Search Results

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 cuff is not designed, sold, or intended for use except as indicated.

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 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 and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

The subject device is categorized into two types of models according to its usage.

Reusable Blood Pressure Cuff models:

1201B1,12L2B1,1202B1,12L3B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,1207B1-

3#,1207B1-4#,1207B15#,1201W2,12L2W2,1202W2,12L3W2,1203W2,

1204W2,1205W2,1206W2 and 1207W2

Disposable Blood Pressure Cuff models:

1201D1,12L2D1,1202D1,12L3D1,1204D1,1205D1,1204D1,1207D1-1#,1207D1-2#,1207D1-

3#,1207D1-4#,1207D1-5#

Connector models: PLINMA-03-127-003, PLINMA-03-T, PLINMA-03-Z3

The provided text is a 510(k) summary for a Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. The information about a study proving device performance is limited.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily refers to meeting ISO standards and does not present a table of specific acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) versus reported device performance in a clinical setting. It states that the device was "tested according to ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type". However, it does not provide the results of this testing in a quantifiable form or against specific, pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "The subject and predicate devices are exactly the same. Since the blood pressure cuffs are identical, no further clinical testing is necessary." This implies that no separate test set with human subjects was used for this 510(k) submission to evaluate the performance of the device in terms of blood pressure measurement accuracy. The data provenance is assumed to be from the predicate device's testing, but details are not provided here.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no separate clinical performance testing was conducted for this submission, no experts were used to establish ground truth from newly collected data for this specific device.

4. Adjudication Method for the Test Set:

Not applicable, as no dedicated clinical performance test set was used for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable, as this is a blood pressure cuff and not an AI-powered diagnostic imaging device. The document does not describe any human reader involvement or AI assistance.

6. Standalone Performance Study:

A standalone performance study focused on technical compliance with ISO 81060-1 was mentioned ("The subject device has been tested according to ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type"). However, the results of this testing, which would quantify its performance against the ISO standard's requirements, are not provided in this summary. The summary only attests that the device "met the requirements."

7. Type of Ground Truth Used:

For the "performance data" mentioned, the ground truth would be the reference measurements and methods defined within the ISO 81060-1 standard for non-invasive sphygmomanometers. For the biocompatibility testing, the ground truth would be the established scientific methods and criteria for evaluating cytotoxicity, sensitization, and irritation.

8. Sample Size for the Training Set:

Not applicable, as this is a medical device (blood pressure cuff) and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of Acceptance Criteria and Study (based on available information):

Study Details:

• Test Set Sample Size: Not applicable for clinical performance testing, as it was deemed unnecessary due to the device being "exactly the same" as predicates. For technical testing to ISO 81060-1, the sample size is implicitly defined by the standard's requirements for testing a physical device.
• Data Provenance: Not specified for the ISO 81060-1 technical testing, but typically conducted in a laboratory setting.
• Experts for Ground Truth: Not applicable for clinical performance as no new human data was collected. Ground truth for technical testing is established by standard operating procedures and reference equipment.
• Adjudication Method: Not applicable for clinical performance.
• MRMC Study: No.
• Standalone Study: Yes, a technical standalone study was performed to ISO 81060-1 and biocompatibility standards, with results indicating compliance, although specific performance metrics are not listed in this summary.
• Type of Ground Truth: ISO standard requirements and established biocompatibility testing protocols.
• Training Set Sample Size: Not applicable (not an AI/ML device).
• Training Set Ground Truth Establishment: Not applicable.

The document primarily relies on demonstrating substantial equivalence to predicate devices and adherence to relevant ISO standards, rather than presenting a detailed clinical performance study specific to this submission.

Ask a specific question about this device

The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. 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 and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The subject device is categorized into two types of models according to its reusability.

This document describes the FDA's 510(k) clearance for a "Blood Pressure Cuff" by JKH USA, LLC. The key aspect of this clearance is the assertion that the subject device and the predicate devices are exactly the same. Therefore, the "study that proves the device meets the acceptance criteria" is primarily a claim of identity to previously cleared devices, rather than a new performance study.

