(104 days)
Not Found
No
The document describes a blood pressure cuff and its performance testing, but there is no mention of AI or ML technology being used in the device itself or the associated NIBP measurement systems. The algorithms mentioned (SuperSTAT and Classic NIBP) are standard NIBP algorithms, not explicitly identified as AI/ML.
No
The device is an accessory (blood pressure cuff) used with NIBP measurement systems to measure arterial pressure, not to treat or alleviate a condition.
Yes
The device is a blood pressure cuff and facilitates the measurement of automated non-invasive blood pressure (NIBP), which is a diagnostic measurement.
No
The device description explicitly states it is a physical blood pressure cuff with an inflatable bladder and connection tubing, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a blood pressure cuff used in conjunction with noninvasive blood pressure (NIBP) measurement systems to measure radial arterial pressure on the forearm. This is a physiological measurement taken directly from the patient's body.
- Device Description: The description details a physical cuff that inflates to occlude an artery for blood pressure measurement. This is a mechanical process, not a diagnostic test performed on a sample taken from the body.
- No mention of in vitro testing: The text does not mention any testing of samples (like blood, urine, etc.) outside of the body.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure cuff does not fit that definition.
N/A
Intended Use / Indications for Use
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. The RADIAL-CUF is intended for use with automated oscillometric NIBP devices to measure radial arterial pressure on the forearm. The RADIAL-CUF is available in adult size only. The device is non-sterile and is semi-disposable (may be single-patient use or optional limited reuse). The cuff is intended for use in patients whose upper arm circumference is greater than 40cm or in patients where currently marketed GE CRITIKON upper arm cuffs cannot be used, due to excess width of the cuff or conical shape of the upper arm. The forearm cuff is intended to be placed on the patient's forearm with circumference ranging from 26cm -36cm. The devices are not designed, sold or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The RADIAL-CUF is a Non-Invasive Blood Pressure cuff that incorporates an inflatable non-distensible bladder, sized to encircle a patient's forearm. Connection tubing allows air to flow in and out of the cuff for inflation and deflation. Inflation allows for the occlusion of the Radial artery. The RADIAL-CUF facilitates the measurement of automated non-invasive blood pressure (NIBP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm
Indicated Patient Age Range
adult
Intended User / Care Setting
Not Found
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)
To better measure noninvasive blood pressure (NIBP) in special populations, GE Healthcare has designed a new cuff, the GE CRITIKON RADIAL-CUF, for use on the adult forearm. To provide evidence that this new cuff performs properly, a set of studies using the new cuff design was undertaken using subjects who fit the special population demographic requirements.
The first objective for this study was to test the accuracy of the measurements taken with the new cuff on the forearm using the corresponding radial artery as the reference. Two GE Healthcare devices, the GE DASH 4000 with SuperSTAT (NIBP) algorithm and CARESCAPE V100 with Classic NIBP algorithm, were used for the study. The ANSI/AAMI/ISO 81060-2:2009 standard was used as the basis for analysis. The second objective was to evaluate the accuracy of the NIBP measurements using a marketed upper arm cuff used on the forearm.
The DASH 4000 was used for collecting the continuous invasive radial arterial blood pressure and ECG waveform. The DASH 4000 and CARESCAPE V100 collected the NIBP values using the forearm cuff. The noninvasive systolic, diastolic, and mean blood pressures were compared to the invasive data using the requirements detailed in the ISO 81060-2 standard. The forearm data for each of the two NIBP devices were analyzed independently as separate ISO 81060-2 studies. The data comparing the NIBP results using the non-radial marketed SOFT-CUF on the forearm was also analyzed independently from the forearm cuff data.
The results demonstrate that the GE CRITIKON RADIAL-CUF meets the ISO 81060-2 accuracy standards using the DASH 4000 with SuperSTAT NIBP algorithm and the CARESCAPE V100 with Classic NIBP algorithm. The non-radial marketed SOFT-CUF applied to the forearm failed to meet the ISO 81060-2 accuracy standards, as it did not provide accurate radial artery referenced NIBP results when used on the forearm.
In summary, the GE CRITIKON RADIAL-CUF provides accurate radial artery referenced NIBP measurements using GE automatic NIBP devices
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
§ 870.1120 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).
