(119 days)
The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).
The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the sensor to determine systolic pressure and diastolic pressure.
The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.
This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.
This FDA 510(k) clearance letter pertains to three models of wrist automatic blood pressure monitors (LD-735, LD-752, LD-753) submitted by HONSUN (Nantong) Co.,Ltd. The clearance is based on the substantial equivalence of these devices to a legally marketed predicate device, the Wrist Automatic Blood Pressure Monitor LD-737 (K131463).
The primary focus of the submission and the FDA's review is on demonstrating that the new devices do not raise new issues of safety or effectiveness compared to the predicate. The document thoroughly compares the technical characteristics and functions of the subject devices to the predicate.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantitative set of thresholds for clinical performance that the device must meet in a specific study. Instead, the "acceptance criteria" appear to be implicit in the compliance with recognized standards and the declared measuring accuracy specification. The study performed is a non-clinical bench testing comparison to the predicate device and compliance with relevant safety and performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Measuring Accuracy (Static Pressure): $\pm$3mmHg (based on predicate device spec) | $\pm$3mmHg for static pressure (Subject devices claim same specification, implying they meet this through compliance with ISO 80601-2-30) |
| Measuring Accuracy (Pulse Rate): $\pm$5% of the reading (based on predicate device spec) | $\pm$5% of the reading for the pulse rate (Subject devices claim same specification, implying they meet this through compliance with ISO 80601-2-30) |
| Biocompatibility: Compliance with ISO 10993-5 and ISO 10993-10 | All user-directly contacting materials are compliant with ISO 10993-5 and ISO 10993-10 requirements (claimed to be same materials as predicate) |
| Electrical Safety: Compliance with ANSI AAMI ES 60601-1 | Complies with ANSI AAMI ES 60601-1 |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Home Healthcare Environment: Compliance with IEC 60601-1-11 | Complies with IEC 60601-1-11 |
| Automated Non-Invasive Sphygmomanometers: Compliance with ISO 80601-2-30 | Implied compliance through similar specifications and general statement of performance. The standard itself outlines the performance requirements for such devices. |
| Software Verification & Validation: Compliance with FDA guidance | Performed in accordance with "Guidance for the Content of Premarket Submissions for Software Contained In Medical Devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "bench testing" was conducted. However, it does not provide any details on the sample size used for this testing or the specific data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is primarily related to compliance with various electrical, EMC, and environmental standards, as well as biocompatibility. For measuring accuracy, the statement merely re-iterates the specification as being the same as the predicate, suggesting that this specification was verified during the "bench testing" rather than proven with a new clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention any human experts establishing ground truth for the "test set." The evaluation appears to be based on engineering and laboratory testing for compliance with technical standards and comparison to the predicate device's specifications. This is a blood pressure monitor, not an AI/imaging diagnostic device that would typically require expert ground truth labeling.
4. Adjudication Method for the Test Set
Since no human experts were involved in establishing ground truth for a test set in the traditional sense (e.g., for diagnostic accuracy), there was no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was done or is applicable to this device. This is a standalone medical device (blood pressure monitor), not an AI-based diagnostic tool intended to assist human readers or clinicians.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document outlines an assessment of non-clinical testing which included electrical safety, EMC, biocompatibility, and software verification/validation. The device itself is an "automatic blood pressure monitor," meaning its core function is to autonomously measure blood pressure. Therefore, the "bench testing" and compliance with standards like ISO 80601-2-30 (Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) serve as the standalone performance evaluation for the device's accuracy and safety, without human intervention in the measurement process itself. The document states: "The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use." This indicates a standalone performance assessment against established benchmarks (the predicate and relevant standards).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the primary function of blood pressure measurement accuracy, the ground truth is implicitly defined by the measurement standards provided in ISO 80601-2-30, which typically refers to reference measurements from a calibrated clinical-grade sphygmomanometer (e.g., mercury sphygmomanometer). For other aspects, the ground truth for compliance is the relevant international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).
