(102 days)
Not Found
No
The device description and intended use focus solely on the physical components and function of a blood pressure cuff, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device is a blood pressure cuff, which is an accessory used for measurement systems. It does not provide any therapy or treatment itself.
No
Explanation: This device is a blood pressure cuff, which is an accessory used with blood pressure measurement systems. The cuff itself does not perform the diagnostic measurement or provide medical insight; it facilitates the measurement by the blood pressure system.
No
The device description explicitly details physical components like cuffs, bladders, and air hoses, and mentions materials like non-woven fabrics, PVC, and PU. This indicates a hardware-based medical device, not a software-only one.
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 blood pressure cuff is an "accessory used in conjunction with noninvasive blood pressure measurement systems." Its function is to be placed on a patient's limb to facilitate the measurement of blood pressure. This is a physical interaction with the patient's body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
- Performance Studies: The performance studies mentioned focus on physical and biological compatibility (cytotoxicity, irritation, sensitization) and compliance with standards related to non-invasive sphygmomanometers, not on the accuracy or performance of a diagnostic test on a biological sample.
Therefore, the reusable and disposable blood pressure cuffs described are medical devices used for non-invasive physiological measurement, not in vitro diagnostic devices.
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)
DXO
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 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), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.
The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 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 PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.
The reusable blood pressure cuff has 16 models with 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
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 Caremed Blood Pressure Cuffs 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 Caremed Blood Pressure 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 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 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
The test was selected to show substantial equivalence between the subject device and the predicate.
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
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December 17, 2018
Shenzhen Caremed Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A. Nanshan Medical Devices Industrial Park Nanshan District Shenzhen, 518067 Cn
Re: K182433
Trade/Device Name: Caremed Reusable Blood Pressure Cuff, Caremed Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: November 26, 2018 Received: November 26, 2018
Dear Kevin 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. 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/cfpmp/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
Stephen C. Browning -S5
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182433
Device Name
Caremed Reusable Blood Pressure Cuff, Caremed 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 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2018/08/31
1. Submission sponsor
Name: Shenzhen Caremed Medical Technology Co., Ltd. Address: East Side, 3/F, C Building, Kelunte Low-Carbon Industries, Gaofeng Community, Dalang Office, Longhua District, Shenzhen, Guangdong, China Contact person: Alan Xie Title: Quality Manager E-mail: cm003@szcaremed.com Tel: +86-755-36560977-889
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Caremed Reusable Blood Pressure Cuff,
Caremed Disposable Blood Pressure Cuff |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Caremed Reusable Blood Pressure Cuff: N1A-PS, N1N-PS, N1N-PD, N1I-PS,
N1I-PD, N1C-PS, N1C-PD, N1S-PS, N1S-PD, N1A-PD, N1AL-PS, N1AL-PD,
N1L-PS, N1L-PD, N1T-PS, N1T-PD. |
| | Caremed Disposable Blood Pressure Cuff: N1A-TS, N1LL-TS, N1LL-TD, N1L-
TS, N1L-TD, N1AL-TS, N1AL-TD, N1A-TD, N1S-TS, N1S-TD, N1C-TS,
N1C-TD, N1I-TS, N1I-TD, N1N1-TS, N1N1-TD, N1N2-TS, N1N2-TD, N1N3-
TS, N1N3-TD, N1N4-TS, N1N4-TD, N1N5-TS, N1N5-TD |
| Common Name | Non-invasive Blood Pressure Cuff |
| Regulatory Class | Class II |
| Classification | 21CFR 870.1120 / Blood pressure cuff / DXQ |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
By submission of the Traditional 510(k), Shenzhen Caremed Medical Technology Co., Ltd. is requesting clearance for Reusable Blood Pressure Cuff and Disposable Blood Pressure Cuff. It is comparable to the following legally marketed system:
4
-
- Unimed Medical Supplies Inc. Reusable Blood Pressure Cuff under K112544.
-
- Unimed Medical Supplies Inc. Disposable Blood Pressure Cuff under K120364.
The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety. So, the conclusion is that the subject device is substantial equivalent to the predicate.
5. 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 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), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.
The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 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 PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.
The reusable blood pressure cuff has 16 models with 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.
Intended use & Indication for use 6.
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.
5
| Features | Subject Device
Caremed Reusable Blood
Pressure Cuff | Predicate Device K112544
Unimed Reusable Blood
Pressure Cuff | Remark | | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------|------|
| | Applicant | Shenzhen Caremed Medical
Technology Co., Ltd. | | Unimed Medical supplies Inc. | / |
| | 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 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 Unimed Blood Pressure Cuff
is an accessory used in
conjunction with non-invasive
blood pressure measurement
systems. The cuff is non-sterile
and may be reused. It is available
in pediatric and adult sizes. The
cuff is not designed, sold, or
intended for use except as
indicated. | Different
(1) | | |
| Patient
Populations | Adults/Pediatrics | Adults/Pediatrics | Same | | |
| Tube Number | One or two | One or two | Same | | |
| 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) | Conform to AHA bladder sizes
recommendations
Neonatal (6-11cm)
Infant (10-19cm)
Child (18-26cm)
Small Adult (20-28cm)
Adult (25-35cm)
Adult Long (25-35cm)
Large Adult (33-47cm) | Conform to AHA bladder sizes
recommendations
Neonatal (6-11cm)
Infant (10-19cm)
Pediatric (18-26cm)
Small Adult (20-28cm)
Adult (25-35cm)
Adult Long (25-35cm)
Large Adult (33-47cm) | Different
(2) | | |
| Features | Subject Device | Predicate Device K112544 | Remark | | |
| | Caremed Reusable Blood
Pressure Cuff | Unimed Reusable Blood
Pressure Cuff | | | |
| | Adult Thigh (44-66cm) | Large Adult Long (33-47cm)
Adult Thigh (44-66cm) | | | |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same | | |
| Sterility | Non-sterile | Non-sterile | Same | | |
| Max. Leakage |