(288 days)
WX non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model. The device is applicable to all patients at least 2 years of age.
WX non-Automated Blood Pressure Meter is 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. Besides a manometer (Aneroid gauge), the accessories of MODEL WX02, WX0201, WX0202, WX0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model WX0201, WX0202, WX0203 include additional stethoscope (Single head, Dual head, and Sprague Rappaport). It is conjunction with Stethoscope when use.
The provided text describes WX non-Automated Blood Pressure Meters. Here's an analysis of the acceptance criteria and supporting studies based on the document:
1. Table of acceptance criteria and the reported device performance:
| Criteria | Device Performance (New Device) Total Result |
| :--------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :----------- |
| Accuracy (Pressure) | +/- 3 mmHg of reading | SAME |
| Biocompatibility | Biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10 | SAME |
| Performance | Compatible as requirement of ISO 81060-1 | SAME |
| Display | Aneroid Manometer | SAME |
| Monitor Scale | From 0 to 300 mmHg with a minimum interval of 2 mmHg | SAME |
| Compatibility with environment | It can be used from 50°F to 104°F (10°C to 40°C) and 15%~85%RH humidity. | SAME |
The document states that the new device meets these criteria by being "compatible as requirement of ISO 81060-1" for performance and "biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10" for biocompatibility. The accuracy is explicitly stated as "+/- 3 mmHg of reading". For all these criteria, the "Result of Comparison" field in the table is marked as "SAME" when compared to the predicate device.
2. Sample sized used for the test set and the data provenance:
The document mentions "Non-clinical testing included biocompatibility and bench testing." It does not specify the sample size used for these tests. There's no information about data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The document refers to "bench testing" and compliance with standards (ISO10993 and ISO81060-1), which implies objective measurements rather than expert-established ground truth in the context of clinical interpretation.
4. Adjudication method for the test set:
Not applicable, as no external expert review or adjudication process for a test set is mentioned. The testing mentioned is non-clinical bench testing.
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:
Not applicable. The device is a "non-Automated Blood Pressure Meter" and does not involve AI or human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical, non-automated blood pressure meter. It does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the accuracy and performance criteria, the "ground truth" would be established by reference measurement instruments or standardized methods as defined by the ISO 81060-1 standard for non-invasive sphygmomanometers. For biocompatibility, the ground truth is established by adherence to the testing protocols outlined in the ISO 10993 series. These are objective standards, not subject to expert consensus in the diagnostic sense.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI, and therefore does not have a training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
May 18, 2022
Wenzhou Xikang Medical Instruments Co., Ltd % Sandy Liu, Consultant Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, 70447 Taiwan
Re: K212416
Trade/Device Name: WX non-Automated Blood Pressure Meter, MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: April 6, 2022 Received: April 22, 2022
Dear Sandy Liu:
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.
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
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Indications for Use
510(k) Number (if known) K212416
Device Name
WX non-Automated Blood Pressure Meter, MODEL WX02 and WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
Indications for Use (Describe)
WX non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model. The device is applicable to all patients at least 2 years of age.
| 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)
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Image /page/3/Picture/1 description: The image shows the logo for Wenzhou Xikang Medical Instruments Co., LTD. The logo features the letters "WX" in a stylized font, with a stethoscope wrapped around the letters. The text "WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD" is written in bold, black letters to the right of the logo.
510(k) Summary
| Company Name: | WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD |
|---|---|
| Company Address: | NO.1478 Haining Road, Haibin Street, Longwan District, Wenzhou, Zhejiang325024, China |
| Telephone: | 86-577-86876969 |
| Fax: | N/A |
| Contact Person: | WANG TIANCE |
| Summary Preparation Date: | May 11, 2022 |
| Device Trade Name: | WX non-Automated Blood Pressure Meter, MODEL WX02 and WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201,WX0202, WX0203 |
| Classification Name: | Blood pressure cuff |
| Regulation Number: | 21 CFR 870.1120 |
| Product Code: | DXQ |
| Device Class: | Class 2 |
| Panel: | Cardiovascular |
PREDICATE DEVICE:
RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 (K190902)
INDICATIONS FOR USE
WX non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model. The device is applicable to all patients at least 2 years of age.
DEVICE DESCRIPTION
WX non-Automated Blood Pressure Meter is 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. Besides a manometer (Aneroid gauge), the accessories of MODEL WX02, WX0201, WX0202, WX0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model WX0201, WX0202, WX0203 include additional stethoscope (Single head, Dual head, and Sprague Rappaport). It is conjunction with Stethoscope when use.
