(27 days)
No
The summary describes a mechanical device (a sheath) for delivering leads and catheters and contains no mention of AI, ML, image processing, or data analysis.
No
The device is a lead delivery sheath, indicated for introducing other medical devices (pacing or defibrillator leads and catheters) into the body, rather than directly treating a condition itself.
No
The device, the Modified Acumen Lead Delivery Sheath, is described as a delivery sheath for introducing leads and catheters, not for diagnosing conditions.
No
The device description clearly 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.
- Device Description and Intended Use: The description clearly states the device is a "percutaneous catheter" intended to "introduce various types of pacing or defibrillator leads and catheters." This is a device used within the body for a procedural purpose (delivering leads/catheters), not for testing samples outside the body.
The device is a surgical/interventional tool, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Product codes
DYB
Device Description
The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
AUG 2 3 2006
5. 510(k) Summary General Information
Date Compiled
Classification
Trade Name
Submitter
July 26, 2006 Class II
Orion 11
Modified Acumen Lead Delivery Sheath
Models: LDS-10-57, LDS-10-64, LDS-10-57-90, and LDS-10-64-90
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 Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters ..
Predicate Devices
Acumen Lead Delivery Sheath Manufactured by Acumen Medical, Inc. K051515
Device Description
The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.
Matcrials
All materials used in the manufacture of the Modified Acumen LDS are suitable for this use 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 Modified Acumen Lead Delivery Sheath is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are cither identical or substantially equivalent to existing legally marketed predicate product.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2006
Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085
Re: K062145
Trade/Device Name: Modified Acumen Lead Delivery Sheath Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 26, 2006 Received: July 27, 2006
Dear Ms. Marybeth 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 yours,
B/Summner for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 4.
This application 510(k) Number (if known):
Device Namc: Modified Acumen Lead Delivery Sheath
Indications for Use:
.
The Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Prescription Use _X (Pcr 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Pcr 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)
Blummina
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060145