(28 days)
Not Found
No
The 510(k) summary describes a disposable sheath for endoscopes and does not mention any AI or ML capabilities.
No
The device is described as a "protective covering for the scope" and its primary function is to "eliminate the need for high-level disinfection of the scope". While it allows a "visual-only" scope to be used as a "multipurpose diagnostic and therapeutic device" by providing a working channel, the device itself is a sheath that facilitates the use of other tools, not a therapeutic device in and of itself.
Yes
Explanation: The "Device Description" states that the device allows a "visual-only diagnostic flexible ENT scope to be utilized as a multipurpose diagnostic and therapeutic device." This directly indicates its role in diagnosis.
No
The device description explicitly states it consists of "modified sterile, disposable sheaths," which are physical components, not software. The performance studies also focus on physical properties like microbial barrier, tensile strength, and leak/burst testing, further indicating a hardware-based device.
Based on the provided information, the EndoSheath® System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device provides a protective covering for a scope used during flexible endoscopic examination of the upper airway, vocal cords, and nasal passages. This is a procedure performed in vivo (on a living patient), not in vitro (outside the body, typically on biological samples).
- Device Description: The description focuses on the physical characteristics of the sheath and its function in protecting the scope and providing a working channel. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnostic information derived from laboratory testing
The EndoSheath® System is a medical device used to facilitate an endoscopic procedure, which is a clinical examination performed directly on the patient.
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.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The device system described in this 510(k) consists of modified sterile, disposable sheaths designed to fit various models of flexible fiberoptic ENT scopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The disposable sheath features a specially designed working channel that allows a "visual-only" diagnostic flexible ENT scope to be utilized as a multipurpose diagnostic and therapeutic device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airway, vocal cords and/or 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)
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 and sheath leak/burst testing is included in Design Validation and Verification planning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 0 9 2003
510(k) Summary
| Trade Name: | Vision-Sciences EndoSheath® System for use with Flexible ENT
Scopes |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
Registration #1223490 |
| Device Generic Name: | Disposable sheath for flexible ENT scopes |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K990354 - Modified 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 modified sterile, disposable sheaths designed to fit various models of flexible fiberoptic ENT scopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The disposable sheath features a specially designed working channel that allows a "visual-only" diagnostic flexible ENT scope to be utilized as a multipurpose diagnostic and therapeutic device
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.
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 and sheath leak/burst testing 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 EndoSheath® System for use with Flexible ENT Scopes has been shown to be safe and effective for its intended use.
1
| Proposed Modified VSI
Channel ENT EndoSheath® System
(Current Submission) | Currently Marketed, Unmodified
VSI ENT EndoSheath® System
(K990354, K012534) | Currently Marketed, Unmodified
VSI Bronchoscope EndoSheath®
System
(K021344) |
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Same as VSI predicate devices | Thermoplastic elastomer | Thermoplastic elastomer |
| Same as VSI predicate devices | Thermoplastic polymer | Thermoplastic polymer |
| Same as VSI predicate devices | N/A - no luer connector | Thermoplastic polymer |
| Same as VSI predicate devices | N/A - no working channel | 2.1 mm |
| 2.1 mm | N/A - no working channel | Thermoplastic polymer |
| Same as VSI predicate devices | Thermoplastic polymer | Yes |
| Same family of adhesives as VSI
predicate devices | Yes | Thermoplastic polymer |
| Identical to VSI predicate devices | Thermoplastic polymer | Yes |
| Yes | Yes | VSI Bronchoscope |
| Vision-Sciences ENT-2000/E-F100
Olympus ENF-P4/P3/P2
Pentax VNL-1330 and FNL-
10S/10BS/10P2/10RP3/13S
Welch Allyn RL-150 | Vision-Sciences ENT-2000/E-F100
Olympus ENF-P4/P3/P2
Pentax VNL-1330 and FNL-
10S/10BS/10P2/10RP3/13S
Welch Allyn RL-150 | Vision-Sciences ENT-2000/E-F100 |
| Karl Storz 11101RP/11101RP1 | Karl Storz 11101RP/11101RP1 | |
| 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) |
| .002" | .002" | .002" |
| For use in flexible, endoscopic
examination of the upper airway, vocal
cords and/or nasal passages. | For use in flexible, endoscopic
examination of the upper airway, vocal
cords 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. |
Figure D.2 Figure D.2
Design/Materials Comparison
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and sides. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
Vision-Sciences, Inc. c/o Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K024095
Trade/Device Name: Endosheath System for use with Flexible ENT Scopes Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: December 6, 2002 Received: December 12, 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. Iisting 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
3
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. 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) 594-4692. 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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Page 1
510(k) Number (if known): ¥02 ¥095
Device Name: EndoSheath® System for use with Flexible ENT Scopes
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Keun H. baker
Jivision Sig Division of Oph Nose and Throat
| Labels | Values |
|---|---|
| 510(k) Number | Ko 24095 |