(44 days)
Not Found
No
The device description explicitly states it is a "manual non-invasive aneroid sphygmomanometer" and relies on manual inflation, deflation, and detection of Korotkoff sounds. There is no mention of any automated or computational processes that would involve AI/ML.
No
The device is a diagnostic tool for measuring blood pressure, not a therapeutic device intended for treating a disease or condition.
Yes
This device is intended for the measurement of systolic and diastolic pressure, which are used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description clearly outlines physical components such as an inflation cuff, manual inflation bulb, manometer (aneroid gauge), and optional stethoscope. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RH non-Automated Blood Pressure Meter measures blood pressure by applying and releasing pressure to an artery in the arm. This is a non-invasive measurement taken directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for measuring systolic and diastolic pressure on children or adults, which is a physiological measurement, not a diagnostic test performed on a sample.
- Device Description: The description details a manual sphygmomanometer, cuff, bulb, and manometer, all components used for direct physiological measurement.
Therefore, the RH non-Automated Blood Pressure Meter falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RH 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.
Product codes
DXQ, LDE
Device Description
RH 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 Max02, Max0201, Max0202, Max0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model Max0202, Max0203 include additional Stethoscope (Single head, Dual head and Sprague Rappaport). It is conjunction with Stethoscope when use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Arm (leg for child)
Indicated Patient Age Range
children or adults.
Intended User / Care Setting
medical professionals or in the home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO10993 and ISO81060-1, were included. Results of testing were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure:+/- 3 mmHg of reading
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
May 22, 2019
Wenzhou Renhua Instruments Co., Ltd Wang Saijie General Manager #.1-1704 Wanda Business Building Yongding Road, Longwan Wenzhou, 325024 CN
Re: K190902
Trade/Device Name: RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff
Regulatory Class: Class II Product Code: DXQ, LDE Dated: March 29, 2019 Received: April 8, 2019
Dear Wang Saijie:
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Matthew Hillebrenner Director (Acting) 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) K190902
Device Name
RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203
Indications for Use (Describe)
RH 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.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Registration Use (Part 1 of CFR 201 Subpart D) One-Time Correction (1 of CFR 201 Subpart C) | Registration Use (Part 1 of CFR 201 Subpart D) | One-Time Correction (1 of CFR 201 Subpart C) |
| Registration Use (Part 1 of CFR 201 Subpart D) | ||
| One-Time Correction (1 of CFR 201 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Wenzhou Renhua Instruments Co., LTD. The logo consists of the letters "RH" in a stylized font, with the company name written in blue text to the right of the letters. The company name is written in all capital letters.
510(k) Summary
| Company Name: | WENZHOU RENHUA INSTRUMENTS CO.,LTD |
|---|---|
| Company Address: | #.1-1704 WANDA BUSINESS BUILDING YONGDING ROAD, |
| LONGWAN ,Wenzhou ,Zhejiang325024 ,CHINA | |
| Telephone: | +86-577-86893308 |
| Fax: | N/A |
| Contact Person: | WANG SAIJIE |
| Summary Preparation Date: | 2019.3.29 |
| Device Trade Name: | RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non- |
| Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, | |
| Max0202, Max0203 | |
| Classification Name: | Blood pressure cuff, Stethoscope, manual |
| Regulation Number: | 21 CFR 870.1120/ 21 CFR 870.1875 |
| Product Code: | DXQ; LDE |
| Device Class: | Class 2 |
| Panel: | Cardiovascular |
PREDICATE DEVICE:
ANEROID SPHYGMOMANOMETER (K173246)
INDICATIONS FOR USE
RH 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.
DEVICE DESCRIPTION
RH 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 Max02, Max0201, Max0202, Max0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model Max0202, Max0203 include additional Stethoscope (Single head, Dual head and Sprague Rappaport). It is conjunction with Stethoscope when use.
