(87 days)
K/DEN: Not Found
No
The device description and performance studies focus on a disposable protective sheath for an endoscope, with no mention of AI/ML capabilities or image processing.
No
The device is described as a protective covering for an endoscope and is not directly involved in treating a disease or condition. Its function is to provide a sterile barrier during endoscopic examination.
No
The device is described as a protective covering for an endoscope used during examination, not as a tool for making a diagnosis itself. Its function is to cover the scope and be disposed of after a procedure.
No
The device is described as a "sterile, disposable, protective sheath" which is a physical component, not software. The performance studies also focus on physical properties like tensile strength and microbial 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 a scope used during an endoscopic examination of the sigmoid colon. This is a device used during a medical procedure on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description confirms it's a physical sheath that covers the scope.
- Performance Studies: The performance studies described are functional tests of the sheath itself (tensile strength, microbial barrier), not tests evaluating its ability to diagnose a condition based on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a procedural accessory.
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 SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope 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 SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope:
- Sheath Functional and Performance Test 1.
-
- Sheath Tensile Test
Microbial barrier testing using live polio virus as well as the Phi X 174 bacteriophage was also presented in support of the proposed label claims.
- Sheath Tensile Test
Key Metrics
Not Found
Predicate Device(s)
K921690, K961591, K943895, 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
Vision Sciences, Inc. 510(k) Premarket Notification
ﺮﺳﻤﻴﺔ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮ
August 23, 1996 Modified EndoSheath® for VSI Fiberoptic Sigmoidoscope
Summary of Safety and Effectiveness
NOV 21 1996
९।०१२
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: | SS-F32 EndoSheath® for use with the Vision-Sciences
Model S-F100 Sigmoidoscope |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| 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-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690)
EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591)
EndoSheath for Use with the VSI C-F100 Colonoscope (K943895)
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 SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope 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.
Indications for Use:
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.
1
K96 3344
p2042
Safety and Performance:
The following in vitro functional tests were performed on the proposed SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope:
- Sheath Functional and Performance Test 1.
-
- Sheath Tensile Test
Microbial barrier testing using live polio virus as well as 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 SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope has been shown to be safe and effective for its intended use.