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.

AI/ML Overview

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.

Summary

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PREMARKET NOTIFICATION [510(K)] SUMMARY

Date Prepared:	February 26, 2008
Submitter:	St. Jude Medical, CRMD
Address:	15900 Valley View Court	MAR 13 2008
	Sylmar, CA 91324
Phone:	818 493-2960
Fax:	818 493-3615
Contact Person:	Colleen Canan
Trade Name/Proprietary Name:	CPS Duo™ Left Heart Lead Delivery System
Common Name:	CPS Duo Guidewire, CPS Duo StyletModel Numbers: DS2M001, DS2M002, DS2M005,DS2M006, DS2M007
Classification:	Class II, 21 CFR 870.1380
	Class II, 21 CFR 870.1330
Legally marketed deviceto which your firm isclaiming equivalence:	St. Jude Medical Model 4078S approved under (P030054)and Model 4078G approved under (K011084).

Device Description:

The CPS Duo™ Left Ventricular Lead Delivery System indication for use is as follows:

The St. Jude Medical CPS Duo™ Left Heart Lead Delivery system is designed to facilitate placement of SJM left heart leads to target vessel/site.

Technological Characteristics of the Device Compared to the Predicate Device:

The CPS Duo™ Left Heart Lead Delivery System, including the CPS Duo™ Stylet and the CPS Duo™ Guidewire use similar technology; have similar intended uses, functions, materials and method of operation of the following predicate devices.

. St. Jude Medical Model 4078S approved under (P030054) on June 30, 2004 and Model 4078G cleared under (K011084) on May 10, 2001.
11

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Summary of Studies:

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.

Biocompatibility:

St. Jude Medical has performed biocompatibility testing on the patient tissue contacting materials used in the CPS Duo™ Left Heart Lead Delivery System and have been found to be biocompatibility testing (QTR 2143) is provided in appendix 4.

Sterilization Validation:

The CPS Duo™ Left Heart Lead Delivery System is sterilized using a validated Ethylene Oxide (EtO) sterilization process.

Conclusion:

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized symbol. The text element encircles the symbol and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol is a stylized representation of a human figure embracing a globe, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

St. Jude Medical Cardiac Rhythm Management Division Colleen Canan 15900 Valley View Court Sylmac, CA 91342

Re: K072864

Trade/Device Name: CPS Duo™ Left Heart Lead Delivery System Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter stylet Regulatory Class: Class II (two) Product Code: DRB, DQX Dated: February 26, 2008 Received: March 3, 2008

Dear Ms. Canan:

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 - Ms. Colleen Canan

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 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 vours.

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): K072864

Device Name: CPS Duo™ Left Heart Lead Delivery System

Indications for Use:

The CPS DuoTM guidewire and stylet are indicated for:

Facilitation of placement of St. Jude Medical left heart leads to target vessel/site. .
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)

Bimmerman

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Kony C

Regulation Number and Section

§ 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).