Aneroid Type Blood Pressure Kit

{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. June 18, 2019 Dongguan Mars Medical Products Co., Ltd % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou. 511660 CHINA Re: K191209 Trade/Device Name: Aneroid Type Blood Pressure Kit Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: May 6, 2019 Received: May 6. 2019 Dear Jinghua Zhou: 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, Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K191209 Device Name Aneroid Type Blood Pressure Kit Indications for Use (Describe) The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The models MS-200, MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method. | Y Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------ # Section 5 - 510(k) Summary Date of Summary Preparation: April 30, 2019 ### 1. Submitter's Identifications Submitter's Name: Dongguan Mars Medical Products Co., Ltd Address: 381, Manfeng West Road, Manfeng Group, Dani Village, Shatian Town, Dongguan City, Guandgong 523993, China Contact Person: Lily Liao Contact Title: Sales representative Contact E-mail Address: lily@mars.com.tw Telephone: +86-769-85834233 Fax: +86-769-85834232 #### 2. Correspondent's Identifications Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549 #### 3. Name of the Device Device Classification Name: Blood Pressure Cuff Product Name: Blood Pressure Cuff Trade Name: Aneroid Type Blood Pressure Kit Model: MS-200, MS-200D, MS-200M Classification Panel: Cardiovascular Product Code: DXQ Device Classification: Class II ### 4. The Predicate Devices K780715 Aneroid Type Blood Pressure Kit #### 5. Device Description Aneroid Type Blood Pressure Kit, models MS-200D and MS-200M are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. The proposed device has three models, MS-200/MS-200D/MS-200M. The three models have same intended use, same design and measuring principle, same measuring range and same main components. The only differences among the three {4}------------------------------------------------ models are assembly accessories for fixation and installation of the aneroid sphygmomanometer. | Table 1 Model Differences Comparison | | | | | |--------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Model | Type | Main<br>components | Assembly accessories | Picture | | MS-200 | Wall<br>mounted<br>type | | Same parts:<br>● Four (4) 1" Screws<br>● Four (4) drywall<br>anchors<br>● Two (2) ¼" lock<br>screws | Image: MS-200 | | MS-200D | Desk<br>type | ● Aneroid<br>gauge<br>● Wall clock<br>mount<br>bracket | Different parts only<br>used for Desk type:<br>one lower bracket<br>M6 screw & washer<br>one base and base pad | Image: MS-200D | | MS-200M | Mobile<br>type | ● Adult size<br>cuff with<br>bladder and<br>inflation bulb<br>● Metal leur<br>connector set<br>● Black<br>plastic<br>double-ended<br>male<br>connector<br>● Coil tubing<br>● Mini<br>screwdriver | ● Floor Stand<br>● Five(5)Caster<br>Wheels<br>● Metal Basket<br>● 3-piece Pole<br>Assembly(black pole,<br>silver pole, spring)<br>● Height Adjustment<br>Knob<br><b>Floor Stand<br/>Hardware</b><br>● One (1) 4.8/M8<br>Screw Bolt with 2<br>Washers<br>● Two (2) 3/8"<br>Screws with<br>Integrated Washers +<br>Two (2)<br>● Washers<br>● Two (2) ½" Screws<br><b>Wall Mount<br/>Hardware</b><br>Same as the “Same<br>parts” | Image: MS-200M | # Table 1 Model Differences Comparison {5}------------------------------------------------ #### Main components: Aneroid gauge: indicate the measurement result Wall clock mount bracket: fix the aneroid gauge Adult size cuff with bladder and inflation bulb: the cuff is inflated and deflated by the manual inflation bulb Metal leur connector set: connect the black plastic double-ended male connector and the rubber tube Black plastic double-ended male connector: connect the metal leur connector set and the coil tubing Coil tubing: