Reusable NIBP Cuff
Device Facts
| Record ID | K191253 |
|---|---|
| Device Name | Reusable NIBP Cuff |
| Applicant | Shenzhen Changke Connect Electronics Co., Ltd. |
| Product Code | DXQ · Cardiovascular |
| Decision Date | Sep 17, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1120 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications 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.
Device Story
Reusable NIBP cuff accessory; used with noninvasive blood pressure measurement systems. Device consists of cuff with bladder and single-tube air hose. Operation involves wrapping bladder around patient limb, securing with hook-and-loop closure, and connecting air hose to blood pressure monitor. Used in clinical settings by healthcare providers. Output is pneumatic pressure transmission to monitor for blood pressure calculation. Benefits include reliable, reusable interface for patient blood pressure monitoring.
Clinical Evidence
Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Performance testing conducted per ISO 81060-1 (non-invasive sphygmomanometers) and leakage testing (< 4 mmHg/min).
Technological Characteristics
Reusable cuff with bladder and single-tube air hose. Materials: CK-XT-78211-XXX series (PU synthetic leather cuff, TPU bladder/hose, nylon hook/loop); CK-XT-78243-XXX series (nylon cuff, TPU bladder, silica gel hose, nylon hook/loop). Pressure range 0-300 mmHg. Non-sterile. Complies with ISO 81060-1, ISO 10993-5, and ISO 10993-10.
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
- Shenzhen Caremed Medical Technology Co., Ltd. Reusable Blood Pressure Cuff (K182433)
Submission Summary (Full Text)
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September 17, 2019
Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A. NanShan Medical devices Industrial Park Nanshan District Shenzhen, 518067 CHINA
Re: K191253
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 29, 2019 Received: August 29, 2019
Dear Kevin Wang:
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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K191253
Device Name Reusable NIBP Cuff
Indications for Use (Describe)
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressurement 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.
| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right:5px;"> <span style="border: 1px solid black; padding: 0px; display: inline-block; width: 13px; height: 13px; text-align: center;"> ✓ </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="padding-right:5px;"> <span style="border: 1px solid black; padding: 0px; display: inline-block; width: 13px; height: 13px; text-align: center;"> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
### Prepared Date: 2019/04/08
#### 1. Submission sponsor
Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, P.R. China Contact person: Yahui Zhou Title: General manager E-mail: zhouyahui(@szcklt.com
Tel: +86 136 1301 2560
#### 2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067
Contact person: Kevin Wang
E-mail: kevin(@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Reusable NIBP Cuff |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | CK-XT-78211-001, CK-XT-78211-003, CK-XT-78211-005, CK-XT-78211-006,<br>CK-XT-78211-007, CK-XT-78211-008, CK-XT-78243-000, CK-XT-78243-001,<br>CK-XT-78243-003, CK-XT-78243-005, CK-XT-78243-007, CK-XT-78243-008 |
| 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
By submission of the Traditional 510(k), Shenzhen Changke Connect Electronics Co., Ltd. is requesting clearance for Reusable NIBP Cuff. It is comparable to the following legally marketed system:
- Shenzhen Caremed Medical Technology Co., Ltd. Reusable Blood Pressure Cuff under 1. K182433.
The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety.
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So, the conclusion is that the subject device is substantial equivalent to the predicate.
#### 5. Device Description
The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.
The subject device includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube.
The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.
