(160 days)
The CPS DuoTM guidewire and stylet are indicated for: Facilitation of placement of St. Jude Medical left heart leads to target vessel/site.
CPS Duo™ Left Heart Lead Delivery System is a combination of a CPS Duo™ Stylet and a CPS Duo™ Guidewire designed to facilitate the delivery of a SJM lead to the target vessel/site. The CPS Duo™ stylet has a lumen to allow a CPS Duo™ guidewire to pass through it. The CPS Duo™ Guidewire is specially designed to function in concert with the CPS Duo™ Stylet.
This document ([K072864](https://510k.innolitics.com/search/K072864)) describes a medical device submission that is a 510(k) premarket notification for the CPS Duo™ Left Heart Lead Delivery System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness through clinical trials with specific acceptance criteria as one would find in a PMA (Premarket Approval) application for novel, high-risk devices.
Therefore, the information requested regarding acceptance criteria, device performance against those criteria, and detailed study parameters for device performance evaluation (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone studies) are not present in this document in the manner typically associated with AI/software performance evaluations.
Instead, the submission focuses on demonstrating technological equivalence and safety.
Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not applicable:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) submission for this type of device. The document does not define specific "acceptance criteria" for clinical performance metrics (like accuracy, sensitivity, specificity) of the CPS Duo™ Left Heart Lead Delivery System in the way an AI/software device would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and adherence to design specifications through verification testing.
- Reported Device Performance: The document states:
- "Device comparison testing was performed to support equivalency of the CPS Duo™ Left Heart Lead Delivery System with the predicate devices, SJM Models 4078S and 4078G."
- "In addition verification testing was completed, including mechanical, functional and biocompatibility testing with the CPS Duo™ Left Heart Lead Delivery System meeting all specified design and performance specification test report is in QTR 2179."
- "St. Jude Medical considers the CPS Duo™ Left Heart Lead Delivery System 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."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This document does not describe clinical performance "test sets" in the context of evaluating a software algorithm or AI model. The studies mentioned are "device comparison testing" and "verification testing" (mechanical, functional, biocompatibility) to show substantial equivalence and safety, not clinical efficacy or diagnostic accuracy on a patient data set. There's no mention of sample sizes of patients or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. As there's no "test set" for clinical performance evaluation (like image interpretation or diagnostic accuracy) in this 510(k), there's no mention of experts establishing ground truth for such a purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical "test set" and thus no adjudication method is described.
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. This is not an AI-powered device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (lead delivery system), not an algorithm or AI. Standalone performance is not applicable in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the traditional sense. For a physical delivery system, "ground truth" relates to successful deployment, mechanical integrity, material properties, and biocompatibility rather than diagnostic accuracy. The "ground truth" for the verification testing would be the pre-defined engineering and safety specifications (e.g., tensile strength, flexibility, biocompatibility standards).
8. The sample size for the training set
- Not applicable/Not provided. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set, this is not applicable.
Summary of the Study type in the K072864 submission:
This 510(k) submission describes studies focused on demonstrating substantial equivalence to existing predicate devices and ensuring the safety of the CPS Duo™ Left Heart Lead Delivery System. The studies performed include:
- Device Comparison Testing: To support equivalence with predicate devices (SJM Models 4078S and 4078G). This likely involves comparing design features, materials, and functional aspects.
- Verification Testing: This encompassed:
- Mechanical Testing: To ensure the device meets specified design and performance specifications (e.g., strength, flexibility, torque).
- Functional Testing: To confirm the device operates as intended (e.g., guidewire passage through a stylet).
- Biocompatibility Testing: Performed on patient tissue-contacting materials to ensure they are safe for contact with the body.
- Sterilization Validation: Using an Ethylene Oxide (EtO) process to ensure the device is sterile.
Conclusion of the Document:
The FDA reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. This allows the device to be marketed, subject to general controls and applicable special controls for Class II devices.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).