(69 days)
Not Found
No
The summary describes a sterile, disposable protective sheath for an endoscope and focuses on its physical and barrier properties, with no mention of AI or ML.
No.
The device is described as a sterile, disposable, protective covering for an endoscope used for examination, not for treatment.
No.
The device is described as a protective covering for an endoscope used during examination, not a device that provides a diagnosis.
No
The device description clearly states it is a "sterile, disposable, protective sheath" which is a physical component, not software. The performance studies also focus on physical properties and biocompatibility.
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 examination of the upper airway, vocal chords, and/or nasal passages. This is a physical barrier function during a clinical procedure.
- Device Description: The device is described as a "sterile, disposable, protective sheath." This reinforces its role as a physical covering.
- Lack of In Vitro Testing for Diagnosis: The performance studies listed are primarily focused on the physical and functional properties of the sheath (burst strength, angulation, light transmittance, resolution, etc.) and its biocompatibility. While microbial barrier testing is mentioned, this is related to preventing contamination during the procedure, not analyzing a sample in vitro for diagnostic purposes.
- No Mention of Analyzing Samples: There is no indication that this device is used to collect, prepare, or analyze biological samples (like blood, urine, tissue, etc.) outside of the body for the purpose of diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body in vitro (outside the body) to provide information for diagnostic or other clinical purposes. This device's function is entirely related to protecting the endoscope and the patient during an in vivo (within the body) procedure.
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 upper airway, vocal chords, and/or nasal passages.
Product codes
Not Found
Device Description
The VSI EndoSheath for use with the VSI Model E-F100 Nasopharyngoscope 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
upper airway, vocal chords, and/or nasal passages
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
The following in vitro functional tests were performed on the proposed Endosheath for use with the VSI Model E-F100 Nasopharyngoscope:
-
- Functional and Burst Test
- Scope Angulation (With and Without Sheath) 2.
- Scope OD (With and Without Sheath) 3.
- Sheath Longitudinal and Radial Strain when Loaded on Scope 4.
- న. Light Transmittance
- Field of View 6.
- Scope Resolution (With and Without Sheath) 7.
The following biocompatibility data was presented in support of this Premarket Notification:
-
- Irritation
-
- Sensitization
-
- Cytotoxicity
-
- Acute Systemic Toxicity
- ડ. Hemolysis
- ર્. Implantation
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Vision Sciences, Inc. 510(k) Premarket Notification
April 22, 1996 EndoSheath® for E-F100 Nasopharyngoscope
Summary of Safety and Effectiveness
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 E-F100 Nasopharyngoscope |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Nasopharyngoscope 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:
EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
Product Description:
The VSI EndoSheath for use with the VSI Model E-F100 Nasopharyngoscope 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 upper airway, vocal chords, and/or nasal passages.
1
Safety and Performance:
The following in vitro functional tests were performed on the proposed Endosheath for use with the VSI Model E-F100 Nasopharyngoscope:
-
- Functional and Burst Test
- Scope Angulation (With and Without Sheath) 2.
- Scope OD (With and Without Sheath) 3.
- Sheath Longitudinal and Radial Strain when Loaded on Scope 4.
- న. Light Transmittance
- Field of View 6.
- Scope Resolution (With and Without Sheath) 7.
The following biocompatibility data was presented in support of this Premarket Notification:
-
- Irritation
-
- Sensitization
-
- Cytotoxicity
-
- Acute Systemic Toxicity
- ડ. Hemolysis
- ર્. Implantation
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 EndoSheath for use with the VSI Model E-F100 Nasopharyngoscope has been shown to be safe and effective for its intended use.
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