(66 days)
No
The device description and performance studies focus on the physical properties and barrier function of a disposable sheath, with no mention of AI/ML or related concepts like image processing for analysis.
No
The device is described as a protective covering for an endoscope and its use is for examination, not treatment.
No
The device is described as a "protective covering for the scope" used during endoscopic examinations, and its function is to provide a sterile, disposable sheath. It does not perform any diagnostic analysis or interpretation on its own.
No
The device description clearly states it is a "sterile, disposable, protective sheath" which is a physical, hardware component. The performance studies also focus on physical properties and barrier testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a sterile, disposable protective covering for an endoscope used during a clinical procedure (endoscopic examination of the sigmoid colon). This is a device used in vivo (within the body) during a medical procedure, not in vitro (outside the body) for diagnostic testing of samples.
- Device Description: The description reinforces that it's a protective sheath for a scope used during a clinical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The performance studies focus on the physical properties of the sheath and its ability to act as a microbial barrier, which are relevant to its function as a protective covering during a procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.
Product codes
Not Found
Device Description
The EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sigmoid colon
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 in vitro functional tests were performed on the proposed EndoSheath:
-
- Air/Water Tubing Tensile/Elongation Test
-
- Distal Head Image Quality Evaluation
Microbial barrier testing using the Phi X 174 bacteriophage was also presented in support of the proposed label claims.
Key Metrics
Not Found
Predicate Device(s)
SS-V32 EndoSheath for use with the VSI S-V100 Sigmoidoscope (K932843), SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690), EndoSheath for use with the VSI C-F100 Colonoscope (K943895), EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591), EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809)
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
K964100 8172
DEC I 6 1996
Vision Sciences Inc. 510(k) Premarket Notification Modified EndoSheath® for VSI Flexible Sigmoidoscopes October 10, 1996
510(k) Summary
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® for use with the Vision-Sciences Model S-F100 and S-V100 Sigmoidoscopes |
|---|---|
| Owner/Operator: | Vision-Sciences, Inc. |
| 6 Strathmore Rd. | |
| Natick, MA 01760 | |
| Manufacturing Site: | Vision-Sciences, Inc. |
| 6 Strathmore Rd. | |
| Natick, MA 01760 | |
| Reg. # 1223490 | |
| 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 874.4760). | |
| Predicate Devices: | SS-V32 EndoSheath for use with the VSI S-V100 Sigmoidoscope (K932843) |
| SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690) | |
| EndoSheath for use with the VSI C-F100 Colonoscope (K943895) | |
| EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591) | |
| EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809) |
Manufactured and Distributed by:
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick, MA 01760#### Product Description:
The EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.
1
p2072
Vision Sciences Inc. 510(k) Premarket Notification Modified EndoSheath® for VSI Flexible Sigmoidoscopes October 10, 1996
Indications for Use:
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.
Safety and Performance:
The following in vitro functional tests were performed on the proposed EndoSheath:
-
- Air/Water Tubing Tensile/Elongation Test
-
- Distal Head Image Quality Evaluation
Microbial barrier testing using the Phi X 174 bacteriophage was also presented in support of the proposed label claims.
Conclusion:
Based on the indications for use, technological characteristics, and safety and performance testing, the EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes has been shown to be safe and effective for its intended use.