(204 days)
Not Found
Not Found
No
The device description and performance studies do not mention AI or ML, and the device is described as requiring the physician to make all clinical decisions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used where short-term demand pacing is indicated for therapeutic purposes."
No
The device is an external pulse generator used for temporary single-chamber pacing, which is a therapeutic function. While it assists the physician by offering workflow stages like 'pacing capture check', the physician is explicitly stated to make all clinical decisions regarding contact with pace-able tissue, 1:1 capture, and appropriate conditions for rapid pacing. This indicates the device is primarily for delivering therapy, not for diagnosing conditions.
No
The device description explicitly states it is an "AC main powered with battery backup, single chamber, temporary pacemaker" and mentions hardware components like being "bed mountable." It also details electrical safety and EMC testing, which are related to hardware performance.
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 Solo Pace Control external pulse generator is a device that directly interacts with the patient's body by delivering electrical pulses to the heart through a pacing lead system. It is a therapeutic device used for temporary pacing.
- Intended Use: The intended use clearly states it's for "temporary single chamber pacing in a clinical environment" and lists various cardiac conditions where pacing is indicated. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details its function as a temporary pacemaker that provides electrical stimulation to the heart.
The device's purpose is to provide therapy (pacing) to the patient, not to analyze a biological sample for diagnostic information.
N/A
Intended Use / Indications for Use
The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to: - · Complete heart block - · Sinus bradycardia - Sick sinus syndrome - · Bradycardia with congestive heart failure - · Cardiac complications during invasive or surgical procedures - Support, management, and evaluation of a patient before permanent pacemaker implantation - Support during permanent pacemaker replacement - · Interventional cardiology procedures where pacing is required
Product codes (comma separated list FDA assigned to the subject device)
DTE
Device Description
The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel / clinical environment
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)
Performance testing was performed in accordance with recognized international and domestic standards and FDA guidance documents. The performance verified the device design and materials through the following testing. -. System level verification testing - Subsystem verification testing - Electrical safety testing per IEC 60601-1 - EMC testing per IEC 60601-1-2 - Immunity with regard to intended use per IEC 60601-4-2 - Safety and performance of external pacemaker per IEC 60601-2-31 - Evaluation of wireless coexistence ANSI C63.27-2001 and AAMI C63.270-2021 - Software verification and validation - Cybersecurity risk management and testing - Package integrity testing to confirm sterility - Shelf-life testing to confirm sterility and functionality -. Design validation with clinical users to validate user inputs and labeling The results of the above performance testing met the specified acceptance criteria and demonstrate that differences in technological characteristics did not raise new safety or performance issues. Therefore, the Solo Pace Control described in this submission result in a device that is substantially equivalent to the predicate.
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.
Medtronic Model 5392 External Pulse Generator (EPG)
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
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.
0
January 10, 2025
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Solo Pace, Inc. % Wanda Carpinella Regulatory Consultant Insight Medical Consulting, LLC 7 Barrows Road Shrewsbury, Massachusetts 01545
Re: K241781
Trade/Device Name: Solo Pace Control Regulation Number: 21 CFR 870.3600 Regulation Name: External pacemaker pulse generator Regulatory Class: Class II Product Code: DTE Dated: December 12, 2024 Received: December 12, 2024
Dear Wanda Carpinella:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Sara M. Royce -S Sara M. Royce -S
Sara M. Royce -S Date: 2025.01.10 13:26:19 -05'00' Sara Royce Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241781
Device Name Solo Pace Control
Indications for Use (Describe)
The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to:
- · Complete heart block
- · Sinus bradycardia
- Sick sinus syndrome
- · Bradycardia with congestive heart failure
- · Cardiac complications during invasive or surgical procedures
- · Support, management, and evaluation of a patient before permanent pacemaker implantation
- · Support during permanent pacemaker replacement
- · Interventional cardiology procedures where pacing is required
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Traditional Premarket Notification 510(k) Summary Solo Pace Control 510(k) Number K241781
Date Prepared: January 10, 2025
l. SUBMITTER
Solo Pace, Inc. 1201 Sutter St Suite 303 San Francisco, CA 94952
Contact Person
David Daniels, MD Solo Pace, Inc. 1201 Sutter St Suite 303 San Francisco, CA 94109 415-385-9243
II. DEVICE
Name of Device: Solo Pace Control Common or Usual Name: External pulse generator Classification Regulation: 21 CFR § Regulation Name: 870.3600 - External pacemaker pulse generator Product Codes: DTE (Class 2) - Pulse-Generator, Pacemaker, External Regulatory Class: II
III. PREDICATE
Name of Device: Medtronic Model 5392 External Pulse Generator (EPG) Common or Usual Name: External pulse generator Classification Regulation: 21 CFR § Regulation Name: 870.3600 - External pacemaker pulse generator Product Codes: DTE (Class 2) - Pulse-Generator, Pacemaker, External Regulatory Class: II
IV. DEVICE DESCRIPTION
The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)
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V. INDICATIONS FOR USE
The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to:
- . Complete heart block
- Sinus bradycardia
- Sick sinus syndrome
- Bradycardia with congestive heart failure
- Cardiac complications during invasive or surgical procedures
- Support, management, and evaluation of a patient before permanent pacemaker implantation
- Support during permanent pacemaker replacement
- Interventional cardiology procedures where pacing is required
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISICS WITH PREDICATES Intended Use
The subject device and predicate are external pulse generators intended to be used with a patient lead system to provide temporary, external cardiac pacing in a clinical environment. Solo Pace Control is designed primarily for interventional cardiology procedures that require controlled pacing. It is not intended to be used in a cardiac surgery/post operative situation. As such, reference to surgical procedures have been removed from the indications for use for the subject device. In addition, the use during procedures has been expanded to include interventional cardiology procedures.
Technological Features
Solo Pace Control is consistent in technological features to the Medtronic 5392 system in that it provides sensing and pacing. The design of the Solo Pace is simplified compared to the Medtronic device with only the features necessary for the single chamber pacing utilized in the catheterization laboratory for procedures requiring controlled pacing. The subject device has features of pre-sets organized around the framework of an interventional structural heart procedure, and ability to be controlled from within the sterile filed by the Bluetooth enabled RCM.
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VII. PERFORMANCE DATA
Performance testing was performed in accordance with recognized international and domestic standards and FDA guidance documents. The performance verified the device design and materials through the following testing.
- . System level verification testing
- Subsystem verification testing
- Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2
- Immunity with regard to intended use per IEC 60601-4-2
- Safety and performance of external pacemaker per IEC 60601-2-31
- Evaluation of wireless coexistence ANSI C63.27-2001 and AAMI C63.270-2021
- Software verification and validation
- Cybersecurity risk management and testing
- Package integrity testing to confirm sterility
- Shelf-life testing to confirm sterility and functionality
- . Design validation with clinical users to validate user inputs and labeling
The results of the above performance testing met the specified acceptance criteria and demonstrate that differences in technological characteristics did not raise new safety or performance issues. Therefore, the Solo Pace Control described in this submission result in a device that is substantially equivalent to the predicate.
VIII. CONCLUSION
In conclusion, the Solo Pace Control is substantially equivalent to the commercially available predicate for its intended use as demonstrated by the performance data for the subject device.