Electronic Sphygmomanometer (Model: LT-P30)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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. October 3, 2022 Zhuhai Linte Medical Instrument Co., Ltd. % Becky Chen Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, GuangDong 518052 China Re: K220220 Trade/Device Name: Electronic Sphygmomanometer (Model: LT-P30) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 30, 2022 Received: August 30, 2022 Dear Becky Chen: 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/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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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-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. LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220220 Device Name Electronic Sphygmomanometer (Models: LT-P30) Indications for Use (Describe) Measure blood pressure (systolic and diastolic) and pulse rate. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510 (k) Summary This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92. ## (1) Applicant information: | 510(k) owner's name: | Zhuhai Linte Medical Instrument Co., Ltd. | |----------------------------|-----------------------------------------------------------------------------------------------------------------| | Address: | 4th Floor, Building 1, No.66, Yongda Road, Hongqi Town,<br>Jinwan District, Zhuhai, Guangdong, 519090 P.R.China | | Contact person: | Wallace Huang | | Phone number: | +86 13823146691 | | Email: | wallace.huang@lintemed.com | | Date of summary prepared: | January 10, 2022 | | Reason for the submission: | New device, there were no prior submissions for the<br>device. | ## (2) Proprietary name of the device | Trade name/model: | Electronic Sphygmomanometer /Model: LT-P30 | |----------------------|---------------------------------------------------| | Common name: | Blood Pressure Monitor | | Classification name: | System, measurement, blood-pressure, non-invasive | | Regulation number: | 21CFR 870.1130 | | Product code: | DXN | | Review panel: | Cardiovascular | | Regulation class: | Class II | ## (3) Predicate device | Sponsor | A&D Engineering, Inc. | |-----------------------|--------------------------------------------------| | Device Name and Model | A&D Medical UA-651Digital Blood Pressure Monitor | | 510(k) Number | K141160 | | Product Code | DXN | | Regulation Number | 21CFR 870.1130 | | Regulation Class | Class II | ## (4) Description/ Design of device: The Electronic Sphygmomanometer uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START/STOP" button, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal {4}------------------------------------------------ exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. The device will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time. ## (5) Intended use: The Electronic Sphygmomanometer is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate. ## (6) Indications for use: Measure blood pressure (systolic and diastolic) and pulse rate. ## (7) Materials | Component name | Material of<br>Component | Body Contact<br>Category | Contact Duration | |----------------|--------------------------|--------------------------|--------------------| | Arm cuff | 210D raw silk cloth | Surface skin contact | Less than 24 hours | We have directly purchased arm cuff from qualified supplier which has obtained Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion". | Item | Targeted device | Predicate device | Remark | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Trade name | Electronic<br>Sphygmomanometer<br>(Models: LT-P30) | A&D Medical<br>UA-651Digital Blood<br>Pressure Monitor | / | | 510 (k) number | Pending | K141160 | / | | Regulation<br>number | 21CFR 870.1130 | 21 CFR 870.1130 | Same | | Regulation<br>description | Noninvasive blood<br>pressure measurement<br>system | Noninvasive blood pressure<br>measurement system | Same | | Product code | DXN | DXN | Same | | Class | II | II | Same | | Indications for<br>use | Measure blood pressure<br>(systolic and diastolic) and<br>pulse rate. | Measure blood pressure<br>(systolic and diastolic) and<br>pulse rate. | Same | | Intended use | The Electronic<br>Sphygmomanometer is | The A&D Medical UA-651<br>family digital blood | Same | | Item | Targeted device | Predicate device | Remark | | | intended for used by a<br>person older than twelve<br>(12) years to measure the<br>systolic and diastolic<br>blood pressure and pulse<br>rate. | pressure monitor is intended<br>for used by a person older<br>than twelve (12) years to<br>measure the systolic and<br>diastolic blood pressure and<br>pulse rate. | | | Intended patient | Person older than 12 years | Person older than 12 years | Same | | Application sites | Upper arm | Upper arm | Same | | Location for use | OTC | OTC | Same | | Operation<br>principle | Oscillometric | Oscillometric | Same | | Measurement<br>range | Pressure: 20-280mmHg<br>Pulse Rate: 30-200bpm | Pressure: 20-280mmHg<br>Pulse Rate: 30-200bpm | Same | | Accuracy | Pressure: ±3mmHg or<br>±2% of measured value,<br>whichever is greater;<br>Pulse Rate: ±5% | Pressure: ±3mmHg or ±2%<br>of measured value,<br>whichever