Aneroid Sphygmomanometer 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.

Device Description

The proposed device is composed of manometer, cuff bladder, inflation bulb and optioned stethoscopes. It is available in four models, MC-20A, MC-30 and MC-50, which are different in cuff material, cuff bladder material and stethoscope option. The aneroid sphygmomanometer should be used in conjunction with a stethoscope. For model MC-50, there are three types of stethoscope for option: Single Head, Dual Head and Sprague Rappaport stethoscope, while the other models of the proposed device do not have stethoscope in configuration. There are also six sizes of cuff for each model device in order to fit varies arm circumference of user. The proposed device is Over-The-Counter use, non-sterile, reusable device.

AI/ML Overview

This document is a 510(k) Summary for an Aneroid Sphygmomanometer (blood pressure cuff). It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for an AI/CADe device.

However, I can extract and structure the information related to performance criteria that would be relevant for a medical device like this, based on the non-clinical tests conducted.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Accuracy (Pressure Measurement)	+/- 3 mmHg of reading (meets ISO 81060-1 standard)
Biocompatibility (Cytotoxicity)	Complies with ISO 10993-5:2009
Biocompatibility (Irritation & Sensitization)	Complies with ISO 10993-10:2010
Performance (General Standard Compliance)	Compatible as requirement of ISO 81060-1, 2007 Edition
Operating Environment	50°F to 104°F (10°C to 40°C) and 15% ~ 85%RH humidity
Monitor Scale Range	0 to 300 mmHg with a minimum interval of 2 mmHg

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

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no information provided regarding a sample size for a test set based on human subjects or its provenance. The testing appears to be primarily laboratory-based to ensure compliance with specific ISO standards.

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

Given that no clinical study was conducted, there were no human subjects or experts required to establish a clinical ground truth for the device's performance in measuring blood pressure on patients. The ground truth for the technical specifications (e.g., pressure accuracy) would be established by the calibration standards and measurement techniques outlined in the ISO standards.

4. Adjudication method for the test set

Not applicable, as no clinical study involving human judgment on a test set (like image interpretation) was performed.

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

Not applicable. This device is a manual aneroid sphygmomanometer and does not involve AI or human "readers" in the context of comparative effectiveness studies against AI.

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

Not applicable. This device is a mechanical medical instrument, not an algorithm. Its standalone performance is assessed against technical standards like ISO 81060-1.

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

The "ground truth" for this device's performance relies on:

Standardized Calibration: For pressure accuracy (+/- 3 mmHg), the device's readings are compared against a precisely calibrated reference pressure source as per ISO 81060-1.
Laboratory Testing: For biocompatibility, in-vitro (cytotoxicity) and in-vivo (irritation and sensitization) tests are conducted according to ISO 10993 series to assess the material's interaction with biological systems.
Technical Specifications: The operating environment, monitor scale range, and physical design aspects are verified against design specifications and relevant parts of ISO 81060-1.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no "training set."

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

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

Summary

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March 23, 2021

Wuxi Exanovo Medical Instrument Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120 China

Re: K203620

Trade/Device Name: Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II Product Code: DXO, LDE Dated: January 22, 2021 Received: January 22, 2021

Dear Diana Hong:

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.

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

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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,

for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K203620

Device Name

Aneroid Sphygmomanometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Tab #6 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K203620

1. Date of Preparation: 12/15/2020
1. Sponsor Identification

Wuxi Exanovo Medical Instrument Co., Ltd.

No.42, Xixin Road, Zhangjing, Xibei Town, Wuxi City, 214194, China

Establishment Registration Number: Not assigned

Contact Person: Xiao Huang Position: General Manager Tel: +86-0510-83791431 Fax: +86-0510-83796580 Email: wuximedical(@vip.163.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Aneroid Sphygmomanometer Classification Name: Blood pressure cuff

Regulatory Information Classification Name: Blood pressure cuff Classification: II; Product Code: DXQ Regulation Number: 21CFR 870.1120 Review Panel: Cardiovascular

Regulatory Information

Classification Name: Stethoscope, manual Classification: II; Product Code: LDE Regulation Number: 21 CFR 870.1875 Review Panel: Cardiovascular

