(90 days)
No
The device description and performance studies focus on the physical characteristics and basic functionality of a disposable blood pressure cuff, with no mention of AI or ML.
No
Explanation: The device is an accessory (disposable blood pressure cuff) used for measurement, not for treating a condition or disease.
No
The device is described as an "accessory used in conjunction with noninvasive blood pressure measurement systems." It is a blood pressure cuff, which is a component used to take a measurement, not a device that itself diagnoses a condition.
No
The device description explicitly states it is a disposable blood pressure cuff made of non-woven fabrics and PVC, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be an accessory for noninvasive blood pressure measurement systems. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The device is a blood pressure cuff, which is a mechanical component used to apply pressure to a limb for blood pressure measurement. It does not involve the analysis of biological samples.
- Performance Studies: The performance studies focus on biocompatibility and compliance with standards for non-invasive sphygmomanometers. These are relevant to a medical device used on a patient, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the device is a medical device used for a physiological measurement on a patient, not an IVD which analyzes biological samples in a lab setting.
N/A
Intended Use / Indications for 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.
Product codes
DXO
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 disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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 ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007. The test was selected to show substantial equivalence between the subject device and the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
March 25, 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: K193629
Trade/Device Name: Disposable NIBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: December 24, 2019 Received: December 26, 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.
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,
LT 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) K193629
Device Name Disposable NIBP Cuff
Indications for Use (Describe)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
FORM FDA 3881 (7/17)
3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2019/12/24
Submission sponsor 1.
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 | Disposable NIBP Cuff |
|---|---|
| Model | CK-XT-88062-001, CK-XT-88062-003, CK-XT-88062-005, CK-XT-88062- |
| 007, CK-XT-88062-008, CK-XT-88062-010 | |
| Common Name | Non-invasive Blood pressure cuff |
| Regulatory Class | Class II |
| Classification | 21CFR 870.1120 / Blood pressure cuff / DXQ |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.
Device: Caremed Disposable Blood Pressure Cuff
510(k) No.: K182433.
Device Description 5.
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 disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube.
4
The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.
6. Intended use & Indication for 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.
| Features | Subject Device
Disposable NIBP Cuff | Predicate Device K182433
Disposable 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 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 | One | Same |
| 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 | Conform to AHA bladder sizes | Conform to AHA bladder sizes | Different |
Comparison to the Predicate Device 7.
5
| Circumference | recommendations | recommendations | (1) |
|---|---|---|---|
| (Range in cm) | Neonatal (7-13 cm) | Neonatal 1 (3-6 cm) | |
| Infant (9-14.8 cm) | Neonatal 2 (4-8 cm) | ||
| Child (13.8-21.5 cm) | Neonatal 3 (6-11 cm) | ||
| Adult (27.5-36.5 cm) | Neonatal 4 (7-13 cm) | ||
| Large Adult (35.5-46 cm) | Neonatal 5 (8-15 cm) | ||
| Adult Thigh (45-56.5 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) | |||
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Max. Leakage |