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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an aneroid sphygmomanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or algorithm performance.

Therefore, the requested information (acceptance criteria for an AI/device algorithm, MRMC study, standalone performance, training/test set details, expert ground truth establishment, etc.) is largely not applicable to this specific document as it pertains to a traditional medical device (manual blood pressure cuff) and not an AI/ML-driven diagnostic or assistive device.

However, I can extract and present the performance criteria that are relevant to this device type based on the provided document:

Acceptance Criteria and Device Performance (for an Aneroid Sphygmomanometer)

Since this is a traditional medical device (aneroid sphygmomanometer) and not an AI/ML-driven device, the acceptance criteria and performance evaluation focus on its physical and functional accuracy for blood pressure measurement, as well as biocompatibility, rather than AI performance metrics like sensitivity, specificity, or AUC.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria (Standard Reference)	Reported Device Performance (Subject Device)
Accuracy (Pressure)	± 3 mmHg of reading (ISO 81060-1)	± 3 mmHg of reading
Biocompatibility	Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10	Biocompatible as required by ISO 10993-1, ISO 10993-5, ISO 10993-10
Environmental Compatibility	50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity	Can be used from 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity
Monitor Scale	From 0 to 300mmHg with a minimum interval of 2mmHg	From 0 to 300mmHg with a minimum interval of 2mmHg
Inflation Method	Manual by inflation bulb	Manual by inflation bulb
Deflation Method	Manual deflation via valve	Manual deflation via valve
Display Type	Aneroid Manometer	Aneroid Manometer

2. Sample size used for the test set and the data provenance:

The document does not specify a patient sample size for testing the aneroid sphygmomanometer itself. The testing performed was "Non-clinical testing" conducted to verify compliance with standards like ISO 81060-1. This standard typically involves technical accuracy testing, often on a test bench or with simulated pressures, and potentially with a limited number of human subjects for specific validation aspects depending on the exact test protocol followed.
The data provenance is not explicitly stated as it would be for a clinical study. The device is manufactured by Zhejiang LuDe Technology Development Co., Ltd. in China. The testing would have been conducted by the manufacturer or a designated testing facility to meet regulatory requirements.
The testing was described as "Non-clinical testing," implying it was not a large-scale prospective clinical trial with a defined patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the device is a manual blood pressure monitor. "Ground truth" for blood pressure measurement (the actual pressure) is established through standardized calibration and reference measurement methods, not through expert consensus on images or interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. For a physical measurement device like a sphygmomanometer, accuracy is determined by comparison to a calibrated reference standard.

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:

No, an MRMC study was not done. This type of study is specifically designed for AI-assisted diagnostic tools and involves human readers interpreting cases with and without AI assistance. This document is for a traditional, manual blood pressure monitor without AI capabilities.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not have a standalone algorithm in the sense of an AI interpreting medical data. Its "performance" refers to its physical accuracy in measuring blood pressure.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the "Accuracy" criterion would be calibrated reference pressures, produced by a precisely controlled pressure source. This is standard for testing blood pressure measuring devices against the ISO 81060-1 standard.

8. The sample size for the training set:

Not applicable. This device is a hardware product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for an AI/ML model is involved.

Summary

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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)

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

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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

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

K221857

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Subjective device: Aneroid sphygmomanometer Model QL-20, QL-201

