(21 days)
AMPLATZER® Sizing Balloon II 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.
The AMPLATZER® Sizing Balloon II is a triple lumen balloon catheter with three (3) radiopaque marker bands located inside the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4mm apart (inside to inside), and one (1) marker band 15 mm proximal of that pair.
The provided document is a 510(k) summary for the AMPLATZER® Sizing Balloon II, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel efficacy through detailed acceptance criteria and a comprehensive study with specific performance metrics for a new AI device.
Therefore, the information required to populate the tables and answer the questions related to acceptance criteria, AI performance, and AI-specific ground truth methodologies is not present in the provided text. The document describes a non-clinical evaluation of a physical medical device, not a software algorithm or AI.
However, I can extract the relevant information from the document as it pertains to the device's "performance" in the context of a 510(k) submission for a physical device:
Device Performance and Acceptance Criteria (Non-AI device)
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (Summary) |
|---|---|
| Inflation time | Performed (Results not detailed, but deemed acceptable) |
| Deflation time | Performed (Results not detailed, but deemed acceptable) |
| Burst volume | Performed (Results not detailed, but deemed acceptable) |
| Bifurcation separation | Performed (Results not detailed, but deemed acceptable) |
| Tip separation | Performed (Results not detailed, but deemed acceptable) |
| Sidearm stopcock to tube separation | Performed (Results not detailed, but deemed acceptable) |
| Sidearm luer to tube separation | Performed (Results not detailed, but deemed acceptable) |
| Marker band placement | Performed (Results not detailed, but deemed acceptable) |
| Biological testing | Performed (Results not detailed, but deemed acceptable) |
Study Details (Based on the provided K053440 document, for a physical device)
- Sample size used for the test set and the data provenance: Not specified in the provided summary. The tests are "non-clinical" and likely involved a batch of manufactured devices, but the exact sample size for each test is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device where human experts establish ground truth. The "ground truth" for these tests would be established by engineering specifications and measurements.
- Adjudication method for the test set: Not applicable. This is not an AI device.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the ground truth would be based on engineering specifications, physical measurements, and established testing standards for medical devices.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
Conclusion from The Document:
The document concludes that "The AMPLATZER® Sizinq Balloon II is substantially equivalent to currently marketed balloon catheters used for temporary vessel occlusion," based on design modifications, a new supplier, and an additional catheter size, without altering the intended use or fundamental scientific technology of the predicate product. The non-clinical tests listed were performed to support this claim of substantial equivalence.
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K05340
:
OEC 3 0 2005
APPENDIX D 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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510(K) SUMMARY AS DESCRIBED IN 21 CFR 807.92
| Manufacturer: | AGA Medical Corporation682 Mendelssohn AvenueGolden Valley, MN 55427 |
|---|---|
| Establishment Registration: | 2135147 |
| Contact: | Amanda Johnson, Regulatory Affairs Manager(888) 546-4407 phone, (763) 513-9226 faxajohnson@amplatzer.com (e-mail) |
| Date: | December 8, 2005 |
| Product Trade Name: | AMPLATZER® Sizing Balloon II |
| Common/Usual Name: | Temporary Occluding Catheter |
| Classification Name: | Catheter, Intravascular Occluding, Temporary21 CFR 870.4450 (Product Code MJN) |
| Predicate Devices: | The AMPLATZER® Sizing Balloon II is equivalentin design to currently marketed balloon cathetersfor temporary vessel occlusion:• AMPLATZER Sizing Balloon (K993248)• Numed PTA-OS Sizing Balloon (K003320) |
| Performance Standards: | No performance standards have been developedunder section 514 for this device. |
| Device Description: | The AMPLATZER® Sizing Balloon II is a triplelumen balloon catheter with three (3) radiopaquemarker bands located inside the balloon to allow forradiographic measurement. The center of theballoon contains a pair of marker bands 0.4mmapart (inside to inside), and one (1) marker band 15mm proximal of that pair. |
| Intended Use: | The AMPLATZER® Sizing Balloon II is intended foruse in those patients with cardiovascular defectswherein accurate measurement of the defect isimportant to select the appropriately sized occluderdevice. |
Summary of Non-Clinical Testing: The following non-clinial tests were performed on the AMPLATZER® Sizing Balloon II:
- Inflation time .
- Deflation time .
- Burst volume .
- Bifurcation separation .
.
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- . Tip separation
- Sidearm stopcock to tube separation .
- Sidearm luer to tube separation .
- Marker band placement .
- . Biological testing
Conclusions:
The currently marketed AMPLATZER Sizing Balloon (K993248) has been modified to include design modifications, a new supplier and an additional catheter size (18mm). This modified product has been given the trade name AMPLATZER Sizing Balloon II. The modifications made did not alter the intended use or fundamental scientific technology of the predicate product.
The AMPLATZER® Sizinq Balloon II is substantially equivalent to currently marketed balloon catheters used for temporary vessel occlusion, which include the AMPLATZER Sizing Balloon and Numed PTA-OS Sizing Balloon.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
DEC 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AGA Medical Corporation c/o Ms. Amanda Johnson Regulatory Affairs Manager 682 Mendelssohn Avenue Golden Valley, Minnesota 55427
Re: K053440
Trade Name: Amplatzer® Sizing Balloon II Regulation Number: 21CFR 870.4450 Regulation Name: Sizing Balloon Regulatory Class: II (two) Product Code: MJN Dated: December 8, 2005 Received: April 15, 2005
Dear Ms. Johnson:
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. Maureen Montbriand
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blummenau for
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
510(k) Number (if known):
Device Name: AMPLATZER® Sizing Balloon II
Indications for Use:
AMPLATZER® Sizing Balloon II 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR Over-The-Counter Use_
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
An finte for Bram D. Zuckerman-
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K053440
§ 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).