The PVC or nature latex inflation bulb and optional various size of cuffs which cuffs outside layer is
4
K190902
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 (K173246), ANEROID SPHYGMOMANOMETER 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 device | Predicate device | Result of
Comparasion | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------|
| Applicant | WENZHOU RENHUA
INSTRUMENTS CO.,LTD | Wenzhou Bokang
Instruments Co., Ltd | Different | | |
| | Classification | Class II | Class II | SAME | |
| Regulation
number | 21CFR 870.1120 | 21CFR 870.1120 | SAME | | |
| | Product code | DXQ, LDE | DXQ, LDE | SAME | |
| Indications for
use | The device is intended to be
used by medical
professionals or at home for
the measurement of systolic
and diastolic pressure by | The device is intended to be
used by medical
professionals or at home for
the measurement of systolic
and diastolic pressure by | SAME | | |
| | | RH non-Automated Blood
Pressure Meter, MODEL
Max02 and RH non-
Automated Blood Pressure
Meter with Stethoscope,
MODEL Max0201,
Max0202, Max0203 | ANEROID
SPHYGMOMANOMETER,
BK2002/BK2002a (K173246) | | |
| | | comparison item | New device | Predicate device | Result of
Comparasion |
| | | | RH non-Automated Blood
Pressure Meter, MODEL
Max02 and RH non-
Automated Blood Pressure
Meter with Stethoscope,
MODEL Max0201,
Max0202, Max0203 | ANEROID
SPHYGMOMANOMETER,
BK2002/BK2002a (K173246) | |
| | | | detecting Korotkoff sounds. | detecting Korotkoff sounds. | |
| Over-The-
Counter Use | | Yes | Yes | SAME | |
| Where used | | Home, Hospital, healthcare
facility, ambulance etc. | Home, Hospital, healthcare
facility, ambulance etc. | SAME | |
| Target population | | infants, children, young
adults and adults | infants, children, young
adults and adults | SAME | |
| Anatomical sites | | Upper Arm (leg for child) | Upper Arm (leg for child) | SAME | |
| Measurement
Method | Auscultatory Korotkoff
sounds Method | Auscultatory Korotkoff
sounds 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
minimum interval of 2
mmHg. | From 0 to 300 mmHg with a
minimum interval of 2
mmHg. | SAME | | |
| Design of blood
pressure meter | The device comprises
tubing attached to a soft
inelastic cuff with an | The device comprises
tubing attached to a soft
inelastic cuff with an | Same as
(BK2002/2002a) | | |
| comparison item | New device | Predicate device | Result of
Comparasion | | |
| | RH non-Automated Blood
Pressure Meter, MODEL
Max02 and RH non-Automated Blood Pressure
Meter with Stethoscope,
MODEL Max0201,
Max0202, Max0203 | ANEROID
SPHYGMOMANOMETER,
BK2002/BK2002a (K173246) | | | |
| | integrated inflatable bladder
that is wrapped around the
patient's limb and secured
by hook and loop closure. | integrated inflatable bladder
that is wrapped around the
patient's limb and secured
by hook and loop closure. | | | |
| Design of
Stethoscope | Three types option:
Single head
Dual head
Sprague Rappaport | One type option:
Single head | Different | | |
| Materials | The manometer: aluminum
and stainless steel materials.
The tubing, inflation bulb:
PVC or nature latex.
Cuff: Nylon cloth or cotton
cloth for outside layer.
Cuff bladder: PVC or nature
latex | The manometer: aluminum
and stainless steel materials.
The tubing, inflation bulb:
PVC or nature latex.
Cuff: Nylon cloth or cotton
cloth for outside layer.
