(55 days)
Not Found
No
The summary describes a mechanical catheter and does not mention any AI/ML components or functions.
No
The device is a delivery catheter for introducing other medical devices (pacing or defibrillator leads and catheters), not one that directly treats a medical condition itself.
No
The device is described as a delivery catheter for introducing pacing or defibrillator leads, which is an interventional or therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter and associated hardware components (stylets, sheath). There is no mention of software as the primary or sole component.
Based on the provided information, the SPIRIT™ Navigable Lead Delivery Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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 reinforces this by stating it's a "single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters." It also mentions its use in the "vasculature," which is part of the circulatory system within the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens outside the body.
Therefore, the SPIRIT™ Navigable Lead Delivery Catheter is a medical device used for a procedural purpose within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Product codes
DYB
Device Description
The SPIRIT™ Navigable Lead Delivery Catheters are single-use percutaneous catheters intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), 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
Not Found
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
1083855
510(k) Summary
General Information
Date Compiled Classification
Trade Name
Submitter
December 18, 2008
FEB 1 7 2009
Class II,
SPIRITTM Navigable Lead Delivery Catheter
Acumen Medical, Inc. 275 Santa Ana Court Sunnyvale, CA 94085
Tel: 408-530-1810 Fax: 408-530-1811
Contact
Kevin MacDonald Tel. 415-609-9875
Intended Use
The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Predicate Devices Acumen Lead Delivery Sheath with Stylet Manufactured by Acumen Medical, Inc.
Device Description
The SPIRIT™ Navigable Lead Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), to aid in positioning of the device in the vasculature.
Materials
All materials used in the manufacture of the SPIRIT™ Navigable Lead Delivery Catheter are suitable for this use, meet the biocompatibility requirements per ISO 10993-1, 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 SPIRIT™ Navigable Lead Delivery Catheter 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2009
Acumen Medical, Inc. Kevin MacDonald 275 Santa Ana Court Sunnyvale, CA 94085
Re: K083855
Trade/Device Name: SPIRITTM Navigable Lead Delivery Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 26, 2009 Received: January 29, 2009
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 Hederal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (EMA). 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
Enclosure
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 Biometrics' (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, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use Statement
510(k) Number (if known):
Device Name:
SPIRIT
Indications for Use:
SPIRIT™ Navigable Lead Delivery Catheter
The SPIRIT™ Navigable Lead Delivery Catheter 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)
Oomlee
(Division Sign-Off) Division of Cardiovascular Devices KOB3855 510(k) Number