(260 days)
Not Found
No
The device description and intended use clearly define the device as a physical blood pressure cuff and inflation system, with no mention of software, algorithms, or data processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
No
The device, a blood pressure cuff, measures blood pressure, but does not provide a therapeutic effect. It is an accessory to a measurement system.
No
The device is a blood pressure cuff, which is an accessory used with blood pressure measurement systems to facilitate the measurement of blood pressure. It does not perform a diagnostic function itself, but rather provides the means for another device to take a measurement.
No
The device description clearly states it is a physical blood pressure cuff with an inflatable bladder, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the blood pressure cuffs are "accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems." They facilitate the measurement of blood pressure.
- Device Description: The description explains how the cuffs work mechanically to occlude an artery for blood pressure measurement.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. These blood pressure cuffs interact directly with the patient's limb and do not involve the analysis of any biological specimens.
Therefore, the GE CRITIKON blood pressure cuffs described are medical devices used for a physiological measurement in vivo (on the living body), not in vitro (outside the living body).
N/A
Intended 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. 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.
Product codes
DXQ, DXO
Device Description
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). Indirect measurement of blood pressure Intended Use: Adult and pediatric CLASSIC-CUF and SOFT-CUF (limited 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
Adult and pediatric, Neonatal, 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)
The subject of this premarket submission, Non-Invasive Blood Pressure Cuffs, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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KIDO 125
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. There are three small breaks in the circle around the letters.
ど
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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 Martin |
| Regulatory Affairs Leader | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: (414) 336-9228 | |
| Fax: (414) 362-2585 | |
| Secondary Contact Person: | Doug Kentz |
| Regulatory Affairs Director | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: (414) 581-8987 | |
| Fax: (414) 362-2585 | |
| Trade Name: | |
| Device: | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF |
| Blood Pressure Cuffs | |
| Common/Usual Name: | Blood Pressure Cuff |
| Classification Names: | Blood Pressure Cuff |
| Product Code: | DXQ |
| Predicate Device(s): | K974080 Soft Blood Pressure Cuff |
| K022482 SENSA CUFF | |
| Device Description: | 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). |
.
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.
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.
2
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
3
Page 2 - Mr. Jeff D. Rongero
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 |
|---|---|
| --------------- | --------- |