(28 days)
The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
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.
The provided 510(k) summary for the BRK™ Transseptal Needle does not contain detailed information regarding acceptance criteria or the specifics of a study proving the device meets those criteria in the way typically expected for complex diagnostic or AI-driven devices.
The submission focuses on establishing substantial equivalence based on performance requirements for a medical instrument rather than a "device" in the context of diagnostic algorithms or imaging. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth for training) are not applicable or not provided in this type of submission.
Here's an attempt to address the request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary broadly states that "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."
Specific acceptance criteria and quantitative performance metrics are not detailed in this summary. For a device like a transseptal needle, these typically involve:
- Mechanical Strength: Withstand forces during insertion and manipulation.
- Dimensional Accuracy: Meet specified outer diameter, length, and curve.
- Material Biocompatibility: Non-toxic and compatible with human tissue.
- Sterility: Absence of viable microorganisms.
- Functionality: Smooth stylet/guidewire passage, effective puncture capability, secure stopcock.
- Tip Integrity: No damage or dulling after puncture.
Since the document provided is a summary, the detailed test reports outlining these specific criteria, methods, and acceptance ranges would be in the full submission, but are not included here.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Device meets product specifications. | "BRK™ Transseptal Needle design meets product specifications..." |
| Device meets performance requirements (e.g., mechanical, functional). | "...and performance requirements." |
| Device is substantially equivalent to predicate devices. | "Results of the testing demonstrate that the BRK™ Transseptal Needle design meets product specifications and performance requirements." "The St. Jude BRK™ Transseptal Needle has similar indications for use and technological characteristics as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The summary mentions "Bench testing of the BRK™ Transseptal Needle." This implies a series of laboratory tests on physical samples of the device.
- Sample Size for Test Set: Not specified. Testing would likely involve multiple units manufactured to ensure consistency.
- Data Provenance: The testing was "bench testing," meaning in a laboratory environment, likely at St. Jude Medical's facilities (United States, given the submitter address). It is a prospective test in the sense that the new device's performance was evaluated against pre-defined criteria. It is not clinical data from patients or retrospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not relevant for a physical medical instrument like a transseptal needle. "Ground truth" (in the context of expert review) is typically for diagnostic assessments (e.g., interpreting images). For a physical device, performance is measured against engineering specifications and functional benchmarks, not expert-established ground truths.
4. Adjudication Method for the Test Set
Not applicable. This is typically used in clinical trials or diagnostic studies involving human interpretation. Bench testing results are usually objective measurements against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are for evaluating diagnostic accuracy, especially when comparing human readers with and without AI assistance on a set of cases. This device is a physical instrument, not a diagnostic algorithm.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
Not applicable. This refers to the performance of an AI algorithm independently. The BRK™ Transseptal Needle is a manual surgical instrument.
7. The Type of Ground Truth Used
The "ground truth" for a physical medical device's performance is its adherence to engineering specifications, design requirements, and recognized industry standards for safety and efficacy. This is established through objective measurements and validated test methods. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set." Its design is based on engineering principles and existing predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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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 Medical14901 DeVeau PlaceMinnetonka, MN 55345-2126 |
|---|---|
| Contact Person: | Laura Moen-FtacekRegulatory Affairs SpecialistTel: 952-351-1453Fax: 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.
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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.
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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
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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
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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
§ 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.