Indications for Use

Device Description

న్. Identification of Predicate Device

510(k) Number: K190902

Product Name: RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications

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as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed 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.
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;
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device	Predicate Device	Remark
Product Code	DXQ, LDE	DXQ, LDE	SE
Regulation No.	21 CFR 870.1120	21 CFR 870.1120	SE
Class	II	II	SE
Indication for Use	Aneroid Sphygmomanometer 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.	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.	SE
Over-The Counter Use	Yes	Yes	SE
Where used	Home, Hospital, healthcare facility, ambulance etc.	Home, Hospital, healthcare facility, ambulance etc.	SE
Target population	infants, children, young adults and adults	infants, children, young adults and adults	SE
Anatomical sites	Upper Arm (leg for child)	Upper Arm (leg for child)	SE
Measurement Method	Auscultatory Korotkoff sounds Method	Auscultatory 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 monitorscale	From 0 to 300 mmHg with aminimum interval of 2 mmHg.	From 0 to 300 mmHg with aminimum interval of 2 mmHg.	SE
Design of bloodpressure meter	The device comprises tubingattached to a soft inelastic cuff withan integrated inflatable bladder thatis wrapped around the patient's limband secured by hook and loopclosure.	The device comprises tubingattached to a soft inelastic cuff withan integrated inflatable bladder thatis wrapped around the patient's limband secured by hook and loopclosure.	SE
Design ofStethoscope	Three types option:Single headDual headSprague Rappaport	Three types option:Single headDual headSprague Rappaport	SE
Materials	The manometer: aluminum andstainless steel materials.The tubing, inflation bulb: PVC ornature latex.Cuff: Nylon cloth or cotton cloth foroutside layer.Cuff bladder: PVC or nature latex	The manometer: aluminum andstainless steel materials.The tubing, inflation bulb: PVC ornature latex.Cuff: Nylon cloth or cotton cloth foroutside layer.Cuff bladder: PVC or nature latex	SE
Accuracy	Pressure: +/- 3 mmHg of reading.	Pressure: +/- 3 mmHg of reading.	SE
Compatibilitywith environment	It can be used from 50°F to 104°F(10°C to 40°C ) and15% ~ 85%RH humidity.	It can be used from 50°F to 104°F(10°C to 40°C ) and15%~85%RH humidity.	SE
Cuff Sizes	21" × 5.7"(540mm145mm)26" × 6.9" (660mm175mm)30.7" × 8.67" (780mm220mm)14.96" × 4.33" (380mm110mm)11.81" ×2.76" (300mm70mm)9.84" × 2.16"(250mm55mm)	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" x 3" (260mm75mm)	Analysis 1
CuffCircumference	Fits arm circumferences 8.7" to17.3" (220mm to 440 mm), Thestandard cuff should be available foruse in measuring a child's leg bloodpressure and for children with largerarms.	Fits arm circumferences 8.7" to17.3" (220mm to 440 mm), Thestandard cuff should be available foruse in measuring a child's leg bloodpressure and for children with largerarms.	SE
Cuff bladder Size	8.7"×4.7" (220mm120mm)11.8"×5.9" (300mm150mm)14.76" × 7.28"(375mm185mm)6.9"×3.3"(175mm85mm)3.15" x 1.57"(80mm40mm)3.54" × 0.98"(90mm25mm)	8.7" x 4.7" (220mm120mm)11.8" x 5.9"(300mm150mm)13.4" x 6.7" (340mm170mm)6.9" x 3.3"(175mm85mm)7.5" x 2"(190mm*50mm)	Analysis 2

Table 1 Comparison of Technology Characteristics

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Cuff Color	Black	Blue, Pink, Black	Analysis 3
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)	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

Analysis 1 - Cuff Sizes

The cuff sizes of proposed device are different from predicate device. However, the cuff size of proposed device is similar to the predicate device and the Cuff Circumference of the two devices is the same. The Velcro on cuff is designed to fit varies arm circumference. This difference doesn't raise new problems on the safety and effectiveness of the proposed device. Therefore, this difference does not affect the substantially equivalence between the proposed device and predicate device.

Analysis 2 – Cuff bladder Size

The cuff bladder size of the proposed device is partly different from predicate device. However, the cuff bladder size of proposed device is similar to the predicate device. It could fit varies requirements of users. This difference doesn't raise new problems on the safety and effectiveness of the proposed device. Therefore, this difference does not affect the substantially equivalence between the proposed device and predicate device.

Analysis 3 – Cuff Color

The cuff color of the proposed device is different from the predicate device. However, the biocompatibility of the cuff of proposed device had been tested and the test results show no adverse effect of the material. Therefore, this difference does not affect the substantially equivalence between the proposed device and predicate device.

Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed device are 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).