(43 days)
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.
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 models are assembly accessories for fixation and installation of the aneroid sphygmomanometer.
The provided text is a 510(k) summary for the "Aneroid Type Blood Pressure Kit" (models MS-200, MS-200D, MS-200M). This type of device is a traditional medical instrument and not an AI-powered diagnostic tool, therefore many of the questions related to AI device performance are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Measuring Range | Pressure: 0 - 300 mmHg (Same as predicate) |
| Accuracy | Pressure: ± 3 mmHg (Same as predicate) |
| Storage Condition | -10°C ~ +60°C, 10% ~ 95% RH (Same as predicate) |
| Operating Condition | +10°C ~ +40°C, 15% ~ 85% RH (Same as predicate) |
| Cuff Dimensions | Infant, Child, Adult, Large Adult, Thigh sizes with specified dimensions and arm girths (Same as predicate) |
| Standards Compliance | ISO 81060-1 (The proposed device performed tests complying with this standard, which updated and replaced the predicate's ANSI/AAMI SP9) |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (Same as predicate) |
The document explicitly states: "The proposed device have performed test complying with ISO 81060-1:2007." and "Results of testing were acceptable." This indicates that the device met the acceptance criteria defined by these standards.
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set or the data provenance for the non-clinical testing. It only mentions "Non-clinical testing included biocompatibility and bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a manual aneroid sphygmomanometer, not an AI system or a diagnostic device requiring expert interpretation for ground truth. The accuracy is assessed on pressure measurements against a standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of device and testing described. Adjudication methods are typically used for establishing ground truth in image analysis or diagnostic studies, not for the performance of a mechanical blood pressure monitor.
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
This is not applicable as the device is not an AI system. It is a manual blood pressure kit. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm. It is a manual blood pressure kit and inherently involves a human-in-the-loop (medical professional or home user) for operation and reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy testing, the "ground truth" would be established by reference standard equipment capable of precisely measuring pressure. The document refers to compliance with ISO 81060-1, which provides specific protocols for accuracy testing of non-invasive sphygmomanometers. This standard dictates the methods for determining the accuracy of the device against a known pressure.
8. The sample size for the training set
This is not applicable as the device is not an AI system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI system that requires a training set.
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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.
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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
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Indications for Use
510(k) Number (if known)
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)
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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
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models are assembly accessories for fixation and installation of the aneroid sphygmomanometer.
| Table 1 Model Differences Comparison | ||||
|---|---|---|---|---|
| Model | Type | Maincomponents | Assembly accessories | Picture |
| MS-200 | Wallmountedtype | Same parts:● Four (4) 1" Screws● Four (4) drywallanchors● Two (2) ¼" lockscrews | Image: MS-200 | |
| MS-200D | Desktype | ● Aneroidgauge● Wall clockmountbracket | Different parts onlyused for Desk type:one lower bracketM6 screw & washerone base and base pad | Image: MS-200D |
| MS-200M | Mobiletype | ● Adult sizecuff withbladder andinflation bulb● Metal leurconnector set● Blackplasticdouble-endedmaleconnector● Coil tubing● Miniscrewdriver | ● Floor Stand● Five(5)CasterWheels● Metal Basket● 3-piece PoleAssembly(black pole,silver pole, spring)● Height AdjustmentKnobFloor StandHardware● One (1) 4.8/M8Screw Bolt with 2Washers● Two (2) 3/8"Screws withIntegrated Washers +Two (2)● Washers● Two (2) ½" ScrewsWall MountHardwareSame as the “Sameparts” | Image: MS-200M |
Table 1 Model Differences Comparison
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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(inches) | Arm Girth(inches) | Dimensions(Centimeters) | Arm Girth(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.
