(32 days)
Not Found
No
The summary describes a mechanical device (sheath and stylet) for lead delivery and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is described as a "lead delivery sheath with stylet" intended for the introduction of leads and catheters, not for directly treating a disease or condition.
No
The device is described as an "introduction sheath" for leads and catheters, indicating its function is for delivery, not diagnosis. It facilitates the placement of other medical devices.
No
The device description clearly states it is a "single-use percutaneous catheter" and includes physical components like a "guidewire lumen" and a "lumen for introduction of leads," 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 confirms it's a percutaneous catheter for introducing leads. This is a surgical/interventional tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are used for testing and analysis of biological specimens.
Therefore, the Acumen Lead Delivery Sheath with Stylet is a medical device used for a surgical or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acumen Lead Delivery Sheath with Stylet 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 with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.
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
FEB 2 3 2007
Acumen Lead Delivery Sheath January 19, 2007
Acumen Medical, Inc.
510(k) Summary 5.
General Information
| Date Compiled | January 19 2007 |
|---|---|
| Classification | Class II, |
| Trade Name | Acumen Lead Delivery Sheath with Stylet |
| Submitter | 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 Acumen Lead Delivery Sheath with Stylet is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
| Predicate Devices | |
|---|---|
| Acumen Lead Delivery Sheath | K062145 |
| Manufactured by Acumen Medical, Inc. |
Device Description
The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.
Materials
MI materials used in the manufacture of the Acumen Lead Delivery Sheath with Stylet 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 Acumen Lead Delivery Sheath with Stylet is substantially equivalent to the predicate product. The intended use, method of operation, methods of ounstruction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, and a wavy line representing its tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2007
Acumen Medical, Inc. C/O Marybeth Gamber 275 Santa Ana Court Sunnyville, CA 94085
Re: K070197
Trade/Device Name: Acumen Lead Delivery Sheath with Stylet Regulation Number: 21 CFR 870.1340 Regulation Name: Regulatory Class: Class II Product Code: DYB Dated: January 19, 2007 Received: January 23, 2007
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. Iisting 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. 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,
BHummar fr
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):
Acumen Lead Delivery Sheath with Stylet Device Name:
Indications for Use:
The Acumen Lead Delivery Sheath with Stylet 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)
House Hotel Color State Childer Hotel Comment He School Collection Child Children Children Children Children Children Children Children Children Children Children Children
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hummer
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ 270197
Confidential