The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young 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 device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device. The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.

AI/ML Overview

This document is a 510(k) Premarket Notification for an Aneroid Sphygmomanometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/CADe device.

Therefore, the information required to answer the prompt (acceptance criteria and study details for an AI/CADe device) is not present in the provided document. The document details a traditional medical device (a manual blood pressure cuff) and its compliance with standards like ISO 81060-1 for non-automated sphygmomanometers, and biocompatibility standards. It explicitly states: "No clinical study is included in this submission."

The prompt asks for details typical of an AI/CADe device submission, such as:

Acceptance criteria table and reported performance: This document lists "Accuracy: +/- 3 mmHg of reading" as a specification, derived from ISO 81060-1, but this is a design specification, not an AI model's performance on a test set. There is no reported performance against this.
Sample size and data provenance for a test set: No test set is specified for evaluating AI performance.
Number of experts and qualifications for ground truth: Not applicable as there is no AI model or ground truth establishment based on expert consensus.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth: Not applicable.
Training set sample size: Not applicable.
Ground truth for training set: Not applicable.

In summary, this document is for a non-AI/non-CADe medical device. It does not contain the type of study information requested for an AI/CADe device.

Summary

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October 19, 2021

Shanghai Caremate Medical Device Co. Ltd Mark Chu General Manager Building 4, No. 281, Hong An Road, Jinshan District, Shanghai. 201503 China

Re: K211084

Trade/Device Name: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: August 28, 2021 Received: September 16, 2021

Dear Mark Chu:

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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K211084

Device Name

Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope

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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510(k) Summary

Sponsor Identification and Designated Submission Correspondent

Company name	Shanghai Caremate Medical Device Co. Ltd
Address	Building 4, No. 281, Hong An Road, Zhujing Town, JinshanDistrict, Shanghai, 201503, China
Establishment Registration Number	3007699082
Contact name	Mark Chu
Contact title	General Manager
Phone	+86-21-57341588
Fax	+86-21-37284210
Email	mark@carematemed.com

Date of Preparation: 9/8/2021

Predicate Device Information
510(k) Number	K192500
Trade Name	Aneroid sphygmomanometer, Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3Aneroid sphygmomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D

Proposed Device Information
Trade Name	Aneroid sphygmomanometer,Aneroid sphygmomanometer with stethoscope
Classification Name	Blood pressure cuff
Regulatory Information
Classification Product code	DXQ
Subsequent Product Code	LDE
Regulation Number	CFR 870.1120,CFR 870.1875
ReviewPanel	Cardiovascular

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Indications for Use of Propose Device

Device Description of Propose Device

The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.

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:

ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type [FDA recognition No .: 3-96].

ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity[FDA recognition No.: 2-245];

ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization[FDA recognition No .: 2-174];

Biocompatibility testing:

The biocompatibility evaluation for the cuff and stethoscope was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process ." September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing items included:

· Cytotoxicity
· Sensitization
· Irritation

Performance testing:

Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007;

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Clinical Test Conclusion

No clinical study is included in this submission.

