(111 days)
The St. Jude Medical CPS Aim™ Inner Catheter is designed for intracardiac access of the coronary sinus and subselection 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 guidewires. In addition, the inner catheters can work with outer guide catheters as a system.
The inner catheter is an introducer that shall be used to primarily subsclect a coronary sinus vein branch in the venous system. The CPS Aim730 Inner Catheters will have eight different curve configurations. The catheters will have a working length of 71 cm, are radiopaque, and have a flexible distal tip. The inner diameter of the catheter is lined with polytetrafluoroethylene (PTFF) to ensure additional lubricity. The catheters function as an inner catheter and can work with an outer guide catheter as a system.
Here's an analysis of the provided information regarding the acceptance criteria and study for the CPS Aim™ Inner Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K053217) is a 510(k) premarket notification summary. For this type of submission, especially for a Class II device like the CPS Aim™ Inner Catheter, the regulatory pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than establishing completely new performance criteria through extensive clinical trials with explicit acceptance metrics.
Therefore, the document does not contain a table of explicit acceptance criteria with specific numerical targets (e.g., sensitivity, specificity, accuracy) or reported device performance in the way one might expect for an AI/diagnostic device.
Instead, the acceptance criteria are implicit in the demonstration of equivalence to predicate devices, which means:
- Similar technological characteristics: The device uses similar technology, intended uses, functions, materials, and method of operation.
- Meeting general design and performance specifications: The device underwent verification testing to ensure it meets its own internal design and performance specifications.
- Biocompatibility: Materials are biocompatible.
- Sterilization validation: The sterilization process is validated.
The "reported device performance" is essentially that it "met all specified design and performance specifications" and was found to be "substantially equivalent" to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not report on a "test set" in the context of clinical data or patient imaging. The studies mentioned are primarily engineering-based device comparison testing, mechanical testing, functional testing, and biocompatibility testing.
Therefore, information on:
- Sample size used for a test set
- Data provenance (country of origin, retrospective/prospective)
...is not applicable or not provided in this 510(k) summary, as it's not a study that involved clinical data in the form of patient populations or images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a catheter and the studies described are device comparison testing, mechanical, functional, and biocompatibility testing, the concept of "experts used to establish ground truth" (e.g., radiologists interpreting images) for a clinical test set is not applicable. The "ground truth" for these tests would be established by engineering standards, industry best practices, and laboratory measurements.
4. Adjudication Method for the Test Set
As there is no clinical "test set" in the conventional sense involving patient data or interpretations by human experts, there is no adjudication method provided or applicable.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a physical catheter, not an AI or diagnostic imaging system that would involve human readers interpreting output from an AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the verification and device comparison testing described would have been established through:
- Engineering specifications and design documents: For mechanical and functional testing, the "ground truth" is whether the device meets its pre-defined specifications (e.g., dimensions, flexibility, tensile strength, flow rates).
- Established laboratory protocols and standards: For biocompatibility and sterilization, the "ground truth" is adherence to recognized ISO standards and validated testing methodologies.
- Predicate device characteristics: For device comparison, the "ground truth" refers to the known characteristics and performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.
8. The Sample Size for the Training Set
There is no "training set" in the context of machine learning or AI described in this document. The studies performed are engineering verification and validation, not model training.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI/algorithm, the concept of establishing ground truth for it is not applicable.
In Summary:
The provided document (K053217) pertains to a 510(k) premarket notification for a physical medical device (an inner catheter). The regulatory approval is based on demonstrating "substantial equivalence" to existing predicate devices through engineering, material, and performance testing, rather than clinical studies with explicit statistical acceptance criteria, ground truth established by experts, or AI performance metrics. Therefore, many of the requested details related to "acceptance criteria" and "studies" as they apply to AI or diagnostic imaging devices are not present or applicable to this submission.
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K 053 217
PREMARKET NOTIFICATION [510(K)] SUMMARY
| Date Prepared: | November 16, 2005 |
|---|---|
| Submitter: | St. Jude Medical, CRMD |
| Address: | 15900 Valley View CourtSylmar, CA 91324 |
| Phone: | 818 493-2629 |
| Fax: | 818 493-3615 |
| Contact Person: | Deanna Hughes |
| Trade Name/ProprietaryName: | CPS Aim™ Inner Catheter |
| Common Name: | Catheter, Percuatenous |
| Classification: | Class II, 21 CFR 870.1250 |
| Legally marketed deviceto which your firm isclaiming equivalence: | Medtronic Attain™ Select (K042194), Guidant Rapido™(K021455) |
Device Description:
The inner catheter is an introducer that shall be used to primarily subsclect a coronary sinus vein branch in the venous system.
The CPS Aim730 Inner Catheters will have eight different curve configurations. The catheters will have a working length of 71 cm, are radiopaque, and have a flexible distal tip. The inner diameter of the catheter is lined with polytetrafluoroethylene (PTFF) to ensure additional lubricity. The catheters function as an inner catheter and can work with an outer guide catheter as a system.
Intended Use of the Device:
The St. Jude Medical CPS Aim™ Inner Catheter is designed for intracardiac access of the coronary sinus and subsclection 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 guidewires. In addition, the inner catheters can work with outer guide catheters as a system.
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Technological Characteristics of the Device Compared to the Predicate Device:
The CPS Aim™ Inner Catheters use similar technology, have similar intended uses, functions, materials and method of operation of the following predicate devices.
Summary of Studies:
Device comparison testing was performed to support equivalency of the CPS Aim™ Inner Catheters to the predicate devices. Verification was also performed which included mechanical, functional and biocompatibility testing with the CPS Aim™ meeting all specified design and performance specifications.
Biocompatibility Information:
St. Jude Medical has performed biocompatibility testing on the patient tissue contacting materials used in the CPS Aim inner catheter and have been found to be biocompatible.
Sterilization Validation:
The CPS Aim™ Inner Catheters are sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Conclusion:
St. Jude Medical considers the CPS Aim™ Inner Catheters to be substantially equivalent to the legally marketed predicate and referenced devices. The results of the tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
K053217
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Image /page/2/Picture/2 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 8
St. Jude Medical c/o Ms. Deanna Hughes Sr. Regulatory Affairs Specialist 15900 Valley View Court Sylmar, CA 91324
Re: K053217
Trade Name: CPS Aim™ Inner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: February 06, 2006 Received: February 07, 2006
Dear Ms. Hughes:
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 usn 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 – Ms. Deanna Hughes
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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
B.Zimmerman 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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
CPS Aim™ Inner Catheter Device Name:
Indications for Use:
The St. Jude Medical CPS Aim™ Inner Catheter is designed for intracardiac access of the coronary sinus and subselection 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 guidewires. In addition, the inner catheters can work with outer guide catheters as a system.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
B. Zimmerman
n Slan-Off of Cardiovascular Davices
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§ 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).