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Image /page/4/Picture/1 description: The image shows a logo with the letters "WX" in a stylized, three-dimensional font. To the right of the letters is a stethoscope, a medical instrument used for listening to internal sounds in the body. The stethoscope is positioned so that its earpieces are above the "X" and its diaphragm is below, suggesting a connection to healthcare or medical services. The overall design is simple and clean, with a focus on the letters and the medical symbol.
The PVC or nature latex inflation bulb and optional various size of cuffs which cuffs outside layer is made of Nylon Cloth or Cotton Cloth can be selected according to user's need.
Substantial Equivalence Comparison
It is substantially equivalent to the predicate device (K190902), RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 with respect to indications for use, device description, and technical characteristics.
All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.
| comparison item | New deviceWX non-Automated BloodPressure Meter, MODELWX02 and WX non-Automated Blood PressureMeter with Stethoscope,MODEL WX0201, WX0202,WX0203 | Predicate deviceRH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203(K190902) | Result ofComparison |
|---|---|---|---|
| Applicant | WENZHOU XIKANGMEDICALINSTRUMENTS CO., LTD | Wenzhou RenhuaInstruments Co., Ltd | Different |
| Classification | Class II | Class II | SAME |
| Regulationnumber | 21CFR 870.1120 | 21CFR 870.1120 | SAME |
| Product code | DXQ | DXQ | SAME |
| Indications for | The device is intended to be | The device is intended to be | SAME |
| comparison item | New device | Predicate device | Result ofComparison |
| WX non-Automated BloodPressure Meter, MODELWX02 and WX non-Automated Blood PressureMeter with Stethoscope,MODEL WX0201, WX0202,WX0203 | RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203(K190902) | ||
| use | used by medicalprofessionals or at home forthe measurement of systonicand diastonic pressure bydetecting Korotkoff sounds. | used by medicalprofessionals or at home forthe measurement of systonicand diastonic pressure bydetecting Korotkoff sounds. | |
| Over-The-Counter Use | Yes | Yes | SAME |
| Where used | Home, Hospital, heathcarefacility, ambulance etc. | Home, Hospital, heathcarefacility, ambulance etc. | SAME |
| Target population | infants, children, youngadults, and adults | infants, children, youngadults, and adults | SAME |
| Anatomical sites | Upper Arm (leg for child) | Upper Arm (leg for child) | SAME |
| MeasurementMethod | Auscultatory Korotkoffsounds Method | Auscultatory Korotkoffsounds Method | SAME |
| Inflation | Manual by inflation bulb | Manual by inflation bulb | SAME |
| Deflation | Manual deflation via valve | Manual deflation via valve | SAME |
| Display | Aneroid Manometer | Aneroid Manometer | SAME |
| The monitor scale | From 0 to 300 mmHg with a | From 0 to 300 mmHg with a | SAME |
| comparison item | New device | Predicate device | Result of Comparison |
| WX non-Automated BloodPressure Meter, MODELWX02 and WX non-Automated Blood PressureMeter with Stethoscope,MODEL WX0201, WX0202,WX0203 | RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203(K190902) | ||
| minimum interval of 2mmHg. | minimum interval of 2mmHg. | ||
| Design of bloodpressure meter | The device comprisestubing attached to a softinelastic cuff with anintegrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure. | The device comprisestubing attached to a softinelastic cuff with anintegrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure. | SAME |
| Design ofStethoscope | Three types of option:Single headDual headSprague Rappaport | Three types of option:Single headDual headSprague Rappaport | SAME |
| Materials | The manometer: Zinc Alloyor Aluminum materials. Thetubing, inflation bulb: PVCor nature latex.Cuff: Nylon cloth or cotton | The manometer: Zinc Alloyor Aluminum materials. Thetubing, inflation bulb: PVCor nature latex.Cuff: Nylon cloth or cotton | SAME |
| comparison item | New device | Predicate device | Result ofComparison |
| WX non-Automated BloodPressure Meter, MODELWX02 and WX non-Automated Blood PressureMeter with Stethoscope,MODEL WX0201, WX0202,WX0203 | RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203(K190902) | ||
| cloth for outside layer.Cuff bladder: PVC or naturelatex | cloth for outside layer.Cuff bladder: PVC or naturelatex | ||
| Accuracy | Pressure: +/- 3 mmHg ofreading | Pressure: +/- 3 mmHg ofreading | SAME |
| Compatibilitywith environment | It can be used from 50°F to104°F (10°C to 40°C ) and15%~85%RH humidity. | It can be used from 50°F to104°F (10°C to 40°C ) and15% ~ 85%RH humidity. | SAME |
