(58 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA regarding a non-invasive blood pressure (NIBP) cuff. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's accuracy or efficacy as one might find for a more complex AI-driven medical device.
Therefore, the requested information, particularly concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (like an effect size of human readers improving with AI, or standalone algorithm performance), is largely not applicable to this document. This document primarily describes the physical characteristics, intended use, and manufacturing standards of a blood pressure cuff.
However, I can extract the relevant information where available, focusing on performance data related to blood pressure cuffs.
Here's an analysis based on the provided text:
Key Takeaway: This 510(k) submission primarily relies on physical and material testing and comparison to a predicate device to demonstrate substantial equivalence, not a clinical study proving its performance against specific physiological accuracy criteria in humans, nor an AI-driven system's performance.
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of acceptance criteria and corresponding reported device performance in the same way one would for an AI model's diagnostic accuracy. Instead, it refers to compliance with established standards for blood pressure cuffs.
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Acceptance Criteria (as implied by standards compliance):
- Max. Leakage: < 4mm Hg/min (for both reusable and disposable cuffs, identical to predicate)
- Biocompatibility: Compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) for patient-contacting materials.
- Non-Invasive Sphygmomanometers Performance: Compliance with ISO 81060-1 (Requirements and Test Methods for Non-Automated Measurement Type).
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Reported Device Performance:
- Max. Leakage: Met the < 4mm Hg/min criteria (implied by "The test results demonstrated that the proposed device complies with the following standards").
- Biocompatibility: Cytotoxicity, Sensitization, and Irritation tests were conducted and the device "Comply with ISO 10993-5; Comply with ISO 10993-10."
- ISO 81060-1 Compliance: The device met "all design specifications as was Substantially Equivalent (SE) to the predicate device" and complied with ISO 81060-1. This standard outlines accuracy requirements for NIBP devices (e.g., mean difference and standard deviation of blood pressure measurements compared to a reference). While the specific numerical results (mean difference, standard deviation) are not provided in this summary, compliance with this standard indicates these performance metrics were met.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify human clinical trial sample sizes. The testing mentioned is primarily non-clinical (materials, leakage, mechanical). For ISO 81060-1, compliant NIBP devices typically undergo clinical validation with a certain number of subjects (e.g., ANSI/AAMI/ISO 81060-2 specifies requirements, often involving over 85 subjects for accuracy validation). However, this 510(k) summary likely relies on the predicate device's clinical validation and the subject device's adherence to relevant parts of the standard (ISO 81060-1, which focuses on non-automated devices and test methods, rather than the clinical validation part 2). The document notes "Non-clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent".
- Data Provenance: Not specified. Based on the manufacturer and consultant location (Shenzhen, China), it's likely the non-clinical tests were conducted in China. The "retrospective or prospective" nature is not applicable here as no clinical trial data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/algorithm-driven device requiring expert adjudication for ground truth (e.g., radiologists reviewing images). The acceptance criteria relate to physical properties and compliance with medical device standards for blood pressure cuffs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a hardware medical device (blood pressure cuff), not an AI-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by compliance with engineering and biocompatibility standards (e.g., ISO 81060-1 for performance, ISO 10993 for biocompatibility). For accuracy, the "ground truth" is typically a reference blood pressure measurement device.
8. The sample size for the training set
- Not Applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary, this 510(k) notification focuses on the manufacturing, physical characteristics, and material safety (biocompatibility) of blood pressure cuffs, demonstrating their substantial equivalence to a legally marketed predicate device by complying with relevant international standards. The criteria and studies are for a traditional medical device, not an AI-powered system that would involve clinical performance metrics and ground truth establishment involving human interpretation or large datasets.
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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
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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
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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.
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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 DeviceCaremed Reusable BloodPressure CuffK182433 | Subject DeviceReusable NIBP CuffK231961 | Remark |
|---|---|---|---|
| Applicant | Shenzhen Caremed MedicalTechnology Co., Ltd. | Shenzhen SINO-K MedicalTechnology Co., Ltd | / |
| ClassificationRegulation | 21CRF 870.1120 | 21CRF 870.1120 | Same |
| Classificationand Code | Class II,DXQ | Class II,DXQ | Same |
| Commonname | Non-invasive Blood PressureCuff | Non-invasive Blood PressureCuff | 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 BloodPressure CuffK182433 | Reusable NIBP CuffK231961 | ||
| and may be reused. It is availablein neonate, infant, child and adultsizes. The cuff is not designed,sold, or intended for use exceptas indicated. | available in neonate, infant, childand adult sizes. The cuff is notdesigned, sold, or intended for useexcept as indicated. | ||
| PatientPopulations | Adults/Pediatrics | Adults/Pediatrics | Same |
| Tube Number | One or two | One | Different |
| Principles ofOperation | Bladder is wrapped around thepatient's limb and secured byhook and loop closure Air hose isconnected to the noninvasiveblood pressure measurementsystems | Bladder is wrapped around thepatient's limb and secured by hookand loop closure Air hose isconnected to the noninvasive bloodpressure measurement systems | Same |
| LimbCircumference(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, smalladult, 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): PUSynthetic LeatherBladder: TransparentPolyurethane (TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon | Cuff (Patient contacted): PUSynthetic LeatherBladder: Transparent Polyurethane(TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon | Same |
| Biocompatibility | Comply with ISO 10993-5; | Comply with ISO 10993-5; | Same |
| Features | Predicate DeviceCaremed Reusable BloodPressure CuffK182433 | Subject DeviceReusable NIBP CuffK231961 | Remark |
| Comply with ISO 10993-10 | Comply with ISO 10993-10 |
Comparison to Predicate Device Caremed Reusable Blood Pressure Cuff:
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Comparison to Predicate Device Caremed Disposable Blood Pressure Cuff:
| Features | Predicate DeviceCaremed Disposable BloodPressure Cuff | Subject DeviceDisposable NIBP Cuff | Remark |
|---|---|---|---|
| Applicant | Shenzhen Caremed MedicalTechnology Co., Ltd. | Shenzhen SINO-K MedicalTechnology Co., Ltd | / |
| Intended use | The disposable blood pressure cuffis an accessory used in conjunctionwith noninvasive blood pressuremeasurement systems. The cuff isnon-sterile and for single-patientuse. It is available in neonate, infant,child and adult sizes. The cuff is notdesigned, sold, or intended for useexcept as indicated. | The disposable blood pressurecuff is an accessory used inconjunction with noninvasiveblood pressure measurementsystems. The cuff is non-sterileand for single-patient use. It isavailable in neonate, infant,child and adult sizes. The cuff isnot designed, sold, or intendedfor use except as indicated. | Same |
| PatientPopulations | Adults/Pediatrics | Adults/Pediatrics | Same |
| Tube Number | One or two | One | Different |
| LimbCircumference(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 |
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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
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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.
§ 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).