(53 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 infant, pediatric and adult sizes. 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 neonatal, pediatric and adult sizes.
The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics &PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
This is a 510(k) premarket notification for Reusable Blood Pressure Cuffs and Disposable Blood Pressure Cuffs. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by compliance with specific international standards. The performance is reported as meeting these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Non-cytotoxic | Under the conditions of the study, not cytotoxic (Complies with ISO 10993-5:2009/(R) 2014) |
| Non-irritant | Under the conditions of the study, not an irritant (Complies with ISO 10993-10:2010) |
| Non-sensitizer | Under the conditions of the study, not a sensitizer (Complies with ISO 10993-10:2010) |
| Physical/Performance: | |
| Pressure Range: 0-300 mmHg | 0-300 mmHg |
| Max. Pressure: 400 mmHg | 400 mmHg |
| Max. Leakage: < 4 mmHg/min | < 4 mmHg/min |
| Tubing Size (OD, ID, L) | OD = 8.0; ID = 4.0; L = 200 (mm) |
| Conformity to AHA bladder sizes Recommendations | Conform to AHA bladder sizes Recommendations (Specific differences noted but considered not to affect SE) |
| Performance and Biocompatibility Test (ISO 81060-1) | Complies with ISO 81060-1:2007 (for non-automated measurement type) |
| Safety (ISO 10993-1) | Complies with ISO 10993-1 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (biocompatibility and physical performance). The testing was conducted to verify compliance with ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 81060-1). The provenance of the data is not specified in terms of country of origin or whether it was retrospective/prospective, but it would have been generated during product development and testing phases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the acceptance criteria are based on compliance with international standards (e.g., ISO 10993, ISO 81060-1) rather than expert-established ground truth in a diagnostic context. The ground truth for such tests is derived from the established testing methodologies and pass/fail criteria defined within those standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where human interpretation and consensus are needed to establish ground truth. For the non-clinical tests described (biocompatibility, physical performance), outcomes are determined by adherence to standardized testing protocols and objective measurement against defined thresholds in the ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a blood pressure cuff, a measurement accessory, not an AI-powered diagnostic device. Therefore, an MRMC study and analysis of AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical accessory (blood pressure cuff), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating compliance is based on objective measurements and pass/fail criteria defined within recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 81060-1 for non-invasive sphygmomanometers). These standards provide the established benchmarks for device performance and safety.
8. The Sample Size for the Training Set
This is not applicable. As the device is a physical accessory and not an AI/ML algorithm requiring a training set, this information is irrelevant.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2017
Ningbo Albert Novosino Co.,Ltd. % Ms. Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903 of Dongbao Building No. 19 Dongbao Road, Songjiang Area Shanghai, 201316 Cn
Re: K173044
Trade/Device Name: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: September 20, 2017 Received: September 28, 2017
Dear Ms. Doris Dong:
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. 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 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); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173044
Device Name REUSABLE BLOOD PRESSURE CUFF; DISPOSABLE BLOOD PRESSURE CUFF
Indications for Use (Describe)
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 infant, pediatric and adult sizes. 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 neonatal, pediatric and adult sizes.
| 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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Section 5 510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Sponsor
Ningbo Albert Novosino Co.,Ltd. No. 1 Xinheng 3 Road Cicheng Town, Jiangbei District, Ningbo, Zhejiang, P.R. China 315036 Phone: +86 574-83002882 Fax: +86 574-87527880 Contact: Victor Zhou
2. Submission Correspondent
Shanghai CV Technology Co., Ltd. Room 903 of Dongbao Building, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China Phone: 86 21-31261348 Fax: 86 21-57712250 Contact: Doris Dong(Consultant) Email: doris_d@126.com
3. Date Prepared
Sept 20, 2017
4. Device Identification
Trade/Proprietary Name: REUSABLE BLOOD PRESSURE CUFF; DISPOSABLE BLOOD PRESSURE CUFF Common Name/Classification Name: Blood Pressure Cuff Product Code: DXQ Regulation Number: 21 CFR 870.1120 Regulation Class : Class II Review Panel: Cardiovascular
5. Predicate Devices
The proposed devices are substantially equivalent to the following predicate devices :
| Applicant | Device name | 510(k) Number | Product code |
|---|---|---|---|
| Shenzhen Vistar Medical | Disposable Blood Pressure Cuff | K152465 | DXC |
| Supplies Co., Ltd. |
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| Shenzhen Vistar MedicalSupplies Co., Ltd. | Reusable Blood Pressure Cuff | K152468 | DXQ |
|---|---|---|---|
| ----------------------------------------------- | ------------------------------ | --------- | ----- |
6. Device Description
The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes.
