XTRACT CATHETER SYSTEM by LUMEN BIOMEDICAL, INC.

The Xtract Catheter System consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40µm Strainer. The catheter is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub.

AI/ML Overview

The provided text is a 510(k) summary for the Xtract Catheter System, detailing its intended use and a comparison to a predicate device for substantial equivalence. It does not contain information about a study proving device performance against specific acceptance criteria. The summary states that "The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device," but it does not describe the specific acceptance criteria, study design, or its results in detail.

Therefore, I cannot provide the requested table or detailed study information based on the provided document.

To directly address the prompts based on the available information:

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

Acceptance Criteria: Not specified in the provided document. The document states that "the results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device." This implies that the acceptance criteria were based on demonstrating equivalence to the predicate device (LBI Aspiration Catheter, K053372) rather than explicit performance metrics.
Reported Device Performance: Not detailed in the provided document. The document only states that the in vitro bench and biocompatibility testing confirmed equivalence to the predicate device.

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

Not specified in the provided document. The document only mentions "in vitro bench and biocompatibility testing," without detailing sample sizes, data provenance, or study design.

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 as the document describes bench and biocompatibility testing, not clinical studies involving expert interpretation or ground truth establishment in a diagnostic context.

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

Not applicable for the type of testing described (bench and biocompatibility).

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. The Xtract Catheter System is a medical device (catheter), not an AI-powered diagnostic tool. The document does not describe any MRMC studies.

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

Not applicable. The Xtract Catheter System is a medical device, not an algorithm.

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

Not applicable. The document describes in vitro bench and biocompatibility testing, where "ground truth" would be defined by engineering specifications and biological response standards, not clinical diagnostic ground truth methods.

8. The sample size for the training set

Not applicable. The document describes testing for a medical device's equivalence to a predicate, not an AI model's training.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2021

Lumen Biomedical, Inc. Maria Brittle Director, Regulatory Affairs 14505 21st Ave. North Suite 212 Plymouth, Minnesota 55447

Re: K071529

Trade/Device Name: Xtract Catheter System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ

Dear Maria Brittle:

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 August 10, 2007. Specifically, FDA is updating this SE Letter 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. Gregory W. O'connell -S ○'connell -S Date: 2021.09.15
10:19:26-04'00'

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2007

Lumen Biomedical , Inc. c/o Maria E. Brittle, PhD Director Regulatory Affairs 14505 21st Avenue North, Suite 212 Plymouth, MN 55447

K071529 Re:

Xtract™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: July 20, 2007 Received: July 23, 2007

Dear Dr. Brittle:

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. Iisting 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 - Maria E. Brittle, PhD

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Bhimima for

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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Indications for Use

510(k) Number (if known): K071529

Xtract® Catheter System Device Name:

Indications for Use:

The Xtract® Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blammma
(Division Sign Off)

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

Page __ of ___________________________________________________________________________________________________________________________________________________________________

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K071529

Image /page/4/Picture/1 description: The image shows the logo for Lumen Biomedical. The word "LUMEN" is written in large, bold, black letters with two white lines running through it. Below it, the word "BIOMEDICAL" is written in smaller, bold, black letters.

AUG 1 0 2007

Lumen Biomedical, Inc.

14505 21ª Avenue North, Suite 212 Plymouth, MN 55447 (763) 577-9600 Business (763) 557-1044 Fax

510(k) Summary

Contact Person:	Maria BrittleDirector Regulatory Affairs
Summary Date:	June 4, 2007
Product Trade Name:	Xtract™ Catheter System
Common Name:	Catheter, embolectomyCatheter, thrombectomy
Classification Name:	Catheter, embolectomy
Predicate(s):	LBI Aspiration Catheter (K053372)
Intended Use:	The Xtract™ Catheter System is indicated for the removal of fresh, softemboli and thrombi from vessels in the arterial system.
Device Description:	The Xtract Catheter System consists of one (1) Catheter, one (1)Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, andone (1) 40µm Strainer. The catheter is a single-use, 0.014" guidewirecompatible, temporary intravascular extraction and aspiration catheter.It has a distal radiopaque tip marker, a varying stiffness shaft, a rapidexchange port, and a proximal luer-lock hub.
Indication for Use:	The Xtract Catheter System is indicated for removal of fresh, soft embolmaterial and thrombi from vessels in the arterial system.
Safety & Performance:	The results of the in vitro bench and biocompatibility testingdemonstrated the system is equivalent to the predicate device.
Conclusion:	This product is substantially equivalent' and acceptable for the intendeduse.

1 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.

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).