FLEXIPORT ECOCUFF

K122058 · Welch Allyn, Inc. · DXQ · Nov 5, 2012 · Cardiovascular

Device Facts

• Record ID: K122058
• Device Name: FLEXIPORT ECOCUFF
• Applicant: Welch Allyn, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Nov 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FlexiPort EcoCuff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The Flexiport EcoCuff blood pressure cuff is not designed, sold or intended for use, except as indicated. This product is available for sale only upon the order of a physician or licensed health care professional.

Device Story

FlexiPort EcoCuff is a single-patient-use blood pressure cuff; designed for use on the upper arm with noninvasive blood pressure measurement systems. Device consists of a polypropylene cuff with an integrated bladder and hook-and-loop closure system; features a slot for size selection assistance. Used in clinical settings by physicians or licensed healthcare professionals to facilitate blood pressure monitoring. Device provides a mechanical interface for pressure transmission; does not perform automated analysis. Benefits include economical single-patient-use design to support clinical workflows.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Polypropylene construction; single-port FlexiPort technology; integrated bladder; hook-and-loop closure; sizing slot. Standards applied: ISO 10993-1 (biocompatibility), AAMI/ANSI SP10, EN 1060-1/2, ISO 81060-1/2 (sphygmomanometer requirements), ISTA 2A (packaging), ISO 14971 (risk management). Non-sterile.

Indications for Use

Indicated for pediatric through adult patients requiring noninvasive blood pressure measurement on the upper arm. Not for neonatal use. Prescription use only.

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

• Welch Allyn FlexiPort Blood Pressure Cuff (K070060)

Submission Summary (Full Text)

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KI22058

# 510(k) Summary [As described in 21 CFR 807.92]

NOV 5-2012 - 1

Submitted by:

Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220

Contact Person:

Kevin Crossen, Director Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

October 22, 2012 Date Prepared:

Trade Name:

Welch Allyn FlexiPort EcoCuff

Device Classification Name: Blood Pressure Cuff

Device Classification: Class II

Classification Reference: · 870.1120

Classification Product Code: DXQ

Predicate Devices:

Welch Allyn FlexiPort Blood Pressure Cuff 510(k) Number K070060

### Indications for Use:

The FlexiPort EcoCuff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The Flexiport EcoCuff blood pressure cuff is not designed, sold or intended for use, except as indicated.

This product is available for sale only upon the order of a physician or licensed health care professional.

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Image /page/1/Picture/0 description: The image shows the logo for Welch Allyn. The logo is in a bold, serif font. The words "Welch Allyn" are written in black. The logo is simple and recognizable.

## Technological Characteristics:

The subject device has the same technological characteristics and indications for use as the predicate FlexiPort Blood Pressure Cuff. They both use the single port FlexiPort technology. They both are cuffs with an integrated bladder with a hook and loop closure system.

The subject device is made of polypropylene and has a slot feature in addition to the cuff range marker. The polypropylene is an economical material for use in a single patient use setting. The slot provides the clinician an additional means to correctly select the proper cuff size for the patient.

### Non-Clinical Tests:

Bench top testing was conducted to ensure expected performance of the FlexiPort EcoCuff.

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# Welch Allyn.

The following standards were applied to the FlexiPort EcoCuff.

| Standard Identification Number | Version | Title |
|--------------------------------------------------------------------|---------|-----------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | 2009 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing within a Risk Management Process |
| AAMI / ANSI SP10:2002/(R)<br>2008 & ANSI/AAMI<br>SP10:2002/A1:2003 | R2008 | Manual, Electronic, or Automated Sphygmomanometers |
| ISTA 2A | 2008 | Packaged-Products 150 LB (68 KG) or Less |
| EN 1060-1 | 2009 | Non-invasive Sphygmomanometers-Part 1 General<br>Requirements |
| EN 1060-2 | 2009 | Non-invasive Sphygmomanometers - Part 2:<br>Supplementary Requirements for Mechanical<br>Sphygmomanometers |
| ISO 14971 | 2007 | Medical Devices - Application of Risk management to<br>Medical Devices |
| ISO 81060-1 | 2007 | Non Invasive Sphygmomanometers - Part 1:<br>Requirements and Test Methods for Non-automated<br>Measurement Type |
| ISO 81060-2 | 2009 | Non Invasive Sphygmomanometers-Part 2: Clinical<br>Validation of Automated Measurement Type |
| Guidance Document | 1998 | Non-Automated Sphygmomanometer (Blood Pressure<br>Cuff) Guidance Version 1 |

# Clinical Performance Data:

Not Applicable

# Conclusion:

Based on the information presented in this 510(k) premarket notification, Welch Allyn's FlexiPort EcoCuff is determined to be substantially equivalent (as safe, as effective and performs as well as) to the currently marketed FlexiPort Blood Pressure Cuff.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

5 2012 NOV

Welch Allyn, Inc. c/o Mr. Kevin Crossen Director Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

Re: K122058

Trade/Device Names: Welch Allyn FlexiPort EcoCuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXQ Dated: October 22, 2012 Received: October 23, 2012

#### Dear Mr. Crossen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We 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 approvisions of the Act. The Act. The general controls provisions of the Act include the general send 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 If your device is easiling major regulations affecting your device can be found in the Code subject to additions, 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 - Mr. Kevin Crossen

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/ucm] 15809.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 J 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

510(k) Number (if known): K122058

Device Name: Welch Allyn FlexiPort EcoCuff

#### Indications for Use:

The FlexiPort EcoCuff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is ayailable in pediatric through adult sizes. The device is not intended for neonatal applications. The Flexiport EcoCuff blood pressure cuff is not designed, sold or intended for use, except as indicated.

This product is available for sale only upon the order of a physician or licensed health care professional.

Over-The-Counter Use Prescription Use AND/OR :
x (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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(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 Sign-Off)
Division of Cardiovascular Devices

22058 510(k) Number_

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