0
K123996
pg 1 of 3
510(k) Summary
APR 0 9 2013
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: December 21, 2012
Submitter: GE Medical Systems Information Technologies, Inc. 8200 West Tower Ave. Milwaukee, WI 53223 Primary Contact Person: Mary Carter Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Phone: (414) 362-2626 Fax: (262) 362-2585 Secondary Contact Person: Doug Kentz Regulatory Affairs Director GE Medical Systems Information Technologies, Inc. Phone: (414) 362-2038 Fax: (414) 362-2585
Device: Trade Name: RADIAL-CUF Non-Invasive Blood Pressure Cuff
Common/Usual Name: Blood Pressure Cuff
Classification Names: Blood Pressure Cuff
DXQ Product Code: Predicate Device(s): K120125 Non-Invasive Blood Pressure Cuffs
Device Description: The RADIAL-CUF is a Non-Invasive Blood Pressure cuff that incorporates an inflatable non-distensible bladder, sized to encircle a patient's forearm. Connection tubing allows air to flow in and out of the cuff for inflation and deflation. Inflation allows for the occlusion of the Radial artery. The RADIAL-CUF facilitates the measurement of automated non-invasive blood pressure (NIBP).
Intended Use: Indirect measurement of blood pressure.
Technology:
The RADIAL-CUF is based on the cleared SOFT-CUF product line (K120125). Traditional NIBP Cuffs utilize a bladder that is rectangular in shape, to accommodate a limb generally of cylindrical form. The RADIAL-CUF utilizes a bladder of arc form, to accommodate the generally conical shape of the forearm. Cuff materials, tubing and connectors used are identical to those used on the cleared SOFT-CUF product line. The RADIAL-CUF employs the same fundamental scientific technology as its predicate devices.
1
K123996
pg 2 of 3
Summary of Non-Clinical Tests: Determination of
Substantial Equivalence:
The RADIAL-CUF and its applications comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the devices:
- Risk Analysis .
- Requirements Reviews ●
- Design Reviews
- Performance Testing (Verification)
- Compatibility Bench Testing ●
- Clinical Testing .
Summary of Clinical Tests:
To better measure noninvasive blood pressure (NIBP) in special populations, GE Healthcare has designed a new cuff, the GE CRITIKON RADIAL-CUF, for use on the adult forearm. To provide evidence that this new cuff performs properly, a set of studies using the new cuff design was undertaken using subjects who fit the special population demographic requirements.
The first objective for this study was to test the accuracy of the measurements taken with the new cuff on the forearm using the corresponding radial artery as the reference. Two GE Healthcare devices, the GE DASH 4000 with SuperSTAT (NIBP) algorithm and CARESCAPE V100 with Classic NIBP algorithm, were used for the study. The ANSI/AAMI/ISO 81060-2:2009 standard was used as the basis for analysis. The second objective was to evaluate the accuracy of the NIBP measurements using a marketed upper arm cuff used on the forearm.
The DASH 4000 was used for collecting the continuous invasive radial arterial blood pressure and ECG waveform. The DASH 4000 and CARESCAPE V100 collected the NIBP values using the forearm cuff. The noninvasive systolic, diastolic, and mean blood pressures were compared to the invasive data using the requirements detailed in the ISO 81060-2 standard. The forearm data for each of the two NIBP devices were analyzed independently as separate ISO 81060-2 studies. The data comparing the NIBP results using the non-radial marketed SOFT-CUF on the forearm was also analyzed independently from the forearm cuff data.
The results demonstrate that the GE CRITIKON RADIAL-CUF meets the ISO 81060-2 accuracy standards using the DASH 4000 with SuperSTAT NIBP algorithm and the CARESCAPE V100
2
K123996
pg 30 of 3
with Classic NIBP algorithm. The non-radial marketed SOFT-CUF applied to the forearm failed to meet the ISO 81060-2 accuracy standards, as it did not provide accurate radial artery referenced NIBP results when used on the forearm.
In summary, the GE CRITIKON RADIAL-CUF provides accurate radial artery referenced NIBP measurements using GE automatic NIBP devices
Conclusion:
GE Healthcare considers the RADIAL-CUF NIBP cuff to be as safe, as effective, and performance is 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved strokes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2013
GE Medical Systems Information Technologies, Inc. c/o Ms. Mary Carter 8200 West Tower Ave. Milwaukee, WI 53223
Re: K123996
Trade/Device Name: Radial-Cuf Non-Invasive Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: February 25, 2013 Received: February 26, 2013
Dear Ms. Carter:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Ms. Mary Carter
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Owen-PEaris-S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Unknown
Device Name: RADIAL-CUF Non-Invasive Blood Pressure Cuff
Indications for Use:
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. The RADIAL-CUF is intended for use with automated oscillometric NIBP devices to measure radial arterial pressure on the forearm. The RADIAL-CUF is available in adult size only. The device is non-sterile and is semi-disposable (may be single-patient use or optional limited reuse). The cuff is intended for use in patients whose upper arm circumference is greater than 40cm or in patients where currently marketed GE CRITIKON upper arm cuffs cannot be used, due to excess width of the cuff or conical shape of the upper arm. The forearm cuff is intended to be placed on the patient's forearm with circumference ranging from 26cm -36cm. The devices are not designed, sold or intended for use except as indicated.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.04.09 14:41:35
-04'00'
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