Date: | September 6, 1999 | |
Statement of Intended Use:
The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.
2
Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head represented by a simple, curved line.
SEP 2 9 1999
Olympus Winter & IBE c/o Mrs. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Incorporated Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K992141 Olympus Working Element for Probes Dated: September 8, 1999 Received: September 9, 1999 Regulatory Class: II 21 CFR $876.1500/Procode: 78 FDC
Dear Mrs. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
[signature]
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 9921 41 510(k) Number (if known):
Device Name:
Olympus working element for probes, guiding tubes and injection cannula.
Indications for Use:
The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| Presciption Use | OR | Over-the Counter Use | ||
| (per 21CFR 801.109) | (Optional Format 1-2-96) | |||
| (Division Sign-Off) | ||||
| and Radiological Devices | ||||
| 510(k) Number | Division of Reproductive, Abdominal, ENT, |
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