(88 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a physical delivery sheath, with no mention of AI or ML.
No
The device is a delivery sheath used to provide a pathway for other devices, not to directly treat a condition.
No
The device is a delivery sheath designed to provide a pathway for other devices into the peripheral vasculature. Its function is to facilitate the delivery of other instruments, not to diagnose a condition.
No
The device description clearly details a physical medical device (sheath, dilator, materials like Pebax and stainless steel braid) intended for insertion into the body. It is not software.
Based on the provided information, the AMPLATZER TorqVue Delivery Sheath is not an IVD (In Vitro Diagnostic).
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. It mentions materials, construction, and features related to its function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from a patient, not to be inserted into the patient's body to deliver other devices.
N/A
Intended Use / Indications for Use
The AMPLATZER TorqVue 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® 2 Delivery Sheath is a sterile, single-use, 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 peripheral vasculature.
The AMPLATZER® TorqVue® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 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 single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid 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)
Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation.
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
L093476
510(K) Summary (per 21 CFR 807.92)
FEB - 5 2010
-
- Applicant Information Date Prepared:
November 6, 2009
- Applicant Information Date Prepared:
2135147
Submitter:
AGA Medical Corporation 5050 Nathan Lane North Plymouth, MN 55442 USA
Establishment Registration Number:
Contact person:
Diane Carroll Regulatory Affairs Associate Telephone Number: 763.531.3161 Fax Number: 763.647.5932
-
- General Device Information Trade Name:
AMPLATZER® TorqVue® 2 Delivery Sheath
- General Device Information Trade Name:
Common Name:
Classification Name: Classification: Product Code:
Catheter, Percutaneous Class II, 21 CFR 870.1250 DQY
Catheter, Delivery Sheath
Predicate Device:
AMPLATZER® TorqVue® Delivery System, K072313, cleared November 2, 2007 Reg. No. 870.1250
3. Device Description
The AMPLATZER® TorqVue® 2 Delivery Sheath is a sterile, single-use, 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 peripheral vasculature.
The AMPLATZER® TorqVue® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal
1
510(K) Summary (per 21 CFR 807.92) (continued)
end of both the sheath and dilator are straight. The body of each sheath is radiopaque for visibility under fluoroscopy.
The single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid 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® 2 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.
5. Comparison to Predicate
The AMPLATZER® TorqVue® 2 Delivery Sheath has the following similarities when compared to the predicate device:
- · Indications for Use for the TorqVue 2 Delivery Sheath are 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
6. Test Data
The functional characteristics of the AMPLATZER® TorqVue® 2 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation.
7. Summary
Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER® TorgVue® 2 Deliverv Sheath is substantially equivalent to the currently marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
AGA Medical Corporation c/o Ms. Diane Carroll Regulatory Affairs Associate 5050 Nathan Lane Plymouth, MN 55442
FEB - 5 2010
Re: K093476
AMPLATZER® TorqVue® 2 Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 06, 2009 Received: November 09, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
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/Reporta.Problem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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: | K093476 |
|---|---|
| Device Name: | AMPLATZER TorqVue 2 Delivery Sheath |
Indications for Use: The AMPLATZER ToroVue Delivery Sheath is intend
The AMPLATZER TorqVue 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) ് Nivision Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093476
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