	Aneroid sphygmomanometer with stethoscope Model QL-50

Item	Subject Device	Predicate Device	Remark
Applicant	Zhejiang LuDeTechnology DevelopmentCo., Ltd.	Wenzhou RenhuaInstruments Co.,Ltd	/
510(K)number	Applying	K190902	/
Regulationnumber	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 tobe used by medicalprofessional or at home forthe measurement ofsystolic and diastolicpressure by detectingkorotkoff sounds.	The device is intended to beused by medical professionalor at home for themeasurement of systolic anddiastolic pressure bydetecting korotkoff sounds.	SE
Over-the-counter use	Yes	Yes	SE
Targetpopulation	Aged 3 years and above	New born, Infants,children, youngadults,adults	SimilarNote 1
Where used	Hospital, home, office,andambulance, etc.	Hospital, home, office,andambulance, etc.	SE
Anatomicalsites	Upper arm(leg for child)	Upper arm(leg for child)	SE
Measurementmethod	Ausculatory Korotkoffsounds method	Ausculatory Korotkoffsounds 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 monitorscale	From 0 to 300mmHg witha minimum interval of2mmHg	From 0 to 300mmHg with aminimum interval of2mmHg	SE
Design	The device comprisedtubing attached to a cuffwith an integratedinflatable bladder that iswrapped around thepatient's limb and securedby hook and loop closure.	The device comprised tubingattached to a cuff with anintegrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure.	SE
Design ofstethoscope	One type option:Single head	Three types option:Single headDual headRappaport	SimilarNote2
Materials	The manometer :aluminum and stainlesssteel materials.Cuff:Nylon cloth or cottoncloth for outside layer.	The manometer :aluminumand stainless steel materials.Cuff:Nylon cloth or cottoncloth for outside layer.	SE
Accuracy	Pressure : $\pm$ 3mmHg ofreading	Pressure : $\pm$ 3mmHg ofreading	SE
Compatibility	It can be used from 50°F to	It can be used from 50°F to	SE

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Subjective device: Aneroid sphygmomanometer Model QL-20, QL-201

Aneroid sphygmomanometer with stethoscope Model QL-50
14

withenvironment	104°F (10°C to 40°C) and15%~85% RH humidity .	104°F (10°C to 40°C) and15%~85% RH humidity .
Cuff size	185mm55mm255mm75mm345mm110mm500mm140mm540mm145mm615mm175mm780mm*220mm	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)	SimilarNote3
Cuffcircumference	Fits arm circumferences100mm-660mm,thestandard cuff should beavailable for use inmeasuring a child's legblood pressure and forchildren with larger arms.	Fits arm circumferences8.7"to 17.3" (220mm-440cm),the standard cuffshould be available for usein measuring a child's legblood pressure and forchildren with larger arms.	SimilarNote4
Cuff bladdersize	40mm80mm60mm120mm80mm150mm120mm220mm145mm315mm180mm370mm	8.7"×4.7"(220mm120mm)11.8"×5.9"(300mm150mm)13.4"×6.7"(340mm170mm)6.9"×3.3"(175mm85mm)7.5"x2"(190mm*50mm)	SimilarNote5
Contents(withaccessories)	Aneroid gauge, Arm cuff,inflation bulb, andinstruction manual,stethoscope(option)	Aneroid gauge, Arm cuff,inflation bulb, andinstruction manual,stethoscope(option)	SE
Biocompatibility	Biocompatible asrequirement ofISO 10993-1ISO 10993-5ISO 10993-10	Biocompatible asrequirement ofISO 10993-1ISO 10993-5ISO 10993-10	SE
Performance	Compatible as requirementof ISO 81060-1	Compatible as requirementof ISO 81060-1	SE

Discussion of difference:

Note ID	Justification
Note 1	The population range of subject device is smaller than predicatedevice. The different population range don't raise any safety oreffectiveness issue and the performance of subject device was testedin accordance with ISO 81060-1 and no safety issue was found.
Note 2	The subject device only has one kind of the stethoscope (Single headstethoscope), while the predicate has three kinds of stethoscope(Singlehead stethoscope, Dual head stethoscope, Rappaport stethoscope). ThePage 4 of 5

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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 4and Note 5		The different sizes of the cuffs and bladders,cuff circumstance areprovided in order to accommodate varies target population. Allperformance have been tested in this submission in accordance withISO 81060-1 standard and do not raised any safety or effectivenessissue. Therefore, these differences do not raise any new issues onsafety 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.

Regulation Number and Section

§ 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).