8. The Sample Size for the Training Set
Not applicable/Not mentioned. This device is a hardware-based blood pressure monitor using an "oscillometric method with Fuzzy Algorithm." While a "Fuzzy Algorithm" implies some form of computational processing, the document does not indicate that it is a machine learning or AI algorithm that requires a "training set" in the modern sense of deep learning or complex predictive modeling. The algorithm is a fixed part of the device's operation.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned for the same reasons as #8. If the "Fuzzy Algorithm" involved a "training" or calibration phase during its development, the details are not provided in this regulatory document.
FDA 510(k) Clearance Letter - K251795
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
October 9, 2025
HONSUN (Nantong) Co.,Ltd.
Sara Xu
No.8, Tongxing Road
Nantong Economic & Technological Development Area
Nantong, Jiangsu 226009
China
Re: K251795
Trade/Device Name: Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive Blood Pressure Measurement System
Regulatory Class: Class II
Product Code: DXN
Dated: September 12, 2025
Received: September 16, 2025
Dear Sara Xu:
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.
Page 2
K251795 - Sara Xu Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.
Page 3
K251795 - Sara Xu Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
Hetal B. Odobasic -S
for
LCDR Stephen Browning
Assistant Director
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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K251795
Please provide the device trade name(s).
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
Please provide your Indications for Use below.
The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).
Please select the types of uses (select one or both, as applicable).
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
Wrist automatic blood pressure monitor Page 9 of 33
Page 5
Sponsor: HONSUN (Nantong) Co.,Ltd.
Device: Wrist Automatic Blood Pressure Monitor
Summary of special 510(K)
Date prepared: 12-May-2025
1. Submitter
Company: HONSUN(Nantong)Co.,Ltd.
Establishment registration number: 3007740533
Address: No.8, Tongxing Road, Nantong Economic &Technological development Area,Jiangsu, 226009, China
Phone: +86-513-80580116
Fax: +86-513-805800080
Contact Person: Sara Xu
Email: sara-xu@lordmed.com
2. Modified Device information
Name of Device: Wrist Automatic Blood Pressure monitor
Model: LD-735,LD-752,LD-753
Common Name: Non-invasive blood pressure measurement system
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation number: 21 CFR 870.1130
Regulatory Class: II
Product Code: DXN
Review Panel: Cardiovascular
3. Cleared Device information
Name of Device: Wrist Automatic Blood Pressure monitor
Model: LD-737
510k number: K131463
Common Name: Non-invasive blood pressure measurement system
Regulation number: 21 CFR 870.1130
Regulatory Class: II
Product Code: DXN
Review Panel: Cardiovascular
4. Device description
The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms
K251795 Page 1 of 6
Page 6
within the sensor to determine systolic pressure and diastolic pressure.
The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.
5. Intended use and indications for use
The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).
6. Operation principle
This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.