| Cuff Size | 20"x 5.5" (510mm140mm)21.7" x 6.3"(550mm160mm)24.4" x 6.9"(620mm175mm)28.3" x 8.3"(720mm210mm)13.4" x 4.15"(340mm*105mm) | 20"x 5.5" (510mm140mm)21.7" x 6.3"(550mm160mm)24.4" x 6.9"(620mm175mm)28.3" x 8.3"(720mm210mm)13.4" x 4.15"(340mm*105mm) | SAME |
| CuffCircumference | Fits arm circumferences8.7" to 17.3" (220mm to440 mm), The standard cuffshould be available for use | Fits arm circumferences8.7" to 17.3" (220mm to440 mm), The standard cuffshould be available for use | SAME |
| comparison item | New device | Predicate device | Result of Comparison |
| WX non-Automated BloodPressure Meter, MODELWX02 and WX non-Automated Blood PressureMeter with Stethoscope,MODEL WX0201, WX0202,WX0203 | RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203(K190902) | ||
| in measuring a child's legblood pressure and forchildren with larger arms. | in measuring a child's legblood pressure and forchildren with larger arms. | ||
| Cuff bladder Size | 8.7"x 4.7"(220mm120mm)11.8"x5.9"(300mm150mm)13.4"x6.7"(340mm170mm)6.9"x 3.3"(175mm85mm) | 8.7"x 4.7"(220mm120mm)11.8"x5.9"(300mm150mm)13.4"x6.7"(340mm170mm)6.9"x 3.3"(175mm85mm) | SAME |
| Cuff Color | Blue, Pink, Black | Blue, Pink, Black | Same |
| Contents (withaccessories) | Aneroid gauge, Arm Cuff,Inflation Bulb, Vinyl storagepouch and InstructionManual, Stethoscope(option) | Aneroid gauge, Arm Cuff,Inflation Bulb, Vinyl storagepouch and InstructionManual, Stethoscope(option) | Same |
| Biocompatibility | biocompatible asrequirement of ISO 10993-1 | biocompatible asrequirement of ISO 10993-1 | Same |
| ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-10 | ||
| Performance | compatible as requirementof ISO 81060-1 | compatible as requirementof ISO 81060-1 | Same |
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Image /page/5/Picture/1 description: The image shows a logo with the letters "WX" in a stylized, three-dimensional font. To the right of the "X", there is a stethoscope graphic. The stethoscope is positioned so that its earpieces are above the "X" and its chest piece is below the "X", creating a visual connection between the letters and the medical symbol. The overall design suggests a connection to healthcare or medical services.
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Image /page/6/Picture/1 description: The image shows the letters 'WX' in a stylized font, with a stethoscope wrapped around the right side of the 'X'. The letters appear to be made of a textured material, possibly stone or concrete, giving them a three-dimensional look. The stethoscope is drawn in a simple, outlined style, adding a medical or healthcare-related theme to the image. The overall design is clean and modern, suggesting a logo or branding element for a company or organization.
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Image /page/7/Picture/1 description: The image shows a logo with the letters 'WX' in a stylized, three-dimensional font. To the right of the 'X', there is a stethoscope graphic. The stethoscope is positioned so that its tubing curves around the 'X', adding a medical or healthcare-related theme to the logo. The overall design is simple and clean, with a focus on the letters and the medical symbol.
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Image /page/8/Picture/1 description: The image shows a logo with the letters 'WX' in a stylized font. A stethoscope is draped around the 'X', with the earpieces at the top right and the chest piece at the bottom right. The letters and stethoscope are in grayscale.
Discussion
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Image /page/9/Picture/1 description: The image shows the letters 'WX' in a stylized font, with a stethoscope draped over them. The letters appear to be made of a textured material, possibly foam or stone, giving them a three-dimensional look. The stethoscope is drawn in a simple line art style, adding a medical or health-related theme to the image.
Comparing with the predicate device, RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0203 (K190902), WX non-Automated Blood Pressure Meter, MODEL WX02 and WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0202, WX0203 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,
- Package brand name, layout design, trade name and model name.
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.
Clinical Study
No clinical study is included in this submission.
CONCLUSION
WX non-Automated Blood Pressure Meter, MODEL WX02 and WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 have the same intended use and same technological characteristics as the above predicate devices. Thus, WX non-Automated Blood Pressure Meter, MODEL WX02 and WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 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).