(59 days)
Not Found
No
The description focuses on the physical components and materials of a disposable blood pressure cuff, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an accessory used in conjunction with noninvasive blood pressure measurement systems to secure an inflatable bladder around a patient's limb for blood pressure measurement, and its intended use is for measurement, not therapy.
No
The device is a disposable blood pressure cuff, which is an accessory used in conjunction with noninvasive blood pressure measurement systems. Its function is to facilitate the measurement, not to perform the diagnostic analysis itself.
No
The device description clearly states it is a disposable blood pressure cuff made of physical materials (non-woven fabrics, PVC) and contains a bladder and air hose, indicating it is a hardware device.
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 provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a disposable blood pressure cuff. Its function is to be wrapped around a patient's limb and inflated to allow a noninvasive blood pressure measurement system to determine blood pressure. This is a physical interaction with the patient's body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's an "accessory used in conjunction with noninvasive blood pressure measurement systems." This reinforces its role in a physical measurement process, not a diagnostic test on a biological sample.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, analysis of biological samples, or any other characteristics typically associated with IVD devices.
Therefore, the disposable blood pressure cuff is a medical device used for a physical measurement, not an in vitro diagnostic test.
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 neonatal, pediatric and adult sizes.
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, pediatric and adult sizes.
The proposed device is disposable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.
During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.
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 disposable blood pressure cuff is provided as non-sterile.
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
neonatal, infant, pediatric 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)
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:
- 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.
- ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity: Under the conditions of the study, not cyteotoxicity effect.
Irritation: Under the conditions of the study, not an irritant.
Sensitization: Under conditions of the study, not a sensitizer.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of a human figure, with three faces overlapping each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Shenzhen Vistar Medical Supplies Co., Ltd. Mr. Ray Wang Official Correspondent 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CN
Re: K152465
Trade/Device Name: Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: August 25, 2015 Received: August 31, 2015
Dear Mr. Ray 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. 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
1
Page 2 - Mr. Ray Wang
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stei
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) K152465
Device Name Disposable Blood Pressure 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 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
K152465
Page 1 of 5
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________
-
- Date of Preparation:2015/8/26
-
- Sponsor Identification
Shenzhen Vistar Medical Supplies Co., Ltd. 808, Hanhaida Bldg., No. 7 Songgang Blvd. Songgang Town, Shenzhen, China 518105
Establishment Registration Number: Pending
Contact Person: Zhenxun Chen Position: General Manager Tel: +86-0755-85298331 Fax:+86-0755-85298331 Email: chainy.chen@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Tech. Service Co., Ltd
Tel: +86-21-50313932, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
4
K152465 Page 2 of 5
Identification of Proposed Device 4.
Trade Name: Disposable Blood Pressure Cuff Common Name: Blood Pressure Cuff Model(s): V1011N,V1012N,V1013N,V1014N,V1015N,V1011C,V1012C,V1013C,V1014C,V1014C-L,V1015 C. V1015C-L.V1016C: V1021N,V1022N,V1023N,V1024N,V1025N,V1021C,V1023C,V1023C,V1024C,V1024C-L,V102 5C, V1025C-L,V1026C;
Regulatory Information
Classification Name: Blood Pressure Cuff Classification: 2 Product Code: DXQ Regulation Number: 870.1120 Review Panel: Cardiovascular
Indication For Use Statement:
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.
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 is disposable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.
During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.
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 disposable blood pressure cuff is provided as non-sterile.
5
K152465 Page 3 of 5
-
ડ. Identification of Predicate Device(s)
Predicate Device K151290 Disposable/Reusable Blood Pressure Cuff Xuzhou Maicuff Technology Co., Ltd. -
Non-Clinical Test Conclusion 6.
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: -
ハ ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
A ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
K152465 Page 4 of 5
8. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device
(Disposable Blood Pressure Cuff) | Predicate Device (K151290) | Remark |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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
neonatal, 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. | SE |
| Patient
Populations | Adults/Pediatrics | Adults/Pediatrics | |
| Tube
Configuration | One or two tube | One or two tube | SE |
| 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 | SE |
| Size | Conform to AHA bladder sizes
recommendations
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 cm)
Large Adult(35.5-46 cm)
Large Adult (35.5 - 46 cm)
Thigh (45 - 56.5 cm) | Conform to AHA bladder sizes
recommendations
Neonatal 1 (3-5.5 cm)
Neonatal 2 (4-8 cm)
Neonatal 3 (6-11 cm)
Neonatal 4 (7-13 cm)
Infant (9-14.5 cm)
Pediatric (13-21.5 cm)
Small Adult (21-27 cm)
Adult (26-35.5 cm)
Large Adult(35-45 cm) | Analysis 1 |
| Single Use | Y | Y | SE |
| Sterile | No | No | SE |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | SE |
| Max. Pressure | 400 mmHg | >350 mmHg | SE |
| Tubing
Size (mm) | OD = 8.0; ID=4.0; L=200; | OD = 8.0; ID=4.0; L=200; | SE |
| Max. Leakage |