Cuff bladder: PVC or nature
latex | SAME | | |
| Accuracy | Pressure:+/- 3 mmHg of
reading | Pressure:+/- 3 mmHg of
reading | SAME | | |
| Compatibility | It can be used from 50°F to | It can be used from 50°F to | SAME | | |
| comparison item | New device
RH non-Automated Blood
Pressure Meter, MODEL
Max02 and RH non-
Automated Blood Pressure
Meter with Stethoscope,
MODEL Max0201,
Max0202, Max0203 | Predicate device
ANEROID
SPHYGMOMANOMETER,
BK2002/BK2002a (K173246) | Result of
Comparasion | | |
| with environment | 104°F (10°C to 40°C) and
15% ~ 85%RH humidity. | 104°F (10°C to 40°C) and
15% ~ 85%RH humidity. | | | |
| 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"
(340mm105mm)
10.2" x 3" (260mm75 mm) | 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"
(340mm105mm)
10.2" x 3" (260mm75 mm) | SAME | | |
| Cuff
Circumference | Fits arm circumferences
8.7" to 17.3" (220mm to
440 mm), The standard cuff
should be available for use
in measuring a child's leg
blood pressure and for
children with larger arms. | Fits arm circumferences
8.7" to 17.3" (220mm to
440 mm), The standard cuff
should be available for use
in measuring a child's leg
blood pressure and for
children with larger arms. | SAME | | |
| Cuff bladder Size | 8.7"x 4.7"(220mm120mm)
11.8"x
5.9"(300mm150mm)
13.4"x
6.7"(340mm170mm)
6.9"x 3.3"(175mm85mm) | 8.7"x 4.7"(220mm120mm)
11.8"x
5.9"(300mm150mm)
13.4"x
6.7"(340mm170mm)
6.9"x 3.3"(175mm85mm) | SAME | | |
| comparison item | New device | Predicate device | Result of
Comparasion | | |
| | RH non-Automated Blood
Pressure Meter, MODEL
Max02 and RH non-
Automated Blood Pressure
Meter with Stethoscope,
MODEL Max0201,
Max0202, Max0203 | ANEROID
SPHYGMOMANOMETER,
BK2002/BK2002a (K173246) | | | |
| | 7.5"x 2"(190mm50mm) | 7.5"x 2"(190mm50mm) | | | |
| Cuff Color | Blue, Pink, Black | Blue, Gray, Red, Green,
Pink,Yellow, Black | Different | | |
| Contents (with
accessories) | Aneroid gauge, Arm Cuff,
Inflation Bulb, Vinyl storage
pouch and Instruction
Manual, Stethoscope
(option) | Aneroid gauge, Arm Cuff,
Inflation Bulb, Vinyl storage
pouch and Instruction
Manual, Stethoscope
(option) | Same | | |
| Biocompatibility | biocompatible as
requirement of ISO 10993-1
ISO 10993-5
ISO 10993-10 | biocompatible as
requirement of ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same model
and same
supplier | | |
| Performance | compatible as requirement
of ISO 81060-1 | compatible as requirement
of ISO 81060-1 | Same | | |
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Image /page/5/Picture/1 description: The image shows a stylized logo with the letters 'Rh' in a cursive font. The letters are light blue and have a subtle gradient effect, with a slightly darker shade at the bottom. There is a soft drop shadow behind the letters, giving them a three-dimensional appearance against the white background.
6
Image /page/6/Picture/1 description: The image shows the letters "RH" in a stylized font. The letters are in a gradient of light blue, with a darker blue shadow effect. The letters are slightly curved and connected, giving them a flowing appearance. The background is plain white.
7
Image /page/7/Picture/1 description: The image shows a stylized logo with the letters 'RH' in a cursive font. The letters are rendered in a gradient of light blue, giving them a three-dimensional appearance. The logo is simple and elegant, with a clean design.
8
Image /page/8/Picture/1 description: The image shows a stylized logo with the letters 'Rh' in a cursive font. The letters are light blue and have a subtle gradient effect, with a slightly darker shade at the bottom. There is a soft drop shadow behind the letters, giving them a three-dimensional appearance against the white background.
Discussion
Comparing with the predicate device, ANEROID SPHYGMOMANOMETER (K173246), RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 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, the subject cuffs are the same like our own cleared under predicate K173426 and that the biocompatibility standards compliance/reports are the same. The differences between those two devices are as following,
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Image /page/9/Picture/1 description: The image contains the logo for Wenzhou Renhua Instruments Co., LTD. The logo features a stylized, cursive "RH" in a light blue gradient. To the right of the logo, the company name is written in blue, with "WENZHOU RENHUA INSTRUMENTS CO.,LTD" on a single line.
- Comparing the predicate device ANEROID SPHYGMOMANOMETER (K173246), the design of new device is same as BK2002/BK2002a except there are no Gray, Red, Green and yellow cuff color included.
- Design of Stethoscope for new device, there are added the combination of "Dual head" Stethoscope (Max0202) and "Sprague Rappaport" Stethoscope (Max0203). The different type of Stethoscopes didn't raise any safety or effectiveness issue.
- All performance specification of new devices for various cuff sizes were verified to comply with the ISO81060-1 standard. (Please see section 18 of this submission)
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
RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 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, RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 are substantially equivalent to the predicate devices.