(23 days)
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.
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.
This document (K071903) is a Special 510(k) Premarket Notification for a device modification, which means it relies on changes to an already cleared device and doesn't typically include extensive de novo performance studies with new acceptance criteria or human reader studies. The primary focus is on demonstrating that the modifications do not adversely affect safety and effectiveness, often by showing compliance with design controls and risk analysis.
Therefore, many of the requested elements (like a table of acceptance criteria and performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not explicitly provided or applicable in the context of this specific type of submission as presented. The document states that "V & V activities, including sheath functional and performance testing, was addressed through Design Validation and Verification planning," implying that these tests were internal and likely verified against existing specifications for the predicate device, rather than new, independently established acceptance criteria for a novel device.
However, based on the provided text, I can extract what is available and indicate where information is missing or not relevant to this type of submission.
Acceptance Criteria and Device Performance Study Information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use (unmodified) | "Shown to be safe and effective for their intended use." |
| Compliance with 21 CFR 820.30 Design Control requirements | "Certification of compliance to 21 CFR 820.30 Design Control requirements" |
| Adherence to internal Risk Analysis procedures | "Description of the internal Risk Analysis procedure." |
| Functional and performance integrity of the modified sheath | "Sheath functional and performance testing was addressed through Design Validation and Verification planning." |
| Substantial equivalence to predicate device (K031786) | FDA determined the device is "substantially equivalent." |
Note: The document does not provide specific quantitative acceptance criteria or detailed performance results in the public summary. The "performance testing" mentioned is framed as part of Design Validation and Verification (V&V) activities against the device's own specifications and intended use, rather than a new comparative clinical study with defined clinical endpoints.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text. The "performance testing" refers to V&V activities.
- Data Provenance: Not specified. As a device modification, testing would likely be internal to the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/specified. This type of submission (Special 510(k) for device modification) focuses on engineering and functional performance, not typically on clinical ground truth established by external experts for diagnostic accuracy.
- Qualifications of Experts: Not applicable/specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/specified. This is not a diagnostic device undergoing a typical clinical study requiring ground truth adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a medical device (protective sheath for endoscope), not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for this device's performance would be engineering specifications, functional requirements, sterility, biocompatibility, and mechanical integrity, all verified through internal testing and validation.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is a medical device, not an AI algorithm.
Summary of the Study performed (as described in the 510(k) Summary):
The submission is a Special 510(k) Premarket Notification for a Device Modification. The study supporting this clearance was not a traditional clinical trial or an AI performance study, but rather a demonstration of continued safety and effectiveness through:
- Certification of compliance to 21 CFR 820.30 Design Control requirements: This indicates that the device's design, development, and modification processes adhere to FDA's quality system regulations.
- Description of the internal Risk Analysis procedure: This shows that potential risks associated with the modifications were identified, analyzed, and mitigated.
- Design Validation and Verification (V&V) activities including sheath functional and performance testing: This refers to internal testing conducted by Vision-Sciences, Inc., to ensure the modified EndoSheath® Systems meet their design specifications and intended use. The conclusion explicitly states that "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."
The FDA's decision of "substantial equivalence" to the predicate device (K031786) further supports this, indicating that the modifications did not raise new questions of safety or effectiveness.
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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.
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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.
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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
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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
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510(k) Number
010016
§ 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.