is greater;<br>Pulse Rate: ±5% | Same | | Display type | LCD | LCD | Same | | Pressurization<br>source | Automatic internal pump | Automatic internal pump | Same | | Cuff deflation<br>method | Standard exhaust valve | Standard exhaust valve | Same | | Cuff attachment<br>method | By plastic hose connected to monitor | By plastic hose connected to monitor | Same | | Cuff design | D-ring cuffs | D-ring cuffs | Same | | Cuff<br>circumference | Small cuff: 17 ~ 22 cm<br>Medium cuff: 22 ~ 32cm<br>Large cuff: 22 ~ 42 cm | Small cuff: 16 ~ 24 cm<br>Medium cuff: 23 ~ 37cm<br>Large cuff: 31 ~ 45 cm | Similar -<br>Within<br>the scope<br>of<br>predicate<br>device | | Memory | 45×3 recording of<br>measurement data for<br>multiple person | 30 memories | Similar -<br>does not<br>affect the<br>safety and<br>effectiveness of the<br>device | | Power source | 4 AA size batteries and | 4 AA size batteries and AC | Similar | | Item | Targeted device | Predicate device | Remark | | Operating<br>Environment | USB type-C cable as an<br>option | adaptor as an option | | | | Temperature:<br>+5°C~+40°C;<br>Humidity:<br>15~80%RH | Temperature:<br>+10°C~+40°C;<br>Humidity:<br>30~85%RH | Similar-<br>does not<br>affect the<br>safety and<br>effectiveness of the<br>device | | | | | | | Storage<br>Environment | Temperature:<br>-40°C~+55°C;<br>Humidity:<br>$≤$ 93%RH | Temperature:<br>-20°C~+60°C;<br>Humidity:<br>10~95%RH | Similar-<br>does not<br>affect the<br>safety and<br>effectiveness of the<br>device | | | | | | | | | | | | Compliance with<br>voluntary<br>standards | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-1-11;<br>IEC 80601-2-30;<br>ISO 10993-1,-5,-10<br>ISO 81060-2,<br>IEC 80369-5 | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-1-11;<br>IEC 80601-2-30;<br>ISO 10993-1,-5,-10<br>ISO 81060-2 | Same | #### (8) Technological characteristics and substantial equivalence: {5}------------------------------------------------ {6}------------------------------------------------ Zhuhai Linte Medical Instrument Co., Ltd. 510(k)s - Section 8. 510 (k) Summary #### Conclusion: Electronic Sphygmomanometer (Models: LT-P30) is substantial equivalent to the predicate device. #### (10) Performance Data: The performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below: ## Non-Clinical Data The following performance data have been conducted to verify that the Electronic Sphygmomanometer (Models: LT-P30) meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards: #### Biocompatibility Testing: The biocompatibility evaluation for the body-contacting component (arm cuff) of this {7}------------------------------------------------ device was conducted in accordance with the "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Device - Part 1: Evaluation and Testing Within a Risk Management Process", as recongnized by FDA. The arm cuff has performed and passed the Biocompatibility test. So we have reason to believe that the arm cuff is safe for the users. The arm cuff complies with the following standards: - ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For A InVitro Cytotoxicity - A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. ## Electrical and EMC Safety: The electrical safety and EMC safety testing was performed to, and passed, the following standards: - ANSI AAMI ES60601-1, Medical electrical equipment -- Part 1: General A requirements for basic safety and essential performance - IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements A for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - > 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 ## Performance: The performance testing was performed to, and passed, the following standards: - IEC 80601-2-30, Medical Electrical Equipment -- Part 2-30: Particular A Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers - > IEC 80369-5. Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications ## Software: We have also conducted Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". ## Clinical Data The clinical testing has been conducted per ISO 81060-2: 2018 Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type on the Electronic Sphygmomanometer. {8}------------------------------------------------ There are 120 subjected involved in the study, of which 61 female and 59 male. All the subjects are aged from 13 to 85. And the size distribution meets the requirements described in clause 5.1.4 of the standard. The subject devices use the oscillometric method to measure blood pressure, the accuracy of determination depends on the sensor, race and ethnicity differences do not have an effect on the measuring result in the specified measuring scope. During the testing, there were no adverse effects and complications occurred, and the results both meet criterion 1 and criterion 2 of ISO 81060-2. #### Summary: Based on the above non-clinical data and clinical data as documented in this application, the Electronic Sphygmomanometer was found to have a safety and effectiveness profile that is similar to the predicate device. ## (11) Conclusion In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Electronic Sphygmomanometer is to be concluded substantial equivalent to its predicate devices.