(25 days)
The VSI Flexible, Fiberoptic Bronchoscope with EndoSheath® System is used for 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. The EndoSheath® provides a sterile protective covering for the bronchoscope.
The device system described in this 510(k) consists of a modified sterile, disposable sheath designed to fit the modified VSI flexible fiberoptic bronchoscope. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The sheath and scope have been modified to accommodate the "slide-on" sheath installation technique.
This submission is a Special 510(k): Device Modification, and as such, it primarily focuses on demonstrating that the modified device remains safe and effective despite the changes, typically by showing equivalence to a predicate device and compliance with design controls. It does not contain a traditional study with acceptance criteria and reported device performance in the same way a new device would.
However, based on the provided text, we can infer the acceptance criteria and how the device meets them through validation testing and comparison to predicate devices, particularly focusing on the characteristics that changed.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a device modification and the documentation emphasizes equivalence and compliance with design controls, the "acceptance criteria" are implied to be the specifications of the predicate devices or established performance standards for the modified characteristics. The "reported device performance" refers to the results of the validation tests performed.
| Characteristic | Acceptance Criteria (Implied from Predicate/Standard) | Reported Device Performance (from Validation Testing) |
|---|---|---|
| Microbial Barrier | Yes (Identical to predicate) | "Microbial barrier testing" performed; likely met criteria as study concludes safety and effectiveness. |
| Sheath Burst/Leak Integrity | No leaks, adequate burst strength | "Sheath burst/leak test" performed; likely met criteria as study concludes safety and effectiveness. |
| Sheath Tensile/Elongation | Adequate tensile strength and elongation for intended use | "Sheath tensile/elongation test" performed; likely met criteria as study concludes safety and effectiveness. |
| Sheath Installation/System Functionality | Proper slide-on installation, effective system function | "Sheath installation/system functional test" performed; likely met criteria as study concludes safety and effectiveness. |
| Pinch Valve Cycle Test | Adequate cycle life and functionality | "Pinch valve cycle test" performed; likely met criteria as study concludes safety and effectiveness. |
| Down Articulation (sheathed scope) | 170°/120° (Equivalent to unmodified VSI Bronchoscope/sheath system) | 170°/120° (Confirmed in Design Comparison Table D.1) |
| Field of View (apter) | 90° | 90° (Confirmed in Design Comparison Table D.1) |
| Depth of Field | +2/-8 | +2/-8 (Confirmed in Design Comparison Table D.1) |
| Insertion Tube OD | 3 - 50 mm | 3 - 50 mm (Confirmed in Design Comparison Table D.1) |
| Working Channel ID | 6.0 mm | 6.0 mm (Confirmed in Design Comparison Table D.1) |
| Working Length | 2.1 mm | 2.1 mm (Confirmed in Design Comparison Table D.1) |
| Submersible scope | 550 mm | 550 mm (Confirmed in Design Comparison Table D.1) |
| Sheath Installation Method | Slide-on (Identical to VSI ENT Scope/sheath system) | Slide-on (Confirmed in Design Comparison Table D.1) |
| Sheath Wall Thickness | .0020 - .0045" (New specification for modified sheath) | .0020 - .0045" (Confirmed in Design Comparison Table D.1) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each validation test (e.g., microbial barrier testing, tensile/elongation testing, leak testing, functional tests). It generally refers to "validation testing" being included in Design Validation and Verification planning. Given that this is a Special 510(k) for a device modification, the testing likely involved a sufficient number of units to demonstrate statistical confidence for the specific characteristics being evaluated, in accordance with design control requirements.
The data provenance is internal to Vision-Sciences, Inc., generated through their design validation and verification processes. It is prospective testing conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of external experts or an explicit "ground truth" establishment process by experts in the context of clinical images or diagnostic performance. The validation tests are primarily engineering and performance-based tests, such as mechanical and microbiological evaluations. The "truth" or acceptance criteria for these tests would be based on established engineering principles, material science standards, and the performance characteristics of the predicate devices.
4. Adjudication method
Not applicable. This submission concerns device modification validation tests (e.g., mechanical, microbial barrier), not a diagnostic performance study requiring expert adjudication of results.
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
Not applicable. This submission is for a modified bronchoscope and sheath system, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a physical medical device, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for the validation tests would be defined by the performance specifications derived from risk analysis, design inputs, and the characteristics of the predicate devices. For example:
- For Microbial Barrier: The "ground truth" is the ability of the sheath to prevent microbial penetration, likely defined by a pass/fail criterion in a microbiology lab test.
- For Sheath Burst/Leak Test: The "ground truth" is the ability of the sheath to withstand a specified pressure without bursting or leaking.
- For Tensile/Elongation: The "ground truth" is the material meeting specified strength and flexibility parameters.
- For Articulation: The "ground truth" is the bronchoscope achieving the specified angles of articulation while sheathed, matching the predicate device.
