(88 days)
Not Found
No
The summary describes a mechanical introducer device and does not mention any AI or ML components or functionalities.
No
This device is an introducer, which is used to facilitate the insertion of other devices (pacing leads or catheters) into the venous system. It does not itself provide therapy.
No
Explanation: The device is an introducer for inserting pacing leads or catheters, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly indicates it is a physical introducer sheath and dilator, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, the ViaPeel™ Peelable Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous insertion of pacing leads or catheters in the venous system." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device used for insertion, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ViaPeel™ Peelable Introducer is a surgical/procedural device used for accessing the venous system.
N/A
Intended Use / Indications for Use
The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Product codes
DYB
Device Description
The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
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
Performance Testing: The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the ViaPeel Peelable Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Biocompatibility Testing: The material in the components used to create the ViaPeel Peelable Introducer has been demonstrated to be biocompatible through biocompatibility testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
510(K) Summary
510(k) Number: K072248
NOV 0 9 2007
Date Prepared
October 11, 2007
Submitter Information
| Submitter's Name/
Address: | Enpath Medical
2300 Berkshire Lane N
Minneapolis, MN 55441 |
| ------------------------------- | ------------------------------------------------------------------ |
|---|
dical, Inc. shire Lane North Minneapolis, MN 55441
Establishment Registration: 2183787
Contact Person:
Patrice Stromberg Principal Regulatory Affairs Specialist (763) 951-8181 phone (763) 559-0148 fax pstromberg@enpathmed.com
Device Information
Trade Name: Classification Name: Product Code: Regulation: Panel:
ViaPeel™ Peelable Introducer Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular
Performance Standards
No performance standards applicable to this product have been developed under Section 514 of the Act.
Predicate Device
Enpath Medical, Inc. ViaSeal Valved Peelable Introducer (K063182)
1
Device Description
The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.
Indications for Use
The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Summary of Non-Clinical Testing
Performance Testing: The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the ViaPeel Peelable Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Biocompatibility Testing: The material in the components used to create the ViaPeel Peelable Introducer has been demonstrated to be biocompatible through biocompatibility testing.
Summary of Clinical Testing
No clinical evaluations of this product have been performed.
Statement of Equivalence
Through the data and information presented, Enpath Medical, Inc. considers the ViaPeel Peelable Introducer to be substantially equivalent to the cleared Enpath Medical ViaSeal Valved Peelable Introducers based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the ViaPeel Peelable Introducer will perform as intended.
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, composed of three curved lines that resemble feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Enpath Medical, Inc. c/o Ms. Patrice Stromberg, RAC 2300 Berkshire Lane North Minneapolis, MN 55441
Re: K072248
Trade/Device Name: ViaPeel™ Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: October 11, 2007 Received: October 12, 2007
Dear Ms. Stromberg:
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
3
Page 2 - Ms. Patrice Stromberg
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 premated 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
P. luchner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K072248
Device Name: ViaPeel™ Peelable Introducer
Indications for Use:
The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Holmes
(Division Sich-Off) Division o Cardiovascular Devices
510(k) Number_x b72248