(131 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics, materials, and basic performance metrics of a reusable blood pressure cuff, with no mention of AI or ML technologies.
No.
The blood pressure cuff is explicitly described as an "accessory used in conjunction with noninvasive blood pressure measurement systems" and is not designed to directly treat a medical condition.
No
The device is described as an "accessory used in conjunction with noninvasive blood pressure measurement systems" and a "reusable blood pressure cuff." Its purpose is to facilitate blood pressure measurement, not to directly diagnose a medical condition.
No
The device description explicitly states it is a reusable blood pressure cuff made of physical materials (PU synthetic leather, TPU, Nylon, silica gel) and includes a cuff with a bladder and an air hose. This indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this is a reusable blood pressure cuff, an accessory used with noninvasive blood pressure measurement systems. It is applied to the patient's limb to measure blood pressure.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. It is a physical component used externally on the patient.
- Testing Performed: The performance studies mentioned are related to biocompatibility and physical performance (leakage), not the analysis of biological samples.
Therefore, this device falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DXQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
neonate, infant, child and adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was conducted in accordance with ISO 10993-1. The battery of testing included Cytotoxicity, Sensitization, and Irritation.
Non-clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated compliance with ISO 81060-1, ISO 10993-5: 2009, and ISO 10993-10: 2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Max. Leakage
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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,
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
2
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)
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) | ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
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, |
| CK-XT-78211-007, CK-XT-78211-008, CK-XT-78243-000, CK-XT-78243-001, | |
| 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.
4
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 | ||
| Reusable NIBP Cuff | Predicate Device K182433 | ||
| Reusable Blood Pressure Cuff | Remark | ||
| Applicant | Shenzhen Changke Connect | ||
| Electronics Co., Ltd. | Shenzhen Caremed 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 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 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. | Same | ||
| Patient | |||
| Populations | Adults/Pediatrics | Adults/Pediatrics | Same |
| Tube Number | One | One or two | Different |
| (1) | |||
| 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) | Conform to AHA bladder sizes | ||
| recommendations | |||
| CK-XT-78211-XXX Series: | |||
| Infant (10-15cm) | |||
| Child (14-21.5cm) | |||
| Small Adult (20.5-28cm) | |||
| Adult (27-35cm) | |||
| Large Adult (34-43cm) | |||
| Adult Thigh (42-54cm) |
CK-XT-78243-XXX Series:
Neonatal (6-11cm)
Infant (10-19cm)
Child (18-26cm)
Adult (25-35cm)
Large Adult (33-47cm)
Adult Thigh (44-66cm) | Conform to AHA bladder sizes
recommendations
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) | Different
(2) |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Max. Leakage |