The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.
The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics &PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.
The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient.
The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
7. Indication for Use Statement
· 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 infant, pediatric and adult sizes.
· 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 neonatal, pediatric and adult sizes.
8. Comparison of Technological Characteristics
The following table compares the proposed devices to the predicate device with respect to K173044
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Page 3 of 6
intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Trade name | DISPOSABLE BLOOD | DISPOSABLE BLOOD | |
| PRESSURE CUFF | PRESSURE CUFF | ||
| 510(K) | Ningbo Albert Novosino Co.,Ltd. | Shenzhen Vistar Medical | |
| Submitter | Supplies Co., Ltd. | ||
| 510(K) | K173044 | K152465 | |
| Number | |||
| Classification | 21CRF 870.1120 | 21CRF 870.1120 | SE |
| Regulation | |||
| Classification | Class II, | Class II, | SE |
| and Code | DXQ | DXQ | |
| Common | Non-invasive Blood Pressure | Non-invasive Blood Pressure | SE |
| name | Cuff | Cuff | |
| Intended Use | The disposable blood pressure cuff | The disposable blood pressure | SE |
| is an accessory used in | cuff is an accessory used in | ||
| conjunction with noninvasive | conjunction with noninvasive | ||
| blood pressure measurement | blood pressure measurement | ||
| systems. The cuff is non-sterile | systems. The cuff is non-sterile | ||
| and for single-patient use. It is | and for single-patient use. It is | ||
| available in neonatal, pediatric and | available in neonatal, pediatric | ||
| adult sizes. | and adult sizes. | ||
| Patient | Adults/Pediatrics | Adults/Pediatrics | SE |
| Populations | |||
| Tube | One or two tube | One or two tube | SE |
| Configuration | |||
| Principles of | Bladder is wrapped around the | Bladder is wrapped around the | SE |
| Operation | patient's limb and secured by hook | patient's limb and secured by | |
| and loop closure Air hose is | hook and loop closure Air hose is | ||
| connected to the noninvasive | connected to the noninvasive | ||
| blood pres sure measurement | blood pressure measurement | ||
| systems | systems | ||
| Size | Conform to AHA bladder sizes | Conform to AHAbladder sizes | Analysis 1 |
| Recommendations | Recommendations | ||
| Neonatal 1 (3-6 cm) | Neonatal 1 (3-6 cm) | ||
| Neonatal 2 (4-8cm) | Neonatal 2 (4-8 cm) | ||
| Neonatal 3 (6-11 cm) | Neonatal 3 (6-11 cm) | ||
| Neonatal 4 (7-13 cm) | Neonatal 4 (7-13 cm) |
Table 5A - General Comparison(DISPOSABLE BLOOD PRESSURE CUFFS)
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Ningbo Albert Novosino Co.,Ltd.
No.1 Xinheng 3 Road Cicheng Town,Jiangbei District,315036 Ningbo, Zhejiang, P.R. China K173044 Page 4 of 6
| Neonatal 5 (8-15cm) | Neonatal 5 (8-15 cm) | ||
|---|---|---|---|
| Infant (8-14 cm) | Infant (9-14.8 cm) | ||
| Child (13-20 cm) | Child (13.8-21.5 cm) | ||
| Small Adult (18-26 cm) | Small Adult (20.5-28.5 cm) | ||
| Adult (26-35 cm) | Adult (27.5-36.5 cm) | ||
| Adult Long (29-38 cm) | Adult Long (27.5-36.5 cm) | ||
| Large Adult (32-42 cm) | Large Adult(35.5-46 cm) | ||
| Large Adult Long (35-44 cm) | Large Adult (35.5 – 46 cm) | ||
| Thigh (42 – 50 cm) | Thigh (45 – 56.5 cm) | ||
| Single Use | Y | Y | SE |
| Sterile | No | No | SE |
| PressureRange | 0-300 mmHg | 0-300 mmHg | SE |
| Max.Pressure | 400mmHg | 400mmHg | SE |
| TubingSize(mm) | OD = 8.0; ID=4.0; L=200; | OD = 8.0; ID=4.0; L=200; | SE |
| Max. Leakage | < 4mm Hg/ min. | < 4mm Hg/ min. | SE |
| Material | non-woven fabrics & PVC (Cuff)and PVC(Air Hose) | non-woven fabrics & PVC (Cuff)and PVC(Air Hose) | SE |
Table 5B - General Comparison(REUSABLE BLOOD PRESSURE CUFFS)
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Trade name | REUSABLE BLOODPRESSURE CUFF | REUSABLE BLOODPRESSURE CUFF | |
| 510(K)Submitter | Ningbo Albert Novosino Co.,Ltd. | Shenzhen Vistar MedicalSupplies Co., Ltd. | |
| 510(K)Number | K173044 | K152468 | |
| ClassificationRegulation | 21CRF 870.1120 | 21CRF 870.1120 | SE |
| Classificationand Code | Class II,DXQ | Class II,DXQ | SE |
| Commonname | Non-invasive Blood PressureCuff | Non-invasive Blood PressureCuff | SE |
| Intended Use | The reusable blood pressure cuff isan accessory used in conjunctionwith noninvasive blood pressuremeasurementsystems. The cuff is non-sterileand may be reused. It is available | The reusable blood pressure cuffis an accessory used inconjunction with noninvasiveblood pressure measurementsystems. The cuff is non-sterileand may be reused. It is available | SE |
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Ningbo Albert Novosino Co.,Ltd.
