XTRACT CATHETER SYSTEM

K071529 · Lumen Biomedical, Inc. · QEZ · Aug 10, 2007 · Cardiovascular

Device Facts

• Record ID: K071529
• Device Name: XTRACT CATHETER SYSTEM
• Applicant: Lumen Biomedical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Xtract Catheter System is a single-use, 0.014" guidewire-compatible intravascular aspiration catheter used to remove fresh, soft emboli and thrombi from arterial vessels. The system includes the catheter, an extension tube with stopcock, 30cc aspiration syringes, and a 40µm strainer. The catheter features a distal radiopaque tip marker, a shaft with varying stiffness, a rapid exchange port, and a proximal luer-lock hub. It is operated by a clinician in a clinical setting. The device functions by applying manual aspiration via the syringes to extract embolic material through the catheter lumen into the strainer. This process clears arterial obstructions, potentially restoring blood flow and benefiting the patient by resolving ischemia.

Clinical Evidence

Bench testing only. In vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device.

Technological Characteristics

Single-use, 0.014" guidewire-compatible aspiration catheter. Features: distal radiopaque tip marker, varying stiffness shaft, rapid exchange port, proximal luer-lock hub. Accessories: extension tube with stopcock, 30cc aspiration syringes, 40µm strainer. Mechanical aspiration principle. No software or electronic components.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from the arterial system. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• LBI Aspiration Catheter (K053372)

Submission Summary (Full Text)

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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, [phone], 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 [phone]. 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 [phone] or [phone] 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)

1

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

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AUG 1 0 2007

Lumen Biomedical, Inc.

14505 21ª Avenue North, Suite 212 Plymouth, MN 55447 [phone] Business [phone] Fax

## 510(k) Summary

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

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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.