connect the aneroid gauge and the black plastic double-ended male connector Mini screwdriver: adjust and set to zero when the needle of the aneroid gauge is not within the zero square position Assembly accessories: fix and install the aneroid sphygmomanometer as wall type, or desk type, or mobile type #### Cuff types and dimensions: The device includes an Adult sized nylon cuff. Additional cuff sizes are available through your dealer. The types and dimensions of the optional cuff are as below: | Size | Dimensions<br>(inches) | Arm Girth<br>(inches) | Dimensions<br>(Centimeters) | Arm Girth<br>(Centimeters) | |-------------|------------------------|-----------------------|-----------------------------|----------------------------| | Infant | 3.54"W x 11.8"L | 5.12"-7.48" | 9.00cm W x 30.0cm L | 13.0cm-19.0cm | | Child | 4.33"W x 14.2"L | 7.64"-10.5" | 11.00cm W x 36.0cm L | 19.4cm-26.7cm | | Adult | 5.71"W x 21.3"L | 10.0"-16.0" | 14.50cm W x 54.0cm L | 25.4cm-40.6cm | | Large Adult | 6.89"W x 24.6"L | 13.5"-20.0" | 17.50cm W x 62.5cm L | 34.4cm-50.8cm | | Thigh | 8.46"W x 30.5"L | 16.0"-26.0" | 21.50cm W x 77.5cm L | 40.6cm-66.0cm | #### Materials: Aneroid gauge: the enclosure of gauge is made of Aluminum (bottom) and ABS (panel) Wall clock mount bracket: steel Adult size cuff with bladder and inflation bulb: the cuff outside layer is made of nylon cloth or cotton cloth (optional), and inside bladder is made of PVC, or Latex (Rubber), or Latex Free (Neoprene) (optional), and the inflation bulb is made of PVC or Latex (Rubber), the tubes connecting to the inside bladder is made of PVC, or Latex (Rubber), or Latex Free (Neoprene) Metal leur connector set: chrome plated aluminum Black plastic double-ended male connector: PVC Coil tubing: TPU Mini screwdriver: metal #### 6. Intended Use of Device The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The models MS-200, MS-200D and MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method. {6}------------------------------------------------ # 7. Summary of Substantial Equivalence # Table 2 Comparison to Predicate Device | | Proposed Device | Predicate device | Comparison | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | 510k Number | ------- | K780715 | ------- | | Product Code | DXQ | DXQ | Same | | Proprietary Name | Aneroid Type Blood Pressure Kit | Aneroid Type Blood Pressure Kit | Same | | Model | MS-200, MS-200D, MS-200M | MS-115, MS-116, MS-117, MS-200, MS-200D, MS-200M | ------- | | Manufacturer | Dongguan Mars Medical Products Co., Ltd | Dongguan Mars Medical Products Co., Ltd | ------- | | Indications for Use | The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The models MS-200, MS-200D and MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method. | The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The models MS-115, MS-116, MS-117 are intended to be manually attached to a patient and manually inflated along with a manual method and Auscultatory Korotkoff sounds method. The models MS-200, MS-200D and MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method. | Same<br>The proposed device models are contained in those of the predicate device. And the measurement method of models MS-200/200D/200M is same. | | Type of Use | Prescription Use | Over-The-Counter Use | Different<br>The difference does not raise safety and effectiveness of the | 5-4 {7}------------------------------------------------ | K191209 | |-----------------------------------------| | Dongguan Mars Medical Products Co., Ltd | | | | | proposed device | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Operating Principle | Aneroid Type Blood Pressure Kit, models<br>MS-200, MS-200D and MS-200M are a<br>manual non-invasive aneroid<br>sphygmomanometer which respectively<br>uses an inflation cuff wrapped around the<br>upper arm. The cuff is inflated and<br>deflated by a manual