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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. | SameThe 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 | DifferentThe difference does not raise safety and effectiveness of the |
5-4
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| K191209 |
|---|
| Dongguan Mars Medical Products Co., Ltd |
| proposed device | |||
|---|---|---|---|
| Operating Principle | Aneroid Type Blood Pressure Kit, modelsMS-200, MS-200D and MS-200M are amanual non-invasive aneroidsphygmomanometer which respectivelyuses an inflation cuff wrapped around theupper arm. The cuff is inflated anddeflated by a manual inflation bulb. | Aneroid Type Blood Pressure Kit, modelsMS-115, MS-116, MS-117, MS-200,MS-200D and MS-200M are a manualnon-invasive aneroid sphygmomanometerwhich respectively uses an inflation cuffwrapped around the upper arm. The cuff isinflated and deflated by a manual inflationbulb. | Same |
| Basic Design | The Aneroid Type Blood Pressure Kit is anon-invasive blood pressuremeasurement system for monitoringblood pressure levels. Thisnon-automated sphygmomanometer usesan occluding cuff, an aneroidsphygmomanometer to measure pressure. | The Aneroid Type Blood Pressure Kit is anon-invasive blood pressure measurementsystem for monitoring blood pressure levels.This non-automated sphygmomanometeruses an occluding cuff, an aneroidsphygmomanometer to measure pressure(applied for modelsMS-115/116/117/200/200D/200M) and astethoscope for detecting Korotkoff sounds(applied for models MS-115/116/117). | SameThe basic design ofthe proposed device issame as the predicatedevice modelsMS-200/200D/200M. |
| Measuring Method | Aneroid | MS-115/116/117: Aneroid / AuscultatoryMS-200/200D/200M: Aneroid | SameThe measuringmethod of theproposed device issame as the predicatedevice modelsMS-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 gaugeWall clock mount bracketAdult size cuff with bladder and inflation bulbMetal leur connector setBlack plastic double-ended maleconnectorCoil tubingMini screwdriver | MS-115/116/117:Aneroid gaugeInflation bulbBinauralY-TubingAdult size cuffStethoscopeMS-200/200D/200M:Aneroid gaugeWall clock mount bracketAdult size cuff with bladder and inflation bulbMetal leur connector setBlack plastic double-ended male connectorCoil tubingMini screwdriver | SameThe main components of proposed device models are same as those modelsMS-200/200D/200M of predicate device. |
| Materials | Aneroid gauge: the enclosure of gauge is made of Aluminum (bottom) and ABS (panel)Wall clock mount bracket: steelAdult 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 steelBinaural: stainless steel and nature latexY-Tubing: PVCAdult 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)Stethoscope: stainless steelMS-200/200D/200M: Aneroid gauge: the | SameThe materials of the proposed device are same as those of the predicate device modelsMS-200/200D/200M. |
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K191209 Dongguan Mars Medical Products Co., Ltd
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| K191209 |
|---|
| Dongguan Mars Medical Products Co., Ltd |
| (Neoprene)aluminumBlackconnector: PVCCoil tubing: TPUMini screwdriver: metal | Metal leur connector set: chrome platedplasticdouble-endedmale | enclosure of gauge is made of Aluminum(bottom) and ABS (panel)Wall clock mount bracket: steelAdult size cuff with bladder and inflationbulb: the cuff outside layer is made of nyloncloth or cotton cloth (optional), and insidebladder is made of PVC, or Latex (Rubber),or Latex Free (Neoprene) (optional), and theinflation bulb is made of PVC or Latex(Rubber), the tubes connecting to the insidebladder is made of PVC, or Latex (Rubber),or Latex Free (Neoprene)Metal leur connector set: chrome platedaluminumBlack plastic double-ended male connector:PVC | ||||
|---|---|---|---|---|---|---|
| Coil tubing: TPUMini screwdriver: metal | ||||||
| Measuringrange | 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 | SizeInfantChild | Dimension3.54"W x 11.8"L9.00cm W x 30.0cm L4.33"W x 14.2"L | SizeInfantChild | Dimension3.54"W x 11.8"L9.00cm W x 30.0cm L4.33"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"L14.50cm W x 54.0cm L | Adult | 5.71"W x 21.3"L14.50cm W x 54.0cm L | |||
| LargeAdult | 6.89"W x 24.6"L17.50cm W x 62.5cm L | LargeAdult | 6.89"W x 24.6"L17.50cm W x 62.5cm L | |||
| Thigh | 8.46"W x 30.5"L21.50cm W x 77.5cm L | Thigh | 8.46"W x 30.5"L21.50cm W x 77.5cm L | |||
| Size | Arm Girth | Size | Arm Girth | |||
| Arm Girth | Infant | 5.12" – 7.48"13.0cm – 19.0cm | Infant | 5.12" – 7.48"13.0cm – 19.0cm | Same | |
| Child | 7.64" – 10.5"19.4cm – 26.7cm | Child | 7.64" – 10.5"19.4cm – 26.7cm | |||
| Adult | 10.0" – 16.0"25.4cm – 40.6cm | Adult | 10.0" – 16.0"25.4cm – 40.6cm | |||
| LargeAdult | 13.5" – 20.0"34.4cm – 50.8cm | LargeAdult | 13.5" – 20.0"34.4cm – 50.8cm | |||
| Thigh | 16.0" – 26.0"40.6cm – 66.0cm | Thigh | 16.0" – 26.0"40.6cm – 66.0cm | |||
| Standard | ISO 81060-1 | ANSI/AAMI SP9 | SimilarStandards have beenupdated and replaced | |||
| ISO 10993-1 | ISO 10993-1 | |||||
| ISO 10993-5 | ISO 10993-5 | |||||
| ISO 10993-10 | ISO 10993-10 |
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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.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).