(85 days)
Not Found
No
The summary describes a mechanical sheath for introducing leads and catheters and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a sheath for introducing leads and catheters, performing an assistive rather than a direct therapeutic function.
No
The device description indicates that the Acumen Sheath is used for the introduction of leads and catheters, and it is designed to be removed from the lead. It does not mention any function for analyzing patient data or diagnosing conditions. Therefore, it is not a diagnostic device.
No
The device description clearly describes a physical sheath with lumens and a slitter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of pacing or defibrillator leads and catheters into the body. This is a procedural device used in vivo (within a living organism).
- Device Description: The description details a physical sheath with lumens for introducing other devices. It does not describe a test or assay performed on biological samples in vitro (outside of a living organism).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for facilitating the placement of other medical devices within the body.
N/A
Intended Use / Indications for Use
The Acumen 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 Sheath has a guidewire lumen and a lumen for the introduction of various types of I he reading or defibrillator leads and catheters. The sheath is designed to be slittable, thereby allowing its removal from the lead, and a slitter is provided with the device.
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
Prescription Use (Per 21 CFR 801 Subpart D)
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)
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): 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
Acumen Medical, Inc.
SEP - 1 2005
510(k) Summary
| General Information | |
|---|---|
| Date Compiled | June 7, 2005 |
| Classification | Class II |
| Trade Name | Modified Acumen Sheath |
| Model TTW 10-65 | |
| Submitter | Acumen Medical, Inc. |
| 1400 Terra Bella Ave., Suite A | |
| Mountain View, CA 94043 | |
| Contact | Marybeth Gamber |
| Director, Regulatory Affairs | |
| tel: 650-352-5700, ext. 226 | |
| fax: 650-352-5700 |
Intended Use
Intended one
The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Predicate Devices Acumen Sheath, TTW 0767 Manufactured by Acumen Medical, Inc.
Device Description
Device Dossellibrient types of pacing or defibrillator leads and catheters.
The Acumen Sheath has a guidewire lumen and a lumen for the introduction of various types of I he reading or defibrillator leads and catheters. The sheath is designed to be slittable, thereby allowing its removal from the lead, and a slitter is provided with the device.
Materials
All materials used in the manufacture of the Acumen Sheath are suitable for this use and have been used in numerous previously cleared products.
Testing
Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
Summary or Duestantial Dollywers Sheath 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
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center is a stylized depiction of an eagle or bird-like figure, composed of three curved lines representing wings or feathers. The overall design is simple and monochromatic.
SEP - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 1400 Terra Bella Ave., Suite A Mountain View, CA 94043
Re: K051515 Modified Acumen Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: August 4, 2005 Received: August 5, 2005
Dear Ms. Gamber:
We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 910(x) premained is substantially equivalent (for the indications ferenced above and nave determined the arredicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Devices Amendmants for use stated in the encrosule) to regary manced promotical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 20, 1770, the characted in accordance with the provisions of the Federal Food, Drug, devices that have been recassince in accerdance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act. and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the devices, belyer to the manual registration, listing of general controls provisions of the fret meride sequences against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controlls) or class III (PMA), it If your device is classified (sec above) this exist on the sifecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such adultional controller. Extrong may be of 898. In addition, FDA may be found in the Ood of receits 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 1000-100. 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 to regarity 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" (2125) Pro 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 the Division of Sillan
(201) 442-6507 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Vochner
A 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
Ko51515
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | Acumen Sheath |
| Indications for Use: | The Acumen Sheath is indicated 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)
Donne B र
प्रतिक्योगिक संस्थान के साथ को प्रति किया था। जिसके साथ को प्रति किया था। जिसके साथ कि महिला है। होगी है। होगी है । होगी है । होगी है । होगी है । होगी है । होगी है । होगी ह
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K051515