inflation bulb. | Aneroid Type Blood Pressure Kit, models<br>MS-115, MS-116, MS-117, MS-200,<br>MS-200D and MS-200M are a manual<br>non-invasive aneroid sphygmomanometer<br>which respectively uses an inflation cuff<br>wrapped around the upper arm. The cuff is<br>inflated and deflated by a manual inflation<br>bulb. | Same | | Basic Design | The Aneroid Type Blood Pressure Kit is a<br>non-invasive blood pressure<br>measurement system for monitoring<br>blood pressure levels. This<br>non-automated sphygmomanometer uses<br>an occluding cuff, an aneroid<br>sphygmomanometer to measure pressure. | The Aneroid Type Blood Pressure Kit is a<br>non-invasive blood pressure measurement<br>system for monitoring blood pressure levels.<br>This non-automated sphygmomanometer<br>uses an occluding cuff, an aneroid<br>sphygmomanometer to measure pressure<br>(applied for models<br>MS-115/116/117/200/200D/200M) and a<br>stethoscope for detecting Korotkoff sounds<br>(applied for models MS-115/116/117). | Same<br>The basic design of<br>the proposed device is<br>same as the predicate<br>device models<br>MS-200/200D/200M. | | Measuring Method | Aneroid | MS-115/116/117: Aneroid / Auscultatory<br>MS-200/200D/200M: Aneroid | Same<br>The measuring<br>method of the<br>proposed device is<br>same as the predicate<br>device models<br>MS-200/200D/200M. | | Inflation system | Manual inflation with air pump bulb | Manual inflation with air pump bulb | Same | | Deflation system | Manual deflation | Manual deflation | Same | | Main Components | Aneroid gauge<br>Wall clock mount bracket<br>Adult size cuff with bladder and inflation bulb<br>Metal leur connector set<br>Black plastic double-ended male<br>connector<br>Coil tubing<br>Mini screwdriver | MS-115/116/117:<br>Aneroid gauge<br>Inflation bulb<br>Binaural<br>Y-Tubing<br>Adult size cuff<br>Stethoscope<br>MS-200/200D/200M:<br>Aneroid gauge<br>Wall clock mount bracket<br>Adult size cuff with bladder and inflation bulb<br>Metal leur connector set<br>Black plastic double-ended male connector<br>Coil tubing<br>Mini screwdriver | Same<br>The main components of proposed device models are same as those models<br>MS-200/200D/200M of predicate device. | | Materials | Aneroid gauge: the enclosure of gauge is made of Aluminum (bottom) and ABS (panel)<br>Wall clock mount bracket: steel<br>Adult size cuff with bladder and inflation bulb: the cuff outside layer is made of nylon cloth or cotton cloth (optional), and inside bladder is made of PVC, or Latex (Rubber), or Latex Free (Neoprene) (optional), and the inflation bulb is made of PVC or Latex (Rubber), the tubes connecting to the inside bladder is made of PVC, or Latex (Rubber), or Latex Free | MS-115/116/117: Aneroid gauge: the enclosure of gauge is made of steel<br>Binaural: stainless steel and nature latex<br>Y-Tubing: PVC<br>Adult size cuff: the cuff outside layer is made of nylon cloth or cotton cloth (optional), and inside bladder is made of PVC, or Latex (Rubber), or Latex Free (Neoprene) (optional), and the inflation bulb is made of PVC or Latex (Rubber)<br>Stethoscope: stainless steel<br>MS-200/200D/200M: Aneroid gauge: the | Same<br>The materials of the proposed device are same as those of the predicate device models<br>MS-200/200D/200M. | {8}------------------------------------------------ K191209 Dongguan Mars Medical Products Co., Ltd {9}------------------------------------------------ | K191209 | |-----------------------------------------| | Dongguan Mars Medical Products Co., Ltd | | | (Neoprene)<br>aluminum<br>Black<br>connector: PVC<br>Coil tubing: TPU<br>Mini screwdriver: metal | Metal leur connector set: chrome plated<br>plastic<br>double-ended<br>male | enclosure of gauge is made of Aluminum<br>(bottom) and ABS (panel)<br>Wall clock mount bracket: steel<br>Adult size cuff with bladder and inflation<br>bulb: the cuff outside layer is made of nylon<br>cloth