(115 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on material and mechanical features.
No
The device is a blood pressure cuff used in conjunction with blood pressure measurement systems. It does not provide therapy itself.
No
The device is a blood pressure cuff, which is a component used in conjunction with noninvasive blood pressure measurement systems. While these systems are used for diagnostic purposes, the cuff itself is not the diagnostic device; it is a tool for obtaining the measurement.
No
The device description clearly describes a physical blood pressure cuff made of polypropylene with an integrated bladder and hook and loop closure system. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for noninvasive blood pressure measurement on the upper arm. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description details a blood pressure cuff, which is a mechanical device used for physical measurement. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Detection of specific analytes or markers
- Diagnostic interpretation based on laboratory results
Therefore, the FlexiPort EcoCuff Blood Pressure Cuff is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
pediatric through adult sizes. The device is not intended for neonatal applications.
Intended User / Care Setting
physician or licensed health care professional.
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 top testing was conducted to ensure expected performance of the FlexiPort EcoCuff.
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.
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
Image /page/0/Picture/0 description: The image shows the logo for Welch Allyn. The logo is in a bold, serif font. The letters are black and the background is white.
ﺮ ﺍ
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:
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.
1
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.
2
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/AAMI | ||
| 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 |
| Requirements | ||
| EN 1060-2 | 2009 | Non-invasive Sphygmomanometers - Part 2: |
| Supplementary Requirements for Mechanical | ||
| Sphygmomanometers | ||
| ISO 14971 | 2007 | Medical Devices - Application of Risk management to |
| Medical Devices | ||
| ISO 81060-1 | 2007 | Non Invasive Sphygmomanometers - Part 1: |
| Requirements and Test Methods for Non-automated | ||
| Measurement Type | ||
| ISO 81060-2 | 2009 | Non Invasive Sphygmomanometers-Part 2: Clinical |
| Validation of Automated Measurement Type | ||
| Guidance Document | 1998 | Non-Automated Sphygmomanometer (Blood Pressure |
| 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.
3
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.
4
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
5
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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