The device is intended to be used by medical professionals or in 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.

Device Description

Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D 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 HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.

AI/ML Overview

The provided document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results of the device meeting specific acceptance criteria in the same way, for example, a novel AI algorithm might. Therefore, some of the requested information, particularly around clinical studies, ground truth establishment, and expert consensus, is not directly applicable or available in this document.

However, I can extract information related to the device's technical specifications and the standards it aims to meet for substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are primarily defined by the performance requirements of the ISO 81060-1 standard for non-invasive sphygmomanometers, and the "reported device performance" indicates compliance with these standards.

Feature	Acceptance Criteria (from ISO 81060-1, implicitly)	Reported Device Performance (as stated)
Pressure Accuracy	±3mmHg of reading	±3mmHg of reading
Monitor Scale	0 to 300mmHg with a minimum interval of 2mmHg	0 to 300mmHg with a minimum interval of 2mmHg
Operating Environment	10°C to 40°C (50°F to 104°F) and 15%-85% RH humidity	10°C to 40°C (50°F to 104°F) and 15%-85% RH humidity
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10	Biocompatible as requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10
Performance Standard	Compatible with ISO 81060-1	Compatible as requirement of ISO 81060-1

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" for a test set in the context of a clinical study or a dataset for an algorithm. This submission references "Non-clinical testing included biocompatibility and bench testing." It does not provide details on the number of units tested or the specific methodology for these bench tests, beyond stating that they were included in the ISO 10993 and ISO 81060-1 standards.

The data provenance is from non-clinical testing conducted to demonstrate compliance with standards like ISO 10993 and ISO 81060-1. The document does not specify country of origin for this testing data, but the manufacturer is HONSUN (NANTONG) Co., Ltd in China. The testing would be considered bench testing rather than retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. For this type of device (a mechanical aneroid sphygmomanometer), ground truth for performance claims is established through a calibrated reference standard (e.g., a manometer calibrated to a known pressure standard) during bench testing, as specified by standards like ISO 81060-1. There would be no "experts" establishing a ground truth in the context of subjective interpretation like with medical imaging.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation of data, often in clinical trials or studies for AI algorithms. For a mechanical device's performance testing (like pressure accuracy), the measurement is objective against a standard, not subject to adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No. This device is an aneroid sphygmomanometer, which is a manual non-invasive blood pressure measurement device. It does not incorporate artificial intelligence, nor does it involve "readers" in the context of image interpretation or diagnostic decision-making. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a mechanical instrument and does not contain an algorithm. "Standalone performance" in this context would refer to the device's accuracy and performance specifications as outlined in the table above, which are assessed through bench testing against established standards.

7. The Type of Ground Truth Used

For this device, the "ground truth" for pressure accuracy is a calibrated pressure standard as mandated by the ISO 81060-1 standard for non-invasive sphygmomanometers. This standard defines the methods for verifying the accuracy of the device against a known, precise pressure.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical instrument. It does not utilize an algorithm, machine learning, or artificial intelligence; therefore, there is no "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this mechanical device.

Summary

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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.

April 6, 2020

Honsun (Nantong) Co., Ltd Iris Du RA manager No.8, Tongxing Road, Nantong Economic & Technology Development Area Nantong, 226009 CHINA

Re: K192500

Trade/Device Name: Aneroid Sphygmomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C, HS-50B, HS-50D Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: March 6, 2020 Received: March 11, 2020

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,

LT 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) K192500

Device Name

Aneroid Sphygmomanometer Model HS-20A, HS-20D, HS-201Y, HS-201Y, HS-201C1, HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C, HS-50B, HS-50D

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:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

Chapter 6. 510(K) Summary

1.submitter

Company name: HONSUN(NANTONG)Co.,Ltd
Address:No.8, Tongxing Road, Nantong Economic & Technological development Area,Jiangsu, 226009, China
Postal Code:226010
TEL:86-0513-80580127
Contact person: Xinhua Pan (General Manager)

Iris Du(RA Manager)

E-mail:dulh@lordmed.com

2.Subject Device Information

Model HS-20A,HS-20D, HS-50C, HS-50B, HS-50D, HS-201Q3,HS-201C1,HS-201Y, HS-201W
Common name: Blood Pressure Kit(Blood Pressure Cuff)
Trade name: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B,HS-50D
Product Code: DXQ,LDE
Regulation name: 21CFR 870.1120/21CFR 870.1875
Regulation class: II
Review Panel: Cardiovascular

3.Predicate device

RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope.MODEL

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

Max0201,Max0202,Max0203,(K190902)

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.

5.Device description

The subject devices are same as the predicate device(K190902) in terms of PVC or latex inflation bulb and the PVC or latex bladder. Besides, the material of added the optional various size of cuff (nylon or cotton cuff for this application)and the aluminum manometer are identical to the predicate device (K190902).

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

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

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 sphymomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3/ Aneroid sphymomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D.

