(99 days)
Not Found
No
The summary describes a simple delivery sheath and explicitly states that AI, DNN, or ML were not found in the description.
No
This device is a delivery sheath designed to introduce other medical devices (leads and catheters), not to provide a therapeutic treatment itself.
No
The device, a delivery sheath, is intended for the introduction of leads and catheters, not for diagnosing conditions.
No
The device description clearly states it is a "Delivery Sheath," which is a physical, hardware medical device used for introducing leads and catheters. There is no mention of software as the primary or sole component.
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 invasive procedure performed on a living patient.
- Device Description: The device is a sheath and dilator designed to facilitate the insertion of other medical devices. This is a tool used in a medical procedure, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting 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 diagnosis, monitoring, or screening. This device's function is purely procedural, aiding in the delivery of other devices within 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.
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 Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.
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
5. 510(k) Summary
General Information
| Date Compiled | February 9, 2007 | MAY 22 2007 |
|---|---|---|
| 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 | Marybeth Gamber | |
| 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.
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 Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.
Materials
All materials used in the manufacture of the 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 cxisting legally marketed predicate products.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2007
Acumen Medical, Inc. c/o Marybeth Gamber 275 Santa Ana Court Sunnyvale, CA 94085
Re: K070396
Trade/Device Name: Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 11, 2007 Received: May 14, 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, 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 - 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 promated 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,
Brimmer for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. Indications for Use Statement
| 510(k) Number (if known): | K070396 |
|---|---|
| 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 c | |
| 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)
Bhimma
(Division Sign-Om) Division of Cardlov 510(k) Number