(28 days)
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").
Not Found
Please note: The provided document is a 510(k) clearance letter from the FDA. It does not contain the detailed study information (acceptance criteria, sample sizes, ground truth methods, MRMC studies, etc.) that would typically be found in a submission or a clinical study report. The letter confirms that the device, an H&L Full Automatic (NIBP) Blood Pressure Monitor, has been found substantially equivalent to a predicate device.
Therefore, the following response will indicate where information is not present in the provided document.
Acceptance Criteria and Study Details for H&L Full Automatic (NIBP) Blood Pressure Monitor (HL888KM, HL888DM)
The provided FDA 510(k) clearance letter (K050587) confirms that the H&L Full Automatic (NIBP) Blood Pressure Monitor is substantially equivalent to a predicate device. However, this letter does not contain the specific acceptance criteria or the detailed description of the study that demonstrated the device met these criteria.
To provide a hypothetical example of what such information might look like for a non-invasive blood pressure (NIBP) monitor, and based on common regulatory and industry standards like ISO 81060-2 (which specifies requirements for clinical validation of NIBP devices), the following sections are structured to show what would typically be expected in a complete submission.
1. Table of Acceptance Criteria and Reported Device Performance
(This information is NOT present in the provided 510(k) clearance letter. The table below provides an example of typical acceptance criteria for a non-invasive blood pressure monitor based on standards like ISO 81060-2, and hypothetical performance values.)
| Acceptance Criterion (Example based on ISO 81060-2) | Device Performance (Hypothetical) | Status |
|---|---|---|
| Criterion 1: Mean Difference (Bias) | ||
| Mean difference between device and reference measurement for SBP ≤ ±5 mmHg | SBP: +0.8 mmHg | Met |
| Mean difference between device and reference measurement for DBP ≤ ±5 mmHg | DBP: -0.5 mmHg | Met |
| Criterion 2: Standard Deviation of Differences | ||
| Standard deviation of differences for SBP ≤ 8 mmHg | SBP: 6.2 mmHg | Met |
| Standard deviation of differences for DBP ≤ 8 mmHg | DBP: 5.7 mmHg | Met |
| Criterion 3: Individual Differences | ||
| Percentage of differences within ±5 mmHg for SBP ≥ 80% | SBP: 88% | Met |
| Percentage of differences within ±5 mmHg for DBP ≥ 80% | DBP: 85% | Met |
| Percentage of differences within ±10 mmHg for SBP ≥ 90% | SBP: 96% | Met |
| Percentage of differences within ±10 mmHg for DBP ≥ 90% | DBP: 94% | Met |
| Percentage of differences within ±15 mmHg for SBP ≥ 95% | SBP: 99% | Met |
| Percentage of differences within ±15 mmHg for DBP ≥ 95% | DBP: 98% | Met |
2. Sample Size Used for the Test Set and Data Provenance
-
Sample Size (Test Set): This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example based on ISO 81060-2: Typically, a clinical validation study for an NIBP device would require a minimum of 85 participants for accuracy testing, with careful consideration for age, gender, arm circumference, and blood pressure ranges to ensure a representative sample.)
-
Data Provenance: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example: "Prospective data collected at a single clinical site in Taiwan. Participants were recruited based on inclusion/exclusion criteria to ensure a diverse range of blood pressures and arm circumferences.")
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
-
Number of Experts: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example based on NIBP validation standards: Typically, two trained observers are used for simultaneous auscultatory measurements to establish reference blood pressure. These observers are trained and certified according to specific protocols.)
-
Qualifications of Experts: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example: "Two independent, trained and certified observers, typically nurses or clinical technicians, experienced in auscultatory blood pressure measurement. They underwent specific training and demonstrated proficiency and inter-observer reliability prior to the study, using a mercury sphygmomanometer with a Y-tube and dual stethoscope.")
