(29 days)
The Welch Allyn ABPM 6100 is a non-invasive oscillometric ambulatory blood pressure monitor that is to be used with ABPM 6100 Software, a PC based computer program. The ABPM 6100 is capable of recording and displaying up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure adult or pediatric patients systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnosis.
The Welch Allyn ABPM 6100 is a microprocessor based ambulatory blood pressure monitor that uses an oscillometric step deflation technique to determine blood pressure. An internal electric pump is used to inflate the cuff and two valves control deflation. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Welch Allyn ABPM 6100 has the ability to make blood pressure determinations at predetermined intervals (normally from a schedule determined by the physician), or on demand (by using the stop/start key). Each reading is stored in memory, allowing the physician to download all the results obtained during the study period after the study has concluded to be analyzed by PC software. The readings can be displayed on the LCD or the LCD can be disabled to prevent the patient from seeing the readings (see attachment I for photographs of the device).
The Welch Allyn ABPM 6100 is an ambulatory blood pressure monitor. The acceptance criteria and supporting study are described below.
1. Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated by its compliance with recognized standards. The standards themselves contain the acceptance criteria for blood pressure monitors. The submission states that the device meets the requirements called out in these standards.
| Acceptance Criteria Standard | Reported Device Performance |
|---|---|
| EN60601-1 | Meets requirements |
| EN60601-1-1 | Meets requirements |
| EN60601-1-2 | Meets requirements |
| EN60601-2-30 | Meets requirements |
| AAMI SP10 | Meets requirements |
2. Sample Size and Data Provenance
The submission does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature). The claim of meeting the standards implies that testing was conducted, but details are not provided.
3. Number and Qualifications of Experts for Ground Truth
Details regarding the number and qualifications of experts used to establish ground truth are not provided in the document.
4. Adjudication Method
The adjudication method is not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size information regarding human readers' improvement with or without AI assistance. This is expected as the device is a blood pressure monitor, not an AI diagnostic tool for image interpretation.
6. Standalone Performance Study
The submission indicates that the device's performance aligns with the requirements of the listed standards (EN60601-1, EN60601-1-1, EN60601-1-2, EN60601-2-30, and AAMI SP10). These standards typically involve standalone testing of the device's accuracy and functionality. Therefore, a standalone performance study was done by virtue of meeting these standards, although specific details of the study are not included in the provided text.
7. Type of Ground Truth Used
For blood pressure monitors, the ground truth typically involves a reference blood pressure measurement device (e.g., a mercury sphygmomanometer used by trained personnel) against which the device under test is compared. The specific type of ground truth used is not explicitly stated in the document, but it would align with the methodologies prescribed by the AAMI SP10 standard for automated sphygmomanometers, which involves comparison to a simultaneously measured reference.
8. Sample Size for the Training Set
The device is a non-AI/ML blood pressure monitor. Therefore, there is no training set in the context of machine learning. Its operation is based on an oscillometric step deflation technique and microprocessor analysis of cuff pressure changes.
9. How Ground Truth for the Training Set Was Established
As noted in point 8, this device does not utilize a training set in the machine learning sense. The underlying physiological principles and algorithms are established through extensive medical and engineering research, not by "training" with a dataset that requires specific ground truth establishment.
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K021756
page 1 of 2
JUN 2 7 2002
V. 510(k) Summary
188
[As described in CFR 807.92]
| Submitted by: | Welch Allyn Inc.4341 State Street RoadSkaneateles Falls, NY 13153 |
|---|---|
| Contact Person: | David KlementowskiCorporate Regulatory Affairs Manager |
| Date Prepared: | 20 May 2002 |
| Proprietary Name: | Welch Allyn ABPM 6100 |
| Common Name: | Ambulatory Blood Pressure Monitor |
| Classification Name: | Class II 870.1110 Blood Pressure Computer |
| Predicate Devices: | Pressure Trak System Model 222-BSunTech Medical Instruments510(k) Document Control Number K010622Welch Allyn Ambulatory Blood Pressure MonitorWelch Allyn, Inc.510(k) Document Control Number K925899 |
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K021756
page 2 of 2
Description of the Device:
The Welch Allyn ABPM 6100 is a microprocessor based ambulatory blood pressure monitor that uses an oscillometric step deflation technique to determine blood pressure. An internal electric pump is used to inflate the cuff and two valves control deflation. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Welch Allyn ABPM 6100 has the ability to make blood pressure determinations at predetermined intervals (normally from a schedule determined by the physician), or on demand (by using the stop/start key). Each reading is stored in memory, allowing the physician to download all the results obtained during the study period after the study has concluded to be analyzed by PC software. The readings can be displayed on the LCD or the LCD can be disabled to prevent the patient from seeing the readings (see attachment I for photographs of the device).
Intended Use
The Welch Allyn ABPM 6100 is a non-invasive oscillometric ambulatory blood pressure monitor that is to be used with ABPM 6100 Software, a PC based computer program. The ABPM 6100 is capable of recording and displaying up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure adult or pediatric patients systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnosis.
Action Taken to Comply with Section 514 of the Act
The agency has recognized the following standards:
- a) EN60601-1
- b) EN60601-1-1
- c) EN60601-1-2
- d) EN60601-2-30
- e) AAMI SP10
The Welch Allyn ABPM 6100 meets the requirements called out in these standards. Evidence of compliance is on file at Welch Allyn and is available for review upon demand.
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Image /page/2/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's logo, which is a stylized caduceus. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Welch Allyn, Inc. c/o Mr. David Klementowski Corporate Regulatory Affairs Manager 4341 State Street Road Skaneateles Falls, NY 13153
Re: K021756
Trade Name: Welch Allyn ABPM 6100 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 18, 2002 Received: June 19, 2002
Dear Mr. Klementowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. David Klementowski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
signature
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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III. Indications for Use Statement
| 510(k) Number: | Unknown |
|---|---|
| Device Name: | Welch Allyn ABPM 6100 |
| Indications for use: | The Welch Allyn ABPM 6100 is a non-invasiveoscillometric ambulatory blood pressure monitor that is tobe used with ABPM 6100 Software, a PC based computerprogram. The ABPM 6100 is capable of recording anddisplaying up to 250 measurements of systolic and diastolicblood pressure and heart rate. It is intended for use as anaid or adjunct to diagnosis and treatment when it isnecessary to measure adult or pediatric patients systolic anddiastolic blood pressures over an extended period of time.The system is only for measurement, recording, anddisplay. It makes no diagnosis. |
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- See next page for contraindications for use.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Cardiovascu and Respiratory Devine | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------- |
| 510(k) Number | K021756 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | Or | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |
(Per 21 CFR 801.109)
§ 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).