(29 days)
Not Found
No
The device description and performance studies focus on the mechanical and clinical accuracy of a blood pressure cuff, with no mention of AI or ML technologies.
No
The device is described as a cuff used for non-invasive measurement of blood pressure, not for treatment or therapy.
Yes
The device is a non-invasive blood pressure cuff, which is used to measure blood pressure. Blood pressure measurement is a diagnostic activity, providing information about a patient's health status.
No
The device description explicitly states it is a blood pressure cuff made of flexible polymeric material with an integrated inflatable bladder, which are physical hardware components. The performance studies also include mechanical tests on the cuff.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "non-invasive measurement of pediatric and adult human blood pressure." This is a physiological measurement taken directly from the patient's body.
- Device Description: The description details a blood pressure cuff that is applied to a patient's limb and connected to a blood pressure monitor. This is an external device used for a physical measurement.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a medical device used for a physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.
Product codes
DXO
Device Description
The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient limb
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
qualified medical personnel
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
Mechanical tests included
- . Pressure cycle testing to 10,000 cycles and application testing to 1,000 cycles to validate life.
- Mechanical stress testing to validate ring durability .
- Cleaning validation tests to validate cleaning recommendations .
- Label integrity testing to validate label chemical resistance and legibility .
Clinical Accuracy testing performed per the methodology and requirements of AAMI ANSI ISO 81060-2 (2013)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Statcorp Medical Wayne Emmert Director of Operations 14476 Duval Place West Suite 303 Jacksonville, Florida 32218
Re: K152801
Trade/Device Name: Ultracheck Spacelabs ABP Cuff-child, Ultracheck Spacelabs ABP Cuff-small Adult, Ultracheck Spacelabs ABP Cuff-adult, Ultracheck Spacelabs ABP Cuff-large Adult
Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: September 25, 2015 Received: September 28, 2015
Dear Wayne Emmert:
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.
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
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 -S
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) K152801
Device Name
Statcorp Medical UltraCheck Spacelabs ABP Cuffs
Indications for Use (Describe)
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| x Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K152801
Image /page/3/Picture/1 description: The image shows the logo for Statcorp Medical. The logo features the word "Statcorp" in bold, blue letters at the top, followed by a graphic of horizontal blue lines that resemble a sound wave or a stylized medical chart. Below the graphic, the word "Medical" is written in bold, blue letters, mirroring the style of "Statcorp" above. The overall design is clean and professional, suggesting a company in the healthcare or medical technology sector.
UltraCheck® Spacelabs ABP Blood Pressure Cuffs 510(k) Summary of Safety and Effectiveness
1. Applicant Information
A. Applicant Information: Statcorp Medical 14476 Duval Place West, Suite 303 Jacksonville, FL 32218 1-904-786-5113
| B. Official Contact: | Wayne Emmert
Director of Operations |
| ---------------------- | ---------------------------------------- |
|---|
- C. Date of Summary: 9/25/15
II. Device Information
- A. Proprietary Name : UltraCheck® Spacelabs ABP Cuffs
- B. Common Names: Blood Pressure Cuff
- C. Classification Device Name: Blood Pressure Cuff
- D. Classification Regulatory Description: Blood Pressure Cuff
- E. Product Code: DXQ
- F. Regulatory Class: ==
- G. Panel: Cardiovascular
III. Predicate Device
The predicate devices for these cuffs are the Ultracuff Blood Pressure Cuffs (for Spacelabs ABP), 510(k) # K954282.
Statcorp Special 510(k) Section 8
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IV. General Description
The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.
V. Indications
The Statcorp UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.
VI. Comparison to Predicate
The UltraCheck® Spacelabs ABP cuffs in this 510(k) are similar to the Statcorp Ultracuff described in K954282 in that use the same cuff materials, bladder sizes and methods of construction. It differs from the fact that these cuffs are designed to be applied by passing the extended portion through a ring and attaching the cuff back onto itself. The predicate device is merely wrapped around the arm in the same direction. There is also an added fringe on the weld side of the cuff which eases the transition from the stiffer portion of the weld to the edge of the cuff which is added to provide for patient comfort.
VII. Test Summary
Mechanical tests included
- . Pressure cycle testing to 10,000 cycles and application testing to 1,000 cycles to validate life.
- Mechanical stress testing to validate ring durability .
- Cleaning validation tests to validate cleaning recommendations .
- Label integrity testing to validate label chemical resistance and legibility .
Clinical Accuracy testing performed per the methodology and requirements of AAMI ANSI ISO 81060-2 (2013)
VIII. Conclusions
Based upon the above test results the Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are substantially equivalent to the predicate devices cited and safe and effective for their stated intended use.