(22 days)
Not Found
No
The summary describes a sterile, disposable protective sheath for an endoscope and an air pulse stimulator. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies focus on the physical properties of the sheath and the air pulse function.
No.
The device acts as a protective covering for an endoscope and, in conjunction with another device, measures sensory discrimination thresholds, neither of which is a therapeutic function.
Yes
The device is described as being used with a stimulator "to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs," which indicates a diagnostic function for assessing the reflex.
No
The device description explicitly states it consists of a "sterile, single use protective sheath," which is a physical hardware component. The performance studies also focus on physical properties like burst/leak testing and tensile strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EndoSheath® System is a protective covering for an endoscope used for visual examination of the upper airway. While it can be used in conjunction with a sensory stimulator to assess a reflex, its primary function is related to the endoscopic procedure itself, not the analysis of a biological sample.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing performed on specimens outside the body.
The device is a medical device used for a diagnostic procedure (endoscopy and potentially sensory testing), but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. The System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The device system described in this 510(k) consists of a sterile, single use protective sheath for use with the VSI ENT-2000 scope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper airway, vocal cords, 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing and air pulse testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990354, K012543, K024095, K964815
Reference Device(s)
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
2 2003 JUL
Vision-Sciences, Inc. June 9, 2003
510(k) Premarket Notification: Traditional Slide-On™ EndoSheath® System for Sensory Testing
510(k) Summary
| Trade Name: | Vision-Sciences Slide-On™ EndoSheath® System for Sensory
Testing |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
Registration #1223490 |
| Device Common
Name: | Endoscope and Accessories - 77EOB |
| 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
K024095 - Slide-On™ EndoSheath® System for Flexible ENT Scopes
Manufactured by:
Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
K964815 - AP-4000 Air Pulse Sensory Stimulator
Manufactured by:
Pentax Precision Instrument Corp.
3117 Commerce Parkway
Miramar, FL 33025 |
Product Description: The device system described in this 510(k) consists of a sterile, single use protective sheath for use with the VSI ENT-2000 scope.
Indications for Use: The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. The System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.
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 and air pulse testing.
Conclusion: Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Slide-On™ EndoSheath® System for Sensory Testing has been shown to be safe and effective for its intended use.
000084
1
Vision-Sciences, Inc.
June 9, 2003
/SI Trans-Nasal Esophagoscope with EndoSheath® System
Substantial Equivalence Comparison
| Characteristic | Proposed VSI Slide-OnTM
EndoSheath® System for Sensory
Testing
(Current Submission) | Currently Marketed VSI ENT
2000 with EndoSheath® System
(K990354, K012534-K024095) | Pentax ENL-Series ENT Scopes for use
with AP-4000 Air Pulse Sensory
Stimulator
(K964815) |
|-----------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Sheath material | Same as VSI predicate devices | Thermoplastic elastomer | N/A - No sheath |
| Window material | Same as VSI predicate devices | Thermoplastic polymer | N/A - No sheath |
| Luer connector material | Same as VSI predicate devices | N/A - no luer connector | N/A - No sheath |
| Proximal connector
tubing material | Same as VSI predicate devices | Thermoplastic polymer | N/A - No sheath |
| Air channel ID | N/A - no working channel | N/A - no working channel | 1.2 mm |
| Adhesives | Same as VSI predicate devices | UV curable | Unknown |
| Microbial barrier claim | Yes | Yes | 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) | N/A - No sheath |
| Sheath length | 12" | 12" | N/A - No sheath |
| Minimum sheath wall
thickness | .002" | .002" | N/A - No sheath |
| Sheath Packaging | Tyvek/Mylar pouch | Tyvek/Mylar pouch | N/A - No sheath |
| Scope working length
(with sheath) | 300 mm | 300 mm | 300 mm |
| Scope insertion tube OD
(distal tip) | 4.1 mm (w/sheath) | 3.6 mm | 3.4 mm |
| Articulation (Up/Down) | 90°/90° (sheathed scope) | 135°/135° (sheathed scope) | 130°/130° |
| Angle of View | 75° | 75° | 75° |
| Depth of Field | 3 - 50 mm | 3 - 50 mm | Unknown |
2
Vision-Sciences, Inc.
June 9, 2003
| Proposed VSI Slide-On™
EndoSheath® System for Sensory
Testing
(Current Submission) | Currently Marketed VSI ENT
2000 with EndoSheath® System
(K990354, K012534, K024095) | Pentax FNL-Series ENT Scopes for use
with AP-4000 Air Pulse Sensory
Stimulator
(K964815) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The EndoSheath® System provides a sterile,
disposable protective covering for the scope
to be used during flexible endoscopic
examination of the upper airway, vocal
cords and/or nasal passages. The System
may also be used in conjunction with the
Pentax AP-4000 Air Pulse Sensory
Stimulator to elicit Laryngeal Closure
Reflex (Swallow) and to measure the
sensory discrimination threshold at which
the reflex occurs in the area of the Upper
Airway innervated by the Superior
Laryngeal Nerve. | The EndoSheath® System
provides a sterile, disposable
protective covering for the scope
to be used during flexible
endoscopic examination of the
upper airway, vocal cords and/or
nasal passages. | To elicit Laryngeal Closure Reflex (Swallow)
and to measure the sensory discrimination
threshold at which the reflex occurs in the
area of the Upper Airway innervated by the
Superior laryngeal Nerve. The structures
being stimulated in the area of the Upper
Airway innervated by the Superior Laryngeal
Nerve are: the Left and Right Anterior Wall
of the Pyriform Sinus and the Left and Right
Aryepiglottic Folds. The device is intended
to be used with a legally marketed endoscope
compatible with the AP-4000, introduced per
nasally in Adult and Pediatric patient
populations with suspected Dysphagia |
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 stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a circle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus symbol.
2 2003 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vision-Sciences, Inc. c/o Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave. Ayer, MA 01432
Re: K031790
Trade/Device Name: Slide-On101 EndoSheath System® for Sensory Testing Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: June 9, 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 (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.
4
Page 2 - Pamela 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), 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. Paigy 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
5
Page
510(k) Number (if known): K031790
Slide-On™ EndoSheath® System for Sensory Testing Device Name:
Indications for Use:
The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. The System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use
C00007
Kunt Horken
Division Sign-Off
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number __