(118 days)
Not Found
No
The summary describes a traditional angioscopic catheter with a camera and light source, and explicitly states that AI, DNN, or ML were not found in the description.
No.
The device is intended for visualization, temporary occlusion, and to provide a pathway for delivery, rather than for treating a disease or condition.
Yes
The device is described as aiding in the visualization of the coronary sinus and providing NTSC video output, which are functions consistent with diagnostic imaging.
No
The device description clearly states it is a steerable angioscopic catheter with a silicone balloon, integrated light source, and camera, indicating it is a hardware device.
Based on the provided information, the Acumen Coronary Sinus Visualization System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to analyze these samples outside of the body.
- Device Function: The Acumen Coronary Sinus Visualization System is a medical device used within the body (in vivo) to visualize the coronary sinus, provide temporary occlusion, and deliver other devices. It directly interacts with the patient's anatomy.
- Intended Use: The intended use clearly describes a procedure performed on a patient, not the analysis of a biological sample.
- Device Description: The description details a catheter with a balloon, light source, and camera, all designed for internal use.
Therefore, the Acumen Coronary Sinus Visualization System falls under the category of an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The 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 CSVS is a steerable angioscopic catheter with a silicone balloon on the distal end. The balloon is intended to displace blood flow to aid in visualization and to provide temporary occlusion during a venogram. The CSVS includes an integrated light source and a camera providing NTSC video output.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro and in-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032622, K973298, K952638, K855529, K960081
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).
0
DEC 2 8 2004
510(k) Summary
General Information
Date Compiled
Classification
Class II
August 30, 2004
Trade Name
Submitter
Coronary Sinus Visualization System
Acumen Medical, Inc. 1400 Terra Bella Blvd. Suite A Mountain View, CA 94043
Tel: 650 352 5700 Fax: 650 352 5700
Contact
Marybeth Gamber Director, Regulatory Affairs
Intended Use
The 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
| Attain™ Prevail® Left Heart Delivery System
| Manufactured by Medtronic Inc. | K032622 |
|---|---|
| Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter | |
| Manufactured by Cardima Inc. | K973298 |
| ImagCath™ Coronary Angioscope | |
| Manufactured by Baxter Healthcare Corp. | K952638 |
| CCD Solid State Video Camera | |
| Manufactured by Medical Dynamics, Inc. | K855529 |
| Battery Powered Endoscopic Light Source | |
| Manufactured by Mitsubishi Cable America Inc. | K960081 |
1
Device Description
Device Description The Acumen Coronary Sinthe visualization of the coronary sinus, provide temporary cancer intended to and mi the model provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The CSVS is a steerable angioscopic catheter with a silicone balloon on the distal end. The balloon is intended to displace blood flow to aid in visualization and to provide temporary occlusion during a venogram. The CSVS includes an integrated light source and a camera providing NTSC video output.
Materials
All materials used in the manufacture of the CSVS are suitable for this use and have been used in numerous previously cleared products.
Testing
In-vitro and in-vivo 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 believes the CSVS is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2004
Acumen Medical, Inc. c/o Ms. Marybeth Gamber 1400 Terra Bella Blvd. Mountain View, CA 94043-1884
Re: K042381
Trade Name: Coronary Sinus Visualization System, model CSVS 5508 Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: II (two) Product Code: DQY Dated: August 30th, 2004 Received: September 1st, 2004
Dear Ms. Gamber:
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
3
Page 2 - Ms. Marybeth Gamber
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 (301) 594-4591. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mepremp
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
Acumen Medical, Inc.
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
This application
Acumen Coronary Sinus Visualization System
The 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 Subpart D)
AND/OR
Over-The-Counter Use (Per 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)
Mesa Maya
on Slan-C Division of Cardiovascular Devices KO42381 510(k) Number
Confidential