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 NT-20, NT-201/ Aneroid sphygmomanometer stethoscope, Model NT-50 are a manual non-invasive aneroid with 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 NT-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 performance against specific acceptance criteria for a new AI/software-as-a-medical-device (SaMD) feature.

Therefore, the document does not contain the detailed information typically found in a study demonstrating how a device meets acceptance criteria, especially for AI or SaMD. Specifically:

A table of acceptance criteria and the reported device performance: Not provided. The submission states that performance was "compatible as requirement of ISO 81060-1" and that "All performance specification was verified to comply with the ISO 81060-1 standard" and "Pressure : ±3mmHg of reading," but a detailed table of acceptance criteria and results is absent.
Sample size used for the test set and the data provenance: Not provided. The document states "No clinical study is included in this submission," further indicating that a test set against ground truth as would be used for AI/SaMD performance evaluation was not conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study or test set with expert-established ground truth was conducted.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or test set was conducted.
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. This device is a manual aneroid sphygmomanometer, not an AI or imaging device that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual device; there is no algorithm in the sense of AI/SaMD.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined in the context of a "test set" for performance evaluation, as the submission focuses on meeting ISO standards. The accuracy is stated as "Pressure : ±3mmHg of reading", implying comparison against a reference standard.
The sample size for the training set: Not applicable, as this is not an AI/SaMD device requiring a training set.
How the ground truth for the training set was established: Not applicable, as this is not an AI/SaMD device.

Summary of available information related to acceptance criteria and performance:

The acceptance criteria are generally implied to be compliance with relevant standards, primarily ISO 81060-1 for performance and ISO 10993 series for biocompatibility.

Table of Acceptance Criteria and Reported Device Performance (based on implicit statements in the document):

Acceptance Criteria	Reported Device Performance
Accuracy	Pressure: ±3mmHg of reading (compatible as requirement of ISO 81060-1)
Material Biocompatibility	Biocompatible as requirements of ISO 10993-1, ISO 10993-5, ISO 10993-10. Results of testing were acceptable.
Environmental Compatibility	Can be used from 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity.
Performance Standard	Compatible as requirement of ISO 81060-1. All performance specifications verified to comply with ISO 81060-1.
Mechanical Safety	(Implicitly similar to predicate and acceptable based on discussion)

Study Description:

The document states, "No clinical study is included in this submission." Instead, the submission relies on non-clinical testing which included biocompatibility and bench testing. The tests listed in the ISO 10993 series (for biocompatibility) and ISO 81060-1 (for performance) were included. The results of these tests were deemed acceptable, demonstrating that the device meets the performance specifications outlined in the standards. The primary method for proving the device meets the acceptance criteria (which are essentially the requirements of these ISO standards) is through this non-clinical testing and comparison to a predicate device.

Summary

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July 2, 2020

Little Doctor Electronic (Nantong) Co.,Ltd % Iris Du RA manager Little Doctor Electronic (Nantong)Co.,Ltd No.14, Zhenxingxilu Road, Chongchuan Area Nantong, 226000 CHINA

Re: K193259

Trade/Device Name: Aneroid Sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope, Model NT-50 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: May 27, 2020 Received: June 1, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193259

Device Name

Aneroid Sphygmomanometer Model NT-20, NT-201 Aneroid Sphygmomanometer with Stethoscope, Model NT-50

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

Chapter 6. 510(K) Summary

1.submitter

Company name: Little Doctor Electronic(Nantong)Co.,Ltd
Address:No.14, Zhenxingxilu Road, Chongchuan Area, Nantong, Jiangsu, 226000, China
Postal Code:226000
TEL:86-0513-80580127
Contact person: Xinhua Pan (General Manager)

Iris Du(RA Manager)

E-mail:dulh@lordmed.com

2.Subject Device Information

Model: NT-20, NT-201, NT-50
Common name: Blood Pressure Kit(Blood Pressure Cuff)
Trade name: Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid

sphygmomanometer with stethoscope, Model NT-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

RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope. MODEL Max0201,Max0202,Max0203,(K190902)

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Sponsor:Little Doctor Electronic(Nantonq)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

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

This is subject device 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 Decision-Making Process Flowchart which includes the comparison and discussion of indication for use, technology, and performance specifications.

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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

The new device column includes the following device: Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50

Comparisonitem	Subject device:Aneroidsphygmomanometer ModeNT-20, NT-201/ Aneroidsphygmomanometer withstethoscope, Model NT-50	Predicate device :RH non-Automated Bloodpressure meter Model Max02,RH non-AutomatedBlood pressure meterwith stethoscope,Max0201,Max0202,Max0203	Result ofcomparison
Applicant	Little Doctor Electronic(Nantong)Co.,Ltd	Wenzhou RenhuaInstruments Co.,Ltd
510(K)number	Applying	K190902	-
Regulationnumber	21 CFR 870.1120	21 CFR 870.1120	Same
Productcode	DXQ.LDE	DXQ.LDE	Same
Classification	Class II	Class II	Same
Intendeduse	The device is intended to beused by medicalprofessional or at home forthe measurement ofsystolic and diastolicpressure by detectingkorotkoff sounds.	The device is intended tobe used by medicalprofessional or at home forthe measurement ofsystolic and diastolicpressure by detectingkorotkoff sounds.	Same
Over-the-counter use	Yes	Yes	Same
Target	New born, Infants, children,	New born,Infants,children ,	Same
population	young adults,adults	young adults,adults
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
Themonitorscale	From 0 to 300mmHg with aminimum interval of 2mmHg	From 0 to 300mmHg with aminimum interval of 2mmHg	Same
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	One type option:Single head	Three types option:Single headDual headRappaport	Similar
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)and 15%~85% RHhumidity .	It can be used from 50°F to104°F (10°C to 40°C) and15%~85% RH humidity .	Same
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 asrequirement ofISO 10993-1ISO 10993-5ISO 10993-10	Biocompatible asrequirement ofISO 10993-1ISO 10993-5ISO 10993-10	Same
performance	Compatible as requirementof ISO 81060-1	Compatible as requirementof ISO 81060-1	Same

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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

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Sponsor:Little Doctor Electronic(Nantonq)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

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, Max02 01, Max0202, Max0203, the subject device Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50 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 NT-20, NT-201, NT-50 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 single head stethoscope.

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.

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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd

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

Aneroid sphygmomanometer with stethoscope Model NT-50

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 sphymomanometer Model NT-20, NT-201/ aneroid sphymomanometer with stethoscope, Model NT-50 are equivalent to the predicate device(K190902).

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).