(28 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical needle, with no mention of software, algorithms, or data processing.
No
Therapeutic devices are generally used to treat or cure a disease or condition, or to restore function. This device is used to gain "left heart access" during a "transseptal catheterization procedure," which is an interventional diagnostic procedure. While it is used for a medical purpose, it does not directly treat or cure.
No
The device is a needle used for physically puncturing the interatrial septum to gain left heart access during a medical procedure, not for diagnosing conditions.
No
The device description clearly outlines a physical, invasive medical device (a needle and stylet) used for a surgical procedure. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the St. Jude Medical Transseptal Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. This is a surgical/interventional procedure performed directly on a patient's body.
- Device Description: The description details a physical needle and stylet designed for mechanical puncture and access. It does not describe a device used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, assays, or any other components typically associated with IVD devices.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The St. Jude Medical Transseptal Needle is a tool used during a medical procedure, not for analyzing samples.
N/A
Intended Use / Indications for Use
The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Product codes (comma separated list FDA assigned to the subject device)
DRC
Device Description
The St. Jude Medical Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical Transseptal Introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of the St. Jude Medical Transseptal Introducer set. The distal tip of the needle is beveled to facilitate the puncture process. The proximal end of the needle is configured with a pointer flange and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and or guidewire insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum
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)
Bench testing of the BRK™ Transseptal Needle was performed to support substantial equivalence. Results of the testing demonstrate that the BRK™ Transseptal Needle design meets product specifications and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
510(k) Summary As required by 21 CFR 807.92(c)
510(k) Number: Ko72278
Date Prepared:
August 13, 2007
Submitter Information:
| Submitter's Name/
Address: | St. Jude Medical
14901 DeVeau Place
Minnetonka, MN 55345-2126 |
|-------------------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Laura Moen-Ftacek
Regulatory Affairs Specialist
Tel: 952-351-1453
Fax: 952-930-9481 |
Device Information:
Trade Name: Common Name: Classification Name: Class:
BRK™ Transseptal Needle Transseptal Needle Trocar Class II, 21 CFR 870.1390, Product Code DRC
Predicate Device:
-
- Thomas Medical Products, Inc., Transseptal Needle/Trocar (K011727)
-
- St. Jude Medical ACross™ Transseptal Access System (K070417)
Device Description:
The St. Jude Medical Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical Transseptal Introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of the St. Jude Medical Transseptal Introducer set. The distal tip of the needle is beveled to facilitate the puncture process. The proximal end of the needle is configured with a pointer flange and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and or guidewire insertion.
1
Indications for Use:
The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Comparison to Predicate Devices:
The BRK™ Transseptal Needle has the same general intended use and fundamental scientific technology as the predicate device.
Summary of Non-Clinical Testing:
Bench testing of the BRK™ Transseptal Needle was performed to support substantial equivalence. Results of the testing demonstrate that the BRK™ Transseptal Needle design meets product specifications and performance requirements.
Statement of Equivalence:
The St. Jude BRK™ Transseptal Needle has similar indications for use and technological characteristics as the predicate devices. Based on this and the design and engineering data provided in the pre-market notification, SJM's BRK™ Transseptal Needle has been shown to be substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2007
St. Jude Medical Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K072278
Trade/Device Name: BRK™ Transseptal Needle Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC Dated: August 15, 2007 Received: August 16, 2007
Dear Mr. Job:
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.
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
3
Page 2 - Mr. Mark Job
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 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,
uma R. brhmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(K) Number (if known):
Device Name: BRKTM Transseptal Needle
Indications for Use:
The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duna R. Launer
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_ko22228