(66 days)
No
The summary describes a mechanical aspiration catheter system and does not mention any software, algorithms, or capabilities related to AI or ML.
Yes
The device is indicated for "the removal of fresh, soft emboli and thrombi from vessels in the arterial system", which is a therapeutic intervention.
No
Explanation: The device is indicated for the "removal of fresh, soft emboli and thrombi," which describes a therapeutic function rather than a diagnostic one. It is an intravascular extraction and aspiration catheter, not an imaging or analysis tool.
No
The device description explicitly lists physical components like a catheter, extension tube, syringes, and 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 the removal of emboli and thrombi from vessels in the arterial system. This is a therapeutic intervention performed within the body (in vivo).
- Device Description: The device is a catheter system designed for physical extraction and aspiration within blood vessels. This is a medical device used for a procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Xtract® Catheter System is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xtract® 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 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.
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 and biocompatibility testing demonstrated the system is equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
LBI Aspiration Catheter (K053372)
Reference Device(s)
Not Found
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).
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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
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.
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.
2
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)
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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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 Brittle
Director Regulatory Affairs |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Date: | June 4, 2007 |
| Product Trade Name: | Xtract™ Catheter System |
| Common Name: | Catheter, embolectomy
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
emboli 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, 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. |
| Indication for Use: | The Xtract Catheter System is indicated for removal of fresh, soft embol
material and thrombi from vessels in the arterial system. |
| Safety & Performance: | The results of the in vitro bench and biocompatibility testing
demonstrated the system is equivalent to the predicate device. |
| Conclusion: | This product is substantially equivalent' and 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.