LBI CATHETER SYSTEM by LUMEN BIOMEDICAL, INC.

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

AI/ML Overview

The provided text describes a 510(k) submission for the LBI Catheter System (also referred to as Xtract™ Catheter System) and mentions that in vitro bench, biocompatibility, and animal tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria, especially in terms of clinical performance or effectiveness.

It primarily focuses on compliance with standards and the claim of substantial equivalence for safety and performance based on these types of tests, rather than clinical efficacy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or clinical performance comparisons (like MRMC studies) is not available in the provided text.

Here's an attempt to answer the questions based only on the information available:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document beyond general safety and performance.	The results of the in vitro bench, biocompatibility, and animal tests demonstrate the Xtract™ Catheter System for aspiration/extraction is substantially equivalent to the predicate devices. Applicable standards were applied: per ISO 10555-1, 10993-1, 11135, ASTM D 4169-05 (DC13), F 1980-02, F 2096-04 and F 88-05.

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

Sample size for test set: Not specified. The document mentions in vitro bench tests and animal tests, but not the number of samples or animals used.
Data provenance: The tests mentioned are in vitro (bench) and animal, implying a pre-clinical setting. Country of origin not specified, but the manufacturer is in Plymouth, MN, USA. The study type mentioned (bench, animal) indicates prospective testing specific to the device.

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 specified. The tests mentioned are physical (bench) and animal, not reliant on expert review for ground truth in the way a clinical imaging study would be.

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

Not applicable/Not specified. The tests mentioned are physical (bench) and animal, not involving human interpretation for adjudication.

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

No MRMC comparative effectiveness study was done or mentioned. This device is a catheter system, not an AI diagnostic tool.

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

Not applicable/Not specified. This is a medical device (catheter), not an algorithm.

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

For the in vitro bench tests, ground truth would be based on engineering specifications, physical measurements, and performance standards outlined in ISO and ASTM documents.
For the animal tests, ground truth would be based on physiological responses, tissue analysis, and direct observation of the device's performance within the animal model, observed against pre-defined success criteria for the procedure.
No human clinical outcomes or pathology data are mentioned for establishing ground truth in this document.

8. The sample size for the training set

Not applicable/Not specified. This is a medical device, not an AI model requiring a training set in the conventional sense.

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

Not applicable/Not specified. As it's not an AI model, a training set and its ground truth are not relevant in this context.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

September 15, 2021

Lumen Biomedical, Inc. Amy Peterson Consultant 2605 Fernbrook Lane Suite A Plymouth, Minnesota 55447

Re: K053372

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

Dear Amy Peterson:

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 30, 2006. 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,

Digitally signed by Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.09.15
09:13:41 -04'00'

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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, with three curved lines representing the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lumen Biomedical, Inc. c/o Ms. Amy Peterson 2605 Fernbrook Lane, Suite A Plymouth, MN 55447

JUN 3 0 2006

Re: K053372

Trade/Device Name: LBI Catheter System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 26, 2006 Received: June 27, 2006

Dear Ms. Peterson:

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 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.

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Page 2 - Ms. Amy Peterson

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 legal|| marketed predicate device results in a classification for your device and thus. perceits your cevice 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 (2) Cric anote the regulation ( "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon chinia 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/cdrh/industry/support/index.html.

Sincerely yours,

QllS XL

Fisk 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): K053372

Device Name: LBI Catheter System

Indications for Use:

The LBI Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.S.M.

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number K053372

Page 1 of L

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JUN 3 0 2006

510(k) Summary ~ K053372 June 29, 2006

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Trade Names:	Xtract™ Catheter System
Manufacturer:	Lumen Biomedical, Inc., 14505 21st Ave N., Suite 212, Plymouth, MN55447
OfficialContact:	Amy Peterson, Vice President RA & QATelephone: (763) 746-9550 Fax: (763) 577-1044
DeviceGeneric Name:	Catheter, embolectomy
Classification:	Catheter, embolectomy, 21 CFR §870.5150Class II, Product Code - DXEPanel - Cardiovascular
PredicateDevices:	Pronto Extraction Catheter, K032763, K042937, K051193*,K052232Export Aspiration Catheter, K040869, K050139
DeviceDescription:	The Lumen Biomedical Inc. (LBI) Xtract™ Catheter System is asingle-use, 0.014" guidewire compatible, temporary intravascularextraction and aspiration catheter system. It has a distal radiopaquetip marker, a varying stiffness shaft, a rapid exchange port, and aproximal luer-lock hub. The system consists of one (1) Catheter, one(1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes,and one (1) 40um Strainer.
Indicationfor Use:	The Xtract™ Catheter System is indicated for the removal of fresh,soft emboli and thrombi from vessels in the arterial system.
Safety &Performance:	The results of the in vitro bench, biocompatibility, and animal testsdemonstrate the Xtract™ Catheter System for aspiration/extractionis substantially equivalent to the predicate devices. Applicablestandards were applied: per ISO 10555-1, 10993-1, 11135, ASTM D4169-05 (DC13), F 1980-02, F 2096-04 and F 88-05 to demonstratesubstantial equivalence1. No new safety or effectiveness questionswere identified.
Conclusion:	This product is substantially equivalent1 and considered acceptablefor the intended use.

ి.

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).