SOFT-CUF (K120125)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a blood pressure cuff, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used to measure blood pressure, which is a diagnostic function, not a therapeutic one. It facilitates the measurement but does not treat or cure a disease or condition.
No
The device is a blood pressure cuff, which is an accessory used to obtain a blood pressure measurement. It does not perform diagnosis itself.
No
The device description explicitly details a physical blood pressure cuff with an inflatable bladder, tubing, and connectors, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for non-invasive blood pressure measurement systems, which is a physiological measurement taken directly from the patient's body.
- Device Description: The description details a physical accessory (a cuff) that is applied externally to a limb to facilitate a physical measurement (blood pressure).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside of the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body. This blood pressure cuff is a direct measurement device used on the body itself.
N/A
Intended Use / Indications for Use
The blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXO
Device Description
ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement.
Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated.
Blood pressure cuffs do not include serviceable parts or components.
Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK,
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
pediatric and 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)
Summary of Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
- Environmental Conditioning
- Leak
- Pressure Capacity
- Mechanical Strength
- Tensile Testing
- Standards
- Biocompatibility
Biocompatibility testing
Biocompatibility testing was performed in accordance with per ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. In accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 4, 2020.
- Chemical characterization
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
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.
SOFT-CUF (K120125)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 14, 2023
GE Medical Systems Information Technologies, Inc. % Michelle Johnson Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K230145
Trade/Device Name: One-cuf Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: January 18, 2023 Received: January 18, 2023
Dear Michelle Johnson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230145
Device Name ONE-CUF
Indications for Use (Describe)
The blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | January 9, 2023 |
| Primary Contact Person: | Michelle Johnson |
| Senior Quality Staff Manager - Regulatory Affairs | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: +1 414 429 9263 | |
| Email: Michelle.Johnson@ge.com | |
| Secondary Contact Person: | Jennifer Strauther |
| Regulatory Affairs Leader | |
| GE Medical Systems Information Technologies, Inc. | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Phone: +1 262 330 2112 | |
| Email: Jennifer.Strauther@ge.com | |
| Device Trade Name: | ONE-CUF |
| Common/Usual Name: | Blood Pressure Cuff |
| Classification Names: | Blood Pressure Cuff |
| Regulation: | 21 CFR 870.1120 Blood Pressure Cuff |
| Classification: | II |
| Product Code: | DXQ |
| Predicate Device: | SOFT-CUF (K120125) |
| Intended Use: | Indirect measurement of blood pressure |
| Indications for Use: | The blood pressure cuff is an accessory used in conjunction with |
| non-invasive blood pressure measurement systems. It is non-sterile, | |
| single-patient use. It is available in pediatric and adult sizes. The | |
| cuff is not designed, sold or intended for use except as indicated. |
4
5.1 Device Description:
ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement.
Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated.
Blood pressure cuffs do not include serviceable parts or components.
Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK,
5.2 Comparison of Technological Characteristics with the Predicate Device
The Non-Invasive Blood Pressure Cuffs employ the same fundamental scientific technology as its predicate device. The differences between the ONE-CUF and the
| Feature/Function | Predicate Device/System
Name and 510 (k)
SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name
ONE-CUF Blood Pressure Cuff | Comparison Result |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Intended Use | | | |
| • Indications for Use | Indications for Use
GE CRITIKON blood pressure cuffs are
accessories used in conjunction with
noninvasive blood pressure (NIBP)
measurement systems. SOFT-CUF and
CLASSIC-CUF cuffs and inflation systems
are non-sterile and limited reuse (may be
single-patient use or optional limited reuse).
They are available in neonatal, pediatric and
adult sizes. The devices are not designed,
sold or intended for use except as indicated. | Indications For Use
The blood pressure cuff is an accessory
used in conjunction with non-invasive
blood pressure measurement systems. It is
non-sterile, single-patient use. It is available
in pediatric and adult sizes. The cuff is not
designed, sold or intended for use except as
indicated. | Equivalent. |
| • Use | Non-sterile, single patient use or limited
reuse | Non-sterile, Single patient use | Equivalent |
| • Population | Adult, pediatric, neonatal | Adult and Pediatric | Equivalent. |
| • Intended Use | Indirect measurement of blood pressure | Indirect measurement of blood pressure | Identical |
| Environmental Specifications - Operating Conditions | | | |
| • Temperature | 0° C to 46° C | 0° C to 40° C | Equivalent |
predicate SOFT-CUT do not raise any new or questions on the safety and effectiveness.
