(56 days)
Not Found
No
The summary describes a fiberoptic esophagoscope and protective sheath, with no mention of AI, ML, image processing, or any related performance metrics or training/test data descriptions typically associated with AI/ML devices.
No.
The device is indicated for endoscopic access and examination, and to assist in intubation, which are diagnostic and procedural assistance functions, not therapeutic.
Yes
Explanation: The device is indicated for "endoscopic access and examination," which are diagnostic procedures to visualize and assess internal structures for disease or abnormalities.
No
The device description explicitly states it consists of a flexible, fiberoptic esophagoscope and sterile, single use protective sheath, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction" and to "assist in intubation." This describes a procedure performed on the patient's body for visualization and access, not a test performed on a sample taken from the patient's body.
- Device Description: The description of a "flexible, fiberoptic esophagoscope and sterile, single use protective sheath" aligns with an endoscopic device used for direct visualization within the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on the analysis of samples.
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 does not fit that description.
N/A
Intended Use / Indications for Use
The Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist in intubation.
Product codes
EOX
Device Description
The device system described in this 510(k) consists of a flexible, fiberoptic esophagoscope and sterile, single use protective sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx, esophagus, gastro-esophageal junction
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
Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
031786
5 2003
510(k) Premarket Notification: Traditional Trans-Nasal Esophagoscope with EndoSheath® System
510(k) Summary
| Trade Name: | Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath®
System |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
Registration #1223490 |
| Device Common
Name: | Esophagoscope with sheath |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K990354 – Slide-On EndoSheath® for Flexible ENT Scopes
K012543 - EndoSheath® System for Flexible ENT Scopes
K021344 - EndoSheath® System for Flexible Fiberoptic Bronchoscope |
| | Manufactured by:
Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760 |
Product Description: The device system described in this 510(k) consists of a flexible, fiberoptic esophagoscope and sterile, single use protective sheath.
Indications for Use:
The Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist in intubation.
Safety and Performance:
Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing
Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Trans-Nasal Esophagoscope with EndoSheath® System has been shown to be safe and effective for its intended use.
1
510(k) Premarket Notification: Tradition: Tradition: Tradition
VSI Trans-Nasal Esophagoscope with EndoSheath® System
System
| Characteristic | Proposed VSI TNE-2000
Trans-Nasal
Esophagoscope
with EndoSheath®
System
(Current Submission) | Currently Marketed
VSI ENT-2000 with
EndoSheath® System
(K990354, K012534,
K024095) | Currently Marketed
VSI Bronchoscope with
EndoSheath® System
(K021344) | Pentax EE-1540
Trans-Nasal
Esophagoscope
(510(k) # unknown) | Olympus PEF-V
Trans-Nasal
Esophagoscope
(510(k) # unknown) |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Sheath material | Same as VSI predicate
devices | Thermoplastic elastomer | Thermoplastic elastomer | N/A -- No sheath | N/A -- No sheath |
| Window material | Same as VSI predicate
devices | Thermoplastic polymer | Thermoplastic polymer | N/A -- No sheath | N/A -- No sheath |
| Luer connector material | Same as VSI predicate
devices | N/A - no luer connector | Thermoplastic polymer | N/A -- No sheath | N/A -- No sheath |
| Proximal connector
tubing material | Same as VSI predicate
devices | Thermoplastic polymer | Thermoplastic polymer | N/A -- No sheath | N/A -- No sheath |
| Working channel ID | N/A - no working channel | N/A - no working channel | 2.1 mm | 2.0 mm | 2.0 mm |
| Working channel
materials | N/A - no working channel | N/A - no working channel | Thermoplastic polymer | Unknown | Unknown |
| Adhesives | Same as VSI predicate
devices | UV curable | UV curable | Unknown | Unknown |
| Microbial barrier claim | Yes | Yes | Yes | N/A -- No sheath | N/A -- No sheath |
| Sheath installation
method | Slides on and off (no
vacuum/pressure source
required) | Slides on and off (no
vacuum/pressure source
required) | Slides on and off (no
vacuum/pressure source
required) | N/A -- No sheath | N/A -- No sheath |
| Sheath Working Length | 27" | 12" | 24" | N/A -- No sheath | N/A -- No sheath |
| Minimum sheath wall
thickness | .002" | .002" | .002" | N/A -- No sheath | N/A -- No sheath |
| Sheath Packaging | Tyvek/Mylar pouch | Tyvek/Mylar pouch | Tyvek/Mylar pouch | N/A -- No sheath | N/A -- No sheath |
| Scope Working Length | 685 mm | 300 mm | 550 mm | 650 mm | 650 mm |
| Scope Insertion Tube
OD | 3.6 mm (w/out sheath)
4.8 mm (with sheath) | 3.6 mm | 6.0 mm | 5.1 mm | 5.3 mm |
| Articulation (Up/Down) | 180°/90° (sheathed scope) | 135°/135° (sheathed
scope) | 170°/120° (sheathed
scope) | 210°/120° | Unknown |
| Angle of View | 90° | 75° | 90° | 140° | Unknown |
| Characteristic | | | | | |
| | Currently Marketed | Currently Marketed | | | |
| Proposed VSI TNE-2000
Trans-Nasal
Esophagoscope
with EndoSheath® System
(Current Submission) | VSI ENT-2000 with
EndoSheath® System
(K990354, K012534,
K024095) | VSI Bronchoscope with
EndoSheath® System
(K021344) | Pentax EE-1540
Trans-Nasal
Esophagoscope
(510(k) # unknown) | Olympus PEF-V
Trans-Nasal
Esophagoscope
(510(k) # unknown) | |
| Indications for Use | For use in endoscopic
access and examination of
the larynx, esophagus and
gastro-esophageal
junction. The System
may also be used to assist
in intubation. | For use in flexible,
endoscopic examination
of the upper airway, vocal
chords and/or nasal
passages. | Is used during flexible
endoscopic examination
of the trachea and other
major passages of the
lungs, to gather
specimens, and/or to find
and endoscopically
remove foreign objects
from the lungs. | For use in endoscopic
examination of the
larynx, esophagus and
gastro-esophageal
junction. | For use in endoscopic
examination of the
larynx, esophagus and
gastro-esophageal
junction. |
2
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2003
Vision-Sciences, Inc. c/o Pamela Papineau. RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K031786
Trade/Device Name: Trans-Nasal Esophagoscope with EndoSheath® System Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: June 6, 2003 Received: June 10, 2003
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Pamela Papineau, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Palgyi kire.. Tbal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(k) Premarket Notification: Traditional Trans-Nasal Esophagoscope with EndoSheath® System
Page of
510(k) Number (if known): 上の3/フ 86
Trans-Nasal Esophagoscope with EndoSheath® System Device Name:
Indications for Use:
The Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist intubation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Ahalst
Division Slan-Off Nose and Throat De
510(k) Number