(365 days)
Not Found
No
The summary describes a standard blood pressure measurement device using the oscillometric method and manual techniques. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is indicated for measuring blood pressure and heart rate, which are diagnostic measurements, not therapeutic interventions.
No
Explanation: While the device measures blood pressure, which is a vital sign, it is primarily a measurement device and the provided text does not indicate that it is intended for diagnosing a disease or condition. Its purpose is to measure physiological parameters, not to provide a medical diagnosis through interpretation of its results.
No
The device description explicitly states it is a "hand-held device" and mentions "manual measurement methods" and "automatic electronic non-invasive blood pressure (NIBP) measurement devices," indicating it includes hardware components beyond just software. The performance studies also include testing related to hardware, such as mechanical shock, vibration, and battery testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The statMAP Model 7200 is a blood pressure measurement device. It measures physiological parameters (blood pressure and heart rate) directly from the patient's body using non-invasive methods (oscillometric).
- No mention of samples: The description does not mention the device analyzing any samples taken from the body.
Therefore, the statMAP Model 7200 falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The statMAP Model 7200 is designed for use in a variety of settings where Blood Pressure Measurement is required on Adults, Pediatrics, or Neonates: these include hospital departments such as intensive care units, medical/surgical nursing units. emergency department, labor and delivery, radiology, recovery, cardiac care units, and step-down units; statMAP Model 7200 is also designed for use in out-patient centers, physicians offices, the home, as well as EMS environments. The statMAP Model 7200 device will display Systolic, Diastolic, MAP and Heart Rate.
The statMAP Model 7200 Blood Pressure Measurement Device is a prescription device, and is indicated for use to measure systolic, diastolic, mean arterial pressure (MAP) and heart rate of persons ages 12 and over using the oscillometric method of measurement.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The statMAP Model 7200 Blood Pressure (BP) Measurement Device is a hand-held device designed to provide semi-automatic or manual Blood pressure measurement on Adults, Pediatrics and Neonates. The design concept for the statMAP Model 7200 is a small, very compact BP measurement device that combines both the totally manual measurement methods, such as the manual auscultatory and the palpatory methods, and automatic electronic non-invasive blood pressure (NIBP) measurement devices using the oscillometric method of BP determination.
The statMAP Model 7200 allows for two basic modes of NIBP measurement, which are manual NIBP measurement and semi-automatic NIBP measurement. The statMAP Model 7200 measurement modes are summarized as follows:
1) Semi-automatic NIBP Determination
In this mode, the device performs an electronic determination of Blood Pressure (using the oscillometric method) and Heart Rate. The user controls only the inflation of the limb compression cuff while the deflate rate of the cuff is performed automatically by the integrated deflate valve controlled by the statMAP Model 7200 electronics. The BP and I IR values are displayed for the user as a set of illuminated LEDs at the edge of the dial face.
2) Manual BP determination
In this mode, the device functions as a palm style aneroid sphygmomanometer with an integral cuff inflation bulb and manual deflate valve. Blood pressures are determined by the operator using the traditional auscultatory method or the palpatory or the manual oscillometric mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, Pediatrics and Neonates (Device Description)
persons ages 12 and over (Indications for Use)
Intended User / Care Setting
hospital departments such as intensive care units, medical/surgical nursing units. emergency department, labor and delivery, radiology, recovery, cardiac care units, and step-down units; out-patient centers, physicians offices, the home, as well as EMS environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The statMAP Model 7200 has been comprehensively tested to demonstrate its performance, safety and efficacy, specifically:
- EN 60601-1 Safety Medical Equipment .
- IEC601-2-30 Particular Requirements for Automatic Cycling NIBP monitors .
- . Mechanical Shock and Vibration - ISTA2A
- Electromagnetic Compatibility EN60601-1-2 t
- Battery Testing .
- Comparison testing between statMAP Model 7200 and Predicate Device
- Intra-device variability .
- Environmental testing (Temperature and Humidity)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
RAMSEY MEDICAL INC.
JUL 3 1 2008
K072109 ャリア
Page 5 - 1
510(k) SUMMARY
| Date Prepared: | 7/30/2007 |
|---|---|
| Contact: | Ramsey Medical, Inc. |
| 4920 W. Cypress St., Ste. 110 | |
| Tampa, FL 33607, U.S.A. | |
| (813) 289-5555 | |
| 800-231-6370 US | |
| Fax (813) 289-5454 | |
| Contact Person: | Darryl Parmet |
| Engineering Consultant | |
| (813) 382-9091 | |
| Dparmet1@tampabay.rr.com | |
| Device Trade Name: | statMAP Model 7200 Blood Pressure |
| Measuring Device | |
| Common Names: | Blood Pressure Measuring Device, Blood Pressure |
| Monitor | |
| Classification Name: | Non Invasive Blood Pressure |
| Measurement System |
Includes the following parameters:
Systolic Pressure
Diastolic Pressure
Mean Arterial Pressure
Heart Rate
1
Page 5 - 2
RAMSEY MEDICAL INC.
