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.

AI/ML Overview

The provided text does not contain the information required to complete the requested output regarding acceptance criteria and a study proving a device meets them.

The document is a 510(k) summary for the Solera Magnum Thrombectomy Catheter, focusing on demonstrating substantial equivalence to a predicate device (Solera Thrombectomy Catheter). It lists the intended use, device description, materials, and a general statement about testing.

Here's why the information is missing:

No specific acceptance criteria are listed. The document states, "All components, subassemblies, and/or full devices met the required specifications for the completed tests," but it does not specify what those specifications or acceptance criteria were.
No detailed study is described. The document mentions "The Solera Magnum Thrombectomy Catheter was tested in the same manner as the Solera Thrombectomy Catheter (K003570)," and that all components "met the required specifications for the completed tests." However, it does not provide any details about this testing, such as:
- The type of study (e.g., in-vitro, ex-vivo, clinical trial).
- Specific performance metrics measured.
- Sample sizes for anything.
- Data provenance.
- Ground truth establishment.
- Expert involvement.
- Comparative effectiveness.
- AI-related information (this device is a catheter, not an AI/software device).

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document's purpose is to show substantial equivalence through general statements about testing, not to provide detailed study results for specific performance metrics against pre-defined acceptance criteria.

Summary

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K022640

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 DriveSanta Clara, CA 95054
Contact	408-980-8300Gregory J. MathisonVice 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

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

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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

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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

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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

Over-The-Counter Use

(Per 21 CFR 801.109)

Collen
Cardiovascular & Thoracic Surgeons
Story Number K082645

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).