(108 days)
Not Found
No
The device description explicitly states it is a manual, non-invasive aneroid sphygmomanometer using a manual inflation bulb and manual detection of Korotkoff sounds. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
The device is used for measurement (diagnosis) of blood pressure, not for therapy or treatment.
Yes
An aneroid sphygmomanometer measures systolic and diastolic pressure, which are vital signs used by medical professionals to assess a patient's health and diagnose conditions like hypertension.
No
The device description explicitly details physical components like an inflation cuff, manual inflation bulb, manometer (Aneroid gauge), and potentially a stethoscope, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic and diastolic blood pressure. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is a manual non-invasive aneroid sphygmomanometer. It works by physically interacting with the patient's arm to measure pressure.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not analyze samples from the body.
The device is a medical device used for a physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / 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 device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. This product can measure the blood pressure of people aged 3 years and above.
Product codes
DXQ, LDE
Device Description
Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50 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. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model OL-50 also includes a stethoscope. 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
Aged 3 years and above
Intended User / Care Setting
Medical professionals or in the home. Hospital, home, office, and ambulance, etc.
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 tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- A ISO 81060-1:2007, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type ;
- A ISO 10993-5:2009, Biological Evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity:
- A ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure : ± 3mmHg 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 13, 2022
Zhejiang LuDe Technology Development Co., Ltd. Iris Du RA Manager NO. 298 Jichang North Road, Longwan District Wenzhou, Zhejiang 325024 China
Re: K221857
Trade/Device Name: Aneroid sphygmomanometer Model QL-20, QL-201, Aneroid sphygmomanometer with stethoscope, Model QL-50 Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: September 23, 2022 Received: September 23, 2022
Dear Iris Du:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221857
Device Name
Aneroid sphygmomanometer Model QL-20, QL-201, Aneroid sphygmomanometer with stethoscope, Model QL-50
Indications for Use (Describe)
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. This product can measure the blood pressure of people aged 3 years and above.
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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Sponsor:Zhejianq LuDe Technology Development Co., Ltd. Subjective device: Aneroid sphygmomanometer Model QL-20, QL-201 Aneroid sphygmomanometer with stethoscope Model QL-50
Chapter 6. 510(K) Summary
1.submitter
Company name:Zhejiang LuDe Technology Development Co., Ltd. Address:NO.298 Jichang North Road, Longwan District, Wenzhou City, Zhejiang Province, China Postal Code:325024 TEL:86-0513-80580127 Contact person: Iris Du(RA Manager) E-mail:sara-xu(@)lordmed.com
2.Subject Device Information
Model: QL-20, QL-201, QL-50 Common name: Blood Pressure Kit(Blood Pressure Cuff) Trade name: Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50 Product Code: DXQ,LDE Regulation name: 21CFR 870.1120 (Blood pressure cuff)/21CFR 870.1875(Stethoscope) Regulation class: II Review Panel: Cardiovascular
3.Predicate device
Sponsor:Wenzhou Renhua Instruments Co.,Ltd
Device Name: RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-
Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203
510(K) number: K190902
Product Code:DXQ,LDE
Regulation class: II
Review Panel: Cardiovascular
4
4.Intended use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.This product can measure the blood pressure of people aged 3 years and above.
5.Device description
Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50 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. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model OL-50 also includes a stethoscope. It is conjunction with stethoscope when use.
6. Substantial equivalence comparison
It is substantially equivalence 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 indication for use, device description, and technical description.
All comparison table for applied device 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 indication for use, technology, and performance specifications.
The new device column includes the following device: Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50
5
Subjective device: Aneroid sphygmomanometer Model QL-20, QL-201
| Aneroid sphygmomanometer with stethoscope Model QL-50 | |||
|---|---|---|---|
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Applicant | Zhejiang LuDe | ||
| Technology Development | |||
| Co., Ltd. | Wenzhou Renhua | ||
| Instruments Co.,Ltd | / | ||
| 510(K)number | Applying | K190902 | / |
| Regulation | |||
| number | 21 CFR 870.1120 | 21 CFR 870.1120 | SE |
| Product code | DXQ.LDE | DXQ.LDE | SE |
| Classification | Class II | Class II | SE |
| Intended use | The device is intended to | ||
| be used by medical | |||
| professional or at home for | |||
| the measurement of | |||
| systolic and diastolic | |||
