(86 days)
Not Found
Not Found
No
The summary describes a mechanical dilatation catheter and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for percutaneous transluminal angioplasty, which is a therapeutic procedure to open narrowed or obstructed blood vessels.
No
The device is a dilatation catheter used for angioplasty, which is a therapeutic procedure to widen narrowed arteries, not to diagnose a condition.
No
The device description clearly describes a physical catheter with an inflatable balloon, radiopaque markers, and specific dimensions, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The Admiral™ .035 Dilatation Catheter is a physical device used for a medical procedure (angioplasty) within the body (percutaneous transluminal). It is used to dilate arteries and fistulae.
- Lack of Diagnostic Testing: The description and intended use do not mention any testing of samples or providing diagnostic information. It is a therapeutic device used for a physical intervention.
Therefore, based on the provided information, the Admiral™ .035 Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Admiral™.035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.
Product codes
74 LIT
Device Description
The Admiral™.035 Dilatation Catheter is an Over-the-Wire, Coaxial, dual lumen design with a inflatable balloon on the distal end and compatible with 0.035" guidewires. Two radiopaque markers indicate the dilating portion of the balloon and aid in balloon placement. The device is available with balloon diameters of 7.0 - 10.0 mm, balloon lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae
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
Performance testing was conducted to demonstrate Safety and Effectiveness and for comparison to the predicate device. Testing included: Balloon Minimum Burst Strength, Compliance, Fatigue, and Inflation/Deflation performance, Bond Strengths and Coating Integrity.
Key Metrics
Not Found
Predicate Device(s)
Boston Scientific Medi-Tech® MARSHAL™ Balloon Dilatation Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR - 3 2003
K 030062 p 1/1
510(k) Summary - Admiral™.035 Dilatation Catheter
| Submitter | Avantec Vascular Corporation
1049 Kiel Court
Sunnyvale, CA 04089 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 6, 2003 |
| Contact Person | James M. Shy
Phone: (408) 743-3125
FAX: (408) 548-0088
e-mail: jshy@avantecvascular.com |
| Device Trade Name | Admiral™.035 Dilatation Catheter |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class II (two)
Product Code: 74 LIT |
| Predicate Device | Boston Scientific Medi-Tech®
MARSHAL™ Balloon Dilatation Catheter |
| Performance Standards | Not promulgated for PTA Catheters. |
| Intended Use | The Admiral™ .035 Dilatation Catheter is indicated for percutaneous
transluminal angioplasty of the femoral, renal, iliac, popliteal,
peroneal and profunda arteries and native or synthetic arteriovenous
dialysis fistulae. It is not intended for use in the coronary vasculature
or the neurovasculature. |
| Device Description | The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial,
dual lumen design with a inflatable balloon on the distal end and
compatible with 0.035" guidewires. Two radiopaque markers indicate
the dilating portion of the balloon and aid in balloon placement. The
device is available with balloon diameters of 7.0 - 10.0 mm, balloon
lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm. |
| Biocompatibility | The Admiral™ .035 Dilatation Catheter has passed all
Biocompatibility testing. |
| Performance Data | Performance testing was conducted to demonstrate Safety and
Effectiveness and for comparison to the predicate device.
Testing included: Balloon Minimum Burst Strength, Compliance,
Fatigue, and Inflation/Deflation performance, Bond Strengths and
Coating Integrity. |
| Summary | The Admiral™ .035 Dilatation Catheter is constructed of similar
materials, is available in similar diameters and lengths, has a similar
design and the same indications as the Predicate Device and other
currently marketed PTA Catheters. Bench and Biocompatibility
testing has demonstrated the safety and effectiveness of the device. |
| Conclusion | The Admiral™ .035 Dilatation Catheter is substantially equivalent to
the predicate device and other currently marketed PTA Catheters. |
1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2003
Avantec Vascular Corporation c/o Mr. James M. Shy 1049 Kiel Court Sunnyvale, CA 04089
Re: K030062
Trade Name: Admiral™ .035 Dilatation Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: LIT Dated: January 6, 2003 Received: January 7, 2003
Dear Mr. Shy:
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.
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
2
Page 2 -- Mr. James M. Shy
(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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely vours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known):
Device Name: Admiral™ .035 Dilatation Catheter
Indications for Use:
The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.
(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)
OR
Over-The- Counter
(Optional Format 1-1-96)
(Division Sign-Off)
Divas... of Cardiovascula.
510(k) Number 4030062