K Number

Device Name

Aneroid Sphygmomanometer

Manufacturer

Wuxi Exanovo Medical Instrument Co., Ltd.

Date Cleared

2021-03-23

(102 days)

Product Code

DXQ DXO LDE

Regulation Number

870.1120

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K190902

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a manual aneroid sphygmomanometer, which relies on mechanical components and manual detection of Korotkoff sounds, with no mention of AI or ML.

Therapeutic

No.
The device is an aneroid sphygmomanometer used for measuring blood pressure, which is a diagnostic rather than a therapeutic function.

Diagnostic

Yes

Explanation: The device measures systolic and diastolic blood pressure, which provides information about a patient's health status and can be used to identify conditions like hypertension.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a manometer, cuff bladder, inflation bulb, and optional stethoscopes.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The described device, an aneroid sphygmomanometer, measures blood pressure by applying pressure to the arm and listening for sounds (Korotkoff sounds). This is a physical measurement taken on the patient's body, not a test performed on a sample taken from the body.
Intended Use: The intended use clearly states it's for measuring systolic and diastolic pressure on children or adults by being manually attached to a patient. This aligns with a physical measurement device, not an IVD.

The description and intended use clearly indicate that this is a device for in vivo measurement (measurement within or on the living body), not in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DXO, LDE

Device Description

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

children or adults. infants, children, young adults and adults

Intended User / Care Setting

medical professionals or in the home. Home, Hospital, healthcare facility, 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

Non clinical tests were conducted to verify that the proposed device met all design specifications 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;

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: Pressure: +/- 3 mmHg of reading.

Predicate Device(s)

K190902

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

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

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

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

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

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 monitor
scale	From 0 to 300 mmHg with a
minimum interval of 2 mmHg.	From 0 to 300 mmHg with a
minimum interval of 2 mmHg.	SE
Design of blood
pressure meter	The device comprises tubing
attached to a soft inelastic cuff with
an integrated inflatable bladder that
is wrapped around the patient's limb
and secured by hook and loop
closure.	The device comprises tubing
attached to a soft inelastic 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	Three types option:
Single head
Dual head
Sprague Rappaport	Three types option:
Single head
Dual head
Sprague Rappaport	SE
Materials	The manometer: aluminum and
stainless steel materials.
The tubing, inflation bulb: PVC or
nature latex.
Cuff: Nylon cloth or cotton cloth for
outside layer.
Cuff bladder: PVC or nature latex	The manometer: aluminum and
stainless steel materials.
The tubing, inflation bulb: PVC or
nature latex.
Cuff: Nylon cloth or cotton cloth for
outside layer.
Cuff bladder: PVC or nature latex	SE
Accuracy	Pressure: +/- 3 mmHg of reading.	Pressure: +/- 3 mmHg of reading.	SE
Compatibility
with environment	It can be used from 50°F to 104°F
(10°C to 40°C ) and
15% ~ 85%RH humidity.	It can be used from 50°F to 104°F
(10°C to 40°C ) and
15%~85%RH humidity.	SE
Cuff Sizes	21" × 5.7"(540mm*145mm)
26" × 6.9" (660mm*175mm)
30.7" × 8.67" (780mm*220mm)
14.96" × 4.33" (380mm*110mm)
11.81" ×2.76" (300mm*70mm)
9.84" × 2.16"(250mm*55mm)	20" × 5.5" (510mm*140mm)
21.7" × 6.3" (550mm*160mm)
24.4" × 6.9" (620mm*175mm)
28.3" × 8.3" (720mm*210mm)
13.4" × 4.15" (340mm*105mm)
10.2" x 3" (260mm*75mm)	Analysis 1
Cuff
Circumference	Fits arm circumferences 8.7" to
17.3" (220mm to 440 mm), 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 to 440 mm), The
standard cuff should be available for
use in measuring a child's leg blood
pressure and for children with larger
arms.	SE
Cuff bladder Size	8.7"×4.7" (220mm*120mm)
11.8"×5.9" (300mm*150mm)
14.76" × 7.28"(375mm*185mm)
6.9"×3.3"(175mm*85mm)
3.15" x 1.57"(80mm*40mm)
3.54" × 0.98"(90mm*25mm)	8.7" x 4.7" (220mm*120mm)
11.8" x 5.9"(300mm*150mm)
13.4" x 6.7" (340mm*170mm)
6.9" x 3.3"(175mm*85mm)
7.5" x 2"(190mm*50mm)	Analysis 2

Table 1 Comparison of Technology Characteristics

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.