(92 days)
No
The document describes a physical catheter for visualization and delivery, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is intended to aid in visualization, provide temporary occlusion, and provide a pathway for delivery of other devices, rather than directly treating a condition.
Yes
This device is intended to aid in the visualization of anatomy, provide temporary occlusion during a venogram, and provide a pathway for delivery of devices. While it facilitates procedures, its primary function of visualization for diagnostic purposes makes it a diagnostic device. The predicate device "AcuNav Diagnostic Ultrasound Catheter" further supports its diagnostic nature.
No
The device description explicitly states it is a "single-use percutaneous catheter," which is a physical hardware component, not software.
Based on the provided information, this device 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 outside of the body ("in vitro").
- Device Description and Intended Use: The description and intended use clearly state that the Insight Endocardial Visualization System is a percutaneous catheter used within the body (in the right heart) to aid in visualization, provide occlusion, and deliver devices. This is an in vivo application, not an in vitro one.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, chemical reactions, or laboratory testing, which are hallmarks of IVDs.
Therefore, the Insight Endocardial Visualization System is a medical device used for interventional procedures within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, 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. The Insight is intended for use in the right heart only.
Product codes
DQY
Device Description
The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, 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, foramen ovale and other venous and cardiac anatomy, coronary vasculature of the heart, right 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)
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
Insight™ Endocardial Visualization System, K070051
510(k) Summary 5. General Information
| Date Compiled | April 5, 2007 |
|---|---|
| Classification | Class II |
| Trade Name | Acumen Insight Endocardial Visualization System |
| Submitter | Acumen Medical, Inc. |
| 275 Santa Ana Court | |
| Sunnyvale, CA 94085 | |
| Tel: 408-530-1810 | |
| Fax: 408-530-1811 | |
| Contact |
Intended Use
The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, 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. The Insight is intended for use in the right heart only.
| Predicate Devices | |
|---|---|
| Acumen Insight Endocardial Visualization System | |
| Manufactured by Acumen Medical, Inc. | K042381, K062084 |
| AcuNav Diagnostic Ultrasound Catheter | |
| Manufactured by Acuson Corporation | K992631 |
Device Description
The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, 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 Acumen Insight Endocardial Visualization System are suitable for this use, are identical to the those used in the predicate devices, and have been used in numerous previously cleared products
Testing
As there is no change in the design of the device, additional device testing was not required.
Summary of Substantial Equivalence
Acumen Medical, Inc. believes the Acumen Insight Endocardial Visualization System is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = $ 2007
Acumen Medical, Inc. c/o Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085
Re: K070051
Trade/Device Name: Acumen Insight Endocardial Visualization System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: March 7, 2007 Received: March 8, 2007
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.
2
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 vours.
Bfimmerman 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.
| 510(k) Number (if known): | K070051 |
|---|---|
| Device Name: | Acumen Insight Endocardial Visualization System |
| Indications for Use: | The Insight Endocardial Visualization System is intended to |
| aid in the visualization of the coronary sinus, foramen ovale | |
| and other venous and cardiac anatomy, 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. The Insight is intended for | |
| use in the right heart only. |
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)
B.A.mumo