(102 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 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.
The provided document is a 510(k) summary for the Caremed Reusable Blood Pressure Cuff and Caremed Disposable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for a new medical AI or advanced diagnostic device. Therefore, much of the requested information (e.g., sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not directly applicable or available in this type of submission for a blood pressure cuff.
However, I can extract information related to the performance data provided within the context of a 510(k) submission for this device.
1. Table of Acceptance Criteria and Reported Device Performance
For a blood pressure cuff, the "acceptance criteria" and "reported device performance" are primarily related to safety, material biocompatibility, and functional performance (e.g., pressure range, leakage, and compliance with recognized standards).
| Acceptance Criteria / Standard | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility - Cytotoxicity (per ISO 10993-5) | No potential cytotoxicity | Pass |
| Biocompatibility - Sensitization (per ISO 10993-10) | No sensitization observed (test sample score 0) | Pass |
| Biocompatibility - Irritation (per ISO 10993-10) | Negligible (no observed primary irritation, test sample score 0) | Pass |
| Non-Invasive Sphygmomanometers Requirements (per ISO 81060-1:2007) | Device met all design specifications and complied with the standard | Pass |
| Maximum Leakage | < 4mm Hg/ min. | Same as predicate, presumed compliant with relevant standards. |
| Pressure Range | 0-300 mmHg | Same as predicate, presumed compliant with relevant standards. |
| Max. Pressure (for Disposable Cuff) | 400 mmHg | Same as predicate, presumed compliant with relevant standards. |
2. Sample Size Used for the Test Set and Data Provenance
This information is typically not provided in a 510(k) summary for a blood pressure cuff. The "test set" here refers to samples of the device materials tested for biocompatibility and the device itself for functional performance.
- Sample Size for Test Set: Not specified in the document. Standard practice would involve testing a representative number of samples to demonstrate compliance with standards for biocompatibility and functional performance.
- Data Provenance: Not explicitly stated as country of origin but likely conducted by testing laboratories in China, given the manufacturer's location. The studies are "non-clinical" and likely retrospective in that they characterize the manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in this context. The "ground truth" for a blood pressure cuff's performance is typically established by objective physical and chemical testing against established international standards (e.g., ISO for biocompatibility and sphygmomanometers), not by expert consensus or readings.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human reader performance in diagnostic studies, which is not relevant for a blood pressure cuff's mechanical and material performance testing.
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 blood pressure cuff, not an AI-powered diagnostic device. No human-in-the-loop performance or MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these blood pressure cuffs is based on objective measurement against established international standards (e.g., ISO 81060-1 for non-invasive sphygmomanometers, ISO 10993 for biocompatibility) and direct physical/chemical testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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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
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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/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
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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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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:
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-
- 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.
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| Features | Subject DeviceCaremed Reusable BloodPressure Cuff | Predicate Device K112544Unimed Reusable BloodPressure Cuff | Remark | ||
|---|---|---|---|---|---|
| Applicant | Shenzhen Caremed MedicalTechnology Co., Ltd. | Unimed Medical supplies Inc. | / | ||
| 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 isan accessory used in conjunctionwith noninvasive blood pressuremeasurement systems. The cuff isnon-sterile and may be reused. It isavailable in neonate, infant, childand adult sizes. The cuff is notdesigned, sold, or intended for useexcept as indicated. | The Unimed Blood Pressure Cuffis an accessory used inconjunction with non-invasiveblood pressure measurementsystems. The cuff is non-sterileand may be reused. It is availablein pediatric and adult sizes. Thecuff is not designed, sold, orintended for use except asindicated. | Different(1) | ||
| PatientPopulations | Adults/Pediatrics | Adults/Pediatrics | Same | ||
| Tube Number | One or two | One or two | Same | ||
| Principles ofOperation | Bladder is wrapped around thepatient's limb and secured by hookand loop closure Air hose isconnected to the noninvasive bloodpressure measurement systems | Bladder is wrapped around thepatient's limb and secured byhook and loop closure Air hose isconnected to the noninvasiveblood pressure measurementsystems | Same | ||
| LimbCircumference(Range in cm) | Conform to AHA bladder sizesrecommendationsNeonatal (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 sizesrecommendationsNeonatal (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 BloodPressure Cuff | Unimed Reusable BloodPressure 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 | < 4mm Hg/ min. | < 4mm Hg/ min. | Same | ||
| Material | Cuff (Patient contacted): PUSynthetic LeatherBladder: Transparent Polyurethane(TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon | Cuff (Patient contacted): PUSynthetic LeatherBladder: TransparentPolyurethane (TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon | Same | ||
| Biocompatibility | No potential cytotoxicity;No sensitization observed (testsample score 0);Negligible (no observed primaryirritation, test sample score 0) | Comply with ISO 10993-5;Comply with ISO 10993-10 | Same |
Comparison to Primary Predicate Device Unimed Reusable Blood Pressure Cuff:
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K182433
Page 4 of 7
Comparison to Reference Device Unimed Disposable Blood Pressure Cuff:
| Features | Subject DeviceCaremed Disposable BloodPressure Cuff | Predicate Device K120364Unimed Disposable BloodPressure Cuff | Remark |
|---|---|---|---|
| Applicant | Shenzhen Caremed MedicalTechnology Co., Ltd. | Unimed Medical supplies Inc. | / |
| 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. Thecuff is not designed, sold, orintended for use except asindicated. | 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 neonatal, pediatricand adult sizes. The cuff is notdesigned, sold, or intended foruse except as indicated. | Different(3) |
| PatientPopulations | Adults/Pediatrics | Adults/Pediatrics | Same |
| Tube Number | One or two | One or two | Same |
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| Features | Subject DeviceCaremed Disposable BloodPressure Cuff | Predicate Device K120364Unimed Disposable BloodPressure Cuff | Remark |
|---|---|---|---|
| LimbCircumference(Range in cm) | Conform to AHA bladder sizesrecommendationsNeonatal 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) | Conform to AHA bladder sizesrecommendationsNeonatal 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 Long (35.5-46 cm)Thigh (45-56 cm) | Different(4) |
| Pressure Range | 0-300mmHg | 0-300mmHg | Same |
| Max. Pressure | 400mmHg | 400mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Material | Non-woven (Patient contacted);nylon;PVC | Non-woven (Patient contacted);nylon;PVC | Same |
| Biocompatibility | No potential cytotoxicity;No sensitization observed (testsample score 0);Negligible (no observed primaryirritation, test sample score 0) | Comply with ISO 10993-5;Comply with ISO 10993-10 | Same |
Justification of differences:
Justifications for differences between Caremed Blood Pressure Cuff and the predicate device are shown as below:
Different (1): We claim the applicable population in more detail. Neonatal, infant and child are subsets of the pediatric patient population. Thus, this descriptive difference does not raise any safety or effectiveness issue.
Different (2): The limb circumference of subject device and predicate device is same. The subject device is less than predicate device with Large Adult Long. This difference limits use within the subject device and does not raise any safety or effectiveness issue.
Different (3): We claim the applicable population in more detail. Neonatal, infant and child are subsets of the pediatric patient population. Thus, this descriptive difference does not raise any safety or effectiveness
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issue.
Different (4): The limb circumference of subject device and predicate device is same. The subject device is less than predicate device with Thigh. This difference limits use within the subject device and does not raise any safety or effectiveness issue.
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).
8. Performance Data
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.
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K182433 Page 7 of 7
Conclusion 9.
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.
§ 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).