(142 days)
Not Found
No
The document describes a standard temporary pacemaker with basic pacing and sensing controls and analysis features. There is no mention of AI, ML, or any advanced algorithms that would suggest their use. The performance studies focus on electrical safety, EMC, software validation (at a "major" level of concern, which is typical for life-sustaining devices but doesn't imply AI), and bench testing of physical and electrical parameters. The predicate device is also a standard temporary pacemaker.
Yes
The device is described as providing "temporary single chamber synchronous or asynchronous anti-brady pacing therapy" and is indicated for various "symptomatic bradycardia conditions," which directly refers to treating a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that one of its purposes is "to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance." This involves measuring and evaluating physiological parameters to assess a condition, which falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries" and includes a "Patient Cable" accessory. This indicates the presence of hardware components beyond just software. The performance studies also mention "Electrical safety and electromagnetic compatibility (EMC) testing" and "Bench Testing included Physical Characteristics, Electrical Parameters and Features, Cleaning Method Validation, Hardware Reliability, and Environmental Requirements," further confirming it is not a software-only device.
Based on the provided information, the Lifetech Cardio Model 8301 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 an implanted lead system. These are direct interventions and measurements on a living patient, not tests performed on samples taken from the body (which is the hallmark of IVD).
- Device Description: The description reinforces that it's a handheld device for temporary pacing therapy and implanted system analysis.
- 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 Model 8301 Temporary Pacemaker is a therapeutic and diagnostic device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses of Lifetech Cardio Model 8301 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 Model 8301 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 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
Product codes (comma separated list FDA assigned to the subject device)
DTE
Device Description
Lifetech Cardio Model 8301 Temporary Pacemaker (hereinafter called "8301 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. 8301 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.
Patient Cable is an accessory provided along with 8301 TPM and is designed to connect a pacing lead system to 8301 TPM.
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)
Design verification and validation was performed to demonstrate that Lifetech Cardio Model 8301 Temporary Pacemaker and its accessory meet established performance criteria to support substantial equivalence to the referenced predicate device.
Electrical safety and EMC testing were conducted on the Lifetech Cardio Model 8301 Temporary Pacemaker with associated cables as necessary for test. The system complies with the IEC 60601-1 and IEC 60601-2-31 standards for safety and the IEC 60601-1-2 of the standard for EMC.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Bench Testing included:
- Physical Characteristics
- Electrical Parameters and Features
- Cleaning Method Validation
- Hardware Reliability
- Environmental Requirements
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.
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
February 28, 2019
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Stephy Pan Quality and Regulatory Affairs Manager Rm 201, Bldg No.2, Huahan Sci-tech Industrial Park, No.16 Jinniu West Rd Shenzhen, CN 518000 Guangdong
Re: K182839
Trade/Device Name: Lifetech Cardio Model 8301 Temporary Pacemaker Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class III Product Code: DTE Dated: January 9, 2019 Received: January 17, 2019
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
If
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) K182839
Device Name
Lifetech Cardio Model 8301 Temporary Pacemaker
Indications for Use (Describe)
The intended uses of Lifetech Cardio Model 8301 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 Model 8301 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 implantable pacemaker
h) Support during the replacement of implantable pacemaker
i) Cardiac complications occurring during intervention or surgery
i) Support after the cardiac surgery
k) Acute myocardial infarction complicated with cardiac conduction block
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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3
510(k) Summary
| Date Prepared: | September 25th, 2018 |
|---|---|
| 510(k) Owner/Submitter: | Shenzhen Lifetech Cardio Medical Electronics Co., |
| Ltd. | |
| Address: | Shenzhen Lifetech Cardio Medical Electronics Co., |
| Ltd. | |
| A07-A08, Room 201, Building No. 2, Huahan Sci-tech | |
| Industrial Park, No. 16 Jinniu West Road, Pingshan | |
| District, Shenzhen, 518000, P. R. China | |
| Contact: | Stephy Pan |
| Quality and Regulatory Affairs Manager | |
| Telephone: | +86 755 86026855-8833 |
| +86 13632729557 | |
| Fax: | +86 755 8602651 |
| E-mail: | panyuying@lifetechmed.com |
| Proprietary Name: | Lifetech Cardio Model 8301 Temporary Pacemaker |
| Common Name: | External Pacemaker Pulse Generator |
| Device Classification: | Class II (special controls), 21 CFR 870.3600 |
| External Pacemaker Pulse Generator | |
| Product Code: | DTE |
| Regulation Medical Specialty | Cardiovascular |
A. General Information
B. Predicate Device
| Trade Name | Medtronic Model 5318 Temporary Pacemaker /
Implant Tool |
|---------------|------------------------------------------------------------|
| 510(k) Number | K971474 |
| Product Code | DTE |
| Manufacturer | Medtronic, Inc. |
C. Device Description
Lifetech Cardio Model 8301 Temporary Pacemaker (hereinafter called "8301 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. 8301 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
4
measurement.
Patient Cable is an accessory provided along with 8301 TPM and is designed to connect a pacing lead system to 8301 TPM.
D. Intended Use/ Indications for Use
The intended uses of Lifetech Cardio Model 8301 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 Model 8301 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
E. Technological Characteristics
Intended use, technological characteristic and performance are substantially equivalent to the predicate devices referenced.
5
Proposed product: Lifetech Cardio Model 8301 Temporary Pacemaker When compared to the predicate device, Lifetech Cardio Model 8301 Temporary
Pacemaker presented in this submission has the same:
Intended Use
- Intended Use ●
- . Anatomical Sites
- Target Population .
- . Indications for Use
- Contraindications
Technological Characteristic
- Accessory
- Physical Characteristics
- Principles of Operation
Performance
- Pacing Parameters ●
- Analysis Features .
- Safety Features .
- Standards ●
F. Summary of Testing
Design verification and validation was performed to demonstrate that Lifetech Cardio Model 8301 Temporary Pacemaker and its accessory meet established performance criteria to support substantial equivalence to the referenced predicate device.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Lifetech Cardio Model 8301 Temporary Pacemaker with associated cables as necessary for test. The system complies with the IEC 60601-1 and IEC 60601-2-31 standards for safety and the IEC 60601-1-2 of the standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Bench Testing
- Physical Characteristics
- Electrical Parameters and Features ●
- Cleaning Method Validation ●
- Hardware Reliability
6
Proposed product: Lifetech Cardio Model 8301 Temporary Pacemaker
K182839 Version: A/0
- Environmental Requirements
G. Conclusion
Design verification and validation results demonstrate that Lifetech Cardio Model 8301 Temporary Pacemaker performs as intended when used in accordance with its labeling and is considered substantially equivalent to Medtronic Model 5318 Temporary Pacemaker / Implant Tool .