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Found 18 results
510(k) Data Aggregation
(58 days)
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
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 size. The cuff is not designed, sold, or intended for use except as indicated.
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.
The provided document is a 510(k) summary for a blood pressure cuff and does not contain detailed information about acceptance criteria, reported device performance for specific metrics, or any study proving such performance. The document explicitly states:
"No clinical study is included in this submission"
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical data and compliance with voluntary standards for design specifications.
However, I can extract the information that is present:
8. Non-clinical data
- Performance testing: Non-clinical tests were conducted to verify that the proposed devices met all design specifications.
- Compliance with standards: The test results demonstrated that the proposed device complies with ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
Based on this, here's what can be stated about the available information:
- A table of acceptance criteria and the reported device performance: Not provided. The document mentions compliance with ISO 81060-1, which would contain performance requirements for non-automated sphygmomanometers (blood pressure cuffs). However, the specific acceptance criteria used for the device and the reported device performance against those criteria are not detailed.
- Sample sized used for the test set and the data provenance: Not provided. The document only mentions "non-clinical tests" and "performance testing" but does not give details about sample sizes or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study or expert-based ground truth establishment is mentioned. The testing focused on technical specifications and standards compliance.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical study is included in this submission."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a blood pressure cuff, which is a physical accessory, not an algorithm.
- The type of ground truth used: Not applicable for performance evaluation as no clinical data or comparative performance study is provided. For demonstrating substantial equivalence, the ground truth indirectly relies on the established performance and safety of the predicate device and the standards.
- The sample size for the training set: Not applicable. This is a non-AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is a non-AI/ML device.
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(102 days)
Disposable Blood Pressure Cuff
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 subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The device 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 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 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 "Disposable Blood Pressure Cuff" by Wenzhou Xikang Medical Instruments Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria and study results for performance efficacy in the way a clinical trial or algorithm validation study would.
Instead, the "acceptance criteria" for this device are regulatory and technical standards, and the "study" demonstrating it meets these criteria are non-clinical tests to verify design specifications and compliance with recognized standards.
Here's an breakdown based on the information provided, recognizing that it's a regulatory submission rather than a performance study report:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The "Disposable Blood Pressure Cuff" is seeking 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" are compliance with relevant regulatory standards and the predicate device's characteristics, and the "study" involves non-clinical testing to verify this compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Predicate Feature) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Regulatory Classification | Product Code: DXQ | DXQ (Same as predicate) |
| Regulation No.: 21 CFR 870.1120 | 21 CFR 870.1120 (Same as predicate) | |
| Class: II | Class II (Same as predicate) | |
| Intended Use/Indications | Same as predicate device's disposable cuff. | 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. (Same as predicate's disposable cuff indication). |
| Materials/Biocompatibility | Conform to ISO 10993 (part 5 & 10) | Conform with ISO10993-1 (ISO10993-5, ISO10993-10). Tests included: Cytotoxicity, Sensitization, Irritation. (Predicate also compliant with biocompatibility standards). |
| Technical Specifications | ||
| - Material Composition | Similar to predicate (non-woven, PVC) | Cuff (Patient contacted): PVC film stick non-woven fabric; Bladder: PVC; Air Hose: PVC; Hook tape: Nylon; Loop: Nylon. (Same materials as predicate, with explicit detail). |
| - Patient Populations | Adults/Pediatrics | Adults/Pediatrics (Same as predicate). |
| - Tube Number | One or two | One or two (Same as predicate). |
| - Limb Circumference | Conform to AHA bladder sizes recommendations | Conform to AHA bladder sizes recommendations. Range for Neonatal 1-5, Infant, Child, Small Adult, Adult, Large Adult, Thigh. (Some specific ranges are "little different" from predicate, but deemed not to raise safety/effectiveness issues based on performance testing). |
| - Pressure Range | 0-300mmHg | 0-300mmHg (Same as predicate). |
| - Max. Pressure | 400mmHg | 400mmHg (Same as predicate). |
| - Sterility | Non-sterile | Non-sterile (Same as predicate). |
| Performance Safety | Compliance with ISO 81060-1 (Non-Automated Measurement) | Compliance with ISO 81060-1, First Edition 2007 (Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type). (Full results not detailed in summary, but stated to meet specifications). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or cuffs in a typical clinical study. The testing appears to consist of laboratory measurements and evaluations against standards. For biocompatibility, standard test methods typically involve specific numbers of samples for in vitro (cytotoxicity, irritation) and in vivo (sensitization) tests, but these numbers are not detailed in this summary.
