(185 days)
Not Found
No
The summary describes a mechanical embolectomy system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the removal of emboli and thrombi from vessels, which is a therapeutic intervention.
No
The device is described as an "Embolectomy System" indicated for the "removal of fresh, soft emboli and thrombi," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly lists physical components such as a catheter, guidewire, syringes, introducer, and other accessories, 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 fresh, soft emboli and thrombi from vessels in the peripheral vasculature." This is a therapeutic procedure performed directly on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device components (catheter, guidewire, syringes, etc.) are all tools used for a physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically remove blockages from blood vessels, which is a treatment, not a diagnosis.
N/A
Intended Use / Indications for Use
The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEW, DXE
Device Description
The system consists of a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529) and a fiber element on a 0.014" guide wire with attachable actuator tool. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40um cell strainer cup.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Equivalency was demonstrated through comparison to predicate devices, biocompatibility, in vitro and animal testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071529 Xtract Catheter, K892410 Fogarty Thru-Lumen Embolectomy catheter, K002627 ClearWay PTFE Balloon Catheter, K062275, K050130 Rinsperation System, K040010 F.A.S.T. System, K991093 MSD Embolectomy basket, K990639 Hi-Torque Cross-It 300XT guidewire, K994358 ATW guidewire
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
Lumen Biomedical, Inc. Maria Brittle 14505 21st Ave. North Suite 212 Plymouth, Minnesota 55447
Re: K080901
Trade/Device Name: LBI Embolectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
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 October 02, 2008. 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 O'connell -S Pate: 2021.05.20
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/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
QCT 0 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lumen Biomedical, Inc. c/o Maria E. Brittle, Ph.D. Director, Regulatory Affairs 14505 2156 Avenue North, Suite 212 Plymouth, MN 55447
Re: K080901
LBI Embolectomy System (Models E5000, E6000, and E7000) Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: Class II Product Code: DXE Dated: September 16, 2008 Received: September 17, 2008
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device when used for embolic protection have not been established.
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Page 2 - Maria E. Brittle, Ph.D.
Furthermore, the indication for embolectomy use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. A1so, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Page 3 - Maria E. Brittle, Ph.D.
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,
V. Tech
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 4 - Maria E. Brittle, Ph.D.
Indications for Use
510(k) Number (if known): K080901
Device Name: LBI Embolectomy System
Indications For Use:
The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off vices Division of Care 510(k) Number
5
Ko 80901
Lumen Biomedical, Inc.
a
14505 2151 Avenue North, Suite 212 Plymouth, MN 55447 (763) 577-9600 Business (763) 577-1044 Fax
| Contact Person: | Maria Brittle
Director Regulatory Affairs |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Date: | June 27, 2008 |
| Product Trade Name: | LBI Embolectomy System |
| Common Name: | Catheter, embolectomy |
| Classification Name: | Catheter, embolectomy |
| Predicate(s): | K071529 Xtract Catheter
K892410 Fogarty Thru-Lumen Embolectomy catheter
K002627 ClearWay PTFE Balloon Catheter
K062275, K050130 Rinsperation System
K040010 F.A.S.T. System
K991093 MSD Embolectomy basket
K990639 Hi-Torque Cross-It 300XT guidewire
K994358 ATW guidewire |
| Intended Use: | The LBI Embolectomy System is for use in removal of fresh,
soft emboli and thrombi from vessels in the peripheral
vasculature. |
| Device Description: | The system consists of a 0.014" guidewire compatible aspiration
catheter with attachable stopcock assembly (Xtract catheter,
K071529) and a fiber element on a 0.014" guide wire with
attachable actuator tool. System accessories included in the
package consist of two 30 ml syringes, a peel-away introducer,
an actuation template, and a 40um cell strainer cup. |
| Safety & Performance: | Equivalency was demonstrated through comparison to predicate
devices, biocompatibility, in vitro and animal testing. |
| Conclusion: | This product is substantially equivalent1 and acceptable for the
intended use. |
OCT 02 2008
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.