(58 days)
Not Found
No
The device is a blood pressure cuff, an accessory for blood pressure measurement systems. The description focuses on its physical characteristics and compliance with standards for non-automated measurement and biocompatibility. There is no mention of AI, ML, or any computational processing of data beyond basic pressure measurement.
No
The device is described as an accessory used in conjunction with noninvasive blood pressure measurement systems. It does not exert or transmit energy to or from a patient, or provide a means of administering therapeutic agents into a patient; rather, it is used for diagnostic purposes (measuring blood pressure).
No.
The device is a blood pressure cuff, which is an accessory used for measurement systems, not a diagnostic device itself. It does not output diagnostic information or interpret signals clinically.
No
The device description explicitly states it includes physical components: "disposable blood pressure cuff and reusable blood pressure cuff," which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states that the device is a "reusable blood pressure cuff" and a "disposable blood pressure cuff" used as an "accessory used in conjunction with noninvasive blood pressure measurement systems."
- Mechanism of Action: Blood pressure cuffs work by physically constricting a limb to temporarily stop blood flow and then measuring the pressure as the blood flow returns. This is a mechanical process performed on the body, not a test performed on a sample taken from the body.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, chemical reactions, or any other processes typically associated with in vitro diagnostics. The performance studies focus on physical properties (leakage) and biological compatibility (cytotoxicity, irritation, sensitization), not diagnostic accuracy based on sample analysis.
Therefore, the blood pressure cuff described is a medical device used for a non-invasive 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.
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 (comma separated list FDA assigned to the subject device)
DXQ
Device Description
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. 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.
Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811.
Disposable NIBP Cuff: SC0101, SC0102, SC0103, SC0104, SC0105, SC0106, SC0107, SC0108, SC0109, SC0110, SC0111, SC0112.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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)
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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 |