#### 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.
| | 7. Comparison to the Predicate Device | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Features | Subject Device<br>Reusable NIBP Cuff | Predicate Device K182433<br>Reusable Blood Pressure Cuff | Remark |
| Applicant | Shenzhen Changke Connect<br>Electronics Co., Ltd. | Shenzhen Caremed Medical<br>Technology Co., Ltd. | / |
| Classification<br>Regulation | 21CRF 870.1120 | 21CRF 870.1120 | Same |
| Classification<br>and Code | Class II,<br>DXQ | Class II,<br>DXQ | Same |
| Common<br>name | Non-invasive Blood Pressure<br>Cuff | Non-invasive Blood Pressure<br>Cuff | Same |
| Intended use | The reusable blood pressure cuff is<br>an accessory used in conjunction<br>with noninvasive blood pressure<br>measurement systems. The cuff is<br>non-sterile and may be reused. It is<br>available in neonate, infant, child<br>and adult sizes. The cuff is not<br>designed, sold, or intended for use<br>except as indicated. | The reusable blood pressure cuff is<br>an accessory used in conjunction<br>with noninvasive blood pressure<br>measurement systems. The cuff is<br>non-sterile and may be reused. It is<br>available in neonate, infant, child<br>and adult sizes. The cuff is not<br>designed, sold, or intended for use<br>except as indicated. | Same |
| Patient<br>Populations | Adults/Pediatrics | Adults/Pediatrics | Same |
| Tube Number | One | One or two | Different |
| | | | (1) |
| Principles of<br>Operation | Bladder is wrapped around the<br>patient's limb and secured by hook<br>and loop closure Air hose is<br>connected to the noninvasive blood<br>pressure measurement systems | Bladder is wrapped around the<br>patient's limb and secured by hook<br>and loop closure Air hose is<br>connected to the noninvasive blood<br>pressure measurement systems | Same |
| Limb<br>Circumference<br>(Range in cm) | Conform to AHA bladder sizes<br>recommendations<br>CK-XT-78211-XXX Series:<br>Infant (10-15cm)<br>Child (14-21.5cm)<br>Small Adult (20.5-28cm)<br>Adult (27-35cm)<br>Large Adult (34-43cm)<br>Adult Thigh (42-54cm)<br><br>CK-XT-78243-XXX Series:<br>Neonatal (6-11cm)<br>Infant (10-19cm)<br>Child (18-26cm)<br>Adult (25-35cm)<br>Large Adult (33-47cm)<br>Adult Thigh (44-66cm) | Conform to AHA bladder sizes<br>recommendations<br>Neonatal (6-11cm)<br>Infant (10-19cm)<br>Child (18-26cm)<br>Small Adult (20-28cm)<br>Adult (25-35cm)<br>Adult Long (25-35cm)<br>Large Adult (33-47cm)<br>Adult Thigh (44-66cm) | Different<br>(2) |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Max. Leakage | < 4mm Hg/ min. | < 4mm Hg/ min. | Same |
| Material | CK-XT-78211-XXX Series:<br>Cuff (Patient contacted): PU<br>Synthetic Leather<br>Bladder: TPU<br>Tubing: TPU<br>Hook: Nylon<br>Loop: Nylon<br><br>CK-XT-78243-XXX Series:<br>Cuff (Patient contacted): Nylon<br>Bladder: TPU<br>Tubing: Silica gel<br>Hook: Nylon<br>Loop: Nylon | Cuff (Patient contacted): PU<br>Synthetic Leather<br>Bladder: Transparent Polyurethane<br>(TPU Film)<br>Tubing: PVC<br>Hook: Molded Nylon<br>Loop: Nylon | Different<br>(3) |
| y | No sensitization observed;<br>Negligible (no observed primary<br>irritation) | No sensitization observed;<br>Negligible (no observed primary<br>irritation) | |
### Comparison to the Predicate Device 7
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## Justification of differences:
Justifications for differences between subject device and the predicate device are shown as below:
Different (1): The predicate device includes single tube configuration. All models of subject device use single tube. This difference does not raise any safety or effectiveness issue. Different (2): The limb circumference of subject device is included in the range of the predicate device. And it is disclosed in user manual clearly for selection. Therefore, this difference does not raise any safety or effectiveness issue.
Different (3): The material of subject device and predicate device is different, but both of them comply with ISO 10993-5 and ISO 10993-10. Therefore, this difference does not result in any safety and effectiveness issue.
### Conclusion:
The subject devices share the same indications for use, device operation, overall technical and functional capabilities, meet the same standards and requirements and therefore, are substantially equivalent to the predicate device(s).
#### 8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
### Biocompatibility testing
The biocompatibility evaluation for the subject device 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 subject devices 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 subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
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- . 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
The test was selected to show substantial equivalence between the subject device and the predicate.
#### 9. Conclusion
It has been shown in this 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.
