(260 days)
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. DURA-CUF and SENSA-CUF cuffs and inflation systems are non-sterile and may be reused. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated.
Non-Invasive Blood Pressure cuffs incorporate an inflatable non- distensible bladder, sized to encircle a patient's limb. This allows air to flow in and out of the cuff for inflation and deflation. Inflation allows for the occlusion of an artery. The Non-Invasive Blood Pressure Cuffs facilitate the measurement of automated and manual non-invasive blood pressure (NIBP).
This submission focuses on Non-Invasive Blood Pressure Cuffs, which primarily involves mechanical performance and functionality rather than complex AI algorithms. As such, many of the requested categories related to AI performance, such as MRMC studies, training set details, and ground truth establishment, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with voluntary standards detailed in Section 9 of the premarket submission (likely related to blood pressure cuff standards like ISO 81060-1 or AAMI/ANSI SP10). | The Non-Invasive Blood Pressure Cuffs and their applications comply with voluntary standards as detailed in Section 9 of this premarket submission. |
| Performance testing (Verification) to ensure proper function and safety. | Performance testing (Verification) was applied to the development of the devices. |
| Risk Analysis conducted. | Risk Analysis conducted. |
| Requirements Reviews conducted. | Requirements Reviews conducted. |
| Design Reviews conducted. | Design Reviews conducted. |
2. Sample size used for the test set and the data provenance:
Not applicable in the context of an AI device. The submission describes non-clinical performance and safety testing. The number of samples for performance verification of the physical cuffs (e.g., number of cuffs tested for leakage, durability, or pressure accuracy) is not specified in the provided text. The data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for a physical device like a blood pressure cuff would typically be established by established engineering standards and validated measurement equipment, not clinical expert consensus in the same way as AI interpretation of medical images.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically relevant for human review of AI output or for resolving discrepancies in expert interpretations, which is not the case for this physical device.
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:
No. An MRMC comparative effectiveness study was not performed as this is not an AI-enabled device.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
No. This is not an AI-enabled device, so a standalone algorithm performance study was not applicable.
7. The type of ground truth used:
For a non-AI physical device like a blood pressure cuff, the "ground truth" for performance would be based on:
- Engineering Specifications and Standards: Conformance to established industry standards for blood pressure cuffs (e.g., accuracy against a reference manometer, durability tests, biocompatibility).
- Physical Measurement: Direct measurements using calibrated equipment to verify performance parameters like inflation/deflation rates, seal integrity, and pressure accuracy.
The provided text indicates "Performance testing (Verification)" and "compliance with voluntary standards," suggesting these types of ground truth were used.
8. The sample size for the training set:
Not applicable. This is not an AI-enabled device and therefore does not have a "training set" in the machine learning sense. The development process involved risk analysis, requirements reviews, design reviews, and performance testing, which are standard for medical device manufacturing.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI-enabled device, there is no "training set" or corresponding ground truth establishment in that context.
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KIDO 125
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E. II. 14
510(k) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | October 31, 2011 |
| Submitter: | GE Medical Systems Information Technologies, Inc.8200 West Tower Ave.Milwaukee, WI 53223 |
| Primary Contact Person: | Robin MartinRegulatory Affairs LeaderGE Medical Systems Information Technologies, Inc.Phone: (414) 336-9228Fax: (414) 362-2585 |
| Secondary Contact Person: | Doug KentzRegulatory Affairs DirectorGE Medical Systems Information Technologies, Inc.Phone: (414) 581-8987Fax: (414) 362-2585 |
| Trade Name:Device: | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFBlood Pressure Cuffs |
| Common/Usual Name: | Blood Pressure Cuff |
| Classification Names: | Blood Pressure Cuff |
| Product Code: | DXQ |
| Predicate Device(s): | K974080 Soft Blood Pressure CuffK022482 SENSA CUFF |
| Device Description: | Non-Invasive Blood Pressure cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. This allowsair to flow in and out of the cuff for inflation and deflation.Inflation allows for the occlusion of an artery. The Non-InvasiveBlood Pressure Cuffs facilitate the measurement of automatedand manual non-invasive blood pressure (NIBP). |
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GE Healthcare
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510(k) Premarket Notification Submission
Indirect measurement of blood pressure Intended Use: Adult and pediatric CLASSIC-CUF and SOFT-CUF (limited Technology: reuse cuffs or single patient use cuffs), as well as DURA-CUF and SENSA-CUF (reusable cuffs) will now be offered with a fused dual tube bayonet system (referred to as 'CLICK-IT' or 'Click' throughout documentation). Neonatal CLASSIC-CUF and SOFT-CUF cuffs will now be offered with a unique disconnect connection system (referred to as 'SNAP-IT', 'snap' or 'Neo Snap' connector throughout documentation). The Non-Invasive Blood Pressure Cuffs employ the same fundamental scientific technology as its predicate devices. Summary of Non-Clinical Tests: Determination of Substantial Equivalence: The Non-Invasive Blood Pressure Cuffs and its applications
comply with voluntary standards as detailed in Section 9 of this premarket submission. Cumulative changes to the Non-Invasive Blood Pressure Cuffs in addition to the offering of new connection systems require the submission of a premarket notification. The following quality assurance measures were applied to the development of the devices:
- Risk Analysis ●
- Requirements Reviews .
- Design Reviews .
- Performance testing (Verification) .
Summary of Clinical Tests:
The subject of this premarket submission, Non-Invasive Blood Pressure Cuffs, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the Non-Invasive Blood Pressure Cuffs to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT. 3 2012
GE Medical Systems Information Technologies. Inc. c/o Mr. Jeff D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K120125
Trade/Device Names: CLASSIC-CUF, SOFT-CUF, DURA-CUF, SENSA-CUF Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II (two) Product Code: DXO Dated: September 17, 2012 Received: September 18, 2012
Dear Mr. Rongero:
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. 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
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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): Unknown
Device Name: Non-Invasive Blood Pressure Cuffs
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. DURA-CUF and SENSA-CUF cuffs and inflation systems are non-sterile and may be reused. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K120125 |
|---|---|
| --------------- | --------- |
§ 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).