(124 days)
No
The document describes a standard temporary pacemaker with pacing and sensing controls and analysis features. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to provide temporary single-chamber synchronous or asynchronous anti-brady pacing therapy, which is a therapeutic intervention for various bradycardia conditions.
Yes
Explanation: The device is used to "test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance," which are diagnostic functions.
No
The device description explicitly states it is a "handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries," indicating it is a hardware device, not software-only.
Based on the provided information, the Lifetech Cardio Temporary Pacemaker is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses clearly state that the device is for providing temporary pacing therapy and testing the electrical performance of an implanted lead system. These are direct physiological interventions and measurements related to the heart's electrical activity, not tests performed on samples taken from the body (in vitro).
- Device Description: The description reinforces its function as a temporary pacemaker and analysis tool for an implanted system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Lifetech Cardio Temporary Pacemaker falls under the category of a therapeutic and diagnostic device used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
The intended uses of Lifetech Cardio Temporary Pacemaker are
- to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
- to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance (model 7101,7100 excluded).
Lifetech Cardio Temporary Pacemaker is only intended to be operated
- in a clinical setting, and
- by trained professionals.
Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that:
- results from an acute and reversible cause and will likely not require permanent pacing, and
- causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
Examples of specific indications for temporary pacing may include:
a) Sick sinus syndrome
b) Sinus bradycardia
c) Atrial and/or ventricular arrhythmias
d) Complete atrioventricular block
e) Asystole
f) Bradycardia accompanied by congestive heart failure
g) Patient support, management and evaluation before the implantation of implantable pacemaker
h) Support during the replacement of implantable pacemaker
i) Cardiac complications occurring during intervention or surgery
j) Support after the cardiac surgery
k) Acute myocardial infarction complicated with cardiac conduction block
l) High-rate burst pacing for the treatment of supraventricular tachyarrhythmias
Product codes
DTE
Device Description
The Lifetech Cardio Temporary Pacemaker (hereinafter called "TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. The TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.
The accessories for connecting a pacing lead system to the TPM include:
- Patient Cable
- Analysis Cable
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
- in a clinical setting, and
- by trained professionals.
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)
Lifetech Cardio has conducted a risk analysis and has performed the necessary Software and Bench testing (summarized below) in below to demonstrate that the design outputs of the modified device meet the design input requirements in relation to supporting the changes. Changes are verified and validated with the same verification and validation method as used in the previously cleared 510(k).
- Analysis Cable test
- Pacing Percentage Statistics test
- Rapid Atrial Pacing function test
- Software verification and validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 7, 2024
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Stephy Pan Regulatory Affairs Director 1401, Building D1, Nanshan I Park No.1001, Xueyuan Avenue, Taoyuan Street, Nanshan District Shenzhen, Guangdong 518000 China
Re: K232721
Trade/Device Name: Lifetech Cardio Temporary Pacemaker Regulation Number: 21 CFR 870.3600 Regulation Name: External pacemaker pulse generator Regulatory Class: Class II Product Code: DTE Dated: December 8, 2023 Received: December 8, 2023
Dear Stephy Pan:
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.
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 mediation-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-regulatoryassistance/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,
Jessica L. Batista -S Digitally signed by Jessica L Date: 2024.01.07 18:58:05
for
Sara Royce Assistant Director
2
Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OOffice of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232721
Device Name Lifetech Cardio Temporary Pacemaker
Indications for Use (Describe)
The intended uses of Lifetech Cardio Temporary Pacemaker are
-
to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
-
to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance .
Lifetech Cardio Temporary Pacemaker is only intended to be operated 1. in a clinical setting, and 2. by trained professionals.
Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that:
-
results from an acute and reversible cause and will likely not require permanent pacing, and
-
causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
Examples of specific indications for temporary pacing may include:
- a) Sick sinus syndrome
b) Sinus bradycardia
c) Atrial and/or ventricular arrhythmias
d) Complete atrioventricular block
e) Asystole
f) Bradycardia accompanied by congestive heart failure
g) Patient support, management and evaluation before the implantable pacemaker
h) Support during the replacement of implantable pacemaker
i) Cardiac complications occurring during intervention or surgery
j) Support after the cardiac surgery
k) Acute myocardial infarction complicated with cardiac conduction block
- High-rate burst pacing for the treatment of supraventricular tachyarrhythmias
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
A. General Information
| Date Prepared: | June 15th, 2023 |
|---|---|
| 510(k) Owner/Submitter: | Shenzhen Lifetech Cardio Medical Electronics Co., |
| Ltd. | |
| Address: | 1401, Building D1, Nanshan i Park,No.1001, Xueyuan |
| Avenue, Taoyuan Street, Nanshan District, Shenzhen, | |
| Guangdong, 518000, China | |
| Contact: | Stephy Pan |
| Regulatory Affairs Director | |
| Telephone: | +86 755 23251894 |
| +86 13632729557 | |
| E-mail: | panyuying@ltcardio.com |
| Proprietary Name: | Lifetech Cardio Temporary Pacemaker |
| Common Name: | External Pacemaker Pulse Generator |
| Device Classification: | Class II, 21 CFR 870.3600 |
| External Pacemaker Pulse Generator | |
| Product Code: | DTE |
| Regulation Medical Specialty | Cardiovascular |
| Model | 8301,8201,8200,7101,7100 |
B. Predicate Device and Reference Device
Predicate Device
| Trade Name | Lifetech Cardio Model 8301 Temporary Pacemaker |
|---|---|
| 510(k) Number | K182839 |
| Product Code | DTE |
| Manufacturer | Shenzhen Lifetech Cardio Medical Electronics Co.,Ltd |
Reference Device
| Trade Name | Medtronic Model 53401 External Pulse Generator |
|---|---|
| 510(k) Number | K180873 |
| Product Code | DTE |
| Manufacturer | Medtronic, Inc. |
C. Device Description
The Lifetech Cardio Temporary Pacemaker (hereinafter called "TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted
5
system analysis. The TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.
The accessories for connecting a pacing lead system to the TPM include:
- Patient Cable ●
- . Analysis Cable
D. Intended Use/ Indications for Use
The intended uses of Lifetech Cardio Temporary Pacemaker are
-
to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
-
to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance (model 7101,7100 excluded).
Lifetech Cardio Temporary Pacemaker is only intended to be operated
-
- in a clinical setting, and
-
- by trained professionals.
Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that:
-
results from an acute and reversible cause and will likely not require permanent pacing, and
-
causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
Examples of specific indications for temporary pacing may include:
- a) Sick sinus syndrome
- b) Sinus bradycardia
- c) Atrial and/or ventricular arrhythmias
- d) Complete atrioventricular block
e) Asystole
-
f) Bradycardia accompanied by congestive heart failure
g) Patient support, management and evaluation before the implantation of implantable pacemaker -
h) Support during the replacement of implantable pacemaker
-
i) Cardiac complications occurring during intervention or surgery
-
j) Support after the cardiac surgery
-
k) Acute myocardial infarction complicated with cardiac conduction block
-
l) High-rate burst pacing for the treatment of supraventricular tachyarrhythmias
6
E. Comparison of Technological Characteristics with the Predicate
The new RAP (Rapid Atrial Pacing) feature of the subject device is indicated for the high-rate burst pacing for the treatment of supraventricular tachyarrhythmias, which is different from the predicate device. However, the difference does not alter the intended therapeutic use of the device nor do it affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use of providing temporary single chamber pacing therapy and testing electrical performance of an implanted lead system by generating the parametervariable electric pulse and the conduction of pacing lead.
Device
The subject device has the same Physical Characteristics, Principles of Operation, Basic Pacing Parameters, Safety Features and Standards as the predicate device. The Functional Features are different from the predicate device due to the new feature of RAP (Rapid Atrial Pacing). However, the new feature of RAP has the same principles of operation with the basic pacing feature. It is concluded that the new RAP feature of the subject device does not raise new questions of safety and effectiveness and also does not change the technological characteristic of the device. Therefore, the subject device has the same technological characteristic as the predicate device.
F. Performance Tests
Lifetech Cardio has conducted a risk analysis and has performed the necessary Software and Bench testing (summarized below) in below to demonstrate that the design outputs of the modified device meet the design input requirements in relation to supporting the changes. Changes are verified and validated with the same verification and validation method as used in the previously cleared 510(k).
- Analysis Cable test
- Pacing Percentage Statistics test
- Rapid Atrial Pacing function test ●
- Software verification and validation
G. Conclusion
Based on the test data, the same intended use and technological characteristic, the modified Lifetech Cardio Temporary Pacemaker is substantially equivalent to the predicate device.