(55 days)
Not Found
No
The summary describes a physical sheath for introducing leads and catheters and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for the "introduction of various types of pacing or defibrillator leads and catheters," not for treating a disease or condition itself.
No
The device is described as an "introduction sheath" for "pacing or defibrillator leads and catheters," indicating an interventional or therapeutic purpose rather than diagnostic.
No
The device description clearly describes a physical, single-use percutaneous catheter with lumens, coatings, 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), not for testing samples in vitro (outside the body).
- Device Description: The description details a physical sheath used for insertion and delivery of other devices into the body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic testing, measuring biomarkers, or providing information about a patient's health status based on sample analysis.
Therefore, the Acumen Sheath is a medical device used in a surgical or interventional procedure, 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 and a lumen for the introduction of various types of pacing or defibrillator leads and catheters. The delivery lumen is coated with a lubricious coating to aid in device delivery. 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)
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.
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
OCT 2 6 2004
K042376
page 1 of 2
510(k) Summary
General Information
| Date Compiled | August 30, 2004 |
|---|---|
| Classification | Class II |
| Trade Name | 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
The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Predicate Devices SafeSheath Coronary Sinus Guide K003731 Manufactured by Pressure Products, Inc/Thomas Medical Products 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 and a lumen for the introduction of various types of pacing or defibrillator leads and catheters. The delivery lumen is coated with a lubricious coating to aid in device delivery. 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
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.
1
042376
page 2 of 2
Summary of Substantial Equivalence
Summary of Substantial Equiralies
Acumen Medical believes the Acumen Sheath is substantially equivalent to the Acumen Medical believes the Noalien Streation, methods of construction predicale product. "The mended use, method or substantially equivalent to existing legally marketed predicate product.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2004
Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 1400 Terra Bella Blvd., Suite A Mountain View, CA 94043
Re: K042376
Trade Name: Acumen Sheath, Model TTW 7807 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 30, 2004 Received: September 1, 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 for are waver 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 Cosmatic Act (Act). You may, therefore, market the device, subject to the general controls and Ooomette Free (110). - However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you ruer 20, 1973, and evice components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
3
Page 2 - Ms. Marybeth Gamber
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4591. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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,
Bhummer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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)
Bhummer
்பட்டுள்ள Sign-Off) )ivision of Cardiovascular Devices :10(k) Number KOS