(127 days)
The St. Jude Medical™ CPS Direct™, MediGuide Enabled™ slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter are used with the MediGuide System to enable real-time tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system.
The St. Jude Medical CPS DirectTM, MediGuide EnabledTM outer catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX form the proximal to the distal end with a soft, atraumatic distal tip. The distal end is embedded with a sensor coil to enable device tip projection onto the MediGuideTM system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and a molded slit channel. The hub contains a sideport with extension tubing for contrast delivery, aspiration or saline flush using a 3-way stopcock. In addition, the hub contains a port for the connector cable.
This document describes the CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044 and its performance testing. This is a medical device, and the provided text does not contain information related to AI/ML software or studies that would typically include the requested details about acceptance criteria, data sets, expert involvement, or comparative effectiveness studies in the context of an AI/ML algorithm.
Therefore, I cannot provide an answer that directly addresses most of your specific numbered requests (1, 2, 3, 4, 5, 6, 7, 8, 9) because they are designed for evaluating AI/ML models.
However, I can extract the relevant information about the performance testing of this medical device as described in the document.
Here's a summary of the available information regarding the device's performance testing:
Device: CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044
1. A table of acceptance criteria and the reported device performance:
The document lists the types of performance testing conducted, but it does not provide specific numerical acceptance criteria or quantitative performance results for each test. It states that the device "met all specified design and performance specifications."
| Test Category | Reported Device Performance |
|---|---|
| Package Integrity | Met all specified design and performance specifications |
| Seal Strength | Met all specified design and performance specifications |
| Saline and Aspiration Leak Testing | Met all specified design and performance specifications |
| Visual Inspection | Met all specified design and performance specifications |
| Dimensional Testing | Met all specified design and performance specifications |
| Kink Testing | Met all specified design and performance specifications |
| Compatibility Testing | Met all specified design and performance specifications |
| Electrical Integrity | Met all specified design and performance specifications |
| Tensile Testing | Met all specified design and performance specifications |
| Rotation Capacity | Met all specified design and performance specifications |
| Torque Testing | Met all specified design and performance specifications |
| Slit Force | Met all specified design and performance specifications |
| Flex Testing | Met all specified design and performance specifications |
| Radiopacity Testing | Met all specified design and performance specifications |
| Polarity | Met all specified design and performance specifications |
| Static Accuracy | Met all specified design and performance specifications |
| Biocompatibility | Met all specified design and performance specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective for this type of device testing.
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 and not provided for this type of medical device performance testing, which focuses on physical and functional characteristics rather than diagnostic accuracy based on expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for this type of medical device performance testing.
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
This information is not applicable. The device is a physical catheter, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical catheter, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing of a physical medical device, the "ground truth" is typically defined by engineering specifications, material properties, and established industry standards for performance (e.g., specific tensile strength, leak rate limits, etc.). The document does not detail how these "specifications" were established, but it implies they exist as a benchmark for the tests.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" as this is not an AI/ML device.
Additional Information from the document:
- Type of Study: Product verification (non-clinical) to confirm design requirements and applicable industry standards.
- Conclusion: St. Jude Medical considers the device equivalent to predicate devices based on similarities in design, technological characteristics, principle of operation, materials, and indications for use. Performance testing demonstrated that differences do not adversely affect safety and effectiveness.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, possibly representing hair or movement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
St. Jude Medical Zachary Price Senior Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342
Re: K142239
Trade/Device Name: CPS Direct™ Mediguide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 19, 2014 Received: November 20, 2014
Dear Mr. Price,
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
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Melissa A. Torres -S
For
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
CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Device Name: Models DS2M041, DS2M042, DS2M043, DS2M044
Indications for Use: The St. Jude Medical™ CPS Direct™, MediGuide Enabled™ slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter are used with the MediGuide System to enable real-time tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
CPS Direct™ MediGuide Enabled™ Outer Catheter Traditional 510(k) St. Jude Medical
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Image /page/3/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left, with one square rotated. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font. The text is black and the logo is simple and professional.
510(k) Summary
| Submitter: | St Jude Medical, CRMD15900 Valley View CourtSylmar, CA 91324Establishment Registration Number: 2017865 |
|---|---|
| Contact Person: | Zachary PriceSenior Regulatory Affairs SpecialistPhone (818) 493 2903Fax (818) 493 3615 |
| Date Prepared: | August 12, 2014 |
| Trade Name: | CPS DirectTM MediGuide EnabledTM Slittable Outer Guide CatheterModels DS2M041, DS2M042, DS2M043, and DS2M044 |
| Classification: | Class II - 21 CFR 870.1250Catheter Percutaneous |
| Product Code: | DQY |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical andMediGuideTM Devices |
| St Jude Medical CPS DirectTM, MediGuide EnabledTM Slittable OuterGuide Catheter (K120296 cleared on May 11, 2012) | |
| Device Description: | The St. Jude Medical CPS DirectTM, MediGuide EnabledTM outer catheteris made from PEBAX and reinforced with a stainless steel braid. Theshaft has progressively decreasing durometers of PEBAX form theproximal to the distal end with a soft, atraumatic distal tip. The distal endis embedded with a sensor coil to enable device tip projection onto theMediGuideTM system and tungsten stripes for fluoroscopic visibility. Thehub contains an integrated hemostasis valve and a molded slit channel.The hub contains a sideport with extension tubing for contrast delivery,aspiration or saline flush using a 3-way stopcock. In addition, the hubcontains a port for the connector cable. |
| Intended Use: | The St Jude Medical CPS DirectTM MediGuide EnabledTM slittable outerguide catheter is designed for intracardiac access of the venous system ofthe heart and to serve as a conduit during implantation for the delivery ofcontrast medium and St. Jude Medical devices (including implantable leftheart leads and delivery tools), and support of fluids where minimizing |
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Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left, with one square tilted. To the right of the grid is the text "ST. JUDE MEDICAL" in a sans-serif font. The word "MEDICAL" has a trademark symbol next to it.
blood loss is essential. The CPS Direct™ MediGuide Enabled™ slittable outer guide catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™ MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system
Comparison to Predicate Devices: The St Jude Medical CPS Direct™ MediGuide Enabled™ slittable outer guide catheter (from herein referenced as CPS Direct™ MediGuide Enabled™ outer catheter kit) has a similar intended use and the same fundamental scientific technology as the predicate devices. All technological characteristics of CPS Direct™ MediGuide Enabled™ outer catheter kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where differences exist between the subject device and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device.
Performance Testing
(non-clinical): Product verification was performed on the CPS Direct™ MediGuide Enabled™ outer catheter kit to confirm that it meets the design requirements and applicable industry standards. Testing included evaluations of (1) package integrity, (2) seal strength, (3) saline and aspiration leak testing, (4) visual inspection, (5) dimensional testing, (6) kink testing, (7) compatibility testing, (8) electrical integrity, (9) tensile testing, (10) rotation capacity, (11) torque testing, (12) slit force, (13) flex testing, (14) radiopacity testing, (15) polarity, and (16) static accuracy. This evaluation of the mechanical, functional, and biocompatibility properties of the CPS Direct™ MediGuide Enabled™ outer catheter kit demonstrated that it met all specified design and performance specifications.
- St Jude Medical considers the CPS Direct™ MediGuide Enabled™ outer Conclusion: catheter kit to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in design, technological characteristics, and principle of operation, materials and indications for use.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).