WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)

K070060 · Welch Allyn, Inc. · DXQ · Dec 18, 2007 · Cardiovascular

Device Facts

• Record ID: K070060
• Device Name: WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
• Applicant: Welch Allyn, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FlexiPort™ Blood Pressure Cuff is used 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™ Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.

Device Story

FlexiPort™ Blood Pressure Cuffs function as interface components for noninvasive blood pressure measurement systems. Device features standardized FlexiPort™ connector allowing quick exchange of tubing/fittings; enables interface tubing (one- or two-tube) to remain with measurement device while cuff is moved between locations. Port connector rotates 360 degrees to prevent tube kinking. Used in clinical settings by healthcare providers; compatible with manual or electronic sphygmomanometers. Benefits include universal facility use and improved workflow efficiency via standardized connections.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), compatibility with other devices, reprocessing validation, packaging, sterilizability (ETO), environmental testing, mechanical strength, durability, and accuracy per AAMI SP10 (2002) requirements.

Technological Characteristics

Non-sterile, reusable or disposable blood pressure cuffs. Features 360-degree rotating port connector. Materials conform to ISO 10993-1 biocompatibility standards. Compliant with AAMI/AHA bladder size specifications and AAMI SP10:2002 requirements for non-automated sphygmomanometers. Compatible with 1-tube or 2-tube configurations.

Indications for Use

Indicated for indirect blood pressure measurement in pediatric through adult patients. Not for neonatal 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

• Critikon Soft Blood Pressure Cuff (K974080)
• Sensa-Cuff, Models Infant, Child, Adult (K022482)

Submission Summary (Full Text)

{0}------------------------------------------------

## WelchAllyn

| 5. | Premarket Notification [510(k)] Summary | | K070060<br>Pg 1 of 2 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------|
| Date: | January 3, 2007 | | |
| Submitted By: | Welch Allyn, Inc. | | |
| | 4341 State Street Road, P.O. Box 220 | | |
| | Skaneateles Falls, NY 13153-0220 | DEC 1 8 2007 | |
| | Phone: | [phone] | |
| | Fax: | (315) 685- 2532 | |
| | Contact: | John Sawyer | |
| | | Vice President, Quality Assurance and Regulatory Affairs | |
| Common Name: | Blood Pressure Cuff | | |
| Trade Name: | Welch Allyn FlexiPort™ Disposable Blood Pressure Cuff (One-Piece)<br>Welch Allyn FlexiPort™ Reusable Blood Pressure Cuff (One-Piece) | | |
| Classification Name: | Cuff, Blood-Pressure | | |
| Classification: | Class II per 21 CFR 870.1120 | | |
| Predicate Devices: | Critikon Soft Blood Pressure Cuff (K974080) | | |
| | Sensa-Cuff, Models Infant, Child, Adult (K022482) | | |
| Description: | FlexiPort™ Blood Pressure Cuffs are designed with the FlexiPort™, a<br>standardized connector for quick exchange of tubing and fittings that<br>interface with manual or electronic sphygmomanometers and inflation<br>devices. This allows the interface tubing (either one- or two-tube) to<br>remain with the blood pressure measurement device, while the cuff can be<br>easily removed and moved from one location to another to be used<br>universally within a facility on multiple devices. The port connector can<br>also rotate 360 degrees to reduce tube kinking. | | |
| Intended Use: | The FlexiPort™ Blood Pressure Cuff is used in conjunction with<br>noninvasive blood pressure measurement systems. The cuff is nonsterile<br>and is available in pediatric through adult sizes. The device is not intended<br>for neonatal applications. The FlexiPort™ Blood Pressure Cuffs are not<br>designed, sold, or intended for use, except as indicated. | | |
| Performance: | Bench and laboratory testing was conducted to demonstrate<br>performance of the Welch Allyn FlexiPort™ Blood Pressure Cuff.<br>• Biocompatibility<br>• Compatibility with other devices<br>• Reprocessing<br>• Packaging | | |

Section 5 - Page 1 of 1 :

{1}------------------------------------------------

## WelchAllyn

Traditional 510(k) Premarket Notification Welch Allyn FlexiPort™ Blood Pressure Cuffs

070060

Pa 2 &Z

- Sterilizability .
- . Environmental
- . Mechanical Strength
- . Durability
- Accuracy .

