(42 days)
Not Found
No
The device description focuses on mechanical components and aspiration, with no mention of AI or ML terms or functionalities.
Yes
The device is described as a thrombectomy catheter designed for mechanical thrombectomy of synthetic dialysis grafts, which is a therapeutic intervention to remove clots.
No
The device description clearly states its purpose as "mechanical thrombectomy," which involves the removal of clots, not the diagnosis of a condition. Furthermore, the "Intended Use" also confirms its role in mechanical thrombectomy.
No
The device description clearly outlines physical components like a catheter, drive shaft, macerator, protective basket, and a motor drive unit. It is a hardware device with some electrical/mechanical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "mechanical thrombectomy of synthetic dialysis grafts." This describes a procedure performed on the patient's body to remove a clot, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a mechanical device designed to physically interact with and remove material from within a blood vessel. It involves a rotating macerator, a protective basket, and aspiration. This is consistent with a surgical or interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the Solera Plus Thrombectomy Catheter is a therapeutic device used for a medical procedure, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Solera Plus is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Plus has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Plus. The default position is 'off' to and is designed to minimize blood loss during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Solera Plus Thrombectomy Catheter was tested in the same manner as the Solera The Seriera Thrombectomy Catheter (K022640). All components, subassemblies, and/or full Maginan The required specifications for the completed tests. The Solera Plus was designed under the Bacchus Quality System which is in compliance with 21CFR§820.30.
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
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
| FEB - 4 2004 | 510(k) Summary |
|---|---|
| General Information | |
| Classification | Class II |
| Trade Name | Solera™ Plus Thrombectomy Catheter |
| Submitter | Bacchus Vascular, Inc. |
| 3110 Coronado Drive | |
| Santa Clara, CA 95054 | |
| 408-980-8300 | |
| Contact | Gregory J. Mathison |
| Regulatory Affairs Consultant |
Intended Use
The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
Predicate Devices
| Solera Thrombectomy Catheter
| Manufactured by Bacchus Vascular, Inc. | K003570 |
|---|---|
| Solera MagnumThrombectomy Catheter | |
| Manufactured by Bacchus Vascular, Inc. | K022640 |
Device Description
The Solera Plus is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Plus has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Plus. The default position is 'off' to and is designed to minimize blood loss during the procedure.
1
Materials
All materials used in the manufacture of the Solera Plus are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The Solera Plus Thrombectomy Catheter was tested in the same manner as the Solera The Seriera Thrombectomy Catheter (K022640). All components, subassemblies, and/or full Maginan The required specifications for the completed tests. The Solera Plus was designed under the Bacchus Quality System which is in compliance with 21CFR§820.30.
Summary of Substantial Equivalence
The Solera Plus Thrombectomy Catheter is equivalent to the predicate product, the Solera Magnum Thrombectomy Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc. believes the Solera Plus Thrombectomy Catheter is substantially equivalent to existing legally marketed devices
2
Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
Bacchus Vascular, Inc c/o Ms. Lisa Caparra 3110 Coronado Drive Santa Clara, CA 95054
Re: K033997
Solcra Vascular Plus Thrombectomy Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II Product Code: MCW Dated: January 27, 2004 Received: January 28, 2004
Dear Ms. Caparra:
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
Page 2 - Ms. Lisa Caparra
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 (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 yours,
Dmua R. Lochner
( Bram Zuckerman, M. D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | This application-> K033997 |
|---|---|
| Device Name: | Solera Plus Thrombectomy Catheter |
| Indications for Use: | The Solera Plus Thrombectomy Catheter permits |
| mechanical thrombectomy of synthetic dialysis grafts. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Dung R. Vachner
്vision Sign-Off) Vision of Cardiovascular Devices
10(k) Number KO33997
Confidential