(167 days)
Not Found
No
The device description details a purely mechanical needle and stylet for a transseptal procedure, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is described as a needle used for puncturing the septum to gain access. It's an access tool, not something that directly treats a condition or restores health.
No
The device description indicates that the BRKTM Transseptal Needle is used for puncturing the interatrial septum and gaining left heart access through a transseptal catheterization procedure. While it allows for "aspiration, fluid injection/infusion, blood sampling, pressure monitoring", these are functions related to accessing and manipulating the heart, not primarily for diagnosing a condition or disease.
No
The device description clearly outlines a physical, hardware-based medical device (stainless steel needle and stylet) used for a surgical procedure. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The BRKTM Transseptal Needle is a surgical instrument used inside the body (in vivo) to puncture the interatrial septum during a transseptal catheterization procedure. It is a tool for accessing a specific anatomical location, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for a surgical procedure to gain left heart access. There is no mention of analyzing samples or providing diagnostic information based on testing biological material.
Therefore, based on the provided information, the BRKTM Transseptal Needle is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BRKTM 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 BRKTM 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 (indicating distal curve orientation) 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. The stylet is straight and isodiametric throughout its length. The proximal end of the stylet is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed to facilitate needle advancement within the dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, left heart
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 and biocompatibility testing were performed to verify the device modification. It was concluded that the modified BRKTM Transseptal Needle design meets the product specification and intended use. Biocompatibility was confirmed in accordance with ISO 10993-1.
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
FEB 7 2013
:
| 510(k) Summary | |
|---|---|
| 510(k) Number | K122587 |
| Submitter Information: | |
| Date Prepared: | August 16, 2012 |
| Submitter Name & | |
| Address: | St. Jude Medical - Atrial Fibrillation Division |
| 14901 DeVeau Place | |
| Minnetonka, MN 55345 | |
| Establishment Registration Number: 3005188751 | |
| Contact Person: | Harlan Jones |
| Senior Regulatory Affairs Specialist | |
| Phone (651) 756-3429 | |
| Fax (651) 756-3298 | |
| JonesH02@sjm.com | |
| Device Information: | |
| Trade Name: | BRKTM Transseptal Needle |
| Common Name: | Transseptal Needle |
| Classification Name: | Trocar |
| Class: | Class II, 21 CFR 870.1390, Product Code DRC |
| Predicate Device: | BRKTM Transseptal Needle |
| (K072278). | |
| Device Description: | The St. Jude Medical BRKTM 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 (indicating distal curve orientation) 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. | |
| The stylet is straight and isodiametric throughout its length. | |
| The proximal end of the stylet is fitted with a curved clip to | |
| lock onto the proximal needle hub when inserted into the | |
| needle lumen. The stylet is designed to facilitate needle | |
| advancement within the dilator. | |
| Intended Use: | |
| (Indications for Use) | The BRKTM Transseptal Needle is used to puncture the |
| interatrial septum during a transseptal catheterization | |
| procedure to gain left heart access. | |
| Comparison to | |
| Predicate Devices | The modified BRK™ Transseptal Needle has the same |
| intended use and fundamental scientific technology as the | |
| predicate device. The technological characteristics of the | |
| modified BRK™ Transseptal Needle are substantially | |
| equivalent to the predicate device including packaging, | |
| biocompatibility, sterilization, and labeling. Through | |
| biocompatibility and design verification testing it was | |
| demonstrated that the adhesive change does not adversely | |
| affect the safety and effectiveness. | |
| Summary on Non- | |
| Clinical Testing | Bench testing and biocompatibility testing were performed to |
| verify the device modification. It was concluded that the | |
| modified BRK™ Transseptal Needle design meets the | |
| product specification and intended use. Biocompatibility was | |
| confirmed in accordance with ISO 10993-1. | |
| Statement of | |
| Equivalence | The modified St. Jude Medical BRK™ Transseptal Needle |
| has the same indications for use and technological | |
| characteristics as the predicate device. Based on this and the | |
| data provided in this pre-market notification, St. Jude | |
| Medical's modified BRK™ Transseptal Needle has been | |
| shown to be substantially equivalent to the predicate. |
BRK™ Transseptal Needles
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Special 510(k)
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St. Jude Medical
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Special 510(k)
St. Jude Medical
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
FEB 7 2013
St. Jude Medical Mr. Harlan Jones 14901 Deveau Pl. Minnetonka, MN 55345-2126 US
Re: K122587
Trade/Device Name: BRK Transseptal Needle model 407200, 407201, 407205, 407206, 407207, G407208 Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC Dated: January 10, 2013 Received: January 11, 2013
Dear Mr. Jones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Harlan Jones
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman
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: BRK™ Transseptal Needle
Indications for Use:
The BRK™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
(Division Sign-Off)
Division of Cardiovascular Devices
Site Number K122587