(28 days)
Not Found
No
The summary describes a physical catheter device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's stated intended uses are for visualization, temporary occlusion for venograms, and providing a pathway for other devices, not for directly treating a disease or condition.
No
The device is intended to aid in visualization, provide temporary occlusion, and provide a pathway for delivery of devices. It does not perform diagnosis or analyze anatomical signals to determine a medical condition.
No
The device description explicitly states it is a "single-use percutaneous catheter," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is a "single-use percutaneous catheter" intended to be inserted into the body to aid in visualization, provide occlusion, and deliver other devices within the coronary sinus and vasculature. This is an in vivo (within the living body) device, not an in vitro device.
The device's purpose is to facilitate procedures performed directly on the patient's anatomy, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
The 7F Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Product codes
DQY
Device Description
The 7F Acumen Coronary Sinus Visualization System (CSVS) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and coronary vasculature of the heart
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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K062084
p. 1 of 2
Acumen Medical, Inc.
AUG 1 8 2006
510(k) Summary 5.
General Information
Date Compiled Classification Trade Name
Submitter
July 18, 2006
Class II
7F Acumen Coronary Sinus Visualization System
Acumen Medical, Inc. 275 Santa Ana Court Sunnyvale, CA 94085
Tel: 408-530-1810 Fax: 408-530-1811
Contact
Marybeth Gamber Director, Regulatory Affairs
Intended Use
The 7F Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Predicate Devices
Acumen Coronary Sinus Visualization System K042381 Manufactured by Acumen Medical, Inc.
Device Description
The 7F Acumen Coronary Sinus Visualization System (CSVS) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Materials
All materials used in the manufacture of the 7F Acumen Coronary Sinus Visualization System are suitable for this use, are identical to the those used in the predicate device, and have been used in numerous previously cleared products
Testing
Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
Acumen Medical, Inc. believes the 7F Acumen Coronary Sinus Visualization System is substantially equivalem to the predicate product. The imended use, method of operation,
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and the same of the same of the states of the states of the states
methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.
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Confidential
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
Acumen Medical, Inc. c/o Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085
Re: K062084
Trade Name: 7F Acumen Coronary Sinus Visualization System, Model (CSVS) Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 9, 2006 Received: July 21, 2006
Dear Ms. Gamber:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surver to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer to province of the ) 2011-07-12 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 I va may, atteres, and 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.
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Page 2 – Ms. Marybeth Gamber
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/cdrh/industry/support/index.html.
Sincerely yours.
Q.B.M.
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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Acumen Medical, Inc.
Indications for Use Statement 4. ﭗ ﮨﺎ
:
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | 7F Acumen Coronary Sinus Visualization System |
| Indications for Use: | The 7F Acumen Coronary Sinus Visualization System is |
| intended to aid in the visualization of the coronary sinus, | |
| provide temporary occlusion during a venogram, and to | |
| provide a pathway for delivery of transvenous devices to the | |
| coronary sinus and coronary vasculature of the heart. |
Prescription Use __X (Per 21 CFR 801 Subpari D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpari 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 of Cardiovascular Devices 510(k) Number -Ko 62084