Comparison item	Subject device:	Predicate device :	Result of comparison
Applicant	HONSUN(NANTONG)Co.,Ltd	Wenzhou Renhua Instruments Co.,Ltd
510(K) number	Applying	K190902	-
Regulation number	21 CFR 870.1120	21 CFR 870.1120	Same
Product code	DXQ.LDE	DXQ.LDE	Same
Classification	Class II	Class II	Same
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.	Same
	Aneroid sphymomanometerModel HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/Aneroid sphymomanometerwith stethoscope, ModelHS-50C, HS-50B, HS-50D	RH non-Automated Bloodpressure meter Model Max02,RH non-AutomatedBlood pressure meterwith stethoscope, Max0201,Max0202,Max0203

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3

Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

Over-the-counter use	Yes	Yes	Same
Targetpopulation	New born, Infants, children,young adults, adults	New born, Infant, children,young adults, adults	Same
Where used	Hospital, home, office,and ambulance, etc.	Hospital, home, office,and ambulance, etc.	Same
Anatomicalsites	Upper arm(leg for child)	Upper arm(leg for child)	Same
Measurement Method	Ausculatory Korotkoffsounds method	Ausculatory 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 monitorscale	From 0 to 300mmHg with aminimum interval of 2mmHg	From 0 to 300mmHg with aminimum interval of 2mmHg	Same

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-201W, HS-201Y,HS-201C1,HS-201Q3

Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

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 comprisedtubing attached to a cuffwith an integratedinflatable bladder that iswrapped around thepatient's limb and securedby hook and loop closure.	Same
Design ofstethoscope	Three types option:Single headDual headRappaport	Three types option:Single headDual headRappaport	Same
Materials	The manometer:aluminum and stainlesssteel materials.The tubing ,inflationbulb:PVC or latex.Cuff:Nylon cloth or cottoncloth for outside layer.Cuff bladder:PVC or naturelatex	The manometer:aluminum and stainlesssteel materials.The tubing ,inflationbulb:PVC or latex.Cuff:Nylon cloth or cottoncloth for outside layer.Cuff bladder:PVC or naturelatex	Same
Accuracy	Pressure : ±3mmHg ofreading	Pressure : ±3mmHg ofreading	Same
Compatibilitywithenvironment	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

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-201W, HS-201Y,HS-201C1,HS-201Q3

Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

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)	Similar
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),thestandard cuff should beavailable for use inmeasuring a child's legblood pressure and forchildren with larger arms.	Similar
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"×2"(190mm*50mm)	Similar
Contents(withaccessories)	Aneroid gauge,Arm cuff,inflation bulb, andinstruction manual,stethoscope(option)	Aneroid gauge,Arm cuff,inflation bulb, andinstruction manual,stethoscope(option)	Same
Biocompatibility	Biocompatible as requirement ofISO 10993-1ISO 10993-5ISO 10993-10	Biocompatible as requirement ofISO 10993-1ISO 10993-5ISO 10993-10	Same
performance	Compatible as requirement of ISO 81060-1	Compatible as requirement of ISO 81060-1	Same

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

Discussion:

Same in details:

Compared with the predicate device(K190902) RH non-Automated Blood pressure meter Model Max 02,RH non-Automated Blood pressure meter with stethoscope, Max0201, Max0202, Max0203, the subject device Aneroid sphymomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3/ Aneroid sphymomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D are same as the predicate device(K190902) in terms of material s of the inflation bulb,tubing, cuff and manometer.
Predicate device (K190902) and subject device HS-20A, HS-20D, HS-50C, HS-50B, HS-50D, HS-201Q3, HS-201C1, HS-201Y, HS-201W have same classification,indication for use, target population, measurement method, product physical design and operation, performance parameter ranges,mechanical safety, anatomical sites, operation principles and etc. The structure of the predicate device (K190902) are same as the subject device ,which all have manometer, bulb, tube, various size of cuff and stethoscope(optional).The predicate device and subject device all have dual head stethoscope, single head stethoscope and rappaport stethoscope.

6-7

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Sponsor:HONSUN(NANTONG)Co.,Ltd

Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D

Difference in details:

The different sizes of the cuffs and bladders,cuff circumstance are provided in order to accommodate target population. All performance have been tested in this submission and do not raised any safety or effectiveness issue.All performance specification was verified to comply with the ISO 81060-1 standard.

7. Non-clinical testing

Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO 10993 and ISO 81060-1, were included. Results of testing were acceptable.

8. Clinical testing

No clinical study is included in this submission.

Conclusion

RH non-automated blood pressure meter Model Max 02, non-automated blood pressure meter with stethoscope Model Max0201, Max 0202,Max0203(K190902) and subject device have the same intended use and similar technological characteristics. Moreover, information contained in this submission supplied demonstrates that any difference in their characteristic do not raise any new questions of safety or effectiveness. Thus, aneroid sphygmomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3/ aneroid sphygmomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D are equivalent to the predicate device(K190902)..

6-8

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).