(530 days)
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No
The description focuses on a sterile, disposable sheath for endoscopes and performance testing related to its physical properties and barrier function. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is a protective covering for an endoscope used for examination, not for treating any condition.
No
The device is a protective sheath for endoscopes used during examination. It does not perform any diagnostic function itself, but rather facilitates the use of other diagnostic devices (endoscopes) by providing a sterile covering.
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 like expansion, image quality (likely affected by the physical sheath), pressure/burst strength, and biocompatibility. There is no mention of software as the primary or sole component.
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 clinical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a protective sheath that covers the patient contact portion of the scope. This is a physical barrier used during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to maintain sterility and protect the endoscope during a direct examination of the patient's anatomy.
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 Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes consists of a sterile, disposable, protective sheath which covers the patient contact portion of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following in vitro functional tests were performed on the proposed Endosheath:
- Sheath Expansion and Installation Test 1.
- Sheathed Scope Image Quality Test 2.
- Sheath Pressure/Burst Test 3.
The following biocompatibility data was presented in support of this Premarket Notification:
- Irritation 1.
-
- Sensitization
- Cytotoxicity 3.
- Acute Systemic Toxicity 4.
- Humoral Hemolysis
- Implantation 6.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
May 24, 1996
AUG - 5 1996
K950809/A1
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 Machida Model ENT-4L, Olympus
Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S
Nasopharyngoscopes |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | 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 Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes consists of a sterile, disposable, protective sheath which covers the patient contact portion 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:
- Sheath Expansion and Installation Test 1.
- Sheathed Scope Image Quality Test 2.
- Sheath Pressure/Burst Test 3.
The following biocompatibility data was presented in support of this Premarket Notification:
- Irritation 1.
-
- Sensitization
- Cytotoxicity 3.
- Acute Systemic Toxicity 4.
- રું ર Hemolysis
- Implantation 6.
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 EndoSheaths for use with Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-EncoBreams to the 11 TNL-13S endoscopes have been shown to be safe and effective for their intended use.