(207 days)
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.
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.
The provided text describes the 510(k) submission for the "Vision-Sciences Flexible Cystoscope with EndoSheath® System" with an added hysteroscopy indication. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.
The document focuses on substantiating equivalence to predicate devices and lists the types of tests performed. It does not present quantitative acceptance criteria or detailed performance metrics in the way a clinical study or detailed technical report would.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document in a detailed, quantitative table format. The document generically states that "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."
It implies that the device met the necessary performance standards for these tests to be deemed substantially equivalent, but it does not specify what those standards (acceptance criteria) were or the exact numerical results (reported device performance).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "performance testing" but does not detail the sample sizes for these tests, nor does it specify the provenance of any data (e.g., whether it involved human subjects, animal models, or purely bench testing, or its geographical origin or retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided. The described tests are primarily engineering performance tests (e.g., sheath burst, tensile, articulation, image quality, cycle testing) rather than clinical studies requiring expert interpretation of diagnostic results. Therefore, there's no mention of experts establishing a "ground truth" for a test set in the sense you're asking.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are typically used in clinical studies where multiple experts evaluate ambiguous cases. The described tests are performance tests of the device itself, not evaluations of diagnostic accuracy by human readers.
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
This information is not applicable. This submission is for a flexible endoscope system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated above, this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of diagnostic accuracy. For the described engineering performance tests, the "ground truth" would be the engineering specifications and established test methods themselves (e.g., a burst test must withstand X pressure, a tensile test must withstand Y force).
8. The sample size for the training set
This information is not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI or machine learning device.
Summary of what the document does provide regarding safety and performance:
- Basis for Substantial Equivalence: Design characteristics, comparison to predicate devices (K040215, K053560, K891451), and performance testing.
- Types of Performance Testing:
- Sheath burst/leak testing
- Sheath tensile/elongation testing
- Sheathed scope articulation testing
- Sheathed scope image quality evaluation
- Scope cycle testing
The document concludes that "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." This statement implies that the device met the acceptance criteria for these tests, but the specific criteria and results are not detailed.
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510(k) Summary
| Trade Name: | Vision-Sciences Flexible Cystoscope with EndoSheath® System(with additional Hysteroscope Indications for Use) | |
|---|---|---|
| Sponsor: | Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760Registration #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, andCosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K040215 & K053560 - VSI Flexible Cystoscope with Slide-On EndoSheath® SystemManufactured by:Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760Olympus 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.
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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.
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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
Page 1 of 1
§ 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.