(167 days)
The BRKTM Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
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.
The BRK™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. This device is a modification of the predicate device (BRK™ Transseptal Needle (K072278)) due to an adhesive change. The study conducted for this device was a non-clinical study involving bench testing and biocompatibility testing to verify the device modification. The study aimed to demonstrate substantial equivalence to the predicate device and ensure the modification did not adversely affect safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product Specification Compliance | Modified BRK™ Transseptal Needle meets product specification and intended use. |
| Biocompatibility | Confirmed in accordance with ISO 10993-1. |
| Safety and Effectiveness of Adhesive Change | Demonstrated that the adhesive change does not adversely affect safety and effectiveness. |
| Substantial Equivalence to Predicate Device | Modified BRK™ Transseptal Needle has the same indications for use and technological characteristics as the predicate, hence demonstrated substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes non-clinical bench testing and biocompatibility testing. It does not specify a sample size for a "test set" in the context of clinical data or patient studies. The testing was performed on the device itself.
Data provenance: The testing was described as "bench testing and biocompatibility testing," implying laboratory-based testing rather than human clinical data. No country of origin for data or retrospective/prospective nature is applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the study was non-clinical (bench and biocompatibility testing). Ground truth, in the context of expert review, typically refers to clinical diagnosis or assessment.
4. Adjudication Method for the Test Set
This information is not applicable as there was no test set requiring expert adjudication for clinical outcomes. The evaluation involved direct product testing against specifications and standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not performed. This device is a medical needle, and the study was focused on the impact of a material change (adhesive) through non-clinical testing, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical instrument, not an AI or software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study was established by product specifications, intended use, and international standards (ISO 10993-1 for biocompatibility). The performance was measured against these established engineering and safety criteria, not against clinical outcomes or pathology from patients.
8. The Sample Size for the Training Set
This information is not applicable as there was no "training set" in the context of machine learning or AI. The study involved non-clinical testing of a physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no "training set" or AI component involved in this device's evaluation.
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FEB 7 2013
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| 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 aluminal stainless steel needle and solid stainless steel stylet.The distal section of the needle is curved to facilitatepositioning within the heart when used with a St. JudeMedical Transseptal Introducer set. Within this curvedsection, there is an abrupt step down in the outer diameter ofthe needle to mate with the internal diameter of the dilator ofthe St. Jude Medical Transseptal Introducer set. The distal tipof the needle is beveled to facilitate the puncture process. |
| The proximal end of the needle is configured with a pointerflange (indicating distal curve orientation) and is fitted with a2-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 tolock onto the proximal needle hub when inserted into theneedle lumen. The stylet is designed to facilitate needleadvancement within the dilator. | |
| Intended Use:(Indications for Use) | The BRKTM Transseptal Needle is used to puncture theinteratrial septum during a transseptal catheterizationprocedure to gain left heart access. |
| Comparison toPredicate Devices | The modified BRK™ Transseptal Needle has the sameintended use and fundamental scientific technology as thepredicate device. The technological characteristics of themodified BRK™ Transseptal Needle are substantiallyequivalent to the predicate device including packaging,biocompatibility, sterilization, and labeling. Throughbiocompatibility and design verification testing it wasdemonstrated that the adhesive change does not adverselyaffect the safety and effectiveness. |
| Summary on Non-Clinical Testing | Bench testing and biocompatibility testing were performed toverify the device modification. It was concluded that themodified BRK™ Transseptal Needle design meets theproduct specification and intended use. Biocompatibility wasconfirmed in accordance with ISO 10993-1. |
| Statement ofEquivalence | The modified St. Jude Medical BRK™ Transseptal Needlehas the same indications for use and technologicalcharacteristics as the predicate device. Based on this and thedata provided in this pre-market notification, St. JudeMedical's modified BRK™ Transseptal Needle has beenshown to be substantially equivalent to the predicate. |
BRK™ Transseptal Needles
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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
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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
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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
§ 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.