Who is the manufacturer of NIBPCuff?

Shenzhen Sino-K Medical Technology Co.,Ltd filed the 510(k) submission for NIBPCuff (K231961).

What is the FDA product code for NIBPCuff?

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

What is the regulatory pathway for NIBPCuff?

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

Who can help prepare an FDA 510(k) submission like NIBPCuff?

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.

NIBPCuff

K231961 · Shenzhen Sino-K Medical Technology Co.,Ltd · DXQ · Aug 30, 2023 · Cardiovascular

Device Facts

Record ID	K231961
Device Name	NIBPCuff
Applicant	Shenzhen Sino-K Medical Technology Co.,Ltd
Product Code	DXQ · Cardiovascular
Decision Date	Aug 30, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1120
Device Class	Class 2
Attributes	Pediatric

Intended Use

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. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Story

Device consists of reusable and disposable non-invasive blood pressure (NIBP) cuffs; includes bladder and single-tube air hose. Operates by wrapping bladder around patient limb; secured via hook and loop closure; air hose connects to NIBP measurement system. Used in clinical settings to facilitate blood pressure monitoring. Output is pneumatic pressure signal transmitted to host monitor for blood pressure calculation. Benefits patient by enabling non-invasive hemodynamic monitoring.

Clinical Evidence

Bench testing only. Compliance with ISO 81060-1 for non-invasive sphygmomanometers and biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Reusable cuff materials: PU synthetic leather, TPU film bladder, PVC tubing, nylon hook/loop. Disposable cuff materials: non-woven clad PVC, PVC bladder/tubing/hook/loop. Single-tube configuration. Pressure range: 180 mmHg (neonate/infant) to 360 mmHg (others). Leakage < 4 mmHg/min. Non-sterile.

Indications for Use

Indicated for use as an accessory with noninvasive blood pressure measurement systems for neonate, infant, child, and adult patient populations.

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

Caremed Reusable Blood Pressure Cuff, Caremed Disposable Blood Pressure Cuff (K182433)

