(288 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) used for measurement. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on the physical properties and biocompatibility of the device.
No
The device is used for accurate measurement of cardiovascular defects to select an appropriately sized occluder device, which is a diagnostic/measurement function rather than a therapeutic one itself.
Yes
The device is used for "accurate measurement of the defect" in cardiovascular defects, which is a diagnostic function to determine the appropriate size of an occluder device.
No
The device description clearly states it is a "7F double lumen balloon catheter made from radiopaque nylon" and describes physical components like a balloon and shaft, indicating it is a hardware device, not software-only.
Based on the provided information, the AMPLATZER® Sizing Balloon is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device." This describes a device used within the body for a diagnostic procedure (measurement), not a test performed outside the body on biological samples.
- Device Description: The description details a physical catheter with a balloon designed for insertion into the cardiovascular system. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the AMPLATZER® Sizing Balloon is an invasive medical device used for measurement during a cardiovascular procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AMPLATZER® Sizing Balloon is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
Product codes
MJN
Device Description
The AMPLATZER® Sizing Balloon is a 7F double lumen balloon catheter made from radiopaque nylon. The balloon is compliant and made from a very thin stretchable plastic membrane. The balloon-carrying segment is angled to 45° to the shaft providing a more or less right-angled position in relation to the atrial septum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular
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
The following in vitro functional tests were performed on the AMPLATZER Sizing Balloon:
- Calculation of Inflation/Deflation Time, cc, . Leakage and Burst Testing
- Pull Test Bifurcation and Port Tubing
- Pull Test Bifurcation and Shaft .
- Animal Testing .
In addition the following Biocompatibility Testing was performed:
- Hemocompatibility
- Cytotoxicity
- Dermal Sensitization
- Intracutaneous Injection .
- Systemic Toxicity .
- Pyrogenicity .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
K93248
JUL 1 2 2000
Summary of Safety and Effectiveness 2.
Sponsor:
AGA Medical Corporation 682 Mendelssohn Avenue Golden Valley, MN 55427
Contact person:
Jodi L. Locher Regulatory Affairs Manager
October 1, 1999 Submission Date:
Balloon Dilatation Catheter Common/Usual Name:
AMPLATZER® Sizing Balloon Trade/Proprietary name:
Classification Name:
AGA Medical Corporation believes the proposed device can be described by the following device classification names:
Catheter, Percutaneous ( 870.1250) .
Catheter, Balloon Type (878.4200) .
AGA Medical believes the proposed device is Device Classification: classified as a Class II device under:
- 74 DQY .
- 79 GBA .
Device Description: The AMPLATZER® Sizing Balloon is a 7F double lumen balloon catheter made from radiopaque nylon. The balloon is compliant and made from a very thin stretchable plastic membrane. The balloon-carrying segment is angled to 45° to the shaft providing a more or less right-angled position in relation to the atrial septum.
Intended Use: The AMPLATZER® Sizing Balloon is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
1
Substantial Equivalence: The AMPLATZER® Sizing Balloon is equivalent design to currently marketed balloon in catheters used for temporary vessel occlusion.
The intended use is equivalent to the Cordis Corporation STABILIZER Marker Wire and the WIZDOM Marker Wire (K962765).
Safety and Performance: The following in vitro functional tests were performed on the AMPLATZER Sizing Balloon:
- Calculation of Inflation/Deflation Time, cc, . Leakage and Burst Testing
- Pull Test Bifurcation and Port Tubing ●
- Pull Test Bifurcation and Shaft .
- Animal Testing .
In addition the following Biocompatibility Testing was performed:
- Hemocompatibility ●
- Cytotoxicity .
- Dermal Sensitization ●
- Intracutaneous Injection .
- Systemic Toxicity .
- Pyrogenicity .
Statement of Equivalence: The
AMPLATZER® Sizing Balloon is substantially equivalent in product design and packaging to currently marketed balloon catheters used for temporary vessel occlusion. The proposed device is substantially equivalent in intended use (as a measurement tool with of marker bands) to incorporation the Marker Wires STABLIZER and WIZDOM currently marketed by Cordis Corporation.
AMPLATZER® Sizing Balloon
2-2
Premarket Notification
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2000
Ms. Jodi Raus Regulatory Affairs Manager AGA Medical Corporation 682 Mendelssohn Avenue Golden Valley, MN 55427
K993248 Re : Amplatzer® Sizing Balloon Regulatory Class: II (Two) Product Code: MJN June 12, 2000 Dated: Received: June 14, 2000
Dear Ms. Raus:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your section of (i.). He determined the device is the device referenced above and no have to use stated in the substantially equivated (102 cordicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate commerce prior to they connect that have been reclassified
Medical Device Amendments, or to devices that Food, Drug, and Medical Device Amendments, of on on the Federal Food, Drug, and in accordance with the provisions or cal market the device, subject to Cosmeric Act (Act). Tod maj), coof the Act. The general controls the general Controls provisions of the montal registration, and provisions of the nee increase acquiring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device is crassified (bes aboro), it may be subject to such Controls) of Class III (Fremailes of regulations affecting your device additional Controls: "Existing any and Regulations, Title 21, Parts 800
can be found in the Code of Federal Regulations, Title 21, Parts 800 can be round in the Code of reactal nogermination assumes compliance co 655. It babbeansed in the current of the requirements, as set with the Current Cood namall Regulation (QS) for Medical Devices: rorth in the Quarrey byboam negalation and that, through periodic QSS General Tegulation (Er Original Administration (FDA) will werify such Inspections, the rood and bray with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. regaratory acur device in the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premarked inders sections 531 through 542 of the Act obligation you might have ander booses Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Jodi Raus
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Brim E. Aum
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) NUMBER (IF KNOWN): K993748
DEVICE NAME: AMPLATZER®Sizing Balloon
INDICATIONS FOR USE:
The AMPLATZER® Sizing Balloon is indicated for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) X
Brian E. Davagni
OR Over - The - Counter - Use (Optional Format 1-2-96) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ._