(302 days)
Not Found
No
The description focuses on the physical design and materials of a blood pressure cuff, with no mention of AI or ML capabilities. The performance studies are related to accuracy, biocompatibility, shelf life, and antimicrobial properties, not algorithmic performance.
No.
The device is used for non-invasive measurement of blood pressure, which is a diagnostic function to monitor a patient's condition, not to treat or alleviate a medical condition.
No.
The device, a blood pressure cuff, is used to assist in the non-invasive measurement of blood pressure, but it does not diagnose a condition itself. It's a tool for acquiring data that a qualified medical professional would then use for diagnostic purposes.
No
The device description explicitly details physical components like flexible polymeric material, an integrated inflatable bladder, a hook and loop closure system, and a one-piece lumen, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "non-invasive measurement of adult human blood pressure." This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is a blood pressure cuff that is applied to a patient's limb. It works by physically constricting the limb to measure blood pressure.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not involve the analysis of any bodily 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
UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of adult human blood pressure.
UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
OED
Device Description
The UltraCheck® Blood Pressure cuffs including the UltraCheck® Curve Cuffs in this 510(k), are applied to a patient limb and can be connected pneumatically to manual or oscillometric manometers to enable non-invasive blood pressure measurements. While the general shape of the other cuffs in the UltraCheck® product line is rectangular, the UltraCheck® Curve Cuffs in this 510(k) are conical in shape. They are made of flexible polymeric material a section of which forms an integrated inflatable bladder. A hook and loop closure system on each cuff may be used to secure the cuff around the patients limb. The cuff is connected pneumatically through a one piece lumen to a Patient Monitor or Sphygmomanometer.
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
adult human
Intended User / Care Setting
use by or under the supervision of 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical accuracy study showing the accuracy of the cuff is unchanged from the predicate device when used with the manual or electronic sphygmomanometer and the results compared to the measurements collected using the predicate cuffs.
A biocompatibility study of the material per ISO 10993-1 which indicated no biocompatibility issues.
A shelf life study indicating the cuffs performance did not degrade over a three year shelf life.
A textile test performed per Mil Std 810E 508.4 which indicated the antimicrobial agent inhibited fungal growth in the cuff material.
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
K122365
Image /page/0/Picture/1 description: The image shows the logo for Statcorp Medical. The logo consists of the word "Statcorp" in bold, sans-serif font at the top, followed by a graphic of horizontal lines that form a semi-circle. Below the graphic is the word "Medical" in a bold, sans-serif font.
JUN 0 4 2013
UltraCheck® Curve 510(k) Summary
- l. Applicant Information
- A. Applicant Information:
Statcorp Medical 14476 Duval Place West, Suite 303 Jacksonville, FL 32218 1-904-861-2347
-
B. Official Contact:
Wayne Emmert Director of Operations -
C. Date of Summary: 1/30/13
ll. Device Information
- A. Proprietary Name : UltraCheck® Curve Blood Pressure cuff
- B. Common Names: Blood Pressure Cuff
- C. Classification Device Name: Antimicrobial Blood Pressure Cuff
- D. Classification Regulatory Description: Blood Pressure cuff
- E. Product Code: OED
- F. Regulatory Class: ll
- Cardiovascular G. Panel:
III. Predicate Device
The predicate devices for this cuff are the Philips Series of Multi-Patient Cuffs and Single-Patient Cuffs, 510(k) # K071885 and the Ultracuff Blood Pressure Cuff, 510(k) # K954282.
Statcorp Medical
Attachment 2 Page 1 of 4
1
IV. General Description
The UltraCheck® Blood Pressure cuffs including the UltraCheck® Curve Cuffs in this 510(k), are applied to a patient limb and can be connected pneumatically to manual or oscillometric manometers to enable non-invasive blood pressure measurements. While the general shape of the other cuffs in the UltraCheck® product line is rectangular, the UltraCheck® Curve Cuffs in this 510(k) are conical in shape. They are made of flexible polymeric material a section of which forms an integrated inflatable bladder. A hook and loop closure system on each cuff may be used to secure the cuff around the patients limb. The cuff is connected pneumatically through a one piece lumen to a Patient Monitor or Sphygmomanometer.
V. Indications
The UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of 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 table below indicates the similarities and differences between the UltraCheck® Curve and the predicate devices.
| | New
UltraCheck®
Curve Cuffs | UltraCheck®
Cuffs in
K954282 | Philips
K071885 | Philips
K071885 |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models | Adult Bariatric
BRUS3854
BRUD3854 | Adult Large
US3544 &
UD3544 | Adult Large
M4557B | Adult X-Large
for Thigh
M4559B |
| Intended use- as
listed in 510(k)
which may
include other
cuff sizes in the
case of the
predicates.. | "cuffs are to be
used with
identified
devices
intended for
use by, or
under the
supervision of,
a licensed
physician or
other
healthcare
provider for the
non-invasive
measurement
of adult human | cuffs are to be
used with
identified
devices
intended for
use by, or
under the
supervision of,
a licensed
physician or
other
healthcare
provider for the
non-invasive
measurement
of infant. | "cuffs are to be
used with
identified
devices
intended for
use by, or
under the
supervision of,
a licensed
physician or
other
healthcare.
provider for the
non-invasive
measurement
of infant. | cuffs are to be
used with
identified
devices
intended for
use by, or
under the
supervision of,
a licensed
physician or
other
healthcare
provider for the
non-invasive
measurement
of infant. |
2
a marka marka katika katika katika katika katika katika ke mana mana mana Ki22365 milikan ka
:
:
| | | blood pressure | pediatric
and adult
human blood
pressure | pediatric
and adult
human blood
pressure." | pediatric
and adult
human blood
pressure." | |
|--|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--|
| | Base Cuff
Material | Nylon Fabric
w/polyurethane
backing | Nylon Fabric
w/polyurethane
backing | Nylon with
polyurethane
backing | Nylon with
polyurethane
backing | |
| | Antimicrobial
Additive | Micropel -
same as
Phillips
Predicate | None | Micropel | Micropel. | |
| | Tube Material | Dynaflex
G2709-100-00 | Dynaflex
G2709-100-00 | Black unknown | Black unknown | |
| | Number of
adapter tubes | BRUS3854-
single
BRUD3854-
dual | US3544-single
UD3544-Dual | Option of
either 1 or 2
with adapter | Option of
either 1 or 2
with adapter | |
| | Sizes and
Dimensions | 38cm to 54 cm | 35cm to 44cm | 35cm to 44cm | 42cm to 54cm | |
| | Shape | Conical | Rectangular | Rectangular | Rectangular | |
| | Method of
attachment
Storage/Ambient
Temperature
Range: | Velcro | Velcro | Velcro | Velcro | |
| | Compatible
Monitors | Welch Allen
Draeger
Colin
Datascope
Spacelabs
Mindray
Siemens
GE | Welch Allen
Draeger
Colin
Datascope
Spacelabs
Mindray
Siemens
GE | Welch Allen
Draeger
Colin
Datascope
Spacelabs
Mindray
Siemens
GE | Welch Allen
Draeger
Colin
Datascope
Spacelabs
Mindray
Siemens
GE | |
| | | (Marquette)
Datex/Ohmeda
Criticon
Criticare
Phillips
Zoll
CAS
Physio
Invivo | (Marquette)
Datex/Ohmeda
Criticon
Criticare
Phillips
Zoll
CAS
Physio
Invivo | (Marquette)
Datex/Ohmeda
Criticon
Phillips | (Marquette)
Datex/Ohmeda
Criticon
Phillips | |
.
.
:
:
:
Page 3 of 4
:
:
.
3
VII. Test Summary
Testing was performed to show compliance with the following standards and guidance documents.
- 2003: Manual. electronic. automated 2002. Am1: or AAMI/ANSI SP10 o sphygmomanometers.
- ISO 10993-1 2009 Biological evaluation of medical devices 0
- FDA guidance on Premarket Notification [510(k)] Submissions for Medical Devices that O Include Antimicrobial Agents "
This testing included:
A clinical accuracy study showing the accuracy of the cuff is unchanged from the predicate device when used with the manual or electronic sphygmomanometer and the results compared to the measurements collected using the predicate cuffs.
A biocompatibility study of the material per ISO 10993-1 which indicated no biocompatibility issues.
A shelf life study indicating the cuffs performance did not degrade over a three year shelf life.
A textile test performed per Mil Std 810E 508.4 which indicated the antimicrobial agent inhibited fungal growth in the cuff material.
VIII. Conclusions
Based upon the above test results the UltraCheck® Curve Blood Pressure Cuffs are substantially equivalent to the predicate devices cited and safe and effective for their stated intended use.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2013
Statcorp Medical c/o Mr. Wayne Emmert Director of Operations 14476 Duval Place West, Suite 303 Jacksonville, FL 32218
Re: K122365
Trade/Device Name: UltraCheck Curve Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: OED Dated: May 1, 2013 Received: May 2, 2013
Dear Mr. 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
5
Page 2 - Mr. Wayne Emmert
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.
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
6
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
UltraCheck® Blood Pressure Cuff
UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of adult human blood pressure.
UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)