(71 days)
Not Found
No
The summary focuses on improvements to the optical system (image guide to CCD) and resolution, with no mention of AI, ML, or image processing capabilities.
Yes
The device is described as being used for "endoscopic diagnosis and treatment," indicating a therapeutic purpose in addition to diagnosis. Also it is combined with "endo-therapy accessories".
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment." The "Device Description" also reiterates its use for "endoscopic diagnosis and treatment."
No
The device description explicitly states it is an "instrument" with an "optical system modified from image guide to CCD," indicating it is a hardware device with an imaging component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis and treatment within the urethra, bladder, and ureter." This describes a procedure performed directly on the patient's body using an endoscope.
- Device Description: The device is an instrument used for endoscopic procedures, with an optical system for visualization. This is consistent with an in-vivo diagnostic or therapeutic device, not an in-vitro one.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The description of this device does not involve the analysis of any such specimens.
Therefore, this device falls under the category of an in-vivo diagnostic or therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus video system, light source, accommodation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.
Product codes
FGB
Device Description
The subject device is used for endoscopic diagnosis and treatment within the urethra, I ho storeet de roo is as optical system is modified from image guide to CCD and the resolution is improved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder, ureter
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SMDA 5120(k) SUMMERY
OLYMPUS VIDEO URETEROSCOPE, NTSC
Submitter's Name, Address and Phone and Fax Numbers A.
| Name & Address of manufacturer: | Olympus Winter & Ibe, GmbH |
|---|---|
| Kuehnstr. 61 | |
| Hamburg 22045, Germany | |
| Phone: +49 40 669 66-0 | |
| Fax: +49 40 668 15 91 | |
| Registration Number: | 8010313 |
Name of Contact Person B.
| Address of initial importer and contact | Olympus America 2 Corporate Center Drive Melville, N.Y. 11747 |
|---|---|
| Registration Number: | 2429304 |
| Contact: | Tina Steffanie-Oak, Associate R.A. Manager |
| Phone: | 631-844-5477 |
| Fax: | 631-844-5554 |
Device name, Common Name, Classification Name and Predicate Devices C.
| Trade NAME: | OLYMPUS VIDEO URETEROSCOPE, NTSC |
|---|---|
| Common Name: | Ureteroscope and Accessories |
| Classification: | |
| Class II | 21 CFR 876.1500 Endoscope and accessories. - |
| FDA Product Code FGB | |
| Predicate Device: | A2560 510(k)# K951855 |
Description of the Device D.
The subject device is used for endoscopic diagnosis and treatment within the urethra, I ho storeet de roo is as optical system is modified from image guide to CCD and the resolution is improved.
Intended Use of the Device E.
This instrument has been designed to be used with an Olympus video system, light I mis instrament has ovequipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2004
Olympus Winter & Ibe, GmbH c/o Ms. Tina Steffanie-Oak Associate Manager, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747
Re: K033651
Trade/Device Name: OLYMPUS VIDEO URETEROSCOPE, NTSC (S-1546/2) Modification to A2560 Ureteroscope (K951855) Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB Dated: January 21, 2004 Received: January 22, 2004
Dear Ms. Steffanie-Oak:
We have reviewed your Scction 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered process 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). and Cosmotion Fee (110) that the device, subject to the general controls provisions of the Act. The r ou may, aterest, mains 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must of uny I outhates the Act s requirements, including, but not limited to: registration and listing comply with an the rice broquiant Part 801); good manufacturing practice requirements as set (21 OF It 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocglif hill kemine of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaleries a premarket notification. The FDA inding of substantial or 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 advice for your device on our line of good 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 Additionally, for questions on the pronocol an and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Area note the regulation Other segment Office of Compliance at (501) 594-4057. This, production of the general (1) 10 may obtain. Other general by reference to premarket nollication (21GI IT at out of Jaired from the Division of Strail information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance in the del (4cmarkers) Manufacturers, Thiernational and Collsumior Passworldrh/dsma/dsmamain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
Page 2
3
| 510(k) Number (if known): | Not assigned yet K033651 |
|---|---|
| --------------------------- | -------------------------- |
Olympus video ureteroscope, NTSC Device Name:_
Indications for Use: This instrument has been designed to be used with an Olympus Indications for Ose. - Fins meatation equipment, display monitor, endo-therapy video system, ingli source, accumsion for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
David A. Symm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number