NBP CUFF

K092999 · Draeger Medical AG & Co. KG · DXQ · Nov 24, 2009 · Cardiovascular

Device Facts

• Record ID: K092999
• Device Name: NBP CUFF
• Applicant: Draeger Medical AG & Co. KG
• Product Code: DXQ · Cardiovascular
• Decision Date: Nov 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.

Device Story

Device consists of inelastic sleeve with integrated inflatable bladder and tubing; wraps around patient limb; secured via hook-and-loop fastener. Tubing connects to non-invasive blood pressure (NIBP) monitor via extension hose. Used in clinical settings by healthcare providers to facilitate automated blood pressure measurement. Provides physical interface between patient limb and monitor; enables pneumatic inflation/deflation cycles controlled by monitor. Benefits include standardized, reliable blood pressure monitoring across patient populations (adult, pediatric, infant, neonatal).

Clinical Evidence

Bench testing only. Performance data demonstrated device safety and effectiveness within the intended usage range. No clinical data presented.

Technological Characteristics

Inelastic sleeve with integrated inflatable bladder; hook-and-loop fastener; tubing for pneumatic connection to NIBP monitor. Available in various sizes for adults, pediatrics, infants, and neonates. Reusable and single-patient-use configurations. No electronic components or software.

Indications for Use

Indicated for automatic non-invasive blood pressure measurement in adults, pediatrics, infants, and neonates using compatible Dräger and Siemens patient monitors. Neonatal cuffs are for single-patient use.

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

• Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer (K022889)
• Sensa-Cuf (K022482)
• Critikon Soft Blood Pressure Cuff (K974080)
• Critikon Dura-Cuf (Preamendent)
• Sterile Neonatal Blood Pressure Cuff (K991525)

Submission Summary (Full Text)

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092999

Image /page/0/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, and the word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font. The logo is simple and professional.

# 510(k) Summary acc. to 21 CFR 807.92

#### Applicants Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

# NOV 2 4 2009

#### Manufacturer Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

#### Establishment Registration Number :

9611500

#### Contact Person:

Ulrich Schröder Director Regulatory Affairs & Clinical Affairs

Tel. No.: 011 49 [phone] Fax No.: 011 49 [phone]

## Applicants US Contact Person

Joyce Kilrov Vice President, Processes, Quality & Regulatory

Tel. No.: [phone] Fax No.: [phone]

#### Date submission was prepared:

2009/09/25

#### Device Name:

Common Name: Classification Name: Regulation Number: Class:

NBP Cuff / NBP Cuff, Neo blood pressure cuff, DXQ 21 CFR 870.1120 =

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| 510(k) number | Trade name | Company |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| K022889 | Siemens Infinity Modular Monitors, Models<br>SC 8000, SC 7000 & SC 9000XL & Siemens<br>Infinity Explorer<br>(cuffs from supplier Statcorp) | Dräger Medical System, Inc<br>(former Siemens Medical<br>Solutions USA, Inc.) |
| K022482 | Sensa-Cuf | GE Medical Systems Information<br>Technologies |
| K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. |
| Preamendent | Critikon Dura-Cuf® | Critikon Company, LLC |
| K991525 | Sterile Neonatal Blood Pressure Cuff | Deroyal Industries, Inc. |

Legally Marketed Devices to which Substantial Equivalence is claimed:

## Device Description:

The devices comprise tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook-and-loop fastener. The devices tubing is connected to a non-invasive blood pressure measurement system with an extension hose.

The portfolio includes different standard sizes reusable and single-patient-use non-invasive blood pressure cuffs for adults, paediatrics, infants and single-patient-use NiBP-cuffs for neonates. Longer cuffs are marked with an additional range to which they can be safely used.

* NiBP: non-invasive blood pressure

#### Intended Use:

Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement.

Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.

#### Conclusion:

The intended use and general construction as the predicate devices remain the same. The NBP cuffs are identical in fit, form and function to marketed products named in the table above.

The cuffs are made of similar materials and colour coding is aligned to support clinical use. Product labelling has been improved by measures to identify the correct size by arm circumference and arm length. It has been shown that product performance is given within the range the device can be used by clinicians.

The technological characteristics and the results of the performance data demonstrated that the NBP cuffs issued no new risks during design verification and validation which could question device use.

In accordance with the Federal Food and Cosmetic Act and 21 CFR Part 807, based on the information provided in this premarket notification Drager Medical AG & Co. KG concludes that the NBP Cuffs are safe, effective and substantially equivalent to the predicate devices as described in this application.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Draeger Medical AG&G Co., KG c/o Ms. Joyce Kilroy Draeger Medical System, Inc. 3135 Quarry Road Telford, PA 18969

NOV 2 4 2009

Re: K092999

Trade/Device Name: NBP Cuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: II (two) Product Code: 74 DXO Dated: September 25, 2009 Received: September 28, 2009

Dear Ms. Kilroy:

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.

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.

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Page 2 - Ms. Joyce Kilroy

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/ResourcesforYou/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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Indications for Use Statement

510(k) Number (if known)

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Device Name

NBP Cuff

K C92999

Indications for Use

Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors.

Neonatal cuffs are designed for single-patient use.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use

W. Mat

ision Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

**510(k) Number**