| pressure by detecting | |||
| korotkoff sounds. | The device is intended to be | ||
| used by medical professional | |||
| or at home for the | |||
| measurement of systolic and | |||
| diastolic pressure by | |||
| detecting korotkoff sounds. | SE | ||
| Over-the- | |||
| counter use | Yes | Yes | SE |
| Target | |||
| population | Aged 3 years and above | New born, Infants, | |
| children, youngadults,adults | Similar | ||
| Note 1 | |||
| Where used | Hospital, home, office,and | ||
| ambulance, etc. | Hospital, home, office,and | ||
| ambulance, etc. | SE | ||
| Anatomical | |||
| sites | Upper arm(leg for child) | Upper arm(leg for child) | SE |
| Measurement | |||
| method | Ausculatory Korotkoff | ||
| sounds method | Ausculatory Korotkoff | ||
| sounds method | SE | ||
| Inflation | Manual by inflation bulb | Manual by inflation bulb | SE |
| Deflation | Manual deflation via valve | Manual deflation via valve | SE |
| Display | Aneroid Manometer | Aneroid Manometer | SE |
| The monitor | |||
| scale | From 0 to 300mmHg with | ||
| a minimum interval of | |||
| 2mmHg | From 0 to 300mmHg with a | ||
| minimum interval of | |||
| 2mmHg | SE | ||
| Design | The device comprised | ||
| tubing attached to a cuff | |||
| with an integrated | |||
| inflatable bladder that is | |||
| wrapped around the | |||
| patient's limb and secured | |||
| by hook and loop closure. | The device comprised tubing | ||
| attached to a cuff with an | |||
| integrated inflatable bladder | |||
| that is wrapped around the | |||
| patient's limb and secured | |||
| by hook and loop closure. | SE | ||
| Design of | |||
| stethoscope | One type option: | ||
| Single head | Three types option: | ||
| Single head | |||
| Dual head | |||
| Rappaport | Similar | ||
| Note2 | |||
| Materials | The manometer : | ||
| aluminum and stainless | |||
| steel materials. | |||
| Cuff:Nylon cloth or cotton | |||
| cloth for outside layer. | The manometer :aluminum | ||
| and stainless steel materials. | |||
| Cuff:Nylon cloth or cotton | |||
| cloth for outside layer. | SE | ||
| Accuracy | Pressure : $\pm$ 3mmHg of | ||
| reading | Pressure : $\pm$ 3mmHg of | ||
| reading | SE | ||
| Compatibility | It can be used from 50°F to | It can be used from 50°F to | SE |
6
Subjective device: Aneroid sphygmomanometer Model QL-20, QL-201
| Aneroid sphygmomanometer with stethoscope Model QL-50 | ||
|---|---|---|
| 14 |
| 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 | 185mm55mm
255mm75mm
345mm110mm
500mm140mm
540mm145mm
615mm175mm
780mm220mm | 20"×5.5"(510mm140mm)
21.7"×6.3"(550mm160mm)
24.4"×6.9"(620mm175mm)
28.3"×8.3"(720mm210mm)
13.4"×4.15"(340mm105mm)
10.2"×3"(260mm75mm) | Similar
Note3 |
| Cuff
circumference | Fits arm circumferences
100mm-660mm,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-
440cm),the standard cuff
should be available for use
in measuring a child's leg
blood pressure and for
children with larger arms. | Similar
Note4 |
| Cuff bladder
size | 40mm80mm
60mm120mm
80mm150mm
120mm220mm
145mm315mm
180mm370mm | 8.7"×4.7"(220mm120mm)
11.8"×5.9"(300mm150mm)
13.4"×6.7"(340mm170mm)
6.9"×3.3"(175mm85mm)
7.5"x2"(190mm50mm) | Similar
Note5 |
| Contents(with
accessories) | Aneroid gauge, Arm cuff,
inflation bulb, and
instruction manual,
stethoscope(option) | Aneroid gauge, Arm cuff,
inflation bulb, and
instruction manual,
stethoscope(option) | SE |
| 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 | SE |
| Performance | Compatible as requirement
of ISO 81060-1 | Compatible as requirement
of ISO 81060-1 | SE |
Discussion of difference:
| Note ID | Justification |
|---|---|
| Note 1 | The population range of subject device is smaller than predicate |
| device. The different population range don't raise any safety or | |
| effectiveness issue and the performance of subject device was tested | |
| in accordance with ISO 81060-1 and no safety issue was found. | |
| Note 2 | The subject device only has one kind of the stethoscope (Single head |
| stethoscope), while the predicate has three kinds of stethoscope(Single | |
| head stethoscope, Dual head stethoscope, Rappaport stethoscope). The | |
| Page 4 of 5 |
7
Subjective device: Aneroid sphygmomanometer Model QL-20, QL-201
Aneroid sphygmomanometer with stethoscope Model QL-50
| different type of stethoscopes don't raise any safety or effectiveness issue. | ||
|---|---|---|
| Note 3, Note 4 | ||
| and Note 5 | The different sizes of the cuffs and bladders,cuff circumstance are | |
| provided in order to accommodate varies target population. All | ||
| performance have been tested in this submission in accordance with | ||
| ISO 81060-1 standard and do not raised any safety or effectiveness | ||
| issue. Therefore, these differences do not raise any new issues on | ||
| safety and effectiveness of the subject device. |
Discussion:
Compared with predicate device, the subject device has same intended use, component, patient of population, accuracy and etc. The only difference is the cuff and bladder size, cuff circumference. This difference is discussed and evaluated in the above table and it shows that there is no new issues of safety and effectiveness raised. So subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
7. Non-clinical testing
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- A ISO 81060-1:2007,Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type ;
- A ISO 10993-5:2009, Biological Evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity:
- A ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
8. Clinical testing
No clinical study is included in this submission.
9.Conclusion
Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.