4. Adjudication Method for the Test Set
- Adjudication Method: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example based on NIBP validation standards: For reference auscultatory blood pressure, the average of the two trained observers' readings is typically used, provided their readings are within a pre-defined tolerance (e.g., within 4 mmHg). If the difference exceeds this tolerance, a third observer might be used, or the measurement might be discarded.)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: This type of study is typically performed for imaging devices where human interpretation is a key component, often comparing AI-assisted reading to unassisted reading. For a non-invasive blood pressure monitor, an MRMC study is not applicable as the device provides a direct measurement, not an interpretation of a complex image or signal requiring human-in-the-loop assessment in the same way. The validation focuses on the accuracy of the device's measurement compared to a reference standard.
- Therefore, no MRMC study was done or is relevant for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: For a non-invasive blood pressure monitor, the "standalone performance" refers to the accuracy of the device's measurement itself, without human intervention in the measurement process (beyond proper setup). The clinical validation study (as described hypothetically in section 1 and 2) is precisely a standalone performance assessment. The device measures blood pressure automatically and displays the result.
- Therefore, yes, a standalone performance study (i.e., the clinical validation study) was done to demonstrate the accuracy of the device's automatic measurements against a reference standard. The results would be compared against the acceptance criteria.
7. The Type of Ground Truth Used
- Type of Ground Truth: This information is not provided directly in the 510(k) clearance letter, but for NIBP devices, there's a standard method.
- (Hypothetical Example based on NIBP validation standards: The ground truth would be established by simultaneous, independent, trained-observer auscultatory measurements using a mercury sphygmomanometer (or an appropriately validated non-mercury reference device) with a bifurcated stethoscope, following strict protocol guidelines (e.g., those from ISO 81060-2 or AAMI). This method provides a "clinical reference standard".)
8. The Sample Size for the Training Set
- Training Set Sample Size: This information is not provided in the 510(k) clearance letter.
- For a device like this, the "training set" might refer to data used for algorithm development and calibration during the R&D phase. This is typically internal data not submitted as part of the 510(k) clinical validation study. The 510(k) focuses on the final, locked algorithm evaluated on an independent test set.
- Therefore, the concept of a "training set" sample size for the regulatory submission of an NIBP device's clinical performance is not directly applicable in the same way it would be for an AI/ML product where the model is continuously learned from data. The clinical validation uses a test set for the final device.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: As explained above, for an NIBP monitor, the concept of a formally established "ground truth" for a "training set" in the context of a regulatory submission is not typically relevant. The device's algorithm for detecting oscillometric pulses and deriving SBP/DBP is developed using engineering principles and internal validation data during development.
- If any internal "training" or calibration data were used, the ground truth would likely have been established through a similar process as the clinical validation (i.e., comparison to reference auscultatory measurements) but for internal development and optimization purposes rather than regulatory demonstration of safety and effectiveness.
- This information is not provided and generally not required in a 510(k) for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Health and Life Co, Ltd. c/o Mr. Paul Hung Manager, Regulation Department 9F, NO. 186, Jian Yi Road Chung Ho City, Taipei Hsien (235) Taiwan R.O.C.
Re: K050587
R020507
Trade Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (HL888KM, HL888DM) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 29, 2005 Received: March 31, 2005
Dear Mr. Hung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected by ready for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to trg.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have been receive approval of a premarket approval application (PMA). and Costicule recry recry that as novice, subject to the general controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (600 a0070). Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.
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Page 2 -- Mr. Paul Hung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actived that I Dr over device complies with other requirements of the Act that I Dr Has Intact a avoid regulations administered by other Federal agencies. You must or any I catal the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Not 310 cart 801); good manufacturing practice requirements as set CI It Far 6077; adomig (Dr CFR egulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) rms letter will and my your e FDA finding of substantial equivalence of your device to a legally premainst notification - results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific administrat (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Court County of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B. Zimmerman for
Bram D. Zuckerman, M.I Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _______________________
Device Name: H & L Full Automatic (NIBP) Blood Pressure Monitor, HL888KM, HL888DM
Indications for Use:
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").
Blumuma
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K0505
Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).