- Data Provenance: The testing was "non-clinical tests... conducted to verify that the proposed device met all design specifications." This indicates testing was likely performed by the manufacturer or a contract lab. The country of origin of the data is implicitly China, as the manufacturer is Wenzhou Xikang Medical Instruments Co., Ltd. (Wenzhou, Zhejiang, China). The data is retrospective, generated to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as this is not a study involving expert-derived ground truth (e.g., medical image interpretation). The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ISO 81060-1, ISO 10993).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The evaluations are based on objective measurements against defined standards.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a blood pressure cuff and does not involve AI or human interpretation in the way a diagnostic imaging device would.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done in the context of an algorithm. The device itself is a standalone physical accessory. Its performance is evaluated through compliance with physical and biological standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is defined by international and recognized consensus standards for medical device safety and performance, specifically:
- ISO 81060-1: For non-invasive sphygmomanometer performance.
- ISO 10993-1, -5, -10: For biocompatibility.
- The "ground truth" for showing equivalence also includes the technical specifications and materials of the legally marketed predicate device.
8. The sample size for the training set:
- This is not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This is not applicable. As there is no training set for an AI algorithm.
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(102 days)
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
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 |
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(53 days)
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
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: |
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(277 days)
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
Med-link 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 cuff is not designed, sold, or intended for use except as indicated.
The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.
This document is a 510(k) premarket notification for the Med-link Disposable Blood Pressure Cuff. It aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on the FDA recognized consensus standard ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type, and ISO 10993 (Biological evaluation of medical devices) series for biocompatibility.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|---|
| Performance | Compliance with ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013, Part 1: Requirements And Test Methods For Non-Automated Measurement Type | "Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of AAMI/ANSI/ISO81060-1:2007/(R)2013, and results met all relevant requirements in the test standard." |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices-Part 1: Evaluation and testing | "A series of safety, essential performance and in vitro biocompatibility tests were performed... The tests listed below were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10." |
| ISO 10993-5: Test for in vitro cytotoxicity | "Cytotoxicity Test" performed. Data not explicitly detailed in summary but implied to meet criteria. | |
| ISO 10993-10: Tests for Irritation And Skin Sensitization | "Skin irritation Test" and "Skin Sensitization Test (the Guinea Pig maximization test)" performed. Data not explicitly detailed in summary but implied to meet criteria. | |
| Pressure Limit | 0-300mmHg matching predicate devices | Proposed device has a pressure limit of "0-300mmHg," which is identical to the primary and secondary predicate devices. |
| Sterility | Non-sterile matching predicate devices | Proposed device is "Non-sterile," which is identical to the primary and secondary predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing. It mentions "Performance testing was performed on the subject device," but does not specify the number of devices or measurements.
The data provenance is not specified regarding country of origin or specific study design (retrospective or prospective). The tests are described as "non-clinical testing," which suggests laboratory-based evaluations rather than human subject trials for the core performance and biocompatibility aspects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes the testing of a basic medical accessory (blood pressure cuff). The "ground truth" for its performance is established by objective measurements against a recognized standard (ISO 81060-1). There is no mention of experts establishing a "ground truth" in the way one might for diagnostic imaging or a subjective clinical assessment. The ground truth for biocompatibility is established through standardized laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. The performance and biocompatibility tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a 510(k) submission for a blood pressure cuff, which is a physical accessory, not an AI or imaging-based diagnostic device. Therefore, an MRMC comparative effectiveness study, which typically evaluates human readers' performance with and without AI assistance, is not relevant or applicable here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a passive accessory and does not involve an algorithm. Its function is to interface with a blood pressure measurement system.
