(39 days)
Not Found
No
The summary describes a mechanical device for exchanging delivery sheaths and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used to facilitate the removal and exchange of delivery sheaths, not for treating a disease or condition.
No
The provided text indicates the device is used for the "removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath," which describes a procedural or interventional function, not a diagnostic one. There is no mention of the device being used to identify, diagnose, or monitor a disease or condition. Its components and intended use are purely for device exchange.
No
The device description explicitly lists multiple physical components (delivery sheath, dilator, loader, hemostasis valve, delivery cable, and vise), indicating it is a hardware-based medical device.
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 procedure performed within the body (removal and exchange of a delivery sheath). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details components used for delivering and exchanging a sheath within the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
This device is a surgical or interventional medical device used directly on a patient.
N/A
Intended Use / Indications for Use
The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.
Product codes
DQY
Device Description
The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Device verification testing is presented to demonstrate the AMPLATZER TorqVue Exchange System meets established performance criteria and to support equivalency to the predicate device. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met.
Biocompatibility testing consistent with ISO 10993-1: "Biological Evaluation of Medical devices -- Part 1: Evaluation and Testing" is also presented.
The AMPLATZER TorqVue Exchange System will continue to be sterilized using a validated ETO sterilization process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summary
MAY 1 6 2008
| Date Prepared | April 4, 2008 |
|---|---|
| Submitter | AGA Medical Corporation |
| 5050 Nathan Lane | |
| Plymouth, MN 55442 | |
| Contact | Michelle Nivala |
| Sr. Regulatory Affairs Specialist | |
| Telephone | 763.531.3061 |
| Fax | 763.647.5932 |
| mnivala@amplatzer.com | |
| Trade Name | AMPLATZER TorqVue Exchange |
| System | |
| Common Name | Catheter Delivery System |
| Device Classification | Class II, 21 CFR 870.1250 |
| Catheter, Percutaneous | |
| Product Code | DQY |
Summary of Substantial Equivalence
The design, materials and performance of the AMPLATZER TorqVue Exchange System are substantially equivalent to the following predicate device:
- AMPLATZER TorqVue Delivery System K072313 cleared November 2, 2007. -
Device Description
The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.
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Indications for Use
The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.
Technological Characteristics
The design, materials, performance and packaging materials are substantially equivalent or identical to the predicate device referenced.
Summary of Testing
Device verification testing is presented to demonstrate the AMPLATZER TorqVue Exchange System meets established performance criteria and to support equivalency to the predicate device. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met.
Biocompatibility testing consistent with ISO 10993-1: "Biological Evaluation of Medical devices -- Part 1: Evaluation and Testing" is also presented.
The AMPLATZER TorqVue Exchange System will continue to be sterilized using a validated ETO sterilization process.
Conclusion
AGA Medical Corporation considers the AMPLATZER TorqVue Exchange System to be substantially equivalent to legally marketed predicate devices through the data and information presented.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol composed of three curved lines that resemble a human figure or a stylized representation of a person.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2008
AGA Medical Corporation c/o Ms. Michelle Nivala Senior Regulatory Affairs Specialist 5050 Nathan Lane North Plymouth, MN 55442-3209
Re: K080994
Trade Name: Amplatzer Torqvue Exchange System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY, Dated: April 8, 2008 Received: April 7, 2008
Dear Ms. Nivala:
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.
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Page 2 - Ms. Michelle Nivala
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 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 marketed 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 Biometrics' (OSB) 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,
$\qquad$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K080994 |
|---|---|
| Device Name: | AMPLATZER TorqVue Exchange System |
| Indications for Use: | The AMPLATZER TorqVue Exchange System is intended for |
| removal of an AMPLATZER Delivery Sheath and subsequent | |
| exchange for an AMPLATZER Delivery Sheath of equal or larger | |
| diameter. |
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
510(k) Number_K080994
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