The Reusable NIBP Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in adult size.

Device Description

Reusable NIBP Cuff is a reusable accessory used in conjunction with a non-invasive blood pressure measurement system. It comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure.

Reusable NIBP Cuff is made of PU synthetic leather (Cuff), TPU film (bladder) and TPU (Air Hose), and the PU synthetic leather is the material used to contacting with the patient's intact skin.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a reusable NIBP (Non-Invasive Blood Pressure) cuff. It details the device's indications for use, safety and performance testing, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to a diagnostic algorithm or AI performance. The document is for a physical medical device (blood pressure cuff) and focuses on its physical characteristics, materials, and mechanical performance (e.g., durability of inflation cycles, biocompatibility) rather than a software or AI-driven diagnostic.

Therefore, I cannot provide answers to the specific points requested (acceptance criteria table, sample size for test/training sets, expert ground truth, MRMC study, standalone performance, etc.) as they pertain to the evaluation of an AI/algorithm-based device, which is not what this document describes.

The acceptance criteria stated for this device primarily revolve around:

Compliance with recognized standards: ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization).
Biocompatibility: Demonstrated through testing for cytotoxicity, sensitization, and irritation.
Mechanical Durability: 10,000 inflations and 3,000 hook and loop closures.
Pressure Limits: 0-300mmHg.
Intended Use and Patient Population Matching: For adult size, non-sterile, reusability.
Substantial Equivalence: To a legally marketed predicate device (Orantech Inc. Reusable NIBP Cuff, K173197).

The document explicitly states: "Clinical performance is not deemed necessary." and there is no mention of an AI/ML component in this device.

Summary

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September 23, 2021

Shenzhen Coreray Technology Co., Ltd. Simon Fan General Manager Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park Yousong Community, Longhua District Shenzhen, Guangdong 518109 China

Re: K211747

Trade/Device Name: Reusable NIBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: August 17, 2021 Received: August 23, 2021

Dear Simon Fan:

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.

LCDR 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) K211747

Device Name Reusable NIBP Cuff

Indications for Use (Describe)

The Reusable NIBP Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in adult size.

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 - 510(k) Summary

Prepared Date: May 26, 2021

This is a traditional 510k submission, and there were no prior submissions for the subject device.

1. Submitter Information

Sponsor: Shenzhen Coreray Technology Co., Ltd. Address: Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park, Yousong Community, Longhua District, Shenzhen, Guangdong, China Contact Person: Simon Fan Title: General Manager Phone: +86-755-21010817 E-mail: manager@core-ray.com

2. Subject Device Information

Type of 510(k) submission: Traditional Trade/Device Name: Reusable NIBP Cuff Model: CR009-R-PU-005 Classification Name: Blood pressure cuff Review Panel: Cardiovascular Classification Product Code: DXQ, 21 CFR 870.1120 Regulation Class: 2

3. Predicate Device Information

Sponsor: Orantech Inc.

Reusable NIBP Cuff

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Device Name: Reusable NIBP Cuff Classification Name: Blood pressure cuff 510(k) number: K173197 Review Panel: Cardiovascular Classification Product Code: DXQ, 21 CFR 870.1120 Regulation Class: 2

4. Device Description

Reusable NIBP Cuff is made of PU synthetic leather (Cuff), TPU film (bladder) and TPU (Air Hose), and the PU synthetic leather is the material used to contacting with the patient's intact skin.

5. Intended Use

Reusable NIBP Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in adult size.

6. Test Summary

Reusable NIBP Cuff has been evaluated the safety and performance by lab bench testing according to the following standards:

മ ISO 81060-1, Non-Invasive Sphygmomanometers Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
മ ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In

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Vitro cytotoxicity, 2009

മ ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010

7. Biocompatibility

During noninvasive blood pressure measuring process, the patient-directly contacting component information according to ISO 10993-1 in the subject device is in the following list.

Component ofDevice	Material	Body Contact Category	ContactDuration
Cuff	PU syntheticleather	Surface-contacting device:Patient Skin	< 24 hours
Air hose	TPU	Surface-contacting device:Patient Skin	< 24 hours

So, we conduct biocompatibility test on Reusable NIBP Cuff including the following as ISO 10993-1 required.

Cytotoxicity
Sensitization
Irritation

8. Comparison to Predicate Device

Compare with predicate device, the subject device is quite similar in design principle, intended use, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.

Elements ofcomparison	Subject Device	Predicate Device	Verdict
Manufacturer	Shenzhen Coreray Technology Co.,	Orantech Inc.	--
Elements ofcomparison	Subject Device	Predicate Device	Verdict
	Ltd.
510K number	TBD	K173197	--
Product Name	Reusable NIBP Cuff	Reusable NIBP Cuff	--
ClassificationName	Blood pressure cuff	Blood pressure cuff	SE
Regulation Class	2	2	SE
RegulationNumber	21 CFR 870.1120	21 CFR 870.1120	SE
Product Code	DXQ	DXQ	SE
OTC & Rx	Rx	Rx	SE
Indications forUse	Reusable NIBP Cuff is an accessoryused in conjunction with noninvasiveblood pressure measurementsystems. The cuff is non-sterile andmay be reused. It is available in adultsize.	The reusable blood pressure cuff is anaccessory used in conjunction withnoninvasive blood pressuremeasurement systems. The cuff isnon-sterile and may be reused. It isavailable in neonate, infant, child andadult sizes.	SENote 1
PatientPopulations	Adults/Pediatrics/Infants/Neonates	Adults/Pediatrics/Infants/Neonates	SE
Material	Cuff: PU Synthetic LeatherBladder: Transparent Polyurethane(TPU Film)Tubing: TPUHook: Molded NylonLoop: Nylon	Cuff: PU Synthetic LeatherBladder: Transparent Polyurethane(TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon	SENote 2
Tube Number	One	One	SE
LimbCircumference(Range in cm)	Conform to AHA bladder sizesrecommendationsAdult (25-35cm)	Conform to AHA bladder sizesrecommendationsNeonatal (6-11cm)Infant (8-13cm)Child (12-19cm)Small Adult (17-25cm)	SENote 1
Elements ofcomparison	Subject Device	Predicate Device	Verdict
		Adult Extra Long (23-33cm)Large Adult (31-40cm)Large Adult Long (31-40cm)Adult Thigh (38-50cm)
Repeatedinflation	10,000 inflations3,000 hook and loop closures	10,000 inflations3,000 hook and loop closures	SE
Pressure limits	0-300mmHg	0-300mmHg	SE
Sterility	Non-sterile	Non-sterile	SE
Biocompatibility	Comply with ISO 10993biocompatibility evaluation	Comply with ISO 10993biocompatibility evaluation	SE

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Shenzhen Coreray Technology Co., Ltd

Note 1

Although the subject device is only intended for adults and has one size, which is covered by the predicate device, and performance testing accordance with ISO 81060-1 has been conducted and provided with this submission. Therefore, these differences do not affect the safety and effectiveness.

Note 2

Although the tubing material of subject device is different to predicate device, the subject device is complied with ISO 10993 standards, the difference does not affect the safety and effectiveness.

9. Summary for clinical test

Clinical performance is not deemed necessary.

10. Conclusion

The subject device Reusable NIBP Cuff has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent 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).