## Subject Device and Predicate Device Comparison:

| Subject Area | Welch Allyn FlexiPort™ | GE Sensa-Cuff | Critikon Soft Blood<br>Pressure Cuff |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | Indirect measurement of blood<br>pressure | Indirect measurement of blood<br>pressure | Indirect measurement of blood<br>pressure |
| Sizes - arm<br>circumference<br>(Ranges in cm) | Newborn (7-10)<br>Infant (9-13)<br>Small Child (12-16)<br>Child (15-21)<br>Small Adult (20-26)<br>Adult (25-34)<br>Large Adult (32-43)<br>Thigh (40-55) | Infant (8-13)<br>Child (12-19)<br>Small Adult (17-25)<br>Adult (23-33)<br>Large Adult (31-40)<br>Thigh (38-50) | Neonatal 1 (3-6)<br>Neonatal 2 (4-8)<br>Neonatal 3 (6-11)<br>Neonatal 4 (7-13)<br>Neonatal 5 (8-15)<br>Infant (8-13)<br>Child (12-19)<br>Small Adult (17-25)<br>Adult (23-33)<br>Large Adult (31-40)<br>Thigh (38-50) |
| Tube<br>Configuration | 1 and 2 tube, interchangeable | 1 and 2 tube, built into<br>specific cuff model number | 1 and 2 tube, built into<br>specific cuff model number |
| Safety & Efficacy | AAMI SP10, 2002<br>requirements for Non-<br>Automated Sphyg.<br>(SP10 is revision-update of<br>SP9) | AAMI SP9 requirements for<br>Non-Automated Sphyg. | Bench and laboratory tested to<br>demonstrate conformance for<br>biocompatibility, validation of<br>reprocessing, and repeated<br>inflations. |
| | ISO 10993-1 biocompatibility | ISO 10993-1, biocompatibility | |
| | AAMI/AHA bladder sizes | AAMI/AHA bladder sizes | AAMI/AHA bladder sizes |
| Sterility | Not supplied sterile. Capable<br>of being sterilized using ETO. | Not supplied sterile. | Not supplied sterile. |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Demonstrated performance for<br>biocompatibility |

In accordance with the Federal Food, Drug and Cosmetic Act and 21 Conclusion: CFR Part 807, and based on the information provided in this premarket notification, Welch Allyn concludes that this device, the
Welch Allyn FlexiPort™ Blood Pressure Cuff, is safe, effective and substantially equivalent to both the reusable GE Sensa-Cuff (K022482) and the disposable Critikon Soft Blood Pressure Cuff (K974080)

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three curved lines extending from its head.

DEC 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Welch Allyn, Inc. c/o Mr. John Sawyer VP Quality Assurance and Regulatory Affairs 4341 State Street Road, Box 220 Skaneateles Falls, NY 13151-0220

Re: K070060

Trade/Device Name: FlexiPort Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: November 9, 2007 Received: November 13, 2007

Dear Mr. Sawyer:

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 such 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 mav publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. John Sawyer

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); good manufacturing practice requirements as set forth in the quality systems regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Bfremmerfor

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

Konooco 510(k) Number (if known):

> Welch Allyn FlexiPort™ Disposable Blood Pressure Cuff (One-Piece) Device Name: Welch Allyn FlexiPort™ Reusable Blood Pressure Cuff (One-Piece)

Indications for Use:

The FlexiPort™ Blood Pressure Cuff is used 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™ Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.

Prescription Use __ Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

B.Benson
(Division Sign-Off)

(Division Sign-Off) Division of Cardioyascular Devices 510(k) Number

Page 1 of 1