(55 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical occlusion device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "occlusion device" used for "arterial and venous embolizations in the peripheral vasculature," which are therapeutic interventions aimed at blocking blood vessels to treat various conditions.
No
The device is described as an embolization device used for arterial and venous occlusions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, implantable medical device made of Nitinol mesh, along with associated hardware components like a delivery wire and loader device. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arterial and venous embolizations in the peripheral vasculature." This describes a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is a "self-expanding Nitinol mesh occlusion device" designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis.
Therefore, the AMPLATZER® Vascular Plug II is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a stainless steel screw. The AMPLATZER® Vascular Plug II is provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire comes coiled in a hoop dispenser The AMPLATZER® Vascular Plug II is available in fully-expanded diameters of: 3 mm to 22 mm.
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)
Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Vascular Plug II are substantially equivalent to the predicate device cited. This included radial force testing, handoff and advancement forces, device deployment, recapture and detachment verification and overall strength determinations. Animal testing was also performed to validate the product under simulated conditions of use.
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
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
0
K07/699
AUG 1 5 2007
510(k) SUMMARY of Safety and Effectiveness
l. Applicant Information:
| Date Prepared:
Submitter: | June 19, 2007
AGA Medical Corporation |
|-----------------------------------|-----------------------------------------------------|
| Address: | 5050 Nathan Lane North
Plymouth, MN 55442 |
| Establishment
Registration No. | 2135147 |
| Contact Person: | Jodi L. Raus, RAC
Director of Regulatory Affairs |
| Telephone Number:
Fax Number: | (763) 531-3056
(763) 647-5932 |
ll. Device Information:
| Trade Name: | AMPLATZER® Vascular Plug II |
|---|---|
| Common Name: | Catheter Delivery System |
| Classification Name: | Device, Embolization, Vascular |
|---|---|
| Classification: | Class II, 21 CFR 870.3300 |
| Product Code: | KRD |
-
AMPLATZER® Vascular Plug II Predicate Device: 510(k) No. K071125, Reg. No. 870.3300; Product Code: KRD
Predicate Device Intended Use: The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature. -
The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-Device Description: lobed, self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a The AMPLATZER® Vascular Plug II is stainless steel screw. provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire comes coiled in a hoop dispenser
The AMPLATZER® Vascular Plug II is available in fully-expanded diameters of: 3 mm to 22 mm.
AMPLATZER® Vascular Plug - II Special 510(k): Device Modification
510(k) Summary Page 1 of 2
1
The AMPLATZER® Vascular Plug II is indicated for arterial and Intended Use: venous embolizations in the peripheral vasculature.
Comparison to Predicate Device:
The AMPLATZER® Vascular Plug II is substantially equivalent to the predicate device cleared by K071125. The two devices are both embolization devices with identical intended uses, Both devices have exactly the same patient-contacting materials, and have the same Nitinol Delivery Wire. Both devices have the same triple-lobed, multiple wire layer design. Both devices come preloaded in a loader device. The two devices have the same operating principle, where a self-expanding Nitinol mesh device is retrieved in a loader, delivered to the desired embolization site through a delivery catheter and, upon release, both devices expand to occlude the vessel or desired embolization site.
One minor modification was made to the AMPLATZER® Vascular Plug II:
- Extended size range, with the addition of 3 mm, 18 . О mm, 20 mm and 22 mm devices to the currentlyapproved size range of 4-16 mm devices.
Test Data:
Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Vascular Plug II are substantially equivalent to the predicate device cited. This included radial force testing, handoff and advancement forces, device deployment, recapture and detachment verification and overall strength determinations. Animal testing was also performed to validate the product under simulated conditions of use.
Based on the technical information, intended use, laboratory Summary: verification tests and in vitro and in vivo performance information provided, the AMPLATZER® Vascular Plug II is substantially equivalent to the currently marketed predicate device.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2007
AGA Medical Corporation c/o Ms. Jodi L. Raus 5050 Nathan Lane North Plymouth, MN 55442
Re: K071699
Trade/Device Name: AMPLATZER Vascular Plug II Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: July 19, 2007 Received: July 20, 2007
Dear Ms. Raus:
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.
3
Ms. Jodi L. Raus
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 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,
B. Comminsion for
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
510(k) Number (if known): KO71699
AMPLATZER® Vascular Plug II Device Name:
Indications for Use:
The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hummer
ardiovascular 510fk) Numb
AMPLATZER® Vascular Plug – II Special 510(k): Device Modification
Indications for Use Statement Page 1 of 1