(193 days)
Not Found
No
The description focuses on the physical characteristics and function of a delivery sheath, with no mention of AI or ML capabilities.
No
The device is a delivery sheath designed to provide a pathway for other devices to be introduced into the heart, rather than directly treating a condition itself.
No
This device is a delivery sheath designed to provide a pathway for other devices into the heart, not to diagnose a condition.
No
The device description clearly details a physical, sterile, single-use delivery sheath made of Pebax materials, designed to be inserted into the body. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The AMPLATZER TorqVue 45°x45° Delivery Sheath is a medical device used to physically deliver other devices into the heart. It is a tool for intervention, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for providing a "pathway through which devices are introduced within the chambers of the heart." This is a procedural function, not a diagnostic one based on analyzing samples.
- Device Description: The description focuses on the physical characteristics and function of the sheath for delivery, not on any analytical capabilities.
Therefore, based on the provided information, the AMPLATZER TorqVue 45°x45° Delivery Sheath is a medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AMPLATZER TorqVue 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The AMPLATZER® TorqVue® 45°x45° Delivery Sheath is a sterile, singleuse, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the chambers of the heart.
The AMPLATZER® TorqVue® 45°x45° Delivery Sheath has a usable length of 100 cm and is available in 9 Fr, 10 Fr, 12 Fr, and 13 Fr sizes (inner diameter). A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are curved approximately 45° in two dimensions, resulting in a three-dimensional geometry. The 10 Fr, 12 Fr, and 13 Fr sizes also include a flush adapter that facilitates connection of accessories to the proximal end of the sheath.
The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of two segments of different Pebax materials to provide support for device advancement and tip flexibility for vessel engagement. 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
chambers of the heart
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)
Bench testing of the AMPLATZER TorqVue® 45°x45° Delivery Sheath included verification of the distal curve dimensions after sterilization, distribution simulation, and six-month 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.
AMPLATZER® TorqVue® Delivery System, K072313
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
MAY 12 2009
510(K) Summary (per 21 CFR 807.92)
-
- Applicant Information
Date Prepared:
- Applicant Information
October 30, 2008
Submitter:
AGA Medical Corporation 5050 Nathan Lane North Plymouth, MN 55442 USA
Regulatory Affairs Associate
Establishment Registration Number:
Contact person:
Telephone Number: Fax Number:
763.531.3161 763.647.5932
Diane Carroll
2135147
2. General Device Information
| Trade Name: | AMPLATZER® TorqVue® 45°x45° Delivery
Sheath |
|----------------------|------------------------------------------------|
| Common Name: | Catheter, Delivery Sheath |
| Classification Name: | Catheter, Percutaneous |
| Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Predicate Device: | AMPLATZER® TorqVue® Delivery System |
AMPLATZER® TorqVue® Delivery System, K072313, cleared November 2, 2007 Reg. No. 870.1250
3. Device Description
The AMPLATZER® TorqVue® 45°x45° Delivery Sheath is a sterile, singleuse, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the chambers of the heart.
1
The AMPLATZER® TorqVue® 45°x45° Delivery Sheath has a usable length of 100 cm and is available in 9 Fr, 10 Fr, 12 Fr, and 13 Fr sizes (inner diameter). A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are curved approximately 45° in two dimensions, resulting in a three-dimensional geometry. The 10 Fr, 12 Fr, and 13 Fr sizes also include a flush adapter that facilitates connection of accessories to the proximal end of the sheath.
The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of two segments of different Pebax materials to provide support for device advancement and tip flexibility for vessel engagement. 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® 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.
5. Comparison to Predicate
The AMPLATZER® TorqVue® 45°x45° Delivery Sheath has the following similarities when compared to the predicate device:
- . Indications for Use are similar; the AMPLATZER® TorqVue® 45°x45° Delivery Sheath indications are a subset of the predicate's indications
- . Operating principal is the same
- Manufacturing materials and processes are the same .
- ·Sterilization method is the same .
- Sterile package materials are the same .
2
6. Test Data
The functional characteristics of the AMPLATZER TorqVue® 45°x45° Delivery Sheath are substantially equivalent to the predicate device cited. Bench testing of the AMPLATZER TorqVue® 45°x45° Delivery Sheath included verification of the distal curve dimensions after sterilization, distribution simulation, and six-month accelerated aging.
7. Summary
Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER TorqVue® 45°x45° Delivery Sheath is substantially equivalent to the currently marketed predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
MAY 12 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AGA Medical Corporation c/o Ms. Diane Carroll Regulatory Affairs Associates 5050 Nathan Lane North Plymouth, MN 55442-3209
Re: K083214
Trade/Device Name: AMPLATZER® TorqVue® 45° x 45°Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: May 4, 2009 Received: May 5, 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.
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
4
Page 2 - Ms. Diane Carroll
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Bram D. Zuckerman, M.D. Diredtor Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number: | K083214 |
|---|---|
| Device Name: | AMPLATZER TorqVue 45°x45° Delivery Sheath |
| Indications for Use: | The AMPLATZER TorqVue 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart. |
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)
(Division Sign-Off)
Division of Cardiovascular Devices
$10(k) Number K083214
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