(138 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of a pacing catheter, with no mention of AI or ML algorithms for analysis, guidance, or other functions.
Yes
Explanation: The device is indicated for "temporary, transvenous, right ventricular pacing," which directly addresses a medical condition (cardiac rhythm issues) by providing therapy (pacing).
No
This device is a pacing catheter, used for temporary transvenous right ventricular pacing. While it aids in ECG monitoring and confirming proper placement, its primary function is therapeutic (pacing the heart), not diagnostic. The monitoring aspects are to ensure the therapeutic function is successful and properly positioned.
No
The device description clearly details a physical catheter with electrodes, a balloon, and electrical connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pacel™ Flow Directed Pacing Catheter is a medical device designed to be inserted directly into the body (specifically, the right ventricle of the heart) for temporary pacing. It is used for a therapeutic purpose (pacing the heart) and potentially for monitoring electrical signals from the heart, not for analyzing samples from the body.
- Intended Use: The intended use clearly states "temporary, transvenous, right ventricular pacing." This is a direct intervention on the patient's body.
- Device Description: The description details the physical components and how it is used for placement and pacing within the heart. It does not mention any analysis of biological samples.
Therefore, the Pacel™ Flow Directed Pacing Catheter is an invasive medical device used for therapeutic and monitoring purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pacel™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.
Product codes
LDF
Device Description
This catheter is designed to establish temporary right ventricular pacing with or without fluoroscopy guidance for placement. Catheters are depth marked as an aid in catheter placement under fluoroscopy. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. An inflatable balloon, located between two platinum electrodes, allows for flow directed positioning of the catheter in the right ventricle without fluoroscopy guidance. Once inflated, the balloon aids the operator in crossing the tricuspid valve. After the catheter has crossed the valve, the balloon is deflated and the catheter is advanced to the right ventricular apex in the usual manner. Electrograms are monitored to verify proper positioning in the right ventricular apex and pacing thresholds are obtained to confirm both proper location and reliable pacing.
The catheters are available in two curve styles. The distal end of the catheter includes a platinum electrical connector ring and a tip electrode. The proximal end of the catheter includes a two pin electrical connector. The electrical signals can be transmitted to external equipment or from external equipment to the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right ventricular apex
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
Design Verification: Design verification testing has been completed for the Pacel Flow Direct catheter to show that the proposed device will meet Product Specification through the labelled Shelf Life of the device (T=18 mo). Design verification testing is complete and passed all acceptance criteria per the DV requirements.
Testing Performed: Surface Appearance: Adhesive on the balloon and electrodes. Results: Conforming. Balloon Repeat Inflation Strength Results: Conforming. Inflation Decay Results: Conforming.
Biocompatibility: Biocompatibility testing was performed in accordance with ISO 10993. The proposed adhesive, Loctite 4311, used to secure the balloon to the catheter shaft demonstrated an acceptable biocompatibility profile. Biocompatibility testing passed all acceptance criteria.
Chronic GLP Animal Study: Both the test and control devices were considered substantially equivalent regarding clinical pathology, thrombogenicity and pathology/histopathology. The use of both devices was well tolerated. This data demonstrates that the proposed Pacel Flow Direct catheter’s safety is comparable to the control device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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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
November 22, 2016
St. Jude Medical Blair Schwartz Regulatory Affairs Specialist 14901 Deveau Place Minnetonka, Minnesota 55345
Re: K161873
Trade/Device Name: Pacel™ Flow Directed Pacing Catheter Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: October 18, 2016 Received: October 19, 2016
Dear Blair Schwartz:
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.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161873
Device Name
Pacel™ Flow Directed Pacing Catheters
Indications for Use (Describe)
Pacel™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.
