SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF

K120125 · Ge Medical Systems Information Technologies, Inc. · DXQ · Oct 3, 2012 · Cardiovascular

Device Facts

• Record ID: K120125
• Device Name: SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

Non-invasive blood pressure (NIBP) cuffs consist of inflatable, non-distensible bladders designed to encircle patient limbs; used to facilitate manual or automated blood pressure measurement. Cuffs connect to NIBP systems via integrated tubing; inflation occludes the artery to enable pressure monitoring. Subject device introduces new connection systems: 'CLICK-IT' (fused dual tube bayonet) for adult/pediatric cuffs and 'SNAP-IT' (unique disconnect) for neonatal cuffs. Used in clinical settings by healthcare providers. Benefits include standardized, reliable interface for NIBP monitoring across diverse patient sizes.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including risk analysis, requirements reviews, and design reviews.

Technological Characteristics

Non-distensible inflatable bladders; non-sterile. Features new connection interfaces: CLICK-IT (fused dual tube bayonet) and SNAP-IT (unique disconnect). Available in neonatal, pediatric, and adult sizes. Materials and construction consistent with predicate NIBP cuff technology.

Indications for Use

Indicated for use as accessories with non-invasive blood pressure (NIBP) measurement systems for neonatal, pediatric, and adult patient populations.

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 Blood Pressure Cuff (K974080)
• SENSA CUFF (K022482)

Submission Summary (Full Text)

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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.<br>8200 West Tower Ave.<br>Milwaukee, WI 53223 |
| Primary Contact Person: | Robin Martin<br>Regulatory Affairs Leader<br>GE Medical Systems Information Technologies, Inc.<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Doug Kentz<br>Regulatory Affairs Director<br>GE Medical Systems Information Technologies, Inc.<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name:<br>Device: | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF<br>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<br>K022482 SENSA CUFF |
| Device Description: | Non-Invasive Blood Pressure cuffs incorporate an inflatable non-<br>distensible bladder, sized to encircle a patient's limb. This allows<br>air to flow in and out of the cuff for inflation and deflation.<br>Inflation allows for the occlusion of an artery. The Non-Invasive<br>Blood Pressure Cuffs facilitate the measurement of automated<br>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.

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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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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 [phone] or [phone] 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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K120125

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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 |
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