7. Comparisons of technological characteristic with the predicate device
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| Device name | Wrist Automatic Blood Pressure Monitor | Wrist Automatic Blood Pressure Monitor | Wrist Automatic Blood Pressure Monitor | Wrist Automatic Blood Pressure Monitor | Same |
| Classification | II | II | II | II | Same |
| Product code | DXN | DXN | DXN | DXN | Same |
| Regulation number | 870.1130 | 870.1130 | 870.1130 | 870.1130 | Same |
| Indications for use | The wrist automatic blood pressure monitor is intended for the non-invasive measurement of systolic and diastolic arterial | The wrist automatic blood pressure monitor is intended for the non-invasive measurement of systolic and diastolic arterial | The wrist automatic blood pressure monitor is intended for the non-invasive measurement of systolic and diastolic arterial | The Wrist Automatic Blood Pressure Monitor LD-737 is device intended to measure the systolic and diastolic blood | Same |
K251795 Page 2 of 6
Page 7
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| blood pressure and pulse rate in adults (aged 15 and above). | blood pressure and pulse rate in adults (aged 15 and above). | blood pressure and pulse rate in adults (aged 15 and above). | pressure and pulse rate of an adult individual by using non-invasive technique in which an inflatable cuff is wrapped around the wrist. | ||
| Measuring method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Same |
| Cuff location | Wrist | Wrist | Wrist | Wrist | Same |
Specification
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| Measuring range | 40 to 180mmHg (DIA, diastolic pressure) 60 to 260mmHg (SYS, systolic pressure) 40 to 160 beats/minute (PUL, pulse rate) | 40 to 180mmHg (DIA, diastolic pressure) 60 to 260mmHg (SYS, systolic pressure) 40 to 160 beats/minute (PUL, pulse rate) | 40 to 180mmHg (DIA, diastolic pressure) 60 to 260mmHg (SYS, systolic pressure) 40 to 160 beats/minute (PUL, pulse rate) | 40 to 180mmHg (DIA, diastolic pressure) 60 to 260mmHg (SYS, systolic pressure) 40 to 160 beats/minute (PUL, pulse rate) | Same |
| Measuring accuracy | ±3mmHg for static pressure ±5% of the reading for the pulse rate | ±3mmHg for static pressure ±5% of the reading for the pulse rate | ±3mmHg for static pressure ±5% of the reading for the pulse rate | ±3mmHg for static pressure ±5% of the reading for the pulse rate | Same |
| Inflation | Automatic by the pump | Automatic by the pump | Automatic by the pump | Automatic by the pump | Same |
| Rapid deflation | Automatic electronic valve | Automatic electronic valve | Automatic electronic valve | Automatic electronic valve | Same |
| Batteries | 2*AAA batteries | 2*AAA batteries | 2*AAA batteries | 2*AAA batteries | Same |
| Operation condition | 5℃ to 40℃, 15% to 90%RH, 700hPa to 1060hPa | 5℃ to 40℃, 15% to 90%RH, 700hPa to 1060hPa | 5℃ to 40℃, 15% to 90%RH, 700hPa to | 10℃ to 40℃,90% and below(non-condensing) | Similar Note 1 |
K251795 Page 3 of 6
Page 8
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| 1060hPa | |||||
| Transport and storage condition | -25℃ to 70℃, 15% to 90%RH, 700hPa to 1060hPa | -25℃ to 70℃, 15% to 90%RH, 700hPa to 1060hPa | -25℃ to 70℃, 15% to 90%RH, 700hPa to 1060hPa | -20℃ to 55℃,90% and below(non-condensing) | Similar Note 2 |
| Cuff size | Applicable for wrist circumstance 12.5~20.5cm | Applicable for wrist circumstance 12.5~20.5cm | Applicable for wrist circumstance 12.5~20.5cm | Applicable for wrist circumstance 12.5~20.5cm | Same |
| Main body dimension | 62(L)*61(W)*25(H)mm | 66(L)*70(W)*30(H)mm | 66(L)*70(W)*30(H)mm | 66(L)*70(W)*30(H)mm | Similar Note 3 |
| Weight | Approximately 98g without batteries | Approximately 110g without batteries | Approximately 110g without batteries | Approximately 123g without batteries | Similar Note 4 |
Function
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| Memory | Yes (90 memories ) | Yes (2*90 memories in two group) | Yes (2*90 memories in two group) | Yes (2*90 memories in two group) | Similar Note 5 |
| Automatic power-off | Yes | Yes | Yes | Yes | Same |
| Date and time | / | Yes | Yes | Yes | Similar Note6 |
| WHO | / | Yes | Yes | Yes | Similar Note 7 |
| Irregular heartbeat detector | / | Yes | Yes | Yes | Similar Note 8 |
| Low battery detection | Yes | Yes | Yes | Yes | Same |
Applicable for standards
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO 10993-5 and ISO10993-10 requirements | All user directly contacting materials are compliance with ISO 10993-5 and ISO10993-10 requirements | All user directly contacting materials are compliance with ISO 10993-5 and ISO10993-10 requirements | All user directly contacting materials are compliance with ISO 10993-5 and ISO10993-10 requirements | Same |
