(113 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention AI or ML.
No.
The device is intended for "acquisition and attended monitoring" of vital signs and for "diagnostic spot NIBP measurements", which are diagnostic and monitoring functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be used for treatment and diagnostic spot NIBP measurements".
No
The device description explicitly states it includes an "NIBP module which measures and reports the patient's blood pressure and pulse rate readings," indicating a hardware component beyond just software.
Based on the provided information, the Welch Allyn Non-Invasive Blood Pressure device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Welch Allyn NIBP device measures blood pressure and pulse rate directly from the patient's body using a cuff and the oscillometric method. This is a non-invasive measurement taken in vivo (within the living body).
- Intended Use: The intended use describes the device as being used for "acquisition and attended monitoring of noninvasive blood pressure and pulse rate" and "treatment and diagnostic spot NIBP measurements or attended NIBP monitoring." These are all activities performed on the patient directly.
- Device Description: The description details the components and how it measures blood pressure and pulse rate from the patient.
The device is a medical device used for physiological monitoring and measurement, but it does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Welch Allyn NIBP device consists of 1) a software program running on a laptop computer; 2) an NIBP module which measures and reports the patient's blood pressure and pulse rate readings. The device is intended to operate with a series of standard blood pressure cuffs and blood pressure tubing. The Welch Allyn NIBP device is designed to non-invasively measure systolic and diastolic blood pressure and pulse rate for adult, pediatric and neonatal patients using the oscillometric method. The Welch Allyn NIBP device will also calculate Mean Arterial Pressure (MAP). All blood pressure and pulse values are displayed on the large, easy-to-read LCD display of the laptop computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal through adult patients
Intended User / Care Setting
used by clinicians and medically qualified personnel; in hospital departments; alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes. hospital general wards, clinics, and doctor's offices.
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)
Non-clinical performance data: The subject device was also tested to evaluate its safety and effectiveness based on the following standards:
- IEC 60601-1:1988+Al:1991+A2:1995 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- IEC 60601-1-2:2001+Al:2004 Medical Electrical Equipment Part 1-2: . General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test
- IEC 60601-1-4:(2000) General Requirement for Safety: Collateral Standard: . Programmable Electrical Medical Systems
- AAMI SP10: 2002: Manual, electronic or automated sphygmomanometers . (A1:2003, A2:2006)
Clinical performance data: Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard for Manual, electronic or automated sphygmomanometers + Amendment 1 & 2 standards
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the word "Allyn" in bold, black font. Above the word "Allyn" is the number 1867. The font is a serif font.
i
Abbreviated 510(k) Premarket Notification Welch Allyn Non-invasive Blood Pressure (NIBP) Device
Premarket Notification [510(k)] Summary 6. February 3, 2010 Date: APR 1 4 2010 Submitted By: Welch Allyn. Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 (315) 685-3694 Phone: Fax: (315) 685- 2532 Contact: Huy Doan, Senior Manager, Regulatory Affairs Common Name: Non-invasive Blood Pressure (NIBP) Device Trade Name: Welch Allyn Non-invasive Blood Pressure (NIBP) Device Classification Name: Noninvasive blood pressure measurement system Class II; Product Code: DXN- 21 CFR 870.1130 Modification to VSM- Vital Signs Monitor (VSM 300) (K063419) Predicate Devices: Welch Allyn Spot Ultra Vital Signs Device (K040490) The Welch Allyn NIBP device consists of 1) a software program running on a Description: laptop computer; 2) an NIBP module which measures and reports the patient's blood pressure and pulse rate readings. The device is intended to operate with a series of standard blood pressure cuffs and blood pressure tubing. The Welch Allyn NIBP device is designed to non-invasively measure systolic and diastolic blood pressure and pulse rate for adult, pediatric and neonatal patients using the oscillometric method. The Welch Allyn NIBP device will also calculate Mean Arterial Pressure (MAP). All blood pressure and pulse values are displayed on the large, easy-to-read LCD display of the laptop computer. The Welch Allyn NIBP device is intended for use in a wide variety of health care settings. This includes hospital departments; alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes. Indications for Use:
The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.
1
Image /page/1/Picture/0 description: The image contains the text "Welch Allyn" in a stylized font. The word "Welch" is in a lighter, less bold font compared to "Allyn." The text appears to be a logo or brand name.
Premarket Notification [510(k)] Summary 6.
Contraindications for Use:
The Welch Allyn Non-Invasive Blood Pressure device is not intended for use with severe arrhythmia. The Welch Allyn Non-Invasive Blood Pressure device is not intended for patients who are experiencing convulsions or tremors.
Technological Characteristics:
The Welch Allyn NIBP Device utilizes an Oscillometric BP Algorithm that is equivalent to the BP Algorithm in the Spot Ultra Vital Signs and Welch Allyn VSM 53000. The Welch Allyn NIBP Device is powered from USB power from the Laptop PC. It uses the same operating principle and incorporates the same basic material. The subject device has the same technological characteristics as the predicate devices.
Non-clinical performance data:
The subject device was also tested to evaluate its safety and effectiveness based on the following standards:
- IEC 60601-1:1988+Al:1991+A2:1995 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- IEC 60601-1-2:2001+Al:2004 Medical Electrical Equipment Part 1-2: . General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test
- IEC 60601-1-4:(2000) General Requirement for Safety: Collateral Standard: . Programmable Electrical Medical Systems
- AAMI SP10: 2002: Manual, electronic or automated sphygmomanometers . (A1:2003, A2:2006)
Clinical performance data:
Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard for Manual, electronic or automated sphygmomanometers + Amendment 1 & 2 standards
Conclusions:
The intended use and the technological characteristics of the Welch Allyn NIBP device are the same as the predicate devices and the product meets FDA's recognized concensus standards. Therefore Welch Allyn believes the Welch Allyn NIBP device is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure embracing an eagle, symbolizing the department's mission to protect and promote the health and well-being of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 1 4 2010
Welch Allyn, Inc. c/o Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087
Re: K093907
Trade/Device Name: Welch Allyn Non-Invasive Blood Pressure (NIBP) Device Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: March 18, 2010 Received: March 22, 2010
Dear Mr. Lehtonen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Mr. Daniel W. Lehtonen
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/ucm115809.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/ReportalProblem/default.htm for the CDRH's Office of 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,
[signature]
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
510(k) Number (if known): ≤093907
Device Name: Welch Allyn Non-invasive Blood Pressure (NIBP) Device
Indications for Use:
The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.
Prescription Use × AND/OR Over-The-Counter Use
(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)
W.W.C.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093590
Page 1 of 1