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.

AI/ML Overview

This document is a 510(k) summary for the Solera™ Plus Thrombectomy Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in a clinical setting.

Therefore, the information requested in your prompt regarding acceptance criteria and performance study details (e.g., sample size, ground truth, MRMC studies) is not present in the provided text.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Available: The document states that "All components, subassemblies, and/or full Maginan The required specifications for the completed tests," and that mechanical tests were done in the same manner as the predicate device. However, it does not explicitly list specific acceptance criteria (e.g., specific thresholds for thrombus removal percentage, flow rates, or device integrity parameters) nor does it provide a table of reported device performance against such clinical or bench-testing criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available: The document mentions "Testing Summary" but does not specify any sample sizes for tests, nor does it refer to clinical test sets or data provenance in the context of performance proof. The testing appears to be primarily bench or in-vitro, comparing it to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Available: This type of information is relevant for studies involving human interpretation or clinical outcomes. The provided document relates to a medical device's technical specifications and substantial equivalence, not a study evaluating diagnostic or treatment efficacy with expert adjudication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Available: As with point 3, this is not relevant to the type of information presented in this 510(k) summary.

5. 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/Not Available: MRMC studies are typically for diagnostic AI systems or those involving human interpretation. This document describes a mechanical thrombectomy catheter, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Available: This refers to AI algorithm performance. The device is a mechanical catheter.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Available: The document vaguely refers to "required specifications" for mechanical tests, implying engineered benchmarks rather than clinical "ground truth" as typically defined in diagnostic studies.

8. The sample size for the training set

Not Applicable/Not Available: This refers to AI model training data. The device is a mechanical catheter.

9. How the ground truth for the training set was established

Not Applicable/Not Available: This refers to AI model training data. The device is a mechanical catheter.

In summary, the provided 510(k) summary is for a mechanical thrombectomy catheter and focuses on establishing substantial equivalence to previously cleared devices through material suitability and a testing summary that asserts compliance with specifications, rather than a clinical performance study with detailed acceptance criteria and human expert evaluation.

Summary

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FEB - 4 2004	510(k) Summary
General Information
Classification	Class II
Trade Name	Solera™ Plus Thrombectomy Catheter
Submitter	Bacchus Vascular, Inc.3110 Coronado DriveSanta Clara, CA 95054
408-980-8300
Contact	Gregory J. MathisonRegulatory Affairs Consultant

Intended Use

The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.

Predicate Devices

Solera Thrombectomy CatheterManufactured by Bacchus Vascular, Inc.	K003570
Solera MagnumThrombectomy CatheterManufactured by Bacchus Vascular, Inc.	K022640

Device Description

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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

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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.

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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

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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 permitsmechanical 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

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

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).