(71 days)
This instrument has been designed to be used with an Olympus video system, light source, accessory equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.
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.
The provided text is a 510(k) summary for the OLYMPUS VIDEO URETEROSCOPE, NTSC. It focuses on establishing substantial equivalence to a predicate device based on modifications to an existing device (optical system modified from image guide to CCD, and improved resolution).
This type of submission does not typically include a detailed study with acceptance criteria and device performance results in the way a clinical trial or performance study for a novel high-risk device would. Instead, the focus is on demonstrating that the new device's technological characteristics and performance are comparable to a legally marketed predicate device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of regulatory document. The primary "study" is the comparison to the predicate device.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table. The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device, K951855, particularly concerning the improved resolution due to the CCD modification.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. This document relies on engineering and performance testing to show equivalence, not typically a clinical "test set" in the sense of a diagnostic algorithm.
- Data Provenance: Not applicable in the context of a 510(k) for an endoscopic device modification. The "data" would be engineering specifications and comparison to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth and expert consensus are not typically part of a 510(k) submission for a device like this, which focuses on hardware changes and their impact on image quality/resolution in comparison to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device.
7. The type of ground truth used:
- Not applicable in the typical sense of a diagnostic algorithm. The "ground truth" for demonstrating equivalence would be the performance characteristics (e.g., resolution measurements) of both the modified device and the predicate device, against established engineering standards and clinical expectations for visual inspection.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable.
Summary regarding the "Study":
The "study" cited in this 510(k) is the demonstration of substantial equivalence to the predicate device (A2560, K951855). The primary and explicitly mentioned modification is:
- Predicate Device: A2560 Ureteroscope (K951855)
- Modification: "the optical system is modified from image guide to CCD and the resolution is improved."
The acceptance criteria would have been to demonstrate that the new device performs at least as well as, or better than, the predicate device in terms of image quality and resolution for its intended clinical use, and that any technological differences do not raise new questions of safety or effectiveness. The document itself does not provide the specific data from this comparison but states that the FDA found it substantially equivalent.
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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.
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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.
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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
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| 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
§ 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.