Related Devices

K191253 — Reusable NIBP Cuff · Shenzhen Changke Connect Electronics Co., Ltd. · Sep 17, 2019
K171889 — Reusable Blood Pressure Cuff · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Dec 19, 2017
K173044 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff · Ningbo Albert Novosino Co., Ltd. · Nov 20, 2017
K173197 — Reusable NIBP Cuff · Orantech, Inc. · Aug 21, 2018
K182433 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 17, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized caduceus. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font. August 30, 2023 Shenzhen SINO-K Medical Technology Co.,Ltd % Yang Jie Consultant Shenzhen Choncorut Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China Re: K231961 Trade/Device Name: Reusable NIBP Cuff, Disposable NIBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II Product Code: DXQ Dated: June 30, 2023 Received: July 3, 2023 Dear Yang Jie: 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 {1}------------------------------------------------ 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, # Stephen C. Browning -S LCDR Stephen Browning Asistant Director Division of Cardiac Electrophysiology Diagnostic and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231961 Device Name Reusable NIBP Cuff, Disposable NIBP Cuff 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. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. Type of Use (Select one or both, as applicable) 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # 510(K) Summary ### Prepared in accordance with the requirements of 21 CFR Part 807.92 ### Prepared Date: 2023/06/30 #### 1. Submission sponsor Name: Shenzhen SINO-K Medical Technology Co., Ltd. Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, Guangdong, China Contact person: Lao Chengxin Title: General Manager E-mail: boss@sino-k.com Tel: +86 137 15333326 #### 2. Submission correspondent Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Yang Jie E-mail: yangjie(@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Reusable NIBP Cuff, Disposable NIBP Cuff | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model | Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811. Disposable NIBP Cuff: SC0101, SC0102, SC0103, SC0104, SC0105, SC0106, SC0107, SC0108, SC0109, SC0110, SC0111, SC0112. | | Common Name | Non-invasive Blood Pressure Cuff | | Regulatory Class | Class II | | Classification | 21CFR 870.1120 / Blood pressure cuff / DXQ | | Submission type | Traditional 510(K) | #### Subject Device Information 3. #### 4. Predicate Device Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable Blood Pressure Cuff, Caremed Disposable Blood Pressure Cuff under K182433. #### Device Description ട്. The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. {4}------------------------------------------------ The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff. Both disposable and reusable blood pressure cuff have the same structure, which contains Cuff with bladder and single-tube Air Hose. The subject device is categorized into two types of models according to its reusability. Refer to the master list of models below. Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811. Disposable NIBP Cuff: SC0101, SC0102, SC0103, SC0104, SC0105, SC0106, SC0107, SC0108, SC0109, SC0110, SC0111, SC0112. #### 6. Intended use & Indication for use 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. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. #### 7. Comparison to the Predicate Device The following tabulation indicates the detailed differences between the subject devices and the predicate devices. | Features | Predicate Device Caremed Reusable Blood Pressure Cuff K182433 | Subject Device Reusable NIBP Cuff K231961 | Remark | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Applicant | Shenzhen Caremed Medical Technology Co., Ltd. | Shenzhen SINO-K Medical Technology Co., Ltd | / | | Classification Regulation | 21CRF 870.1120 | 21CRF 870.1120 | Same | | Classification and Code | Class II, DXQ | Class II, DXQ | Same | | Common name | Non-invasive Blood Pressure Cuff | Non-invasive Blood Pressure Cuff | Same | | Intended use | The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile | 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 | Same | | Features | Predicate Device | Subject Device | Remark | | | Caremed Reusable Blood Pressure Cuff K182433 | Reusable NIBP Cuff K231961 | | | | and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | | | Patient Populations | Adults/Pediatrics | Adults/Pediatrics | Same | | Tube Number | One or two | One | Different | | Principles of Operation | Bladder is wrapped around the patient's limb and secured by hook and loop closure Air hose is connected to the noninvasive blood pressure measurement systems | Bladder is wrapped around the patient's limb and secured by hook and loop closure Air hose is connected to the noninvasive blood pressure measurement systems | Same | | Limb Circumference (Range in cm) | Neonatal (6-11cm) Infant (10-19cm) Child (18-26cm) Small Adult (20-28cm) Adult (25-35cm) Adult Long (25-35cm) Large Adult (33-47cm) Adult Thigh (44-66cm) | Neonatal (6-11cm) Infant (10-19cm) Pediatric (18-26cm) Adult (25-35cm) Large Adult (33-47cm) | Different | | Pressure Range | 0-300 mmHg | Cuff for neonate and infant: 180mmHg(24kPa) Cuff for small child, child, small adult, adult, large adult: 360mmHg(48kPa) | Different | | Sterility | Non-sterile | Non-sterile | Same | | Max. Leakage | < 4mm Hg/ min. | < 4mm Hg/ min. | Same | | Material | Cuff (Patient contacted): PU Synthetic Leather Bladder: Transparent Polyurethane (TPU Film) Tubing: PVC Hook: Molded Nylon Loop: Nylon | Cuff (Patient contacted): PU Synthetic Leather Bladder: Transparent Polyurethane (TPU Film) Tubing: PVC Hook: Molded Nylon Loop: Nylon | Same | | Biocompatibility | Comply with ISO 10993-5; | Comply with ISO 10993-5; | Same | | Features | Predicate Device Caremed Reusable Blood Pressure Cuff K182433 | Subject Device Reusable NIBP Cuff K231961 | Remark | | | Comply with ISO 10993-10 | Comply with ISO 10993-10 | | Comparison to Predicate Device Caremed Reusable Blood Pressure Cuff: {5}------------------------------------------------ {6}------------------------------------------------ # Comparison to Predicate Device Caremed Disposable Blood Pressure Cuff: | Features | Predicate Device Caremed Disposable Blood Pressure Cuff | Subject Device Disposable NIBP Cuff | Remark | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Applicant | Shenzhen Caremed Medical Technology Co., Ltd. | Shenzhen SINO-K Medical Technology Co., Ltd | / | | Intended use | The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | Same | | Patient Populations | Adults/Pediatrics | Adults/Pediatrics | Same | | Tube Number | One or two | One | Different | | Limb Circumference (Range in cm) | Neonatal 1 (3-6 cm) Neonatal 2 (4-8 cm) Neonatal 3 (6-11 cm) Neonatal 4 (7-13 cm) Neonatal 5 (8-15 cm) Infant (9-14.8 cm) Child (13.8-21.5 cm) Small Adult (20.5-28.5 cm) Adult (27.5-36.5 cm) Adult Long (27.5-36.5/46.5 cm) Large Adult (35.5-46 cm) Large Adult Long (35.5-46 cm) | Neonatal (3-6 cm) Neonatal (4-8 cm) Neonatal (6-11 cm) Neonatal (7-13 cm) Neonatal (8-15 cm) Neonatal (7.7-10.5 cm) Infant (9.8-13.3 cm) Small Child (12.4-16.8 cm) Child (15.8-21.3 cm) Small Adult (20-27 cm) Adult (25.3-34.3 cm) Large Adult (32.1-43.4 cm) | Different | | Pressure Range | 0-300mmHg | Cuff for neonate and infant: 180mmHg(24kPa) Cuff for small child, child, small | Different | | Features | Predicate Device | Subject Device | Remark | | | Caremed Disposable Blood | Disposable NIBP Cuff | | | | Pressure Cuff | | | | | | adult, adult, large adult: 360mmHg(48kPa) | | | Sterility | Non-sterile | Non-sterile | Same | | Material | Non-woven (Patient contacted); | Cuff (Patient contacted): Non- | Different | | | nylon; | woven clad PVC | | | | PVC | Bladder: PVC | | | | | Tubing: PVC | | | | | Hook: PVC | | | | | Loop: PVC | | | Biocompatibility | Comply with ISO 10993-5; | Comply with ISO 10993-5; | Same | | | Comply with ISO 10993-10 | Comply with ISO 10993-10 | | {7}------------------------------------------------ #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. Biocompatibility testing The biocompatibility evaluation for the proposed devices was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") 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 battery of testing included the following tests: - . Cytotoxicity - Sensitization . - Irritation ● The NIBP Cuffs are considered surface contacting for a duration of exceed 24 hours but not 30 days. ## Non-clinical data Non-clinical tests were conducted to verify that the proposed devices 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, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007. - ISO 10993-5: 2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro . Cytotoxicity. - . ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization {8}------------------------------------------------ # 9. Conclusion It has been shown in the 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.