(76 days)
Not Found
No
The summary describes a standard fiberoptic cystoscope and sheath with no mention of AI/ML features, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The intended use explicitly states "to perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to "perform various diagnostic and therapeutic procedures," indicating its role in diagnosis.
No
The device description explicitly states it consists of a flexible, fiberoptic cystoscope and a protective sheath, which are hardware components. The performance studies also focus on hardware testing.
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 access and examination of the lower urinary tract and performing diagnostic and therapeutic procedures. This involves direct visualization and intervention within the body.
- Device Description: The device is a flexible, fiberoptic cystoscope and protective sheath. This is a medical device used for imaging and procedures within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on specimens outside the body.
The device described is a medical device used for internal examination and procedures, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 FAJ
Device Description
The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower urinary tract including the bladder
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)
Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing.
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.
K031786, K021344, K914008, K843084
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
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 Road | |
| Natick, MA 01760 | |
| Registration #1223490 | |
| Device Common | |
| Name: | Cystoscope with sheath |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K031786 – VSI Esophagoscope with Slide-On EndoSheath® |
| K021344 – VSI Bronchoscope with Slide-On EndoSheath® System | |
| Manufactured by: | |
| Vision-Sciences, Inc. | |
| 9 Strathmore Road | |
| Natick, MA 01760 | |
| K914008 - Pentax FCY-15P2 Flexible Fiberoptic Cystoscope | |
| K843084 - 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