7. Type of Ground Truth Used
The ground truth used for performance testing (accuracy and reliability of pressure transmission, cuff inflation/deflation, etc.) is the adherence to the ISO 81060-1 standard's objective requirements and test methods.
For biocompatibility testing, the ground truth is established by the results of standardized laboratory tests (Cytotoxicity, Skin Irritation, Skin Sensitization) as defined by the ISO 10993 series.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(156 days)
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
The Tenso TS-101S and TS-101D 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 infant, pediatric and adult sizes. They are used in hospital settings.
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are an accessory used in conjunction with noninvasive blood pressure measurement systems. They incorporate an inflatable nondistensible bladder, sized to encircle a patient's limb. This allows air to flow in and out of the cuff for inflation and deflation, for the purpose of occlusion of an artery. "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" have a structure which contains Cuff with bladder and Air Hose. Air hose has either single tube or double tubes." The device is secured by hook and loop closure onto the patient limb. It has two variations: TS-101S" is the variant that has single tube structure, while "TS-101D" is the variant that has double-tube structure. The cuff is made from non-woven fabrics, the air hose and tubes are made from polyvinyl chloride. Therefore, the non-woven fabric (cuff) is the material used to contacting with the patient. "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are single use device and are provided as non-sterile. They are available in infant, pediatric and adult sizes. "Tenso TS-101S Disposable Blood Pressure Cuffs" (single tube model) have 6 models with different size for different population with different arm size. "TS-101D Disposable Blood Pressure Cuffs" (double tube model) also have 6 models with different size for different population with different arm size.
Acceptance Criteria and Study for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
This document describes the acceptance criteria and the study performed to demonstrate that the Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Specification (Acceptance Criteria) | Reported Device Performance (Results) |
|---|---|---|
| Mechanical Strength | Able to withstand 300 mm Hg | Meet |
| Fatigue Strength | Able to withstand inflation (to 300 mm Hg) and deflation for at least 300 times | Meet |
| Leakage Rate | Leakage rate |
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(59 days)
Disposable Blood Pressure Cuff
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 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.
The provided document describes the 510(k) premarket notification for a Disposable Blood Pressure Cuff (K152465) by Shenzhen Vistar Medical Supplies Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K151290).
Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:
Key Takeaways:
- This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
- The primary means of demonstrating compliance is through non-clinical testing against recognized industry standards and a comparison of specifications with the predicate device.
- No clinical study was included in this submission. Therefore, there is no information about human reader performance (MRMC studies) or standalone algorithm performance, as these are typically part of clinical trials for AI/software devices.
- The device is a physical medical device (blood pressure cuff), not a software or AI-driven diagnostic tool. Thus, concepts like "ground truth" in the AI sense, expert panels for ground truth establishment, or training sets are not directly applicable in the way they would be for an AI device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards and comparison with the predicate device. The performance is reported as compliance with these standards or equivalence to the predicate.
| Acceptance Criteria / Specification | Reported Device Performance (Proposed Device) |
|---|---|
| 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." (Identical to Predicate) |
| Patient Populations | Adults/Pediatrics (Identical to Predicate) |
| Tube Configuration | One or two tube (Identical to Predicate) |
| 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" (Identical to Predicate) |
| Size | Conform to AHA bladder sizes recommendations. Has similar sizes and more size specifications than the predicate for different patient arm circumferences. |
| 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) | |
| Single Use | Yes (Identical to Predicate) |
| Sterile | No (Identical to Predicate) |
| Pressure Range | 0-300 mmHg (Identical to Predicate) |
| Max. Pressure | 400 mmHg (Predicate: >350 mmHg) |
| Tubing Size (mm) | OD = 8.0; ID=4.0; L=200; (Identical to Predicate) |
| Max. Leakage |
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(46 days)
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
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 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 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 18 models with different size for different population with different arm size, and the 9 models of 18 are use single tube of air hose and other 9 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 10 models with different size for different population with different arm size, and the 5 models of 10 are use single tube of air hose and other 5 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. Both disposable and reusable blood pressure cuff are provided as non-sterile.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device (Disposable/Reusable Blood Pressure Cuff) as "substantially equivalent" to predicate devices, rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. The submission relies on demonstrating equivalence through adherence to recognized standards and comparison of features with predicate devices.
