(47 days)
The St. Jude Medical CPS Aim ™ Universal slittable inner catheter (subselector/cannulator) 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 delivery of contrast medium and St. Jude Medical devices (such as guidewires and implantable left heart leads). In addition the CPS Aim Universal slittable inner catheter (subselector/cannulator) can work with outer guide catheters as a system
The CPS Aim™ Universal slittable inner catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. It is an introducer that is used to cannulate the coronary venous system and act as a conduit for contrast medium. implantable coronary leads, or other devices. The CPS Aim™ Universal slittable inner catheters will be available in the same working lengths, 59 and 65 cm as the predicate and will be available with the same number of curves as the predicate. The key design features of the CPS Aim™ Universal slittable inner catheters have only undergone a minimal change to increase the inner diameter of the catheter and the accessories have not changed. The key design features are listed below:
- . Braid reinforced, varying durometer PEBAX shaft with molded proximal hub.
- Inner diameter of the catheter is PTFE lined .
- Atraumatic distal soft tip.
- . Embedded marker band on soft tip for fluoroscopic visibility.
- Outside surface of the catheter shaft is coated with a hydrophilic coating to . provide lubricity during use.
- . Hub of the catheter is fitted with a retention cap and an integrated valve that includes a sideport assembly with 3-way stopcock.
- The catheters are available in cannulator and sub-selector models. .
- Accessories such as VBT used to assist the insertion of SJM Devices . (leads, guidewires, inner catheters, etc)
The provided text describes a 510(k) submission for a medical device, the CPS Aim™ Universal slittable inner catheter. This is a traditional 510(k) for a device with only minimal changes compared to a predicate device. Therefore, the information provided focuses on demonstrating substantial equivalence rather than a detailed performance study as would be expected for a novel AI/ML device.
Based on the provided text, here's a breakdown of the requested information, noting where specific details are not available due to the nature of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific quantitative acceptance criteria or a comprehensive table of performance metrics. Instead, it indicates that "completion of all verification and validation activities demonstrated that the candidate devices meet their predetermined design and performance specifications." The primary performance "acceptance criterion" appears to be demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets predetermined design and performance specifications | All verification and validation activities were completed and demonstrated the device meets these specifications. The device functions in accordance with product specifications. |
| Substantially equivalent to predicate device (CPS Aim® SL slittable inner catheter K090613) | Concluded by St. Jude Medical based on non-clinical testing. FDA concurred with this determination. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML study, but rather refers to non-clinical verification and validation activities. The non-clinical tests would have involved various physical and mechanical tests on samples of the device. The specific sample sizes for these individual tests are not provided. Data provenance (country of origin, retrospective/prospective) is not applicable in this context as it refers to data used for AI/ML model training or evaluation, not for physical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The "ground truth" for this medical device submission would be the device itself conforming to its design specifications and performing as intended in non-clinical tests. There are no "experts" in the AI/ML sense establishing ground truth for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This is not applicable for a physical device submission. Adjudication methods are typically used in AI/ML performance studies to resolve discrepancies in expert annotations or interpretations.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or prognostic devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. This submission is for a physical medical catheter.
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 not an AI/ML device.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by the device's adherence to its engineering specifications and its performance in various non-clinical (e.g., mechanical, material, functional) tests. This is not pathology, outcomes data, or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML model for which a "training set" would be used. The "training" for a physical medical device involves its design, manufacturing, and internal quality control processes.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no AI/ML model, there is no training set or ground truth established in that context.
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MAR 20 2013
510(k) Summary
The purpose of this Traditional 510(K) is to gain clearance for the CPS Aim™ Universal slittable inner catheter. The key design features of the CPS Aim™ Universal slittable inner catheter have only undergone a minimal change to increase the inner diameter of the catheter as compared to the predicate, CPS Aim® SL slittable inner catheter (K090613).
| Submitter: | St. Jude Medical,CRMD |
|---|---|
| Address: | 15900 Valley View CtSylmar, CA 91342 |
| Phone: | 818 493 2960 |
| Fax: | 818 493 3615 |
| Contact Person: | Colleen Canan |
| Trade Name/ProprietaryName: | CPS Aim™ Universal slittable inner catheter |
| Common Name: | Percutaneous CatheterModel Numbers: DS2N026-59, DS2N027-59, DS2N028-59, DS2N026-65, DS2N027-65, DS2N028-65, DS2N029-65, DS2N030-65 |
| Classification: | Class II, 21 CFR 870.1250 |
| Legally marketed deviceto which your firm isclaiming equivalence: | CPS Aim® SL slittable inner catheter (K090613) |
Device Description:
The device description of the CPS Aim™ Universal slittable inner catheter is as follows.
