(70 days)
The St. Jude Medical Transseptal Catheter Introducer Set is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The Swartz™ Braided Transseptal Guiding Introducer set consists of a fixed compound curve, dilator, and guidewire. The fixed curve Swartz introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.
I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and answer all the questions.
Specifically, the document is a 510(k) summary for a medical device (Swartz™ Braided Transseptal Guiding Introducer) and focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study with acceptance criteria and performance metrics of the device itself.
Here's what I can extract and what's missing:
Missing Information:
- Acceptance Criteria for Device Performance: The document does not state specific performance metrics (e.g., success rates, complication rates, measurement accuracy) or their associated acceptance criteria. Instead, it refers to "mechanical testing" to demonstrate safety and effectiveness for dimensional and material differences.
- Reported Device Performance: No quantitative performance data for the Swartz™ Braided Transseptal Guiding Introducer is provided.
- Study Design Details:
- Sample size for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is more common for diagnostic imaging devices involving human interpretation, not for an introducer catheter. The document does not mention such a study.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used.
- Sample size for the training set (not applicable for this type of device).
- How ground truth for the training set was established (not applicable).
Information that can be inferred or is present (though not in the requested format for a performance study):
- The document implies that the "acceptance criteria" for the device's design changes were met through mechanical testing. However, no specifics of these tests or their acceptance thresholds are provided in this summary.
- The study that "proves the device meets the acceptance criteria" refers to mechanical testing that demonstrated dimensional and material differences do not adversely affect safety and effectiveness. This is not a clinical study with patient outcomes or expert reviews in the way typically required for AI/diagnostic devices.
Based on the provided text, I can only state that a direct answer to your request regarding acceptance criteria and a detailed study proving device performance (as if it were an AI diagnostic device) cannot be given.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, expert information, or ground truth details.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on ground truth establishment for training sets.
The core of this 510(k) submission is about demonstrating "substantial equivalence" to legally marketed predicate devices, primarily through comparison of technological characteristics and, where differences exist, through mechanical testing to ensure safety and effectiveness. It is not a clinical performance study with defined endpoints and ground truth experts as would be expected for an AI-powered diagnostic tool.
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510(k) Summary (As required by 21 CFR 807.92)
Submitter Information A.
| Submitter's Name: | St. Jude Medical |
|---|---|
| Address: | 14901 DeVeau Place |
| Minnetonka, Minnesota 55345-2126 U.S.A. | |
| Telephone Number: | 1-800-328-3873 |
| Fax Number: | (952) 930 - 9481 |
| Contact Person: | Glenn Jacques |
| Date Submission Prepared: | September 23, 2005 |
B. Device Information
| Trade Name: | Swartz™ Braided Transseptal Guiding Introducer |
|---|---|
| Common or Usual Name: | Transseptal Catheter Introducer |
| Classification Name: | Catheter Introducer (per 21CFR 870.1340) |
| Predicate Devices: | Fast-Cath™ (Two-Piece AMAS) Transseptal CatheterIntroducers (K964518) |
| Agilis™ Steerable Catheter Introducer (K042623) | |
| Device Description: | The Swartz™ Braided Transseptal Guiding Introducerset consists of a fixed compound curve, dilator, andguidewire. The fixed curve Swartz introducer is fittedwith a hemostasis valve to minimize blood loss duringcatheter introduction and/or exchange. A sideport withthree-way stopcock is provided for air or bloodaspiration, fluid infusion, blood sampling and pressuremonitoring. The introducer features distal vent holes tofacilitate aspiration and minimize cavitation, and aradiopaque tip marker to improve fluoroscopicvisualization. The device is provided sterile and isintended for single-use only. |
| Intended Use: | The St. Jude Medical Transseptal Catheter IntroducerSet is used for introducing various cardiovascularcatheters into the left side of the heart through theinteratrial septum. |
Comparison of Required Technological Characteristics ं
All technological characteristics of the Swartz™ Braided Transseptal Guiding Introducer are substantially equivalent to the predicate devices including product design, packaging, biocompatibility, sterilization, and labeling. Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical testing demonstrated that these differences do not adversely affect safety and effectiveness.
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Support of the Substantial Equivalence D.
St. Jude Medical considers the Swartz™ Braided Transseptal Guiding Introducer to be St. Jude Medical considers the predicate devices, Fast-Cath™ (Two-Piece AMAS) Transseptal Substancially oquivalorit to the pilis™ Steerable Catheter Introducer.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC & 2005
St. Jude Medical c/o Mr. Glenn Jacques Regulatory Affairs Manager 14901 Deveau Pl. Minntonka, MN 55345
K052644 Swartz™ Braided Transseptal Guiding Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: September 23, 2005 Received: September 26, 2005
Dear Mr. Jacques:
Re:
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.
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Page 2 - Mr. Glenn Jacques
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised film i Dri b looka.co or our device complies with other requirements of the Act that IDA has made a determination and Joinistered by other Federal agencies. You must of ally reactal statutes and regulanents ancluding, but not limited to: registration and listing (21 comply will an the rice orequirements)01); good manufacturing practice requirements as set CFK Fat 807), adoling (21 OF R Part 820); and if applicable, the electronic forth in the quality by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) 100 marketing your device as described in your Section 510(k) I his icher will anow you to begin mailing of substantial equivalence of your device to a legally prematice notification: "The 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 If you desire specific arrivater J at (240) 276-0120. Also, please note the regulation entitled, Conidor the Office of Comment to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R. Vachner
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:
Swartz™ Braided Transseptal Guiding Introducer
Indications for Use:
The St. Jude Medical Transseptal Catheter Introducer Set is used Fire Bt. Jude House cardiovascular catheters into the left side of the heart through the interatrial septum.
X 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)
10 Market States Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments o
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Duma R. Vines
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052644
§ 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).