(79 days)
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):
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Compliance with ISO 81060-1 for non-automated measurement type | "The subject device has been tested according to ISO 81060-1... and met the requirements." |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | "The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation." |
| Functional equivalence to predicate devices | Stated that "The subject and predicate devices are exactly the same." |
| Limb Circumference Range (as per ISO 81060-1 and labeling) | "the size of limb circumference of subject device met the requirements of ISO 81060-1, and the limb circumference was marked in the labeling." |
| Tube Configuration (meeting ISO 81060-1) | "The subject device met the requirements of ISO 81060-1." |
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.
§ 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).