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510(k) Data Aggregation
(196 days)
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated: Prescription Use, Part 21 CFR 801 Subpart D
Per CFR 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Legacy Medical Blood Pressure Cuff comprises a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and
The provided document describes the Legacy Medical Blood Pressure Cuff, which is intended for use with non-invasive blood pressure measuring devices. The document highlights the regulatory submission (510(k) summary) and the performance testing conducted to demonstrate substantial equivalence to 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:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI SP10 (2002+A1:2003+A2:2006+(R)2008) for manual, electronic, or automated sphygmomanometers | Tested according to the standard. Non-clinical tests showed substantial equivalence in functional and operational performance characteristics including compression, pressure control, and leakage when connected to inflation and measurement equipment. |
| ISO 10993-5 (1999) Biological evaluation of medical devices, Part 5: Tests for In Vitro cytotoxicity | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
| ISO 10993-12 (Date not specified) Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "comparative bench testing" as the method used to assess and prove similarity of function between the Legacy Medical Blood Pressure Cuff and predicate devices.
- Sample Size: The document does not specify the sample size used for the test set. It only mentions "non-clinical tests."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's "bench testing," it's likely conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document describes "non-clinical tests" and "comparative bench testing" for functional and operational performance. This type of testing typically relies on standardized measurement equipment and protocols rather than human expert opinion to establish ground truth for performance parameters like compression, pressure control, and leakage.
Therefore, this section is not applicable as expert consensus is not the method for establishing ground truth for these types of mechanical and functional performance tests.
4. Adjudication Method for the Test Set:
As mentioned above, the testing involved "comparative bench testing" against predicate devices using objective measurements. This typically does not involve an adjudication method in the context of human interpretation or review. Therefore, this section is not applicable.
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 "Non-clinical tests - comparative bench testing was utilized to assess and prove similarity of function." This type of study focuses on mechanical and functional performance, not human reader interpretation of images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical blood pressure cuff, not an algorithm or AI system. The testing described is for the physical and functional aspects of the cuff.
7. The Type of Ground Truth Used:
The ground truth for the "comparative bench testing" appears to be based on objective measurements performed in accordance with established engineering and medical device standards (ANSI/AAMI SP10, ISO 10993). The performance of the Legacy Medical Blood Pressure Cuff was compared against these standards and against the performance of predicate devices.
8. The Sample Size for the Training Set:
This section is not applicable. The device is a physical medical device (blood pressure cuff), not a machine learning or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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