However, based on the non-clinical tests conducted, we can infer some "acceptance criteria" through compliance with the listed standards and the qualitative results:
| Criteria Category | Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity (ISO 10993-5) | "Under the conditions of the study, not cytotoxicity effect" |
| No irritation (ISO 10993-10) | "Under the conditions of the study, not an irritant" | |
| No sensitization (ISO 10993-10) | "Under conditions of the study, not a sensitizer." | |
| Functional/Performance | Compliance with ISO 81060-1:2012 (Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type) | "The test results demonstrated that the proposed device complies with the following standards" (including ISO 81060-1:2012) |
| Pressure Limits | 0-300 mmHg | 0-300 mmHg (matching predicate) |
| Cuff Sizes | Conform to AHA bladder sizes recommendations | Proposed device sizes are listed and compared to predicate sizes |
| Intended Use | Accessory for noninvasive blood pressure measurement systems | Matches predicate, "SE" (Substantially Equivalent) |
| Sterility | Non-sterile | Non-sterile (matching predicate) |
| Reuse | Disposable for single-patient use (Disposable cuff) | Matches predicate |
| Reusable (Reusable cuff) | Matches predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data for performance evaluation. Instead, it refers to non-clinical tests conducted to verify design specifications and substantial equivalence.
- Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of cuffs tested for biocompatibility or pressure limits). The document only mentions that "Non clinical tests were conducted."
- Data Provenance: The tests were conducted internally by the manufacturer (Xuzhou Maicuff Technology Co.,ltd.) or by a testing laboratory on their behalf, in the context of a 510(k) submission to the FDA. The country of origin for the manufacturing and testing would likely be China, where the company is based. The tests are prospective in the sense that they were conducted for this specific submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a blood pressure cuff and the testing described is non-clinical (biocompatibility, performance to standards), not a diagnostic or AI-driven device requiring expert adjudication of "ground truth" for patient cases.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical test set requiring expert adjudication for ground truth. The evaluation is based on non-clinical testing against established standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical accessory (blood pressure cuff), not a diagnostic tool where reader performance would be a primary concern.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical accessory (a blood pressure cuff), not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant.
7. The Type of Ground Truth Used:
For the biocompatibility tests, the "ground truth" is established by the accepted scientific methodologies and criteria outlined in the ISO 10993 standards (e.g., cell viability for cytotoxicity, skin reaction assessment for irritation and sensitization).
For the functional/performance tests, the "ground truth" or reference values are derived from the requirements and test methods detailed in ISO 81060-1:2012 for non-invasive sphygmomanometers.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical accessory, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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(137 days)
Minhua Disposable Blood Pressure Cuff
The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.
This document is solely a 510(k) premarket notification summary for a medical device (Minhua Disposable Blood Pressure Cuff). It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device.
The provided text describes a traditional medical device (blood pressure cuff) and focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of Features: Intended use, patient populations, tube configuration, sterility, pressure limits, biocompatibility, cuff and tube port materials, hook & loop fastener, and conformity to AHA bladder sizes.
- Compliance with Standards: ANSI/AAMI SP 10 (sphygmomanometers) and ISO 10993 (biocompatibility).
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it pertains to the evaluation of AI/ML devices, which is not the subject of this document.
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(59 days)
Disposable Blood Pressure Cuff Guard
This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.
This device is a cover for blood pressure cuffs. It is made of polyethylene coated on Tyvck. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination.
When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff Guard can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff Guard has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff Guard has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff Guard is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff Guard becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff Guard.
The blood cuff Guard has a two layer structure. The inner layer is made of Tyvck. The outer layer is made of cast film of polyethylene.
