(116 days)
No
The device description focuses on mechanical components and aspiration, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for mechanical thrombectomy, which is a therapeutic intervention to remove blood clots.
No
The device description indicates that the Solera Magnum Thrombectomy Catheter is used for "mechanical thrombectomy," which is a treatment to remove clots, not to diagnose a condition.
No
The device description clearly outlines physical components like a catheter, drive shaft, macerator, and protective basket, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Solera Magnum Thrombectomy Catheter is a device used inside the body (in vivo) to mechanically remove blood clots from synthetic dialysis grafts. It directly interacts with the patient's anatomy.
- Intended Use: The intended use clearly states "permits mechanical thrombectomy of synthetic dialysis grafts," which is a therapeutic procedure performed within the body.
The description of the device and its function aligns with an interventional medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Solera Magnum Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
Product codes
MCW
Device Description
The Solera Magnum is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Magnum 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 Magnum. 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
synthetic dialysis grafts
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 Magnum Thrombectomy Catheter was tested in the same manner as the Solera Thrombectomy Catheter (K003570). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Solera Magnum 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Bacchus Vascular, Inc.
510(k) Summary
General Information
| Classification | Class II | DEC 0 2 2002 |
|---|---|---|
| Trade Name | Solera™ Magnum Thrombectomy Catheter | |
| Submitter | Bacchus Vascular, Inc. | |
| 3110 Coronado Drive | ||
| Santa Clara, CA 95054 | ||
| Contact | 408-980-8300 | |
| Gregory J. Mathison | ||
| Vice President, Clinical and Regulatory Affairs, Quality Assurance |
Intended Use
The Solera Magnum Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
| Predicate Devices | |
|---|---|
| Solera Thrombectomy Catheter | K003570 |
| Manufactured by Bacchus Vascular, Inc. |
Device Description
The Solera Magnum is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Magnum 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 Magnum. The default position is 'off' to and is designed to minimize blood loss during the procedure.
Materials
All materials used in the manufacture of the Solera Magnum are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The Solera Magnum Thrombectomy Catheter was tested in the same manner as the Solera Thrombectomy Catheter (K003570). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Solera Magnum was designed under the Bacchus Quality System which is in compliance with 21CFR§820.30.
Summary of Substantial Equivalence
The Solera Magnum Thrombectomy Catheter is equivalent to the predicate product, the Solera Thrombectomy Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc. believes the Solera Magnum Thrombectomv Catheter is substantially equivalent to existing legally marketed devices.
Confidential
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 2 2002
Bacchus Vascular c/o Mr. Gregory J. Mathison 3110 Coronado Drive Santa Clara, CA 95054
Re: K022640
Solera™ Magnum Thrombectomy Catheter Regulation Number: 870.4875 Regulation Name: Peripheral Atherectomy Catheter Regulatory Class: Class II (two) Product Code: MCW Dated: November 21, 2002 Received: November 22, 2002
Dear Mr. Mathison:
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
2
Page 2 - Mr. Gregory J. Mathison
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. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Bacchus Vascular, Inc.
and the comments of the comments of
Indications for Use
510(k) Number (if known):
:
This application
·
Device Name:
Indications for Use:
Solera™ Magnum Thrombectomy Catheter
The Solera Magnum 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
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Collen
Cardiovascular & Thoracic Surgeons
Story Number K082645
(Optional Format 1-2-96)