- For Image Quality: The "ground truth" is the image quality remaining acceptable and comparable to the predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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MAY 24 2002
Vision-Sciences, Inc. April 24, 2002
pecial 510(k) Premarket Notification: Modified Flexible Fiberoptic Bronchoscope and EndoSheath® System
510(k) Summary
| Trade Name: | Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath®System |
|---|---|
| Sponsor: | Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760Registration #1223490 |
| Device Generic Name: | Flexible, fiberoptic bronchoscope with protective sheath system |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
| Predicate Devices: | K963795 – Bronchoscope with Disposable EndoSheath®K990354 – Modified EndoSheath® for Flexible ENT Scopes |
| Manufactured by: | Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760 |
Product Description: The device system described in this 510(k) consists of a modified sterile, disposable sheath designed to fit the modified VSI flexible fiberoptic bronchoscope. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The sheath and scope have been modified to accommodate the "slide-on" sheath installation technique.
Indications for Use:
The Bronchoscope with EndoSheath® System is used for 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.
Safety and Performance:
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. Validation testing including microbial barrier testing, sheath tensile/elongation testing, sheath leak testing, sheathed scope articulation testing and sheathed scope image quality evaluation is included in Design Validation and Verification planning.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VSI Flexible Fiberoptic Bronchoscope and EndoSheath® System has been shown to be safe and effective for its intended use.
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Special 510(k) Premarket Notification.
Design Compariso Table D.1
| Characteristic | Proposed ModifiedBronchoscope withSlide-onEndoSheath® System(Current Submission) | Currently Marketed,UnmodifiedBronchoscope withEndoSheath® System(K963795) | CurrentlyMarketed Slide-onEndoSheath®System for use withENT Scopes(K990354) | Currently MarketedVSI Flexible GIScope/EndoSheath®Systems* | Substantial EquivalenceComparison:Proposed ModifiedBronchoscope with Slide-onEndoSheath® System |
|---|---|---|---|---|---|
| Down Articulation(sheathed scope) | 170°/120° | 170°/120° | Equivalent to unmodifiedVSI Bronchoscope/sheathsystem | ||
| Field of View(apter) | 90° | 90° | |||
| Depth of Field | +2/-8 | +2/-8 | |||
| Insertion Tube OD | 3 - 50 mm | 3 - 50 mm | |||
| Working Channel ID | 6.0 mm | 6.0 mm | |||
| Working Length | 2.1 mm | 2.1 mm | |||
| Submersible scope | 550 mm | 550 mm | |||
| Microbial barrier claim | Yes | Yes | Yes | Yes | Identical to unmodified VSIBronchoscope/sheath system |
| Listing scope models | VSI Bronchoscope | VSI Bronchoscope | Various | VSI GI Scopes | Identical to VSI ENTScope/sheath system |
| Sheath installation method | Slide-on | Vacuum | Slide-on | Pressure | Identical to VSI ENTScope/sheath system |
| Sheath wall thickness | .0020 - .0045" | .010 ± .002" | .0020 - .0045" | No S.E. comparison required - differentsheath material |
Currenty marketed Vision-Sciences G1 Endoscope with EndoSheath System (Sigrem (Sigrem (Sigrem (Sigrem (Sigrem (Sigrem (Sigrem (Signem (Signem (Sig
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| Change Description | Where/How Evaluated (V&V Tests) |
|---|---|
| Sheath material changed | • Sheath burst/leak test• Sheath tensile/elongation test• Sheath installation/system functional test• Microbial barrier test |
| Sheath working channelconstruction changed | • Sheath burst/leak test• Sheath tensile/elongation test• Sheath installation/system functional test• Microbial barrier test |
| Suction valve moved fromsheath to scope | • Sheath installation/system functional test• Pinch valve cycle test |
Table D.3 Product Changes/Testing Summary
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
MAY 2 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vision Sciences. Inc. C/O Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, MA 01432 Attn: Ms. Pam Papineau
Re: K021344
Trade/Device Name: B-F200 Bronchoscope with BSS-F21 Endosheath System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: April 24, 2002 Received: April 29, 2002
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 (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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Page 2 - Ms. Pam Papineau
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal
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
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Special 510(k) Premarket Notification: Device Modification Modified Flexible Fiberoptic Bronchoscope and EndoSheath® System
Page
510(k) Number (if known): DJ2 13 44
Device Name: Flexible Fiberoptic Bronchoscope with EndoSheath® System
Indications for Use:
The VSI Flexible, Fiberoptic Bronchoscope with EndoSheath® System is THE VST rexible, I lochopic Eronomooootic examination of the trachea and other major assages of the lungs, to gather specimens, and/or to find and passagos of the fange, to gign objects from the lungs. The EndoSheath® endoscopioally romove role protective covering for the bronchoscope.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use √
21 CFR 801.109)
(Divisio Division of Ophthalmic Ear, Nose and
510(k) Number K02 1344
Over-the -Counter Use
000008
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. 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 rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.