5
| Feature/Function | Predicate Device/System
Name and 510 (k)
SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name
ONE-CUF Blood Pressure Cuff | Comparison Result |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Environmental Specifications - Storage Conditions | | | |
| • Relative Humidity | 15% to 90% humidity, non-condensing | 15% to 90% humidity, non-condensing | Identical |
| • Temperature | -20° C to 55° C | -20° C to 55° C | Identical |
| • Relative Humidity | 0% to 95% humidity, non-condensing | 0% to 95% humidity, non-condensing | Identical |
| Physical Specifications | | | |
| • Limb Circumference
(Ranges in cm) | Neonatal #1 (3-6)
Neonatal #2 (4-8)
Neonatal #3 (6-11)
Neonatal #4 (7-13)
Neonatal #5 (8-15)
Infant (8-13)
Child (12-19)
Child Long (12-19)
Small Adult (17-25)
Small Adult Long (17-25)
Adult (23-33)
Adult Long (23-33)
Large Adult (31-40)
Large Adult Long (31-40)
Thigh (38-50) | Infant (8-13)
Child (12-19)
Small Adult (17-25)
Adult (23-33)
Adult Long (23-33)
Large Adult (31-40) | Equivalent |
| • Bladder Size | Various bladder sizes for neonate, pediatric
and adult populations | Various bladder sizes for pediatric and adult
populations | Equivalent |
| Feature/Function | Predicate Device/System
Name and 510 (k)
SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name
ONE-CUF Blood Pressure Cuff | Comparison Result |
| • Cuff Connector
Configurations | Adult and Pediatric 2-Tube configuration:
• Screw Connector
• Sub-Miniature Connector
• Mated Subminiature Connector
• Dual CLICK-IT (branded as
"DINACLICK") Connector
Adult and Pediatric 1-Tube configuration:
• Bayonet Connector
• Screw
• Sub-Miniature Connector
Neonatal
• 1-Tube and 2-Tube Male Slip Luer Taper
• 1-Tube and 2-Tube SNAP-IT (branded as
"NeoSnap") Connectors | Adult and Pediatric 2-Tube configuration:
• Dual CLICK-IT (branded as
"DINACLICK") Connector
Adult 1-Tube configuration:
• Bayonet Connector | Equivalent. |
| Materials | | | |
| • Cuff / Integrated
Bladder | SOFT-CUF: Laminate of polyester /
polyvinyl chloride | ONE-CUF: Laminate of polyester /
polyvinyl chloride | Equivalent. |
| • Ink | SOFT-CUF: Zephyron-Ion Solvent Based | ONE-CUF: Zephyron-Ion Solvent Based | Identical. |
| Compatibility | | | |
| • Device | Single / dual tubes, adaptors and bulb / valve
assemblies for use with manual and
automated sphygmomanometers. | ONE-CUF: Single / dual tubes for use with
manual and automated
sphygmomanometers. | Equivalent. |
| Performance Specifications | | | |
| • Leak Rate | Maximum allowable pressure loss rate is 0.6
sccm (standard cubic cm per minute) | Maximum allowable pressure loss rate is
0.6 sccm (standard cubic cm per minute) | Identical |
| • Air Leakage | Less than 4mmHg/min | Less than 4mmHg/min | Identical |
| • Pressure Range | 0-300 mmHg | 0-300 mmHg | Identical |
| Standards Compliance (Applicable Sections) | | | |
| • Automated/Manual
Sphygmomanomete
rs | SP10:2002/A1:2003/A2:2006 | IEC 80601-2-30:2018 (applicable sections)
ISO 81060-1:2007 (applicable sections) | Equivalent |
| • Automated/Manual
Sphygmomanomete
rs | EN 1060-1:1995/A1:2002/A2:2009
(applicable sections)
EN 1060-2:1995/C1:2002/A1:2009
(applicable sections)
IEC 80601-2-30:2009 (applicable sections)
ISO 81060-1:2007 (applicable sections) | IEC 80601-2-30:2018 (applicable sections)
ISO 81060-1:2007 (applicable sections) | Equivalent |
| Feature/Function | Predicate Device/System
Name and 510 (k)
SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name
ONE-CUF Blood Pressure Cuff | Comparison Result |
| Biocompatibility | | | |
| Biocompatibility
Standard Compliance | Cuff fabric, ink, loop evaluated per
ISO10993-1:2009
IrritationSensitizationCytotoxicity | Cuff fabric and loop evaluated per
ISO10993-1:2018
IrritationSensitizationCytotoxicity | Equivalent |
6
7
5.3 Determination of Substantial Equivalence:
Summary of Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
- Environmental Conditioning ●
- Leak
- Pressure Capacity ●
- Mechanical Strength ●
- Tensile Testing ●
- Standards .
- Biocompatibility ●
Biocompatibility testing
Biocompatibility testing was performed in accordance with per ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. In accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 4, 2020.
- Chemical characterization ●
- . Cytotoxicity
- Sensitization ●
- Irritation/intracutaneous reactivity
Compliance with Voluntary Standards
The ONE-CUF Warmer is designed and tested for compliance with the following performance standards:
8
-
- IEC 80601-2-30:2018 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
-
- ISO 81060-1:2007 Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type
Animal Study
The ONE-CUF did not required animal tests to support substantial equivalence.
Clinical Studies
The ONE-CUF did not required clinical tests to support substantial equivalence.
Human Factors Validation
The ONE-CUF performed summative usability to support substantial equivalence.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject ONE-CUF has been shown to be substantially equivalent to legally marketed predicate device.