(53 days)
No
The description focuses on the physical components, materials, and sizes of blood pressure cuffs, which are passive accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an accessory used in conjunction with noninvasive blood pressure measurement systems to measure blood pressure, not to treat a condition.
No
Explanation: The device is a blood pressure cuff, which is an accessory used for noninvasive blood pressure measurement systems. It does not independently provide a diagnosis but is a component of a system that measures a physiological parameter.
No
The device description explicitly details physical components (cuff, bladder, air hose) made of materials like non-woven fabrics, PVC, and Nylon TPU. It also describes different sizes and configurations (single/double tube), indicating a hardware-based device.
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.
- Device Description: The device is a blood pressure cuff, which is a mechanical component used to apply pressure to a limb to measure blood pressure.
- 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. This device does not perform any such tests on biological samples.
- Performance Studies: The performance studies mentioned are related to biological evaluation (cytotoxicity, irritation, sensitization) and compliance with standards for non-invasive sphygmomanometers, not in vitro diagnostic performance metrics.
Therefore, the description clearly indicates a device used for direct physiological measurement on a patient, not for testing biological samples in vitro.
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 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.
Product codes
DXO
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.
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
The REUSABLE BLOOD PRESSURE CUFF is available in infant, pediatric and adult sizes.
The DISPOSABLE BLOOD PRESSURE CUFF is available in neonatal, pediatric and adult sizes.
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)
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
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 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
1
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
2
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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3
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. |
4
| Shenzhen Vistar Medical
| Supplies 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
5
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 |
| Pressure | |||
| Range | 0-300 mmHg | 0-300 mmHg | SE |
| Max.Pressure | 400mmHg | 400mmHg | SE |
| Tubing | |||
| Size(mm) | OD = 8.0; ID=4.0; L=200; | OD = 8.0; ID=4.0; L=200; | SE |
| Max. Leakage |