(160 days)
P030054, K011084
Not Found
No
The summary describes a mechanical guidewire and stylet system for lead delivery and does not mention any AI/ML components or capabilities.
No
This device is a guidewire and stylet system designed to facilitate the placement of leads, not to provide a therapeutic effect itself.
No
The device is a guidewire and stylet system used to facilitate the placement of leads, not to diagnose a condition.
No
The device description clearly states it is a combination of a guidewire and a stylet, which are physical hardware components. The performance studies also describe mechanical, functional, and biocompatibility testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Facilitation of placement of St. Jude Medical left heart leads to target vessel/site." This describes a device used in vivo (within the body) for a surgical or interventional procedure.
- Device Description: The description details a guidewire and stylet designed to facilitate lead delivery. These are physical tools used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly intended for use inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
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.
The CPS DuoTM guidewire and stylet are indicated for:
- Facilitation of placement of St. Jude Medical left heart leads to target vessel/site.
Product codes (comma separated list FDA assigned to the subject device)
DRB, DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left heart leads to target vessel/site.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
The CPS Duo™ Left Heart Lead Delivery System is sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P030054, K011084
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Stylet | |
| Model Numbers: DS2M001, DS2M002, DS2M005, | ||
| DS2M006, DS2M007 | ||
| Classification: | Class II, 21 CFR 870.1380 | |
| Class II, 21 CFR 870.1330 | ||
| Legally marketed device | ||
| to which your firm is | ||
| claiming equivalence: | St. Jude Medical Model 4078S approved under (P030054) | |
| and Model 4078G approved under (K011084). |
Device Description:
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.
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
1
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