No.1 Xinheng 3 Road Cicheng Town,Jiangbei District,315036 Ningbo, Zhejiang, P.R. China K173044 Page 5 of 6
| in infant, pediatric and adult sizes. | in infant, pediatric and adult sizes. | ||
|---|---|---|---|
| PatientPopulations | Adults/Pediatrics | Adults/Pediatrics | SE |
| TubeConfiguration | One or two tube | One or two tube | SE |
| Principles ofOperation | Bladder is wrapped around thepatient's limb and secured by hookand loop closure Air hose isconnected to the noninvasiveblood pressure measurementsystems | Bladder is wrapped around thepatient's limb and secured byhook and loop closure Air hose isconnected to the noninvasiveblood pressure measurementsystems | SE |
| Size | Conform to AHA bladder sizesRecommendationsInfant (8-14 cm)Child (13-20 cm)Small Adult (18-26 cm)Adult (26-35 cm)Adult Long (29-38 cm)Large Adult (32-42 cm)Large Adult Long (35-44 cm)Thigh (42 - 50 cm) | Conform to AHA bladder sizesRecommendationsInfant (8-13 cm)Child (12-19 cm)Small Adult (17-25 cm)Adult (23-33 cm)Adult Long (23-33 cm)Large Adult(31-40 cm)Large Adult Long (31 - 40 cm)Thigh (38 - 50 cm) | Analysis 1 |
| Single Use | Y | Y | SE |
| Sterile | No | No | SE |
| PressureRange | 0-300 mmHg | 0-300 mmHg | SE |
| Max.Pressure | 400mmHg | 400mmHg | SE |
| TubingSize(mm) | OD = 8.0; ID=4.0; L=200; | OD = 8.0; ID=4.0; L=200; | SE |
| Max. Leakage | < 4mm Hg/ min. | < 4mm Hg/ min. | SE |
| Material | 210D Nylon TPU (Cuff) and PVC(Air Hose) | 210D Nylon TPU (Cuff) and PVC(Air Hose) | SE |
Analysis 1:
The proposed device has different cuff sizes compared with the predicate device for different patient arm circumference. The proposed devices are compliant with the ISO 81060-1 for the performance and Biocompatibility test and ISO 10993-1 for safety. We consider that these differences do not affect the substantial equivalence, safety or effectiveness when compared with the predicate device.
| Table 5C - Biocompatibility Comparison | |||
|---|---|---|---|
| -- | -- | -- | ----------------------------------------- |
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Cytotoxicity | Under the conditionsof the study, not | Comply with ISO10993-5 | SE |
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Ningbo Albert Novosino Co.,Ltd.
No.1 Xinheng 3 Road Cicheng Town.Jiangbei District.315036 Ningbo, Zhejiang, P.R. China K173044 Page 6 of 6
| cyteotoxicity effect | |||
|---|---|---|---|
| Irritation | Under the conditions of the study, not an irritant | Comply with ISO 10993-10 | SE |
| Sensitization | Under conditions of the study, not a sensitizer. | SE |
Conclusion:
The proposed 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).
9. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device 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:
· AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices --Part 5: Tests For In Vitro Cytotoxicity.
· ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
· ISO 81060-1:2007 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Statement of Substantial Equivalence
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. Therefore the proposed devices are determined to be substantially equivalent to the referenced predicate Devices.
§ 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).