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510(k) Data Aggregation
(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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(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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