Comparison of Technology Characteristics

ITEM	Proposed DeviceAneroid Sphygmomanometer	Predicate DeviceK192500	Remark
Productname	Aneroid sphygmomanometer,Aneroid sphygmomanometer withstethoscope	Aneroid sphygmomanometer,Model HS-20A, HS-20D,HS-201W, HS-201Y, HS-201C1,HS-201Q3Aneroid sphygmomanometer withstethoscope, Model HS-50C,HS-50B, HS-50D
ProductCode	DXQ, LDE	DXQ, LDE	Same
RegulationNo.	21 CFR 870.112021 CFR 870.1875	21 CFR 870.112021 CFR 870.1875	Same
Class	II	II	Same
Indicationfor Use	The device is intended to be used bymedical professionals or in the homefor the measurement of systolic anddiastolic pressure on new borns,infants, children, young adults andadults. The device is intended to bemanually attached to a patient andmanually inflated along with amanual method for detectingKorotkoff sounds.	The device is intended to be used bymedical professionals or in thehome for the measurement ofsystolic and diastolic pressure. Thedevice is intended to be manuallyattached to a patient and manuallyinflated along with a manualmethod for detecting Korotkoffsounds.	Different 1
Over-TheCounterUse	Yes	Yes	Same
Whereused	Home, Hospital, healthcare facility,ambulance etc.	Home, Hospital, healthcare facility,ambulance etc.	Same
Targetpopulation	New borns, infants, children, youngadults and adults	New borns, infants, children, youngadults and adults	Same
Anatomicalsites	Upper Arm (leg for child)	Upper Arm (leg for child)	Same
MeasurementMethod	Auscultatory Korotkoff soundsMethod	Auscultatory Korotkoff soundsMethod	Same
Method
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 300 mmHg with aminimum interval of 2 mmHg.	From 0 to 300 mmHg with aminimum interval of 2 mmHg.	Same
Design ofthe device	The device comprises tubing attachedto a soft inelastic cuff with anintegrated inflatable bladder that iswrapped around the patient's limb andsecured by hook and loop closure.	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	Same
Materials	The manometer: aluminum or ABSThe tubing, inflation bulb and cuffbladder: Neoprene or Silicon rubberor Nature latex or PVC	The manometer: aluminum andstainless steel materials.The tubing, inflation bulb and cuffbladder: PVC or nature latex.	Different 2
	Cuff: Nylon cloth for outside layer.	Cuff: Nylon cloth for outside layer.
Accuracy	Pressure: +/- 3 mmHg of reading.	Pressure: +/- 3 mmHg of reading.	Same
Cuff sizes	31.49" × 8.66" (800mm220mm)24.41" × 6.89" (620mm175mm)20.47" × 5.51" (520mm140mm)13.4" × 4.33" (340mm110mm)9.84"×3.15" (250mm80mm)8.27" × 2.36" (210mm60mm)	780mm220mm615mm175mm540mm145mm500mm140mm345mm110mm255mm75mm185mm*55mm	Different 3






Cuffcircumference	Fits arm circumferences100mm-620mm, the standard cuffshould be available for use inmeasuring a New born, infant, child'sleg blood pressure and for child, youngadult, and adult with larger arms	Fits arm circumferences100mm-660mm, the standard cuffshould be available for use inmeasuring a New born, infant,child's leg blood pressure and forchild, young adult, and adult withlarger arms	Different 4




Cuffbladdersize	13.39" × 6.69" (340mm170mm)12.2"×5.51" (310mm140mm)8.66"×4.72' (220mm120mm)6.69"×3.15" (170mm80mm)4.33" × 2.36" (110mm*60mm)	180mm370mm145mm315mm120mm220mm80mm150mm60mm*120mm	Different 5





Configuration	Manometer, cuff, cuff bladder,inflation bulb and with/withoutstethoscope.	Manometer, cuff, cuff bladder,inflation bulb and with/withoutstethoscope.	Same
Biocompatibility	biocompatible as requirement of ISO10993-1, ISO 10993-5, ISO 10993-10	biocompatible as requirement ofISO 10993-1, ISO 10993-5, ISO10993-10	Same
Performance	compatible as requirement of ISO81060-1	compatible as requirement of ISO81060-1	Same

Table 1 Comparison of Technology Characteristics

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Different 1- Indications for use

The indications for use of proposed device include the target population, while the predicate device doesn't include this information. But they have the same target population, therefore, the proposed device and predicate device have the same indications for use.

Different 2- Material

The material of out shell of manometer, material of tubing and inflation bulb of proposed device is different from the predicate device. But these material is not the patient-contact material, therefore the difference on material does not raise new questions on safety and effectiveness of the proposed device.

Different 3 - 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 on cuff size does not raise new questions on safety and effectiveness of the proposed device.

Different 4 - Cuff circumference

The arm circumferences for the proposed cuff is 100mm-620mm, and the arm circumferences for the predicate cuff is 100mm-660mm. The range of arm circumferences for proposed device is covered by that of the predicate device, the difference on cuff circumference does not raise new questions on safety and effectiveness of the proposed device.

Different 5 - 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 on cuff bladder size does not raise new questions on safety and effectiveness of the proposed device.

Conclusion

Based on the comparison and analysis above, the proposed devices are as safe, as effective, and performs as well as the legally marketed predicate device K192500.

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).