(30 days)
Not Found
No
The summary describes a mechanical sheath for introducing leads and catheters and makes no mention of AI or ML.
No.
The device is for introduction of leads and catheters, but the device itself does not provide therapy. The therapy would be delivered by the pacing or defibrillator leads/catheters that are introduced via this device.
No.
The device's stated indication is for the introduction of leads and catheters, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly describes a physical, single-use percutaneous catheter with a guidewire lumen 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 an in vivo procedure, meaning it's performed within a living organism.
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens outside the body to diagnose diseases or conditions.
Therefore, the Acumen Sheath is a medical device used for a therapeutic or procedural purpose within the body, not an in vitro diagnostic device.
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
DYB
Device Description
The Acumen Sheath is a single-use percutaneous catheter indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Acumen Sheath has a guidewire lumen for the introduction of various types of pacing or defibrillator leads and catheters. The sheath is designed to be splittable, 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
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)
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)
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
Acumen Medical, Inc.
FEB - 3 2005
510(k) Summary
y
K050015
| General Information | |
|---|---|
| Date Compiled | January 3, 2004 |
| Classification | Class II |
| Trade Name | Modified Acumen Sheath |
| Submitter | Acumen Medical, Inc. |
| 1400 Terra Bella Blvd., 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 Use
The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Predicate Devices Acumen Sheath K042376 Manufactured by Acumen Medical, Inc.
Device Description
The Acumen Sheath is a single-use percutaneous catheter indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Acumen Sheath has a guidewire lumen for the introduction of various types of pacing or defibrillator leads and catheters. The sheath is designed to be splittable, 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
Acumen Medical believes the Acumen 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/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Public Health Service
FEB = 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marybeth Gamber Director, Regulatory Affairs Acumen Medical, Inc. 1400 Terra Bella Blvd., Suite A Mountain View, CA 94043
Re: K050015
Trade/Device Name: Modified Acumen Sheath, Model TTWO 767 Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 3, 3005 Received: January 4, 2005
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
2
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dinna R. Vochmer
- Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Acumen Medical, Inc.
Indications for Use
| 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)
Dianna R. Vicluner
(Division Sign-Off) Division of Cardiovascular Devices
Confidential
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510(k) Number_Ko 5 (נוצ