Type of Use (Select one or both, as applicable)
| ☒ Exemption Use (Part 21 CFR 601.21, Subpart E) | ☐ Compassionate Use (21 CFR 601.21, Subpart E) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------ |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
The 510(k) Summary of the Pacel™ Flow Directed Pacing Catheters, per 21 CFR 807.92, is provided below.
| 510(k) Summary | ||
|---|---|---|
| 510(k) Number | K161873 | |
| Submitter Information: | ||
| Date Prepared: | July 06, 2016 | |
| Submitter Name & | ||
| Address: | St. Jude Medical | |
| 14901 DeVeau Place | ||
| Minnetonka, MN 55345 | ||
| Establishment Registration Number: 2182269 | ||
| Contact Person: | Blair Schwartz | |
| Regulatory Affairs Specialist | ||
| 5050 Nathan Lane N | ||
| Plymouth MN 55426 | ||
| Phone (651) 756-2706 | ||
| BSchwartz@sjm.com | ||
| Device Information: | ||
| Trade Name: | Pacel™ Flow Directed Pacing Catheters | |
| Common Name: | Electrode, Pacemaker, Temporary | |
| Class | II | |
| Classification Name: | 21CFR § 870.3680 – Cardiovascular permanent or temporary | |
| pacemaker electrode | ||
| Predicate Device: | Pacel™ Flow Directed Pacing Catheters (K914185) | |
| 510(k) Summary | ||
| Device Description: | This catheter is designed to establish temporary right ventricular pacing with or without fluoroscopy guidance for placement. Catheters are depth marked as an aid in catheter placement under fluoroscopy. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. An inflatable balloon, located between two platinum electrodes, allows for flow directed positioning of the catheter in the right ventricle without fluoroscopy guidance. Once inflated, the balloon aids the operator in crossing the tricuspid valve. After the catheter has crossed the valve, the balloon is deflated and the catheter is advanced to the right ventricular apex in the usual manner. Electrograms are monitored to verify proper positioning in the right ventricular apex and pacing thresholds are obtained to confirm both proper location and reliable pacing. | |
| The catheters are available in two curve styles. The distal end of the catheter includes a platinum electrical connector ring and a tip electrode. The proximal end of the catheter includes a two pin electrical connector. The electrical signals can be transmitted to external equipment or from external equipment to the heart. | ||
| Intended Use: | ||
| (Indications for Use) | Pacelt™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing. | |
| Description of Change and | ||
| Comparison to Predicate | ||
| Devices | The Pacel™ Flow Directed Pacing Catheter that is the subject of this application remains substantially equivalent to the predicate device. There have been no changes to the packaging, sterilization, final device specifications or labeling. The proposed change is to switch the current moisture cured cyanoacrylate adhesives, Loctite 4013 which is used to bond the latex balloon to the catheter and Loctite 4031 which is used to seal/trim around the metal electrode ring edges to a visible light cured cyanoacrylate adhesive, Loctite 4311 | |
| 510(k) Summary | ||
| Summary on Non-Clinical | ||
| Testing | Design Verification: | Design verification testing has been completed for the |
| Pacel Flow Direct catheter to show that the proposed | ||
| device will meet Product Specification through the | ||
| labelled Shelf Life of the device (T=18 mo). Design | ||
| verification testing is complete and passed all | ||
| acceptance criteria per the DV requirements. | ||
| Testing Performed: | ||
| Surface Appearance: Adhesive on the balloon | ||
| and electrodes. | ||
| Results: Conforming Balloon Repeat Inflation Strength Results: Conforming Inflation Decay Results: Conforming | ||
| Biocompatibility: | Biocompatibility testing was performed in accordance | |
| with ISO 10993. The proposed adhesive, Loctite 4311, | ||
| used to secure the balloon to the catheter shaft | ||
| demonstrated an acceptable biocompatibility profile. | ||
| Biocompatibility testing passed all acceptance criteria. | ||
| Chronic GLP Animal Study: | Both the test and control devices were considered | |
| substantially equivalent regarding clinical pathology, | ||
| thrombogenicity and pathology/histopathology. The use | ||
| of both devices was well tolerated. This data | ||
| demonstrates that the proposed Pacel Flow Direct | ||
| catheter's safety is comparable to the control device. | ||
| 510(k) Summary | ||
| Statement of Equivalence | The Pacel TM Flow Directed Pacing Catheters that are subject | |
| of this application have the same indications for use and | ||
| technological characteristics as the predicate device. Based on | ||
| this and the data provided in this pre-market notification, the | ||
| subject device remains substantially equivalent to the | ||
| predicate device. |
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Pacel Pacing Catheter
Premarket Notification 510(k) K161873
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Pacel Pacing Catheter
Premarket Notification 510(k) K161873
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