(22 days)
Not Found
No
The summary describes a mechanical delivery sheath and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a delivery sheath used to provide a pathway for other devices; it does not directly treat a disease or condition.
No
Explanation: The device is described as a "delivery sheath" intended to "provide a pathway through which devices are introduced within the peripheral vasculature." Its function is to facilitate the delivery of other devices, not to diagnose a condition or disease.
No
The device description clearly details a physical medical device (sheath, dilator) made of materials like Pebax and stainless steel, intended for insertion into the body. It is not software.
Based on the provided information, the AMPLATZER® TorqVue® 3 Delivery Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide a pathway through which devices are introduced within the peripheral vasculature." This describes a device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details a physical sheath designed for insertion into blood vessels.
- Anatomical Site: The anatomical site is the "Peripheral vasculature," which is within the body.
- Input Imaging Modality: Fluoroscopy is used for visualization during the procedure, not for analyzing biological samples.
- Performance Studies: The performance studies focus on physical properties and device interaction, not on the analysis of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AMPLATZER® TorqVue® 3 Delivery Sheath does not perform this function.
N/A
Intended Use / Indications for Use
The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.
The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.
The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
The functional characteristics of the AMPLATZER® TorqVue® 3 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 3 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to torque and bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation at baseline (Time=0) and after 3-year accelerated aging.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
JUL - 9 2009
1091793
510(K) Summary (per 21 CFR 807.92)
-
- Applicant Information
Date Prepared:
- Applicant Information
June 15, 2009
Submitter:
5050 Nathan Lane North Plymouth, MN 55442 USA
2135147
AGA Medical Corporation
Registration Number:
Contact person:
Establishment
Diane Carroll Regulatory Affairs Associate
Telephone Number: Fax Number:
763.531.3161 763.647.5932
2. General Device Information
Trade Name: Common Name:
Classification Name: Classification: Product Code:
Predicate Device:
AMPLATZER® TorqVue® 3 Delivery Sheath Catheter, Delivery Sheath
Catheter, Percutaneous Class II, 21 CFR 870.1250 DQY
AMPLATZER® TorqVue® Delivery System, K072313, cleared November 2, 2007 Reg. No. 870.1250
AMPLATZER® TorqVue® LP Delivery System, K080757, cleared April 18, 2008 Reg. No. 870.1250
1
510(K) Summary (per 21 CFR 807.92) (continued)
3. Device Description
The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.
The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.
The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.
4. Intended Use
The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.
5. Comparison to Predicate
The AMPLATZER® TorqVue® 3 Delivery Sheath has the following similarities when compared to the predicate device:
- Indications for Use for the TorqVue 3 Delivery Sheath are identical . to the TorqVue LP Delivery System and a subset of the TorqVue Delivery System
- . Operating principal is the same
- Manufacturing materials and processes are similar .
- Sterilization method is the same ●
- Sterile package materials are the same
2
6. Test Data
The functional characteristics of the AMPLATZER® TorqVue® 3 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 3 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to torque and bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation at baseline (Time=0) and after 3-year accelerated aging.
7. Summary
Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER® TorqVue® 3 Delivery Sheath is substantially equivalent to the currently marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 9 2009
AGA Medical Corporation c/o Ms. Diane Carroll Regulatory Affairs Associate 5050 Nathan Lane Plymouth, MN 55442
Re: K091793
Trade/Device Name: AMPLATZER TorqVue 3 Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: June 15, 2009 Received: June 17, 2009
Dear Ms. Carroll:
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.
4
Page 2 - Ms. Diane Carroll
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 device-related adverse events) (21 CFR 803); 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.
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Duna D. Vorhmer
h
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number:
K_091793
Device Name:
AMPLATZER® TorqVue® 3 Delivery Sheath
Indications for Use:
The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter-Use (Part 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)
Dura R. LaLonde
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
14091793 510(k) Number
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