K Number
K070060
Device Name
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
Manufacturer
Date Cleared
2007-12-18

(347 days)

Product Code
Regulation Number
870.1120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
FlexiPort™ Blood Pressure Cuffs are designed with the FlexiPort™, a standardized connector for quick exchange of tubing and fittings that interface with manual or electronic sphygmomanometers and inflation devices. This allows the interface tubing (either one- or two-tube) to remain with the blood pressure measurement device, while the cuff can be easily removed and moved from one location to another to be used universally within a facility on multiple devices. The port connector can also rotate 360 degrees to reduce tube kinking.
More Information

Not Found

No
The 510(k) summary describes a standard blood pressure cuff and does not mention any AI or ML capabilities. The testing focuses on physical and functional performance, not algorithmic performance.

No.
The "Intended Use" states that the device is "used in conjunction with noninvasive blood pressure measurement systems," suggesting a diagnostic rather than therapeutic purpose. Additionally, the device's function as a blood pressure cuff and the description of performance studies related to accuracy and compatibility, rather than treatment outcomes, further indicate it's not a therapeutic device.

No
The device is a blood pressure cuff and is used in conjunction with noninvasive blood pressure measurement systems. It does not independently diagnose; it is an accessory for measurement.

No

The device description clearly indicates it is a physical blood pressure cuff with a connector, not a software-only device.

Based on the provided information, the FlexiPort™ Blood Pressure Cuff is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a person's health. The FlexiPort™ Blood Pressure Cuff is a physical device used externally on the body to measure blood pressure.
  • The intended use clearly states it's used in conjunction with noninvasive blood pressure measurement systems. This is a physiological measurement, not an in vitro diagnostic test.
  • The device description focuses on the physical design and function of the cuff for blood pressure measurement. There is no mention of analyzing biological samples.

Therefore, the FlexiPort™ Blood Pressure Cuff falls under the category of a non-invasive medical device used for physiological monitoring.

N/A

Intended Use / 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.
Indirect measurement of blood pressure

Product codes (comma separated list FDA assigned to the subject device)

DXQ

Device Description

FlexiPort™ Blood Pressure Cuffs are designed with the FlexiPort™, a standardized connector for quick exchange of tubing and fittings that interface with manual or electronic sphygmomanometers and inflation devices. This allows the interface tubing (either one- or two-tube) to remain with the blood pressure measurement device, while the cuff can be easily removed and moved from one location to another to be used universally within a facility on multiple devices. The port connector can also rotate 360 degrees to reduce tube kinking.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

arm

Indicated Patient Age Range

pediatric through adult sizes. The device is not intended for neonatal applications.
Sizes - arm circumference (Ranges in cm): Newborn (7-10), Infant (9-13), Small Child (12-16), Child (15-21), Small Adult (20-26), Adult (25-34), Large Adult (32-43), Thigh (40-55)

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)

Bench and laboratory testing was conducted to demonstrate performance of the Welch Allyn FlexiPort™ Blood Pressure Cuff.
• Biocompatibility
• Compatibility with other devices
• Reprocessing
• Packaging
• Sterilizability
• Environmental
• Mechanical Strength
• Durability
• Accuracy
Safety & Efficacy: AAMI SP10, 2002 requirements for Non-Automated Sphyg. (SP10 is revision-update of SP9); ISO 10993-1 biocompatibility; AAMI/AHA bladder sizes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K022482, K974080

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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).

0

WelchAllyn

| 5. | Premarket Notification [510(k)] Summary | | K070060
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: | (315) 685-4571 | |
| | 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)
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
standardized connector for quick exchange of tubing and fittings that
interface with manual or electronic sphygmomanometers and inflation
devices. This allows the interface tubing (either one- or two-tube) to
remain with the blood pressure measurement device, while the cuff can be
easily removed and moved from one location to another to be used
universally within a facility on multiple devices. The port connector can
also rotate 360 degrees to reduce tube kinking. | | |
| 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. | | |
| Performance: | Bench and laboratory testing was conducted to demonstrate
performance of the Welch Allyn FlexiPort™ Blood Pressure Cuff.
• Biocompatibility
• Compatibility with other devices
• Reprocessing
• 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
Pressure Cuff |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | Indirect measurement of blood
pressure | Indirect measurement of blood
pressure | Indirect measurement of blood
pressure |
| Sizes - arm
circumference
(Ranges in cm) | Newborn (7-10)
Infant (9-13)
Small Child (12-16)
Child (15-21)
Small Adult (20-26)
Adult (25-34)
Large Adult (32-43)
Thigh (40-55) | Infant (8-13)
Child (12-19)
Small Adult (17-25)
Adult (23-33)
Large Adult (31-40)
Thigh (38-50) | Neonatal 1 (3-6)
Neonatal 2 (4-8)
Neonatal 3 (6-11)
Neonatal 4 (7-13)
Neonatal 5 (8-15)
Infant (8-13)
Child (12-19)
Small Adult (17-25)
Adult (23-33)
Large Adult (31-40)
Thigh (38-50) |
| Tube
Configuration | 1 and 2 tube, interchangeable | 1 and 2 tube, built into
specific cuff model number | 1 and 2 tube, built into
specific cuff model number |
| Safety & Efficacy | AAMI SP10, 2002
requirements for Non-
Automated Sphyg.
(SP10 is revision-update of
SP9) | AAMI SP9 requirements for
Non-Automated Sphyg. | Bench and laboratory tested to
demonstrate conformance for
biocompatibility, validation of
reprocessing, and repeated
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
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
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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