(23 days)
Not Found
No
The summary describes a physical device (flexible endoscope with sheath) and its intended use for examination. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on functional and performance testing of the sheath system, not algorithmic performance.
No
The device is used for examination and access, not for treating a disease or condition. While it can assist intubation, its primary purpose is diagnostic or assistive rather than therapeutic.
No
The device is described as an endoscope and sheath system intended for "endoscopic access and examination." While examination can lead to diagnosis, the device itself is a tool for visualization and access, not for performing the diagnostic assessment. It also mentions assisting intubation, which is a procedural use, not diagnostic.
No
The device description clearly indicates it is a physical sheath system intended to cover an endoscope, which is a hardware component. 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 clearly states the device is for "endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction" and to "assist intubation." This describes a procedure performed directly on the patient for visualization and access, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "flexible trans-nasal esophagoscope with sheath system" and "protective sheath systems." This aligns with an endoscopic device used for direct examination.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device is used for direct visualization and access within the body.
N/A
Intended Use / Indications for Use
The flexible trans-nasal esophagoscope with EndoSheath® System is intended for use in endoscopic access and examination of the larynx, esophagus, and gastro-esophageal junction. The device may also be used to assist intubation.
Product codes
EOX
Device Description
The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the flexible endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx, esophagus, and 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
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities, including sheath functional and performance testing, was addressed through Design Validation and Verification planning.
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
Vision-Sciences, Inc. July 6, 2007
Special 510(k) Premarket Notification: Device Modification lodified EndoSheath® Systems for Use with VSI Flexible TNE Scopes
510(k) Summary
Owner's Name: Address:
Telephone Number: Fax Number: Contact Person:
Subject Device Name: Common/Usual Name: Product Codes: FDA Regulations: Device Classification:
Predicate Device Name:
Common/Usual Name: Product Codes:
Device Classification:
Premarket Notification:
FDA Regulations:
Vision-Sciences, Inc. 9 Strathmore Road Natick, MA 01760 (508) 650-9971 (508) 650-9976 Charles Iannaccone; QA/RA Manager
AUG - 2 2007
EndoSheath® Systems for use with VSI Flexible TNE Scope Protective sheath for use with flexible endoscope EOX 21 CFR 874.4710 Class II
EndoSheath® Systems for use with VSI Flexible TNE Scope Protective sheath for use with flexible endoscope EOX 21 CFR 874.4710 Class II K031786
Device Description
The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the flexible endoscope.
Intended Use
The flexible trans-nasal esophagoscope with sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.
Performance Testing
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities, including sheath functional and performance testing, was addressed through Design Validation and Verification planning.
Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the modified VSI EndoSheath® Systems for use with the VSI flexible TNE scope have been shown to be safe and effective for their intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 2007
Vision-Sciences, Inc. c/o Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave. Aver, MA 01432
Re: K071903
Trade/Device Name: EndoSheath® Systems for use with VSI Flexible TNE Scope Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: July 6, 2007 Received: July 10, 2007
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 for association 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will you to organizal equivalence of your device of your device to a legally prematics in the month 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 rryou desire specific an reices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 01161 ation" (21CFR Part 807.97). For questions regarding postmarket surveillance, premarket nonnoulon (210-101 Surveillance and Biometric's (OSB's) Division of Postmarket prease connect ODICT 8 3474. For questions regarding the reporting of device adverse events Burveillance at 210 210 b 1 10 b 1 10 b 1 contact the Division of Surveillance Systems at 240-(Mcdical DV100 reporting (the 1999) progral information on your responsibilities under the Act from 270 - 101: Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egeland, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Vision-Sciences, Inc. July 6, 2007
Special 510(k) Premarket Notification: Device Modification Modified EndoSheath® Systems for Use with VSI Flexible TNE Scopes
510(k) Number (if known):
EndoSheath® Systems for use with VSI Flexible TNE Scope Device Name:
Indications for Use:
The flexible trans-nasal esophagoscope with EndoSheath® System is intended for use in The liextble trans-nasal esophagosopo with Enastronomis and gastro-esophageal endoscopic access and exalso be used to assist intubation.
Prescription Use _ X (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amabolel
(Division Sign-Off)
Division of Ophthalmic Ear,
Nage and Throat Devises
Nece
Page 1 of 1
510(k) Number
010016