The CPS Aim™ Universal slittable inner catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. It is an introducer that is used to cannulate the coronary venous system and act as a conduit for contrast medium. implantable coronary leads, or other devices. The CPS Aim™ Universal slittable inner catheters will be available in the same working lengths, 59 and 65 cm as the predicate and will be available with the same number of curves as the predicate. The key design features of the CPS Aim™ Universal slittable inner catheters have only undergone a minimal change to increase the inner diameter of the catheter and the accessories have not changed. The key design features are listed below:
CPS Aim™ Universal Catheters Inner Catheter Traditional 510(k) St. Jude Medical
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- . Braid reinforced, varying durometer PEBAX shaft with molded proximal hub.
- Inner diameter of the catheter is PTFE lined .
- Atraumatic distal soft tip.
- . Embedded marker band on soft tip for fluoroscopic visibility.
- Outside surface of the catheter shaft is coated with a hydrophilic coating to . provide lubricity during use.
- . Hub of the catheter is fitted with a retention cap and an integrated valve that includes a sideport assembly with 3-way stopcock.
- The catheters are available in cannulator and sub-selector models. .
- Accessories such as VBT used to assist the insertion of SJM Devices . (leads, guidewires, inner catheters, etc)
The indication for use is as follows:
The St. Jude Medical CPS Aim™ Universal slittable inner catheter (subselector/cannulator) 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 delivery of contrast medium and St. Jude Medical devices (such as guidewires and implantable left heart leads). In addition the CPS Aim Universal slittable inner catheter (subselector/cannulator) can work with outer guide catheters as a system.
Technological Characteristics of the Device Compared to the Predicate Device:
The device has the same technological characteristics as the currently marketed CPS Aim® SL slittable inner catheter, with only minimal changes to the inner diameter, outer diameter, valve bypass tool, and design of shaft and hub to accommodate change in diameter of the catheter . 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 devices.
Non-clinical Test Summary:
Completion of all verification and validation activities demonstrated that the candidate devices meet their predetermined design and performance specifications and that the products are substantially equivalent to the predicate devices (Appendix 1).
CPS Aim™ Universal Catheters Inner Catheter Traditional 510(k) St. Jude Medical
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Conclusion (Statement of Equivalence):
The results of the verification and validation tests and the risk analysis have demonstrated the CPS Aim™ Universal slittable inner catheter functions in accordance with product specifications. St. Jude Medical considers the CPS Aim™ Universal slittable inner catheter to be substantially equivalent to the legally marketed predicate device, the CPS Aim® SL slittable inner catheter cleared in 510(k) K090613.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2013
St. Jude Medical, CRMD C/O Colleen Canan 15900 Valley View Ct. Sylmar, CA 91342
Re: K130252
Trade/Device Name: CPS AIMTM Universal Slittable Inner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: January 29, 2013 Received: February 1, 2013
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. 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.
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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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
OwenPFaris-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 Statement
| 510(k)Number(if known) | K130252 |
|---|---|
| Device Name | CPS Aim ™ Universal slittable inner catheter |
| Indicationsfor Use | The St. Jude Medical CPS Aim ™ Universal slittable inner catheter(subselector/cannulator) is designed for intracardiac access of thecoronary sinus and subselection of the venous system of the heart, and toserve as a conduit during implantation for delivery of contrast mediumand St. Jude Medical devices (such as guidewires and implantable leftheart leads). In addition the CPS Aim Universal slittable inner catheter(subselector/cannulator) can work with outer guide catheters as a system |
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IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X (Per 21.CFR 801. 109)
Over-The-Counter Use
Cwer Zi
Owen P. Faris -S
2013.03.20
12:14:29 -04'00'
CPS Aim™ Universal Catheters Inner Catheter Traditional 510(k) St. Jude Medical
§ 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).