(55 days)
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.
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.
The information provided describes the ONE-CUF blood pressure cuff and its path to substantial equivalence, primarily based on non-clinical testing and comparison to a predicate device. It explicitly states that no clinical or animal studies were required to support substantial equivalence. Therefore, there is no study described that proves the device meets specific acceptance criteria related to a model's performance in a diagnostic or predictive context (e.g., accuracy, sensitivity, specificity for an AI algorithm).
The "acceptance criteria" referred to in this document are primarily related to product performance specifications and compliance with voluntary standards for a mechanical medical device, rather than the performance metrics of an AI model.
Here's an attempt to structure the answer based on the provided text, recognizing the limitations regarding AI-specific criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (ONE-CUF) |
|---|---|---|
| Physical Performance | Lead Rate (Maximum allowable pressure loss rate) | 0.6 sccm (standard cubic cm per minute) |
| Air Leakage | Less than 4mmHg/min | |
| Pressure Range | 0-300 mmHg | |
| Mechanical Strength | Data provided in support of substantial equivalence (specific values not detailed in summary) | |
| Tensile Testing | Data provided in support of substantial equivalence (specific values not detailed in summary) | |
| Environmental | Operating Temperature | 0° C to 40° C |
| Storage Temperature | -20° C to 55° C | |
| Relative Humidity (Operating) | 15% to 90% humidity, non-condensing | |
| Relative Humidity (Storage) | 0% to 95% humidity, non-condensing | |
| Biocompatibility | Irritation, Sensitization, Cytotoxicity (evaluated per ISO 10993-1:2018; chemical characterization also performed) | Evaluated per ISO10993-1:2018 |
| Standards Compliance | IEC 80601-2-30:2018 (Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers) | Compliant (applicable sections) |
| ISO 81060-1:2007 (Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type) | Compliant (applicable sections) | |
| Other | Environmental Conditioning | Data provided in support of substantial equivalence (specific details not in summary) |
| Pressure Capacity | Data provided in support of substantial equivalence (specific details not in summary) | |
| Human Factors Validation (Summative Usability) | Performed to support substantial equivalence (specific outcomes not detailed) |
2. Sample size used for the test set and the data provenance
Not applicable. The reported studies are non-clinical, focusing on device performance and safety specifications rather than a diagnostic model's performance on a test set of patient data. There is no mention of a "test set" in the context of an AI algorithm or diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a blood pressure cuff and does not involve AI or diagnostic interpretation requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable. There is no test set for diagnostic performance or AI algorithm output.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a non-AI blood pressure cuff. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a non-AI blood pressure cuff. No standalone algorithm performance was evaluated.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is established by adherence to documented test procedures, engineering specifications, and established international standards (e.g., ISO, IEC) for medical device performance and biocompatibility.
8. The sample size for the training set
Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The “study” proving the ONE-CUF meets its acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing, along with compliance with relevant voluntary standards. The documentation states:
- Non-Clinical Testing: This included evaluations for Environmental Conditioning, Leak, Pressure Capacity, Mechanical Strength, Tensile Testing, and other performance aspects. While specific results are not detailed in the summary, these tests were submitted to support substantial equivalence.
- Biocompatibility Testing: This was performed in accordance with ISO 10993-1:2018 ("Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and included Chemical Characterization, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.
- Compliance with Voluntary Standards: The device was designed and tested for compliance with IEC 80601-2-30:2018 (for automated noninvasive sphygmomanometers) and ISO 81060-1:2007 (for non-automated sphygmomanometer test methods).
- Human Factors Validation: Summative usability testing was performed.
The conclusion is that based on these non-clinical performance data, biocompatibility results, and compliance with standards, the device is considered substantially equivalent to a legally marketed predicate device (SOFT-CUF K120125). No clinical or animal studies were required or performed to support this determination.
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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 (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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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 JohnsonSenior Quality Staff Manager - Regulatory AffairsGE Medical Systems Information Technologies, Inc.Phone: +1 414 429 9263Email: Michelle.Johnson@ge.com |
| Secondary Contact Person: | Jennifer StrautherRegulatory Affairs LeaderGE Medical Systems Information Technologies, Inc.9900 Innovation DriveWauwatosa, WI 53226Phone: +1 262 330 2112Email: 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 withnon-invasive blood pressure measurement systems. It is non-sterile,single-patient use. It is available in pediatric and adult sizes. Thecuff 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/SystemName and 510 (k)SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System NameONE-CUF Blood Pressure Cuff | Comparison Result |
|---|---|---|---|
| Intended Use | |||
| • Indications for Use | Indications for UseGE CRITIKON blood pressure cuffs areaccessories used in conjunction withnoninvasive blood pressure (NIBP)measurement systems. SOFT-CUF andCLASSIC-CUF cuffs and inflation systemsare non-sterile and limited reuse (may besingle-patient use or optional limited reuse).They are available in neonatal, pediatric andadult sizes. The devices are not designed,sold or intended for use except as indicated. | Indications For UseThe blood pressure cuff is an accessoryused in conjunction with non-invasiveblood pressure measurement systems. It isnon-sterile, single-patient use. It is availablein pediatric and adult sizes. The cuff is notdesigned, sold or intended for use except asindicated. | Equivalent. |
| • Use | Non-sterile, single patient use or limitedreuse | 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/SystemName and 510 (k)SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System NameONE-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, pediatricand adult populations | Various bladder sizes for pediatric and adultpopulations | Equivalent |
| Feature/Function | Predicate Device/SystemName and 510 (k)SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System NameONE-CUF Blood Pressure Cuff | Comparison Result |
| • Cuff ConnectorConfigurations | Adult and Pediatric 2-Tube configuration:• Screw Connector• Sub-Miniature Connector• Mated Subminiature Connector• Dual CLICK-IT (branded as"DINACLICK") ConnectorAdult and Pediatric 1-Tube configuration:• Bayonet Connector• Screw• Sub-Miniature ConnectorNeonatal• 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") ConnectorAdult 1-Tube configuration:• Bayonet Connector | Equivalent. |
| Materials | |||
| • Cuff / IntegratedBladder | 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 / valveassemblies for use with manual andautomated sphygmomanometers. | ONE-CUF: Single / dual tubes for use withmanual and automatedsphygmomanometers. | Equivalent. |
| Performance Specifications | |||
| • Leak Rate | Maximum allowable pressure loss rate is 0.6sccm (standard cubic cm per minute) | Maximum allowable pressure loss rate is0.6 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/ManualSphygmomanometers | SP10:2002/A1:2003/A2:2006 | IEC 80601-2-30:2018 (applicable sections)ISO 81060-1:2007 (applicable sections) | Equivalent |
| • Automated/ManualSphygmomanometers | 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/SystemName and 510 (k)SOFT-CUF Blood Pressure Cuff K120125 | Proposed Device/System NameONE-CUF Blood Pressure Cuff | Comparison Result |
| Biocompatibility | |||
| BiocompatibilityStandard Compliance | Cuff fabric, ink, loop evaluated perISO10993-1:2009IrritationSensitizationCytotoxicity | Cuff fabric and loop evaluated perISO10993-1:2018IrritationSensitizationCytotoxicity | 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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-
- 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.
§ 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).