(17 days)
Not Found
No
The summary describes a physical delivery sheath and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a delivery sheath used to introduce other medical devices (pacing or defibrillator leads and catheters) into the body, not to provide therapy itself.
No
This device is a delivery sheath, explicitly stating its purpose is "for the introduction of various types of pacing or defibrillator leads and catheters." It does not mention any function related to diagnosing medical conditions.
No
The device description clearly describes a physical medical device (sheath, dilator) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of various types of pacing or defibrillator leads and catheters." This describes a device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details a physical sheath and dilator designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples outside the body. This device is an invasive medical device used for delivery inside the body.
N/A
Intended Use / Indications for Use
The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.
Product codes
DYB
Device Description
The Modified 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. The Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.
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
In-vitro 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
Kososcc
Acumen Medical, Inc. Premarket Notification - Special 510(k) Revision Date: February 21, 2008
5. 510(k) Summary General Information
| Date Compiled | February 21, 2008 | MAR 13 2008 |
|---|---|---|
| Classification | Class II | |
| Trade Name | Modified 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 | Kevin MacDonald (415-609-9875) |
Intended Use
The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Predicate Devices
| Acumen Single-Lumen Delivery Sheath
| Manufactured by Acumen Medical, Inc. | K053400 |
|---|---|
| Modified Acumen Single-Lumen Delivery Sheath | |
| Manufactured by Acumen Medical, Inc. | K070396 |
Device Description
The Modified 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. The Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.
Materials
All materials used in the manufacture of the Modified Acumen Single-Lumen Delivery Sheath are identical to the predicate device.
Testing
In-vitro 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 Modified Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of three curved lines.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Acumen Medical, Inc. c/o Mr. Kevin MacDonald Regulatory Consultant 275 Santa Ana Court Sunnydale, CA 94085
Re: K080500
Modified Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: February 21, 2008 Received: February 25, 2008
Dear Mr. MacDonald:
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.
2
Page 2 - Mr. Kevin MacDonald
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
| 510(k) Number (if known): | This application KO80500 |
|---|---|
| Device Name: | Modified Acumen Single-Lumen Delivery Sheath |
| Indications for Use: | The Modified 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)
2
(Division Sig
(Division Sig)
Division of Caraiova
510(k) Number K080500