(207 days)
Not Found
No
The summary describes a fiberoptic endoscope and sheath system for visualization and procedures, with no mention of AI or ML capabilities. The performance studies focus on physical characteristics and image quality, not algorithmic performance.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is used to "perform various diagnostic and therapeutic procedures" for the lower urinary tract and for "performing diagnostic and therapeutic/surgical procedures" for the cervical canal and uterine cavity.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to perform "various diagnostic and therapeutic procedures" and "diagnostic and therapeutic/surgical procedures".
No
The device description explicitly states the system consists of a flexible, fiberoptic endoscope and a sterile, single-use protective sheath, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes direct visualization and procedures within the lower urinary tract and the female reproductive tract. This is a direct examination of the body, not the analysis of samples taken from the body.
- Device Description: The device is a flexible endoscope and a protective sheath. This is a tool for internal viewing and procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device is used to directly visualize and interact with internal body structures.
N/A
Intended Use / Indications for Use
The CST-2000A and Slide-On® EndoSheath® System provides 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 CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.
Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.
Product codes
HIH
Device Description
The device system described in this 510(k) consists of a flexible, fiberoptic endoscope and sterile, single use protective sheath. This 510(k) adds a hysteroscopy indication to the currently marketed VSI Cystoscope with EndoSheath® System.
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, cervical canal and the uterine cavity
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)
Substantial equivalence for scope and sheath for hysteroscopy indications was based on design characteristics, comparison to legally marketed predicate devices, and 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
510(k) Summary
| Trade Name: | Vision-Sciences Flexible Cystoscope with EndoSheath® System
(with additional Hysteroscope Indications for Use) | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor: | Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
Registration #1223490 | NOV 1 6 2007 |
| Device Common Name: | Hysteroscope with sheath | |
| Regulation &
Product Code: | 21 CFR 884.1690 / HIH | |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K040215 & K053560 - VSI Flexible Cystoscope with Slide-On EndoSheath® System
Manufactured by:
Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
Olympus HYF-P Flexible Fiberoptic Hysteroscope (K891451) | |
Product Description: The device system described in this 510(k) consists of a flexible, fiberoptic endoscope and sterile, single use protective sheath. This 510(k) adds a hysteroscopy indication to the currently marketed VSI Cystoscope with EndoSheath® System.
Indications for Use:
The CST-2000A and Slide-On® EndoSheath® System provides 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 CST-2000A and Slide-One EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.
Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.
Safety and Performance:
Substantial equivalence for scope and sheath for hysteroscopy indications was based on design characteristics, comparison to legally marketed predicate devices, and 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 scope and sheath system has been shown to be safe and effective for its intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Vision-Sciences, Inc. % Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K071127
Trade Name: Flexible Hysteroscope with EndoSheath® System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: October 26, 2007 Received: October 30, 2007
Dear Ms. Papineau:
We have reviewed your Section 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 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
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510(k) Number (if known):
Device Name: Flexible Hysteroscope with EndoSheath® System
Indications for Use:
The CST-2000A and Slide-On® EndoSheath® System provides 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 CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.
Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-the -Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Julius Reiner
Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
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