(288 days)
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.
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.
The acceptance criteria and study that proves the device meets the acceptance criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| In Vitro Functional Tests | ||
| Inflation/Deflation Time calculation (cc) | Not explicitly stated (implied suitable performance) | Performed |
| Leakage and Burst Testing | Not explicitly stated (implied suitable performance) | Performed |
| Pull Test Bifurcation and Port Tubing | Not explicitly stated (implied suitable performance) | Performed |
| Pull Test Bifurcation and Shaft | Not explicitly stated (implied suitable performance) | Performed |
| Biocompatibility Testing | ||
| Hemocompatibility | Not explicitly stated (implied suitable performance) | Performed |
| Cytotoxicity | Not explicitly stated (implied suitable performance) | Performed |
| Dermal Sensitization | Not explicitly stated (implied suitable performance) | Performed |
| Intracutaneous Injection | Not explicitly stated (implied suitable performance) | Performed |
| Systemic Toxicity | Not explicitly stated (implied suitable performance) | Performed |
| Pyrogenicity | Not explicitly stated (implied suitable performance) | Performed |
| Other Tests | ||
| Animal Testing | Not explicitly stated (implied suitable performance) | Performed |
Note: The document states that these tests were "performed" but does not provide specific quantitative acceptance criteria or the results of these tests, beyond the implication that they were successfully met to establish substantial equivalence.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for any of the performed tests (in vitro functional, biocompatibility, or animal testing).
- Data Provenance: The tests are described as "in vitro functional tests," "biocompatibility testing," and "animal testing," implying laboratory-based and animal-based studies. The country of origin is not specified but is presumably the location of AGA Medical Corporation (Golden Valley, MN, USA). The studies appear to be prospective for the purpose of demonstrating safety and performance.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
Not applicable. The document describes laboratory, in-vitro, and animal testing. There is no mention of human-expert-established ground truth for a test set in the context of diagnostic performance.
4. Adjudication Method (Test Set)
Not applicable. There is no mention of expert adjudication for a test set as the studies involve functional, biocompatibility, and animal testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission focuses on the safety and performance of the device itself, not on the improvement of human readers with or without AI assistance. The device is a physical sizing balloon, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study in the context of an algorithm's performance was not done. The device is a physical medical device (balloon catheter), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests performed would be based on:
- In vitro functional tests: Engineering and materials science standards for catheter performance (e.g., measuring inflation/deflation, material strength, leakage limits).
- Biocompatibility tests: Established ISO standards and guidelines for biological evaluation of medical devices (e.g., absence of cytotoxicity, sensitization, systemic toxicity).
- Animal testing: Physiological and pathological observations in animal models to assess safety and performance in a living system.
8. Sample Size for the Training Set
Not applicable. The document does not describe a training set for an algorithm. The "training set" concept is relevant for machine learning or AI models, which is not the nature of this medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm. The device's design and manufacturing processes are likely informed by established medical device development guidelines and previous knowledge, rather than a data-driven training set.
{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
{4}------------------------------------------------
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 ._
§ 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).