or cotton cloth (optional), and inside<br>bladder is made of PVC, or Latex (Rubber),<br>or Latex Free (Neoprene) (optional), and the<br>inflation bulb is made of PVC or Latex<br>(Rubber), the tubes connecting to the inside<br>bladder is made of PVC, or Latex (Rubber),<br>or Latex Free (Neoprene)<br>Metal leur connector set: chrome plated<br>aluminum<br>Black plastic double-ended male connector:<br>PVC | | | | |---------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------| | | | | Coil tubing: TPU<br>Mini screwdriver: metal | | | | | Measuring<br>range | Pressure: 0 - 300 mmHg | | Pressure: 0 - 300 mmHg | | | Same | | Accuracy | Pressure: ± 3 mmHg | | Pressure: ±3 mmHg | | | Same | | Storage condition | -10°C ~ +60°C, 10% ~ 95% RH | | -10°C ~ +60°C, 10% ~ 95% RH | | | Same | | Operating condition | +10°C ~ +40°C, 15% ~ 85% RH | | +10°C ~ +40°C, 15% ~ 85% RH | | | Same | | Cuff dimension | Size<br>Infant<br>Child | Dimension<br>3.54"W x 11.8"L<br>9.00cm W x 30.0cm L<br>4.33"W x 14.2"L | Size<br>Infant<br>Child | Dimension<br>3.54"W x 11.8"L<br>9.00cm W x 30.0cm L<br>4.33"W x 14.2"L | | Same | | | 11.00cm W x 36.0cm L | | | 11.00cm W x 36.0cm L | | | | | Adult | 5.71"W x 21.3"L<br>14.50cm W x 54.0cm L | | Adult | 5.71"W x 21.3"L<br>14.50cm W x 54.0cm L | | | | Large<br>Adult | 6.89"W x 24.6"L<br>17.50cm W x 62.5cm L | | Large<br>Adult | 6.89"W x 24.6"L<br>17.50cm W x 62.5cm L | | | | Thigh | 8.46"W x 30.5"L<br>21.50cm W x 77.5cm L | | Thigh | 8.46"W x 30.5"L<br>21.50cm W x 77.5cm L | | | | Size | Arm Girth | | Size | Arm Girth | | | Arm Girth | Infant | 5.12" – 7.48"<br>13.0cm – 19.0cm | | Infant | 5.12" – 7.48"<br>13.0cm – 19.0cm | Same | | | Child | 7.64" – 10.5"<br>19.4cm – 26.7cm | | Child | 7.64" – 10.5"<br>19.4cm – 26.7cm | | | | Adult | 10.0" – 16.0"<br>25.4cm – 40.6cm | | Adult | 10.0" – 16.0"<br>25.4cm – 40.6cm | | | | Large<br>Adult | 13.5" – 20.0"<br>34.4cm – 50.8cm | | Large<br>Adult | 13.5" – 20.0"<br>34.4cm – 50.8cm | | | | Thigh | 16.0" – 26.0"<br>40.6cm – 66.0cm | | Thigh | 16.0" – 26.0"<br>40.6cm – 66.0cm | | | Standard | ISO 81060-1 | | | ANSI/AAMI SP9 | | Similar<br>Standards have been<br>updated and replaced | | | ISO 10993-1 | | | ISO 10993-1 | | | | | ISO 10993-5 | | | ISO 10993-5 | | | | | ISO 10993-10 | | | ISO 10993-10 | | | {10}------------------------------------------------ K191209 Dongguan Mars Medical Products Co., Ltd {11}------------------------------------------------ # 8. Substantial Equivalence discussion: Comparing with the predicate device (K780715), Aneroid Type Blood Pressure Kit Model MS-115, MS-116, MS-117, MS-200, MS-200D and MS-200M, modified Aneroid Type Blood Pressure Kit Model MS-200, MS-200D and MS-200M have same product name, classification and product code, product physical design and operation, same aneroid gauge, packaging materials, performance parameter ranges, physical properties, mechanical properties, biocompatibility. The differences between those two devices are as following: - · Type of use for the proposed device is Prescription Use, and the predicate device is OTC. The difference does not raise safety and effectiveness of the proposed device. - · Performance standard complied with the proposed device is ISO 81060-1:2007, and the predicate device is ANSI/AAMI SP9. Standards have been updated and replaced, the proposed device have performed test complying with ISO 81060-1:2007. ## 9. Non-Clinical Testing Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO10993 and ISO81060-1, were included. Results of testing were acceptable. ## 10. Clinical Study No clinical study is included in this submission. ## 11. Conclusion: Aneroid Type Blood Pressure Kit, models MS-200, MS-200D and MS-200M have the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, Aneroid Type Blood Pressure Kit, models MS-200, MS-200D and MS-200M are substantially equivalent to the predicate devices.