The polyethylene is a fluid repellent, and is resistant to microbial penetration, thus provides a barrier between the pressure cuff and patient.
The whole guard is approximately 20 um thick and is available in various different length and width.
The guard is designed as pouchlike with one open, the blood pressure cuff can be packed into it and sealed with adhesive tape, and which can be secured around the patient arm by two velcro. The adhesive tapes are located at the edge of open and the Velcro located at the two ends of outer guard, both of them are not contact with the patient skin.
This document is a 510(k) summary for a Disposable Blood Pressure Cuff Guard (K150227). It describes the device's intention to reduce cross-contamination during blood pressure measurement and claims substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative performance metric sense (e.g., a specific percentage reduction in microbial count). Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to a predicate device by showing that the proposed device meets design specifications and passes certain non-clinical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Proposed Device: "This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff." |
| Predicate Device: (Identical Indication) | |
| Biocompatibility (Cytotoxicity) | Proposed Device: "Under the conditions of the study, not cytotoxicity effect." |
| Predicate Device: "Comply with ISO 10993-5" | |
| Biocompatibility (Irritation) | Proposed Device: "Under the conditions of the study, not an irritant." |
| Predicate Device: "Comply with ISO 10993-10" | |
| Biocompatibility (Sensitization) | Proposed Device: "Under conditions of the study, not a sensitizer." |
| Predicate Device: "Comply with ISO 10993-10" | |
| Design Specifications (Dimensions, Adhesive Tape, Velcro) | Proposed Device: Bench testing for "performance of Dimensions, Adhesive Tape, Compatibility with BP Cuff and Velcro" was conducted. (Specific performance details are not provided, only that tests were done and "met all design specifications"). |
| Basic Design (Packaging the cuff vs. under the cuff) | Analysis 1 states: "The proposed device has different Design to the predicate device, the current design we used is pack the blood cuff, this way could fix the blood cuff around the arm more steadily during measurement process, so we consider this as the proposed device is SE with the predicate device." (This is an explanation for difference, not a performance metric per se). |
| Materials (Tyvek/Polyethylene vs. Polyethylene/Paper) | Analysis 2 states: "The proposed device has different materials to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-5 and ISO 10993-10, the test results showed that the proposed devices did not induce any risk relating to the cytotoxicity, irritation or sensitization." (This points to the biocompatibility results). |
| Closure Method (Velcro/Adhesive Tape vs. Adhesive Tape) | Analysis 3 states: "The proposed device has different closure method to the predicate device, but the Velcro has the effect to fix the guard and cuff, so we consider this as the proposed device is SE with the predicate device." (Similar to basic design, an explanation of difference leading to SE conclusion). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The non-clinical tests (biocompatibility, bench testing) would have involved a certain number of samples or specimens, but the exact count is not provided in this summary.
- Data Provenance: The tests were conducted by Pinghu Sama Medical Packing Co., Ltd. (China). The document does not specify if the data is retrospective or prospective, but as it's for a new device, it would implicitly be prospective testing of the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not stated. The ground truth for biocompatibility studies is typically established by laboratory testing against ISO standards and interpreted by qualified toxicologists or biologists, not through expert consensus in the way a medical image might be. For bench testing, the "ground truth" would be the design specifications and established engineering principles.
- Qualifications of Experts: Not applicable/not stated in this document.
4. Adjudication method for the test set:
Not applicable. This device's evaluation (biocompatibility and bench testing) does not involve a human reader or an adjudication process in the typical sense for diagnostic devices.
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 physical medical device (a cuff guard), not an AI-powered diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Biocompatibility: The ground truth for biocompatibility was established by ISO standards (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization). The test results were compared against the requirements of these standards.
- Bench Testing: The ground truth for bench testing (Dimensions, Adhesive Tape, Compatibility with BP Cuff, Velcro) would be the device's own design specifications and functional requirements.
8. The sample size for the training set:
Not applicable. This device is not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an algorithm that requires a training set.
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