(16 days)
The DuraShock™ Blood Pressure System is intended for the non-invasive blood pressure measurement of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated. The Welch Allyn® DuraShock™ Blood Pressure System is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn® DuraShock™ child is the smallest cuff approved for use with children and infants whose arm circumference fit within the range markings on the cuff.
The Welch Allyn® DuraShock™ Blood Pressure System is a non-invasive blood pressure (BP) measurement device. The DuraShock™ Blood Pressure System is designed to non-invasively measure systolic and diastolic blood pressure for adult and pediatric patients. The Welch Allyn® DuraShock™ Blood Pressure System consists of five components, DuraShock™ Gauge, Integrated One Piece Cuff, Bulb, Valve, and Tubing. The DuraShock™ Blood Pressure System comes in two models. Model ds44 is a lower cost unit with a 5 year warranty, while model ds45 is a higher cost unit that carries a 10 year warranty. Each model will be available in four cuff sizes, Large Adult, Adult, Small Adult, and Child which conform to AAMI SP-9, and AHA. The DuraShock™ Gauge is revolutionary, in that in place of a gear driven movement as found in traditional aneroids, the NCA spring driven movement will be utilized, providing the user with a more durable aneroid. The NCA spring driven movement as opposed to using gears, diaphragm travel is converted to pointer rotation by using a spring wrapped around a pin. The DuraShock™ system also features a Integrated one piece cuff with integral bladder that contains a port where the DuraShock™ Gauge can be directly inserted into the bladder of the cuff. This point of attachment of gauge to cuff, will make it more convenient for use, as well as making it easier for the clinician to read. By attaching directly to the bladder, this will allow the clinician to read the gauge without holding it, thus freeing up their hands to hold the stethoscope head, and bulb and valve to inflate the cuff. The DuraShock™ model ds45 configurations, will utilize a black neoprene bulb, metal valve, and black TPR tubing that is currently being used on the Welch Allyn Tycos® Econo Blood Pressure System. On DuraShock™ model ds44 configurations, a plastic valve, gray PVC bulb and gray TPR tubing will be used.
Here's a breakdown of the acceptance criteria and study information for the Welch Allyn® DuraShock™ Blood Pressure System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Welch Allyn® DuraShock™ Blood Pressure System) | Reported Device Performance (Welch Allyn® DuraShock™ Blood Pressure System) |
|---|---|---|
| Blood Pressure | ||
| BP Determination Method | Non-invasive | Non-invasive (for both ds45 and ds44 models) |
| Initial Cuff Inflation | Operator dependent capable of inflation to 300 mmHg. | Operator dependent capable of inflation to 300 mmHg. (for both ds45 and ds44 models) |
| Measurement Range | ||
| Systolic | 20-300 mmHg | 20-300 mmHg (for both ds45 and ds44 models) |
| Diastolic | 20-300 mmHg | 20-300 mmHg (for both ds45 and ds44 models) |
| Measurement Accuracy | AAMI SP9-1994 (for Blood Pressure) | AAMI SP9-1994 (for Blood Pressure) (for both ds45 and ds44 models) |
| Cuff Pressure Accuracy | +/- 3 mmHg | +/- 3 mmHg (for both ds45 and ds44 models) |
| Measurement time | 30-60 sec. Typical | 30-60 sec. Typical (for both ds45 and ds44 models) |
| Overall System | ||
| Patient Population | Pediatric/Adult | Pediatric/Adult (for both ds45 and ds44 models) |
| Display Type | Dial | Dial (for both ds45 and ds44 models) |
| Operating Temperature | 0 to 46 °C | 0 to 46 °C (for both ds45 and ds44 models) |
| Humidity Range | 0 to 85% RH non-condensing | 0 to 85% RH non-condensing (for both ds45 and ds44 models) |
| Storage Temperature | -34 to 70 °C | -34 to 70 °C (for both ds45 and ds44 models) |
Study Details:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a full clinical effectiveness study with exhaustive information about ground truth establishment, reader studies, etc. It primarily relies on meeting established industry standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to compliance with AAMI SP9-1994 for blood pressure measurement accuracy. This standard typically defines the requirements for clinical validation, including the number of subjects to be recruited (usually a minimum of 85 subjects with specific age and gender distribution). However, the specific number of subjects used in Welch Allyn's testing is not mentioned in this summary.
- Data Provenance: Not explicitly stated. The study for AAMI SP9-1994 compliance would involve prospective collection of blood pressure measurements from human subjects. The geographical origin of these subjects is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. For AAMI SP9-1994 validation, ground truth is typically established by trained observers (often two or three) using a mercury sphygmomanometer, following a specific protocol to minimize bias.
- Qualifications of Experts: Not explicitly stated. However, in studies adhering to AAMI SP9-1994, the observers are highly trained and experienced in taking auscultatory blood pressure measurements.
4. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. For AAMI SP9-1994 clinical validation, if multiple observers are used, their readings are typically used to establish a consensus or averaged reference value. The standard outlines methodologies for comparing the test device's readings against these reference measurements. A common approach involves averaging multiple mercury sphygmomanometer readings.
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 standalone blood pressure measurement device (sphygmomanometer), not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, the concept of improving human readers with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance criteria listed (e.g., +/- 3 mmHg cuff pressure accuracy, AAMI SP9-1994 blood pressure accuracy) describe the standalone performance of the blood pressure system. While a human operates the device (inflates the cuff, reads the dial), the accuracy metrics refer to the device's ability to measure blood pressure correctly against a reference standard, independent of human interpretive errors typically associated with AI diagnostic systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Consensus / Reference Method: The ground truth for blood pressure measurement accuracy would be established by simultaneous or sequential auscultatory blood pressure measurements taken by highly trained observers using a calibrated reference method, typically a mercury sphygmomanometer. This aligns with the requirements of AAMI SP9-1994.
8. The sample size for the training set:
- Not applicable / Not stated. This device is a mechanical sphygmomanometer, not an AI or machine learning system that requires a "training set" in the conventional sense. Its design and calibration are based on engineering principles and adherence to established measurement standards, rather than data-driven learning.
9. How the ground truth for the training set was established:
- Not applicable. As mentioned above, there is no "training set" for this type of device. The accuracy is inherently designed and validated against physical measurement principles and physiological reference methods.
§ 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).