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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Welch Allyn FlexiPort EcoCuff blood pressure cuff. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It explicitly states "Clinical Performance Data: Not Applicable". Therefore, the information requested regarding acceptance criteria, study details (sample size, ground truth, expert involvement, MRMC studies, standalone performance), and training set details for a clinical study cannot be extracted from this document, as such a study was not conducted or presented herein.

The document primarily relies on bench top testing and adherence to relevant standards to establish substantial equivalence.

Here's an attempt to address your request based only on the provided document, acknowledging the significant limitations due to the nature of the submission (non-clinical):

Acceptance Criteria and Study Details (Based on Provided Document)

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific quantitative acceptance criteria with corresponding performance data from non-clinical tests. Instead, it states that "Bench top testing was conducted to ensure expected performance of the FlexiPort EcoCuff" [1]. The acceptance criteria are implicitly met by adherence to the performance requirements outlined in the listed standards for blood pressure cuffs.

Acceptance Criteria (Inferred from Standards & Description)	Reported Device Performance
Material Properties: Suitable for single patient use, economical.	Made of polypropylene, described as an "economical material for use in a single patient use setting" [1].
Functionality: Single port FlexiPort technology, integrated bladder, hook and loop closure.	Confirmed to have "the same technological characteristics" as the predicate device, including "single port FlexiPort technology" and "an integrated bladder with a hook and loop closure system" [1].
Sizing Aid: Slot feature and cuff range marker for correct size selection.	Has a "slot feature in addition to the cuff range marker" which "provides the clinician an additional means to correctly select the proper cuff size for the patient" [1].
Standard Compliance (e.g., Accuracy, Durability, Biocompatibility as per standards):	"The following standards were applied to the FlexiPort EcoCuff" [2]. Successful testing is implied by the conclusion of substantial equivalence. The specific test results (e.g., pressure retention, cycling durability, accuracy when used with a measurement system) are not provided in this summary.
ISO 10993-1 (Biological Evaluation)	Implied compliance by meeting the standard.
AAMI / ANSI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003 (Sphygmomanometers)	Implied compliance by meeting the standard.
ISTA 2A (Packaged-Products)	Implied compliance by meeting the standard.
EN 1060-1 (Non-invasive Sphygmomanometers-Part 1)	Implied compliance by meeting the standard.
EN 1060-2 (Non-invasive Sphygmomanometers - Part 2)	Implied compliance by meeting the standard.
ISO 14971 (Risk Management)	Implied compliance by meeting the standard.
ISO 81060-1 (Non Invasive Sphygmomanometers - Part 1)	Implied compliance by meeting the standard.
ISO 81060-2 (Non Invasive Sphygmomanometers-Part 2: Clinical Validation for Automated Measurement Type)	Although listed, the document states "Clinical Performance Data: Not Applicable", suggesting this standard's clinical validation section was deemed not applicable for this 510(k) submission, likely because cuff performance was assessed via bench tests and comparison to an already validated predicate.
Guidance Document: Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1	Implied compliance by meeting the standard.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes (number of cuffs tested) for the bench top non-clinical tests.
Data Provenance: Not specified, but standard bench testing would typically be performed in a laboratory setting. It is not patient data, so concepts like country of origin or retrospective/prospective do not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical bench test. "Ground truth" in this context would refer to the standards themselves and objective measurements against those standards, not expert clinical assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to clinical image interpretation or data review by multiple experts. The tests conducted were non-clinical bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood pressure cuff, not an AI-powered diagnostic tool. The submission explicitly states "Clinical Performance Data: Not Applicable" [2].

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive medical device (a cuff), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests would be the established specifications and performance requirements outlined in the listed industry standards (e.g., ISO, AAMI, EN). Performance was measured against these mechanical and material standards, not against clinical outcomes or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary of Limitations:

This 510(k) summary explicitly states "Clinical Performance Data: Not Applicable." The regulatory pathway for this device (a blood pressure cuff) allowed for substantial equivalence to be demonstrated through non-clinical bench testing and comparison to a predicate device with similar technological characteristics. Therefore, the questions related to clinical study design, human readers, AI performance, ground truth establishment for clinical data, and training data are not addressed in this document because they were not part of the required submission for this type of device.

Summary

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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: (315) 685-2609 Fax: (315) 685-2532 E-mail: Kevin.Crossen@welchallyn.com

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:

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

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Technological Characteristics:

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:Evaluation and Testing within a Risk Management Process
AAMI / ANSI SP10:2002/(R)2008 & ANSI/AAMISP10:2002/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 GeneralRequirements
EN 1060-2	2009	Non-invasive Sphygmomanometers - Part 2:Supplementary Requirements for MechanicalSphygmomanometers
ISO 14971	2007	Medical Devices - Application of Risk management toMedical Devices
ISO 81060-1	2007	Non Invasive Sphygmomanometers - Part 1:Requirements and Test Methods for Non-automatedMeasurement Type
ISO 81060-2	2009	Non Invasive Sphygmomanometers-Part 2: ClinicalValidation of Automated Measurement Type
Guidance Document	1998	Non-Automated Sphygmomanometer (Blood PressureCuff) 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

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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 (800) 638-2041 or (301) 796-7100 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)

(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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Regulation Number and Section

§ 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).