Who is the manufacturer of Reusable NIBP Cuff?

Shenzhen Coreray Technology Co., Ltd. filed the 510(k) submission for Reusable NIBP Cuff (K211747).

What is the FDA product code for Reusable NIBP Cuff?

DXQ. It is classified under 21 CFR 870.1120 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Reusable NIBP Cuff?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Reusable NIBP Cuff?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Reusable NIBP Cuff

K211747 · Shenzhen Coreray Technology Co., Ltd. · DXQ · Sep 23, 2021 · Cardiovascular

Device Facts

Record ID	K211747
Device Name	Reusable NIBP Cuff
Applicant	Shenzhen Coreray Technology Co., Ltd.
Product Code	DXQ · Cardiovascular
Decision Date	Sep 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1120
Device Class	Class 2

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.

Device Story

Reusable NIBP cuff; accessory for noninvasive blood pressure measurement systems. Comprises inelastic sleeve with integrated inflatable bladder, tubing, and hook-and-loop closure. Wrapped around patient limb; secured manually. Used in clinical settings; operated by healthcare professionals. Functions as pneumatic interface between patient limb and blood pressure monitor; cuff inflation occludes artery to facilitate oscillometric or auscultatory measurement. Output is pressure signal transmitted via tubing to monitor; enables blood pressure determination. Benefits patient by providing noninvasive, repeatable blood pressure monitoring.

Clinical Evidence

No clinical data; bench testing only. Performance evaluated per ISO 81060-1 (non-invasive sphygmomanometers) and biocompatibility evaluated per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Materials: PU synthetic leather (cuff), TPU film (bladder), TPU (air hose), molded nylon (hook/loop). Pressure range: 0-300 mmHg. Durability: 10,000 inflation cycles, 3,000 hook-and-loop closures. Non-sterile. Standalone accessory.

Indications for Use

Indicated for use in adult patients as an accessory for noninvasive blood pressure measurement systems.

Regulatory Classification

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.

Predicate Devices

Reusable NIBP Cuff (K173197)

Related Devices

K173197 — Reusable NIBP Cuff · Orantech, Inc. · Aug 21, 2018
K191253 — Reusable NIBP Cuff · Shenzhen Changke Connect Electronics Co., Ltd. · Sep 17, 2019
K173869 — Med-link Reusable Blood Pressure Cuff · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 2, 2018
K171889 — Reusable Blood Pressure Cuff · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Dec 19, 2017
K233276 — Reusable Blood Pressure Cuff · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Dec 21, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ 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 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. #### 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 {5}------------------------------------------------ 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 of Device | Material | Body Contact Category | Contact Duration | |------------------------|-------------------------|--------------------------------------------|---------------------| | Cuff | PU synthetic leather | 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 of comparison | Subject Device | Predicate Device | Verdict | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Manufacturer | Shenzhen Coreray Technology Co., | Orantech Inc. | -- | | Elements of comparison | Subject Device | Predicate Device | Verdict | | | Ltd. | | | | 510K number | TBD | K173197 | -- | | Product Name | Reusable NIBP Cuff | Reusable NIBP Cuff | -- | | Classification Name | Blood pressure cuff | Blood pressure cuff | SE | | Regulation Class | 2 | 2 | SE | | Regulation Number | 21 CFR 870.1120 | 21 CFR 870.1120 | SE | | Product Code | DXQ | DXQ | SE | | OTC & Rx | Rx | Rx | SE | | Indications for 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. | The reusable blood pressure 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 neonate, infant, child and adult sizes. | SE Note 1 | | Patient Populations | Adults/Pediatrics/Infants/Neonates | Adults/Pediatrics/Infants/Neonates | SE | | Material | Cuff: PU Synthetic Leather Bladder: Transparent Polyurethane (TPU Film) Tubing: TPU Hook: Molded Nylon Loop: Nylon | Cuff: PU Synthetic Leather Bladder: Transparent Polyurethane (TPU Film) Tubing: PVC Hook: Molded Nylon Loop: Nylon | SE Note 2 | | Tube Number | One | One | SE | | Limb Circumference (Range in cm) | Conform to AHA bladder sizes recommendations Adult (25-35cm) | Conform to AHA bladder sizes recommendations Neonatal (6-11cm) Infant (8-13cm) Child (12-19cm) Small Adult (17-25cm) | SE Note 1 | | Elements of comparison | Subject Device | Predicate Device | Verdict | | | | Adult Extra Long (23-33cm) Large Adult (31-40cm) Large Adult Long (31-40cm) Adult Thigh (38-50cm) | | | Repeated inflation | 10,000 inflations 3,000 hook and loop closures | 10,000 inflations 3,000 hook and loop closures | SE | | Pressure limits | 0-300mmHg | 0-300mmHg | SE | | Sterility | Non-sterile | Non-sterile | SE | | Biocompatibility | Comply with ISO 10993 biocompatibility evaluation | Comply with ISO 10993 biocompatibility evaluation | SE | {6}------------------------------------------------ {7}------------------------------------------------ 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.