upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
upper extremity peripheral veins ≥ 3.0mm in diameter, .
ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
A-V access conduits ≥ 3.0mm in diameter and .
for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Device Description

AngioJet Solent Proxi Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Proxi Thrombectomy Set is used with the AngioJet Ultra Console.

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet Solent Proxi Thrombectomy Set. It describes the device, its intended use, and lists various performance tests conducted. However, it does not provide specific quantitative acceptance criteria or detailed results to demonstrate that the device meets those criteria. It also doesn't describe the studies in the way requested in the prompt, focusing instead on the types of tests performed rather than the methodology and specific outcomes against acceptance thresholds.

Given the information available in the document, I can only address the questions to the extent possible. Much of the information requested (such as sample sizes for test sets, ground truth establishment for training and test sets, number/qualifications of experts, adjudication methods, and MRMC studies) is not present in this regulatory submission for a medical device that acts mechanically rather than using AI/machine learning.

Here's an attempt to answer the questions based only on the provided text, with explicit notes where information is not available:

Table of acceptance criteria and the reported device performance

The document lists the types of performance tests conducted but does not specify quantitative acceptance criteria or the reported performance values against those criteria. It only states that "Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use."

Acceptance Criterion (Not specified in document)	Reported Device Performance (No specific data reported)
e.g., Biocompatibility: No cytotoxicity	"Biocompatibility" testing was performed.
e.g., Leak testing: No leaks observed	"Leak testing" was performed.
e.g., Clot removal: X% efficacy	"Clot removal" testing was performed.
e.g., Hemolysis: Y% reduction	"Hemolysis" testing was performed.

Sample sizes used for the test set and the data provenance
- Sample Size: Not specified in the document for any of the performance tests.
- Data Provenance: The studies were internal "Bench and laboratory testing" conducted by MEDRAD Interventional / Possis. No information is given regarding country of origin or whether the data was retrospective or prospective, though for bench testing, these terms are less relevant than for clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device, not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation. The "ground truth" for mechanical performance tests would be based on validated measurement techniques and specifications.
Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on medical images or diagnoses, which is not relevant for the type of device and testing described.
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

No. This device is an AngioJet Solent Proxi Thrombectomy Set, a mechanical thrombectomy device, and is not an AI/ML-based diagnostic or assistive software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a physical medical device (thrombectomy set) that requires human operation, not a standalone algorithm.
The type of ground truth used

For the performance data listed (biocompatibility, leak testing, clot removal, hemolysis, etc.), the "ground truth" would be established by:
- Standardized Test Methods: Using recognized international (e.g., ISO, ASTM) and internal test protocols with predefined acceptance criteria.
- Physical Measurements: Quantifiable measurements from bench and laboratory tests (e.g., tensile strength, temperature, fluid dynamics).
- Analytical Chemistry/Biology: Results from biocompatibility assays (e.g., cytotoxicity, sensitization, hemocompatibility assays).
The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2021

MEDRAD Interventional/Possis Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433

Re: K101406

Trade/Device Name: AngioJet Solent Proxi Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Doug Atkins:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 16, 2010. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.05.20

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 3 2010

MEDRAD Interventional / Possis c/o Mr. Doug Atkins Senior Regulatory Affairs Associate 9055 Evergreen Boulevard Minneapolis, MN 55433-8003

Re: K101406

Angiojet Solent Proxi Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: May 18, 2010 Received: May 19, 2010

Dear Mr. Atkins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Mr. Doug Atkins

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

R. Vihner

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K101406

Device Name: AngioJet® Solent™ Proxi Thrombectomy Set

Indications for Use:

The AngioJet Solent Proxi Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from :

upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
upper extremity peripheral veins ≥ 3.0mm in diameter, .
ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
A-V access conduits ≥ 3.0mm in diameter and .
for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)	Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular Devices

510(k) Number K101406

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K101406

JUN 1 3 2010

Section 5 – 510(k) Summary

Submitter:	MEDRAD Interventional / Possis9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA
Contact Person:	Doug AtkinsSr. Regulatory Affairs AssociatePhone: (763) 450-8060Fax: (763) 780-2227Email: doug.atkins@possis.com
Date Prepared:	June 15, 2010
Trade Name:	AngioJet® Solent™ Proxi Thrombectomy Set
Classification:	870.5150 and 870.1210
Product Code:	DXE and KRA
Predicate Device(s):	The subject device is equivalent to the following devices:K091593 AngioJet Ultra DVX and Xpeedior Thrombectomy Sets
Device Description:	AngioJet Solent Proxi Thrombectomy Set is a sterile, single use,disposable set that includes a Thrombectomy Catheter and Pump inone combined unit. The AngioJet Solent Proxi Thrombectomy Set isused with the AngioJet Ultra Console.
Intended Use:	The AngioJet Solent Proxi Thrombectomy Set is intended for use withthe AngioJet Ultra Console to break apart and remove thrombus from:upper and lower extremity peripheral arteries ≥ 3.0mm indiameter,upper extremity peripheral veins ≥ 3.0mm in diameter,ileofemoral and lower extremity veins ≥ 3.0mm in diameter,
	A-V access conduits ≥ 3.0mm in diameter andfor use with the AngioJet Ultra Power Pulse Kit for the controland selective infusion of physician specified fluids, includingthrombolytic agents, into the peripheral vascular system.
Comparison topredicate:	Design changes were made to the predicate device which included:changes to the catheter shaft design, changes to the catheter manifoldand tip to facilitate guide wire usage, and a change to the strain relief /manifold joint.

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Performance Data:

Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:

. Biocompatibility
- Cytotoxicity (ISO 10993-5) o
- Intracutaneous Reactivity (ISO 10993-10) o
- Sensitization (ISO 10993-10) O
- Acute Systemic Toxicity (ISO 10993-11) o
- Material Mediated Pyrogen (ISO 10993-11) O
- O Physiochemical (ISO 10993-18)
- Hemocompatibility O
- ASTM Hemolysis (ISO 10993-4) -
- Partial Thromboplastin Time Assay (ASTM F2382-04) -
- -C3a Complement Activation (ISO 10993-4)
- SC5b-9 Complement Activation (ISO 10993-4) -
- Thromboresistance (ISO 10993-4) -
. Catheter operational characteristics
Leak testing ●
Guide wire compatibility tests .
Particulate generation .
. Tracking
. Extended use
Kink resistance .
. Corrosion
Clot removal .
. Hemolysis
Catheter pass wall temperature .
. Mechanical integrity (tensile strengths and compression / buckling)

Conclusion:

MEDRAD Interventional / Possis considers the AngioJet Solent Proxi Thrombectomy Set to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).