Classification
| Classification Name | 21 CFR Section | Product Code | Class |
|---|---|---|---|
| Non-Invasive Blood | |||
| Pressure Measurement | |||
| System | 870.1130 | DXN | 2 |
Predicate Devices
Ramscy Medical, Inc., is claiming substantial equivalence to the following legally marketed device:
| Aspect | Device | 510(k) number |
|---|---|---|
| Non-invasive Blood | ||
| Pressure | Critikon Model 8100 Vital Signs | |
| Monitor | K854434 |
Device Description
The statMAP Model 7200 Blood Pressure (BP) Measurement Device is a hand-held device designed to provide semi-automatic or manual Blood pressure measurement on Adults, Pediatrics and Neonates. The design concept for the statMAP Model 7200 is a small, very compact BP measurement device that combines both the totally manual measurement methods, such as the manual auscultatory and the palpatory methods, and automatic electronic non-invasive blood pressure (NIBP) measurement devices using the oscillometric method of BP determination.
The statMAP Model 7200 allows for two basic modes of NIBP measurement, which are manual NIBP measurement and semi-automatic NIBP measurement. The statMAP Model 7200 measurement modes are summarized as follows:
1) Semi-automatic NIBP Determination
In this mode, the device performs an electronic determination of Blood Pressure (using the oscillometric method) and Heart Rate. The user controls only the inflation of the limb compression cuff while the deflate rate of the cuff is performed automatically by the integrated deflate valve controlled by the statMAP Model 7200 electronics. The BP and I IR values are displayed for the user as a set of illuminated LEDs at the edge of the dial face.
2) Manual BP determination
In this mode, the device functions as a palm style aneroid sphygmomanometer with an integral cuff inflation bulb and manual deflate valve. Blood pressures are determined by the operator using the traditional auscultatory method or the palpatory or the manual oscillometric mode.
2
RAMSET MEDICAL INC.
(072109 73/3
Page 5 - 3
Intended Uses
The statMAP Model 7200 is designed for use in a variety of settings where Blood Pressure Measurement is required on Adults, Pediatrics, or Neonates: these include hospital departments such as intensive care units, medical/surgical nursing units. emergency department, labor and delivery, radiology, recovery, cardiac care units, and step-down units; statMAP Model 7200 is also designed for use in out-patient centers, physicians offices, the home, as well as EMS environments. The statMAP Model 7200 device will display Systolic, Diastolic, MAP and Heart Rate.
Comparison of Technological Characteristics
The statMAP Model 7200 and the predicate device share essentially the same intended use and technological characteristics.
Both devices employ the Oscillometric method of Blood Pressure Measurement and use an electronic deflate valve to step-deflate the cuff during the measurement cycle. Systolic, Diastolic, Mean Arterial Pressure, and Heart Rate are displayed.
The predicate device has a built-in pump for inflation whereas the statMAP Model 7200 relies on the user to manually inflate the cuff using its integrated inflation bulb. The statMAP Model 7200 also supports manual blood pressure measurement as a traditional aneroid sphygmomanometer.
The predicate device also has a programmable auto-cycling capability, while the statMAP is not designed for unattended operation.
Device testing
The statMAP Model 7200 has been comprehensively tested to demonstrate its performance, safety and efficacy, specifically:
- EN 60601-1 Safety Medical Equipment .
- IEC601-2-30 Particular Requirements for Automatic Cycling NIBP monitors .
- . Mechanical Shock and Vibration - ISTA2A
- Electromagnetic Compatibility EN60601-1-2 t
- Battery Testing .
- Comparison testing between statMAP Model 7200 and Predicate Device �
- Intra-device variability .
- Environmental testing (Temperature and Humidity) ●
Conclusions
In accordance with 21 CFR part 807.92(b) (3) and as presented in the pre-market notification, Ramsey Medical, Inc., concludes that the new device, statMAP Model 7200 is safe, effective and substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JUL 31 2008
Ramsey Medical Inc. c/o Mr. Darryl Parmet Engineering Consultant 4920 West Cypress Street, Ste. 110 Tampa, FL 33607
Re: K072109
Trade/Device Name: statMAP Model 7200 Blood Pressure Measurement Device Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 26, 2008 Received: June 27, 2008
Dear Mr. Parmet:
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.
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 agencics. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
Page 2 -- Mr. Darryl Parmet
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K072109
Device Name: statMAP Model 7200 Blood Pressure Measurement Device
Indications For Use:
The statMAP Model 7200 Blood Pressure Measurement Device is a prescription device, and is indicated for use to measure systolic, diastolic, mean arterial pressure (MAP) and heart rate of persons ages 12 and over using the oscillometric method of measurement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 Cardiovascular Devices | |
| 510(k) Number | K072109 |
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