(118 days)
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.
The Acumen Coronary Sinus Visualization System 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.
The Coronary Sinus Visualization System (CSVS) by Acumen Medical, Inc. underwent in-vitro and in-vivo testing to ensure it met required specifications. However, the provided document does not detail acceptance criteria or specific performance results in a table, nor does it describe a formal study involving expert consensus, MRMC studies, or standalone algorithm performance.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The provided text states: "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."
No specific acceptance criteria or quantitative performance results are provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in-vitro and in-vivo testing" but does not specify the sample size for the test set, the country of origin of the data, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically not provided for a device like this, which is a medical instrument rather than an AI/diagnostic software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for a test set. Again, this is not typically applicable to the type of device described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a visualization system and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance. The CSVS is a physical medical device (a steerable angioscopic catheter with a balloon, light source, and camera) and not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used. Given the nature of the device (visualization and delivery), "ground truth" would likely refer to objective physical or physiological parameters measured during in-vitro and in-vivo testing to ensure the device performs its intended functions (e.g., successful visualization, temporary occlusion, and pathway provision).
8. The sample size for the training set
The document does not mention any training set or its sample size. This is not relevant to a physical medical device.
9. How the ground truth for the training set was established
The document does not mention any training set or how its ground truth was established. This is not relevant to a physical medical device.
In summary:
The provided 510(k) summary for the Acumen Coronary Sinus Visualization System details its intended use, device description, materials, and substantial equivalence to predicate devices based on in-vitro and in-vivo testing. However, it lacks the specific details regarding acceptance criteria, study design, sample sizes, expert involvement, or any AI-related performance metrics that your questions are looking for. This is likely because the device is a physical medical instrument, not an AI or diagnostic software that would require such extensive validation studies with human readers or trained algorithms. The FDA clearance is based on the device demonstrating substantial equivalence to already legally marketed predicate devices, and meeting safety and performance specifications through general in-vitro and in-vivo testing.
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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.
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Predicate Devices
| Attain™ Prevail® Left Heart Delivery SystemManufactured by Medtronic Inc. | K032622 |
|---|---|
| Vueport™ Coronary Sinus Balloon Occlusion Guiding CatheterManufactured by Cardima Inc. | K973298 |
| ImagCath™ Coronary AngioscopeManufactured by Baxter Healthcare Corp. | K952638 |
| CCD Solid State Video CameraManufactured by Medical Dynamics, Inc. | K855529 |
| Battery Powered Endoscopic Light SourceManufactured by Mitsubishi Cable America Inc. | K960081 |
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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.
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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
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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
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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
§ 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).