(70 days)
The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.
The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.
The provided text describes a 510(k) submission for an aneroid sphygmomanometer, the Multiple Brand KTJ-50. This document focuses on the regulatory clearance process rather than a detailed scientific study proving the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not available in the provided text.
However, based on the information provided, we can infer some details related to its intended use and general performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | Non-invasive measurement of arterial blood pressure using auscultatory method. | Device is an aneroid sphygmomanometer intended for indirect (non-invasive) measurement of arterial blood pressure by detecting Korotkoff Sound. Allows trained individuals to evaluate systolic and diastolic pressure. |
| User | Used by trained medical and healthcare personnel or trained general users. | Device is for trained medical and healthcare personnel or trained general users. |
| Methodology | Utilize Korotkoff sound detection for systolic and diastolic pressure. | Users place the attached stethoscope on the inner arm above the bend in the elbow to detect Korotkoff sound for auditory monitoring and evaluation of systolic and diastolic pressure. |
| Safety and Effectiveness | (Implied) Substantial equivalence to a legally marketed predicate device (Mabis brand, K942072) demonstrating similar performance, safety, and effectiveness. | The FDA determined the device is "substantially equivalent" to the predicate device, K942072. This implies its safety and effectiveness are comparable under its intended use. |
Explanation of Inference:
The provided document is a 510(k) summary, which largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a specific clinical study with predefined acceptance criteria. The "Predicate Device" section and the FDA's letter confirming "substantial equivalence" are key here. For devices like this, the acceptance criteria are generally aligned with established standards for sphygmomanometers (e.g., ANSI/AAMI SP10 or ISO 81060-1 or -2), which would cover accuracy and reproducibility. However, these specific standards or detailed performance figures are not provided in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The manufacturer is Golden Horse Medical Equipment (Wuxi) Co., Ltd. in P. R. China, but whether any testing data originated from China or retrospectively/prospectively is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: Not applicable/not performed for this type of device (aneroid sphygmomanometer) in the context of this 510(k) summary. These studies are typically relevant for imaging or diagnostic algorithms where human readers interpret results.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable for this device. An aneroid sphygmomanometer relies on a human operator to perform the auscultatory method (listening for Korotkoff sounds with a stethoscope) to determine BP values. There is no "algorithm only" performance for this manual device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For a traditional aneroid sphygmomanometer, the "ground truth" for comparative accuracy studies usually involves simultaneous or near-simultaneous measurements by highly trained observers using a reference standard (e.g., mercury sphygmomanometer) or an invasive arterial line. However, the methodology used to establish this for the KTJ-50 is not detailed in the provided submission. The "substantial equivalence" claim implies that its performance would be expected to align with its predicate device when proper technique is used.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a "training set" in the computational sense. The document does not describe any such training process.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this mechanical device.
§ 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).