Given this, I will tailor the response to reflect that the "study" is a comparison and assertion of sameness, rather than a novel clinical trial.

Here's the breakdown of the acceptance criteria and the "study" that supports it:

Acceptance Criteria and Reported Device Performance

Details of the "Study" (Comparison and Assertion of Equivalence):

1. Sample sizes used for the test set and data provenance:
   This 510(k) submission relies on a claim of identicality to previously cleared predicate devices (K112544 and K120364, both "Unimed Blood Pressure Cuff" from UNIMED MEDICAL SUPPLIES INC). Therefore, there is no new clinical test set or patient data presented for this specific submission for the purpose of demonstrating performance. The "sample" is effectively the previously validated predicate device itself. No country of origin for a new test set is provided, and the data provenance is historical, based on the previous clearance of the predicate. This is a retrospective comparison based on design specifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A) to this submission, as no new test set requiring expert ground truth establishment for a novel device performance study was conducted. The ground truth for the predicate devices would have been established at the time of their clearance through their respective validation studies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   N/A. No new test set requiring adjudication was performed.

4. 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:
   N/A. This device is a passive blood pressure cuff, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This device is a physical medical accessory, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests (biocompatibility and standard compliance), the ground truth is established by laboratory test results conforming to the specified ISO standards (e.g., in vitro cytotoxicity, irritation, sensitization tests). For the device's overall performance, the "ground truth" for this submission is the established performance and safety of the predicate devices, which presumably met their own ground truth requirements through standard validations (e.g., accuracy against a reference standard for a blood pressure monitoring system, which the cuff is an accessory to, although the cuff itself simply maintains pressure).

7. The sample size for the training set:
   N/A. This is a passive medical device, not a machine learning model. No training set for an algorithm was used.

8. How the ground truth for the training set was established:
   N/A. No training set for an algorithm was used.

Ask a specific question about this device

Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.

The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.

The provided text describes a 510(k) submission for a blood pressure cuff and references some testing, but does not contain the detailed study information typically required to directly answer all parts of your request.

Specifically, it lacks:

• Explicit "acceptance criteria" for performance that are separate from the testing standards.
• "Reported device performance" in terms of specific metrics like accuracy, bias, or precision of blood pressure measurement.
• Details about a "test set" in the context of AI/algorithm performance (which is not applicable here as this is a physical device).
• Information on "experts" or "ground truth" establishment, as this is a physical measurement device, not an image analysis or diagnostic algorithm.
• Any mention of "multi reader multi case (MRMC) comparative effectiveness study" or "standalone (algorithm only)" performance, as these are related to AI/software.
• Sample sizes for training sets (again, not applicable to this type of device).

The document focuses on substantial equivalence to predicate devices and adherence to recognized standards for physical devices.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with specific performance metrics (e.g., mean difference in mmHg). Instead, it states that the device was tested per AAMI SP10:2002+A1:2003+A2:2006. For blood pressure cuffs, AAMI SP10 is the recognized standard for performance requirements and testing. Compliance with this standard implies that the device meets the performance specifications outlined within it (e.g., accuracy, pressure stability, deflation rates, etc.).

2. Sample size used for the test set and the data provenance

Not applicable in the context of an AI/algorithm test set. For a physical blood pressure cuff, testing typically involves a number of samples of the cuff itself and a number of human subjects for clinical validation studies if required, but these details are not provided in this summary. The summary only states "The device was tested per... AAMI SP10." The data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device intended for measurement, not an AI/algorithm requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable to this type of device or study described.

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 device, not an AI system assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical blood pressure cuff, not an algorithm.

7. The type of ground truth used

For a blood pressure cuff, "ground truth" for blood pressure accuracy is typically established by comparing the device's readings against a reference standard method (e.g., intra-arterial measurement, auscultatory method by trained observers with mercury sphygmomanometer) as specified by standards like AAMI SP10. The document does not specify the exact method used for establishing the ground truth beyond stating compliance with AAMI SP10.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device