(195 days)
Not Found
No
The summary describes a mechanical delivery sheath and does not mention any AI/ML components or functionalities.
No
The device is a delivery sheath, acting as an accessory to introduce other therapeutic devices (pacing or defibrillator leads and catheters) into the body, rather than providing therapy itself.
No
The device, a delivery sheath, is used for the introduction of leads and catheters, which are typically used for therapeutic or interventional procedures, not for diagnostic purposes. Its function is to facilitate access and delivery of other medical devices.
No
The device description clearly states it is a "Delivery Sheath" which is a physical medical device used for introducing leads and catheters. The summary describes physical components like a sheath and dilator, and mentions in-vitro and animal testing, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Acumen Single-Lumen Delivery Sheath clearly state its purpose is for the introduction of pacing or defibrillator leads and catheters into the body. This is an invasive procedure performed in vivo (within a living organism), not in vitro (in a lab setting).
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, laboratory testing, or diagnostic information derived from such testing.
Therefore, based on the provided information, the Acumen Single-Lumen Delivery Sheath is a medical device used for procedural access, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro and animal testing has been performed and all components, subassemblics, and/or fuil devices met the required specifications for the completed tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
General Information
510(k) Summary
JUN 19 2006
K053400
page 1 of 2
| Date Compiled | December 1, 2005 |
|---|---|
| Classification | Class II |
| Trade Name | Acumen Single-Lumen Delivery Sheath |
| Submitter | Acumen Medical, Inc. |
| 275 Santa Ana Court | |
| Sunnyvale CA 94085 | |
| Tel: 408-530-1810 | |
| Fax: 408-530-1811 | |
| Contact | Marybeth Gamber |
| E-mail: MGamber@acumen-medical.com |
Intended Use
The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Predicate Devices
| SafeSheath | K003731 |
|---|---|
| Manufactured by Thomas Medical Products | |
| Attain Access 6216 Left Heart Delivery System | |
| Manufactured by Medtronic, Inc. | K012130 |
Attain Access 6218 Left Heart Delivery System K012083 Manufactured by Medtronic, Inc.
Device Description
The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.
Materials
All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are suitable for this use and have been used in numerous previously clearcd products.
Testing
In-vitro and animal testing has been performed and all components, subassemblics, and/or fuil devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
Acumen Medical, Inc. believes the Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of
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Acumen Medical, Inc.
053400
page 2 of 2
construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.
(Division Sign-Off)
Division of Cardiovascular
510(k) Number
E053/80
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acumen Medical, Inc c/o Ms. Marybeth Gamber Director, Regulatory Affairs
275 Santa Ana Court Sunnyvale, CA 94085
Re: K053400
Device Name: Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2006 Received: June 8, 2006
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.
JUN 19 2006
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.
3
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- 1020. 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.
510(k) Number (if known): This application
Device Name: Acumen Single-Lumen Delivery Sheath
Indications for Use:
The Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.
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)
Rhummunon
(Division Sign-Off)
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