ONE-CUF

K230145 · Ge Medical Systems Information Technologies, Inc. · DXQ · Mar 14, 2023 · Cardiovascular

Device Facts

• Record ID: K230145
• Device Name: ONE-CUF
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Mar 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Indirect measurement of blood pressure

Device Story

ONE-CUF is a non-sterile, single-patient use blood pressure cuff accessory for non-invasive blood pressure (NIBP) measurement systems. It consists of an inflatable, non-distensible bladder sized to encircle a patient's limb, with flanges for flexible tubing and connectors (bayonet or DINACLICK) to attach to NIBP hoses. During operation, the cuff is inflated to occlude an artery, facilitating automated NIBP measurement. It is used in clinical settings by healthcare providers to obtain blood pressure readings. The device does not contain serviceable parts.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including environmental conditioning, leak testing, pressure capacity, mechanical strength, tensile testing, and biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993-1:2018). Summative usability testing was performed.

Technological Characteristics

Materials: Polyester/polyvinyl chloride laminate, Zephyron-Ion solvent-based ink. Sensing: Inflatable bladder for arterial occlusion. Connectivity: Single/dual tube with bayonet or DINACLICK connectors. Standards: IEC 80601-2-30:2018, ISO 81060-1:2007. Pressure range: 0-300 mmHg. Leak rate: max 0.6 sccm. Non-sterile, single-patient use.

Indications for Use

Indicated for use as an accessory in non-invasive blood pressure measurement systems. Available in pediatric and adult sizes. Non-sterile, single-patient use. Not designed, sold, or intended for use except as indicated.

Regulatory Classification

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.

Predicate Devices

• SOFT-CUF (K120125)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10px"> <svg height="10" width="10"> <rect height="10" style="fill:none;stroke:#000000;stroke-width:2" width="10"></rect> <line style="stroke:#000000;stroke-width:2" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:#000000;stroke-width:2" x1="0" x2="10" y1="10" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px"> <svg height="10" width="10"> <rect height="10" style="fill:none;stroke:#000000;stroke-width:2" width="10"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 9, 2023 |
| Primary Contact Person: | Michelle Johnson<br>Senior Quality Staff Manager - Regulatory Affairs<br>GE Medical Systems Information Technologies, Inc.<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact Person: | Jennifer Strauther<br>Regulatory Affairs Leader<br>GE Medical Systems Information Technologies, Inc.<br>9900 Innovation Drive<br>Wauwatosa, WI 53226<br>Phone: [phone]<br>Email: [e-mail] |
| 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<br>non-invasive blood pressure measurement systems. It is non-sterile,<br>single-patient use. It is available in pediatric and adult sizes. The<br>cuff is not designed, sold or intended for use except as indicated. |

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#### 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<br>Name and 510 (k)<br>SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name<br>ONE-CUF Blood Pressure Cuff | Comparison Result |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Intended Use | | | |
| • Indications for Use | Indications for Use<br>GE CRITIKON blood pressure cuffs are<br>accessories used in conjunction with<br>noninvasive blood pressure (NIBP)<br>measurement systems. SOFT-CUF and<br>CLASSIC-CUF cuffs and inflation systems<br>are non-sterile and limited reuse (may be<br>single-patient use or optional limited reuse).<br>They are available in neonatal, pediatric and<br>adult sizes. The devices are not designed,<br>sold or intended for use except as indicated. | Indications For Use<br>The blood pressure cuff is an accessory<br>used in conjunction with non-invasive<br>blood pressure measurement systems. It is<br>non-sterile, single-patient use. It is available<br>in pediatric and adult sizes. The cuff is not<br>designed, sold or intended for use except as<br>indicated. | Equivalent. |
| • Use | Non-sterile, single patient use or limited<br>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.

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| Feature/Function | Predicate Device/System<br>Name and 510 (k)<br>SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name<br>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<br>(Ranges in cm) | Neonatal #1 (3-6)<br>Neonatal #2 (4-8)<br>Neonatal #3 (6-11)<br>Neonatal #4 (7-13)<br>Neonatal #5 (8-15)<br>Infant (8-13)<br>Child (12-19)<br>Child Long (12-19)<br>Small Adult (17-25)<br>Small Adult Long (17-25)<br>Adult (23-33)<br>Adult Long (23-33)<br>Large Adult (31-40)<br>Large Adult Long (31-40)<br>Thigh (38-50) | Infant (8-13)<br>Child (12-19)<br>Small Adult (17-25)<br>Adult (23-33)<br>Adult Long (23-33)<br>Large Adult (31-40) | Equivalent |
| • Bladder Size | Various bladder sizes for neonate, pediatric<br>and adult populations | Various bladder sizes for pediatric and adult<br>populations | Equivalent |
| Feature/Function | Predicate Device/System<br>Name and 510 (k)<br>SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name<br>ONE-CUF Blood Pressure Cuff | Comparison Result |
| • Cuff Connector<br>Configurations | Adult and Pediatric 2-Tube configuration:<br>• Screw Connector<br>• Sub-Miniature Connector<br>• Mated Subminiature Connector<br>• Dual CLICK-IT (branded as<br>"DINACLICK") Connector<br>Adult and Pediatric 1-Tube configuration:<br>• Bayonet Connector<br>• Screw<br>• Sub-Miniature Connector<br>Neonatal<br>• 1-Tube and 2-Tube Male Slip Luer Taper<br>• 1-Tube and 2-Tube SNAP-IT (branded as<br>"NeoSnap") Connectors | Adult and Pediatric 2-Tube configuration:<br>• Dual CLICK-IT (branded as<br>"DINACLICK") Connector<br>Adult 1-Tube configuration:<br>• Bayonet Connector | Equivalent. |
| Materials | | | |
| • Cuff / Integrated<br>Bladder | SOFT-CUF: Laminate of polyester /<br>polyvinyl chloride | ONE-CUF: Laminate of polyester /<br>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<br>assemblies for use with manual and<br>automated sphygmomanometers. | ONE-CUF: Single / dual tubes for use with<br>manual and automated<br>sphygmomanometers. | Equivalent. |
| Performance Specifications | | | |
| • Leak Rate | Maximum allowable pressure loss rate is 0.6<br>sccm (standard cubic cm per minute) | Maximum allowable pressure loss rate is<br>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<br>Sphygmomanomete<br>rs | SP10:2002/A1:2003/A2:2006 | IEC 80601-2-30:2018 (applicable sections)<br>ISO 81060-1:2007 (applicable sections) | Equivalent |
| • Automated/Manual<br>Sphygmomanomete<br>rs | EN 1060-1:1995/A1:2002/A2:2009<br>(applicable sections)<br>EN 1060-2:1995/C1:2002/A1:2009<br>(applicable sections)<br>IEC 80601-2-30:2009 (applicable sections)<br>ISO 81060-1:2007 (applicable sections) | IEC 80601-2-30:2018 (applicable sections)<br>ISO 81060-1:2007 (applicable sections) | Equivalent |
| Feature/Function | Predicate Device/System<br>Name and 510 (k)<br>SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System Name<br>ONE-CUF Blood Pressure Cuff | Comparison Result |
| <i>Biocompatibility</i> | | | |
| Biocompatibility<br>Standard Compliance | Cuff fabric, ink, loop evaluated per<br>ISO10993-1:2009<br>IrritationSensitizationCytotoxicity | Cuff fabric and loop evaluated per<br>ISO10993-1:2018<br>IrritationSensitizationCytotoxicity | Equivalent |

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## 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:

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- 1. IEC 80601-2-30:2018 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
- 2. 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.