(207 days)
No
The summary describes a mechanical catheter system for aspiration and extraction, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the removal of emboli and thrombi, which are conditions that impair the body's natural function and require intervention to restore health.
No
The device is described as an extraction and aspiration catheter system indicated for the physical removal of emboli and thrombi, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components like a catheter, extension tube, syringes, and a strainer, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of emboli and thrombi from vessels in the arterial system. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter system designed for intravascular extraction and aspiration. This is a physical intervention within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
The device described is a medical device used for a therapeutic intervention, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The LBI Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Product codes
OEZ, DXE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the arterial system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K032763, K042937, K051193, K052232
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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.
2
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
3
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
4
JUN 3 0 2006
510(k) Summary ~ K053372 June 29, 2006
..............................................................................................................................................................................
彩
| Trade Names: | Xtract™ Catheter System |
|---|---|
| Manufacturer: | Lumen Biomedical, Inc., 14505 21st Ave N., Suite 212, Plymouth, MN |
| 55447 | |
| Official | |
| Contact: | Amy Peterson, Vice President RA & QA |
| Telephone: (763) 746-9550 Fax: (763) 577-1044 | |
| Device | |
| Generic Name: | Catheter, embolectomy |
| Classification: | Catheter, embolectomy, 21 CFR §870.5150 |
| Class II, Product Code - DXE | |
| Panel - Cardiovascular | |
| Predicate | |
| Devices: | Pronto Extraction Catheter, K032763, K042937, K051193*, |
| K052232 | |
| Export Aspiration Catheter, K040869, K050139 | |
| Device | |
| Description: | 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. | |
| Indication | |
| for 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 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 to demonstrate | |
| substantial equivalence1. No new safety or effectiveness questions | |
| were identified. | |
| Conclusion: | This product is substantially equivalent1 and considered acceptable |
| for 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.