(65 days)
K932843, KU54704
No
The summary does not mention any AI or ML capabilities, image processing, or data sets for training or testing. The performance studies focus on mechanical and optical properties.
Yes
The 'Intended Use / Indications for Use' section states that the device is intended "to perform various diagnostic and therapeutic procedures."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "various diagnostic and therapeutic procedures."
No
The device description clearly states it consists of a reusable video sigmoidoscope with fiberoptic bundles and a disposable sheath, indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "examine the lower bowel tract" and perform "diagnostic and therapeutic procedures." This describes a device used in vivo (within the living body) for direct visualization and intervention.
- Device Description: The description details a sigmoidoscope, which is a medical instrument used to view the inside of the sigmoid colon. This is a physical examination procedure, not a test performed on a sample in vitro (outside the living body).
- Lack of IVD Characteristics: IVD devices typically involve testing biological samples (blood, urine, tissue, etc.) to diagnose conditions. The provided information does not mention any such testing or analysis of samples.
Therefore, the VSI Model S-V200 Color Video Sigmoidoscope is a medical device used for direct visualization and procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes
Not Found
Device Description
The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure. The EndoSheath intended for use with the proposed sigmoidoscope is currently under FDA review in K964100.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower bowel tract
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
The following performance testing was presented in support of this submission:
- Scope Angulation/Cycle Testing (with and without EndoSheath) 1.
-
- Scope Resolution (with and without EndoSheath)
Performance testing for the I ndoSheath is contained in K % 4 (00)
No biocompatibility data was presented in support of this Premarket Notification.
Key Metrics
Not Found
Predicate Device(s)
K932843, KU54704
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
K964326
Jan 3, 1997
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Vision-Sciences is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." VSI chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name:
EndoSheath | VSI Model S-V200 Color Video Sigmoidoscope with Disposable |
---|---|
Owner/Operator: | Vision-Sciences, Inc. |
6 Strathmore Rd. | |
Natick, MA 01760 | |
Manufacturing Site: | EndoSheath: |
Vision-Sciences, Inc | |
6 Strathmore Rd. | |
Natick, MA 01760 | |
Reg. # 1223490 | |
Endoscope: | |
Vision-Sciences, Inc. | |
40 Ramland Rd. South | |
Orangeburg, NY 10962 | |
Reg. #2242464 | |
Device Generic Name: | Sigmoidoscope and accessories |
Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the |
device classification is Class II. Performance Standards (CFR 876.1500). |
Predicate Devices:
-
Vision-Sciences Model S-V100 Video Sigmoidoscope with SS-V32 EndoSheath System 1. (K932843)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 -
- Model VS-200 Video Sigmoidoscope (KU54704)
Manufactured and Distributed by Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153
- Model VS-200 Video Sigmoidoscope (KU54704)
00226
$\pi$
1
Product Description:
The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure. The EndoSheath intended for use with the proposed sigmoidoscope is currently under FDA review in K964100.
Indications for Use:
The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Safety and Performance:
The following performance testing was presented in support of this submission:
- Scope Angulation/Cycle Testing (with and without EndoSheath) 1.
-
- Scope Resolution (with and without EndoSheath)
Performance testing for the I ndoSheath is contained in K % 4 (00)
No biocompatibility data was presented in support of this Premarket Notification.
Conclusion:
Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath has been shown to be safe and effective for its intended use
000207
Jul