(89 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a dilator sheath, with no mention of AI or ML capabilities.
No.
The device's intended use is for percutaneous dilation of tissue and introduction/support of intravascular catheters, which are procedural aids rather than providing a direct therapeutic effect on a disease or condition.
No
The device description and intended use indicate it is a tool for dilation and introduction/support of catheters, not for diagnosing medical conditions. It facilitates a medical procedure rather than identifying a problem.
No
The device description clearly describes a physical, single lumen polymer sheath with metallic radiopaque marker bands, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for procedures like percutaneous dilation and introduction of catheters. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The description details a physical sheath designed to be inserted into the body. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Anatomical Site: The anatomical sites mentioned (tissue surrounding cardiac leads, intravascular) are all within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or providing diagnostic information based on laboratory tests, which are hallmarks of IVDs.
Therefore, the VisiSheath Dilator Sheath is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The VisiSheath™ Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.
Product codes
DRE
Device Description
The VisiSheath™ Dilator Sheath is a single lumen polymer sheath used independently or as a support for an inner sheath to facilitate tissue dilation. One end is terminated with a 45° angle cut, while the other end is blunt. Both ends contain a metallic radiopaque marker band to enable fluoroscopic identification of tip location and orientation. An additional exterior mark aligned with the tip of the 45° angle cut permits visual identification of sheath orientation. There are multiple diameter and length options available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Spectranetics performed device functional testing to support that the VisiSheath™ Dilator Sheath functions as intended. All device functional test results for the VisiSheath™ Dilator Sheath met specified requirements.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
K07237S
510(k) Premarket Notification 510(k) Summary of Substantial Equivalence Visisheath Dilator Sheath
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
NOV - 2 2009
Proprietary Name:
Common Name:
Classification Name:
Device Classification:
Product Classification and Code:
Classification Panel:
Establishment Registration Number: 3007284006
Contact Person:
Cardiovascular Devices Cheryl Hastings Regulatory Affairs
21 CFR 870.1310, DRE
Visisheath™ Dilator Sheath
dilator, vessel, for percutaneous
Dilator sheath
catheterization
Class II
Spectranetics Corporation 9965 Federal Drive Colorado Springs, CO 80921
Telephone: (719) 659-1848 Facsimile: (719) 447-2040 E-mail: Cheryl.hastings(a)spnc.com
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
1
Device Description
The VisiSheath™ Dilator Sheath is a single lumen polymer sheath used independently or as a support for an inner sheath to facilitate tissue dilation. One end is terminated with a 45° angle cut, while the other end is blunt. Both ends contain a metallic radiopaque marker band to enable fluoroscopic identification of tip location and orientation. An additional exterior mark aligned with the tip of the 45° angle cut permits visual identification of sheath orientation. There are multiple diameter and length options available.
Indication for Use
The VisiSheath™ Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.
Substantially Equivalent Devices
In Spectranetics' opinion, the VisiSheath™ Dilator Sheath is believed to be substantially equivalent to the predicate device.
Summary of Studies
Spectranetics performed device functional testing to support that the VisiSheath™ Dilator Sheath functions as intended. All device functional test results for the VisiSheath™ Dilator Sheath met specified requirements.
Conclusion (Statement of Equivalence)
Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the Spectranetics VisiSheath™ Dilator Sheath through this 510(k) Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Spectranetics Corp. ATTN: Cheryl Hastings Regulatory Affairs and Compliance Manager 9965 Federal Drive Colorado Springs, CO 80921
NOV - 2 2009
Re: K092378
Trade/Device Name: Spectranetics VisiSheath Dilator Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: July 24, 2009 Received: August 19, 2009
Dear Ms. Hastings:
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 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Hastings
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.M.R.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number K092378
Device Name: Spectranetics VisiSheath™ Dilator Sheaths
Indications for Use:
The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K092378 |
| Page | 1 of 1 |