(76 days)
For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.
The provided text is a 510(k) summary for a medical device, the Vision-Sciences Flexible Cystoscope with EndoSheath® System. It describes the device, its indications for use, and a general statement about safety and performance. However, it does not contain the detailed study information needed to fully answer your request.
The 510(k) summary states that "Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing." This indicates that tests were performed, but the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or any details about human reader studies are not present in this document.
Therefore, I can only provide a partial answer based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document only lists the types of performance tests conducted, not their specific criteria or results.
2. Sample size used for the test set and the data provenance
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in the provided text.
4. Adjudication method for the test set
Not available in the provided text.
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 device is a flexible cystoscope with a sheath, not an AI-powered diagnostic tool. The concept of "human readers improve with AI" does not apply to this type of medical device based on the provided information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a flexible cystoscope with a sheath, not an AI algorithm.
7. The type of ground truth used
Not available in the provided text. The performance tests mentioned (burst/leak, tensile/elongation, articulation, image quality, cycle testing) suggest engineering and functional performance parameters, which would likely have internal performance specifications as their "ground truth" rather than clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device is a flexible cystoscope with a sheath, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what can be inferred from the provided text:
- Acceptance Criteria & Performance: The document states that performance testing was performed for:
- Sheath burst/leak
- Sheath tensile/elongation
- Sheathed scope articulation
- Sheathed scope image quality
- Scope cycle testing
- However, the specific numeric acceptance criteria and the actual reported performance values are not disclosed in this 510(k) summary.
- Study Type: The studies mentioned are engineering and functional performance tests of the device components, not clinical studies involving patient data or expert interpretation in the way AI performance studies are conducted.
- Conclusion from the 510(k) Summary: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Flexible Fiberoptic Cystoscope with EndoSheath® System has been shown to be safe and effective for its intended use." This indicates that the device did meet whatever acceptance criteria were established for the performance tests conducted, as this is a prerequisite for receiving 510(k) clearance.
{0}------------------------------------------------
K040215
510(k) Premarket Notification: Traditional
Flexible Cystoscope with EndoSheath® System
Vision-Sciences, Inc. January 29, 2004
APR 1 5 2004
510(k) Summary
| Trade Name: | Vision-Sciences Flexible Cystoscope with EndoSheath® System |
|---|---|
| Sponsor: | Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760Registration #1223490 |
| Device CommonName: | Cystoscope with sheath |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
| Predicate Devices: | K031786 – VSI Esophagoscope with Slide-On EndoSheath®K021344 – VSI Bronchoscope with Slide-On EndoSheath® SystemManufactured by:Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760K914008 - Pentax FCY-15P2 Flexible Fiberoptic CystoscopeK843084 - Olympus CYF-4 Flexible Fiberoptic Cystoscope |
Product Description: The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.
Indications for Use:
The Vision-Sciences Flexible Fiberoptic Cystoscope with EndoSheath® System is indicated for use in endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Safety and Performance:
Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing.
Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Flexible Fiberoptic Cystoscope with EndoSheath® System has been shown to be safe and effective for its intended use.
000104
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2004
Vision-Sciences, Inc. c/o Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K040215
Trade/Device Name: Flexible Cystoscope with EndoSheath® System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FAJ Dated: January 29, 2004 Received: January 30, 2004
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becalent on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entrebure) is the enactment date of the Medical Device Amendments, or to conninered phor to may 20, 1978, are occordance with the provisions of the Federal Food, Drug, de vices that mave boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains of the Act include requirements for annual registration, listing of general voltaren profitse, 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 it may be subject to taxations, 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 docs not mean I lease oc devised that I Dr brisean that your device complies with other requirements of the Act that I D. I has mas a sad regulations administered by other Federal agencies. You must or any I ederal bakatoo une ents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct (21 CFR Part 001), acceming (21 CFR Part 820); and if applicable, the electronic form in the quality by one 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) I his letter will anow you to ocgainmation of substantial equivalence of your device to a legally premarket notification. The PDA moming or cassification 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 If you desire specific advice for your down the following numbers, based on the regulation 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, 101 questions on the produce as a so, please note the regulation entitled, "Misbranding Other of Complance at (101) 57 + 100 x 100 .97) you may obtain. Other general by reference to premation on the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collaumics - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
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
{3}------------------------------------------------
510(k) Number (if known):
Device Name: Flexible Cystoscope with EndoSheath® System
Indications for Use:
For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-the -Counter Use (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel R. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Page 1 of 1
000009
§ 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.