| Electrical Safety | Comply with ANSI AAMI ES 60601-1 | Comply with ANSI AAMI ES 60601-1 | Comply with ANSI AAMI ES 60601-1 | Comply with ANSI AAMI ES 60601-1 | Same |
K251795 Page 4 of 6
Page 9
| Items | Subject Device LD-735 | Subject Device LD-752 | Subject Device LD-753 | Predicate Device LD-737(K131463) | Remark |
|---|---|---|---|---|---|
| requirements | requirements | requirements | requirements | ||
| EMC | Comply with IEC 60601-1-2 requirements | Comply with IEC 60601-1-2 requirements | Comply with IEC 60601-1-2 requirements | Comply with IEC 60601-1-2 requirements | Same |
| Others | Comply with IEC 60601-1-11 requirements | Comply with IEC 60601-1-11 requirements | Comply with IEC60601-1-11 requirements | Comply with IEC60601-1-11 requirements | Same |
Discussion：
Note 1：Operation condition
The operation condition of the subject device are different with predicate device LD-737 (K131463), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES 60601-1 provided in this submission, therefore the difference does not raise new risk of safety and effectiveness.
Note 2: Transport and storage condition
The transport and storage condition of the subject device are different with predicate device LD-737 (K131463), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES 60601-1 provided in this submission, therefore the difference does not raise new risk of safety and effectiveness.
Note 3: Main body dimension
As for LD-735, its dimension is different with predicate device LD-737 (K131463) will not affect the safety and effectiveness.
Note 4: Weight
The weight of subject device is different with predicate device LD-737 (K131463) will not affect the safety and effectiveness.
Note 5/6/7/8: Memory, Date & Time, WHO,Irregular heartbeat detector
As for LD-735, it deletes the function of Date & Time, WHO,Irregular heartbeat detector, and only owns the one group with 90 sets of memories compared with predicate device LD-737 (K131463). These functions are additional functions, which will not influence the use of blood pressure monitor. Therefore it will not affect the effectiveness or raise any safety issues.
Conclusion
Based on above comparative analysis, compared with the predicate device LD-737 (K131463), the subject device does not raise new issues of safety and effectiveness. Thus, the subject device is as safe, as effective and substantially equivalent to the predicate device.
8. Assessment of Non-clinical testing
8.1 Electrical safety and Electromagnetic Compatibility Testing
K251795 Page 5 of 6
Page 10
The electrical safety and EMC testing were conducted on the subject device. The related standards are shown as follows:
| Standard | Descriptions |
|---|---|
| ANSI AAMI ES 60601-1 | Medical electrical equipment-Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2 | Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances -Requirements and tests |
| IEC 60601-1-11 | Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| ISO 80601-2-30 | Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanomaters |
8.2 Biocompatibility Evaluation
The biocompatibility evaluations of the subject device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process" and FDA biocompatibility guidance, the Cytotoxicity test, Sensitization test, Irritation test are needed. The subject devices use the same patient-contact materials(cuff) with the predicate device, so the biocompatibility is not affected and it will not affect the effectiveness or raise any safety issues.
8.3 Software Verification and Validation Evaluation
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained In Medical Devices-Guidance for Industry and FDA Staff, May 2005.
9. Conclusion
The wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) have same intended use and similar characteristics as the cleared predicate device, model LD-737. Moreover, bench testing contained in this submission supplied demonstrate that the differences between subject device LD-735, LD-752, LD-753 and predicate device will not raise any safety and effectiveness issue.
The nonclinical tests support the safety of the device and the hardware and software verification and validation demonstrate that the wrist automatic blood pressure monitor perform as intended in the specified use conditions are same with predicate device. The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use.
Thus, the wrist automatic blood pressure monitor, model LD-735, LD-752, LD-753 is substantially equivalent to the predicate device.
K251795 Page 6 of 6
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).