ULTRACHECK CURVE BLOOD PRESSURE CUFFS

K122365 · Statcorp Medical · OED · Jun 4, 2013 · Cardiovascular

Device Facts

• Record ID: K122365
• Device Name: ULTRACHECK CURVE BLOOD PRESSURE CUFFS
• Applicant: Statcorp Medical
• Product Code: OED · Cardiovascular
• Decision Date: Jun 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended 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.

Device Story

UltraCheck® Curve Blood Pressure Cuffs are conical, flexible polymeric cuffs with an integrated inflatable bladder; secured to patient limbs via hook and loop closure. Cuffs connect pneumatically via a one-piece lumen to external manual or oscillometric sphygmomanometers/patient monitors. Used by qualified medical personnel in clinical settings to facilitate non-invasive blood pressure measurement. The conical shape is designed to fit adult limbs; antimicrobial additives inhibit fungal growth. Output is pneumatic pressure transmission to the monitor, which calculates blood pressure values for clinical decision-making.

Clinical Evidence

Clinical accuracy study compared the UltraCheck® Curve cuff to predicate cuffs using manual or electronic sphygmomanometers; results showed accuracy is unchanged. Biocompatibility testing per ISO 10993-1 indicated no issues. Textile testing per Mil Std 810E 508.4 confirmed antimicrobial agent efficacy. Shelf life study demonstrated performance stability over three years.

Technological Characteristics

Conical cuff made of nylon fabric with polyurethane backing; includes Micropel antimicrobial additive. Uses hook and loop (Velcro) attachment. Pneumatic connection via one-piece lumen. Compatible with various manual/oscillometric monitors. Tested per AAMI/ANSI SP10 and ISO 10993-1.

Indications for Use

Indicated for non-invasive blood pressure measurement in adult patients. Intended for use by or under the supervision of qualified medical personnel.

Regulatory Classification

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.

Predicate Devices

• Philips Series of Multi-Patient Cuffs and Single-Patient Cuffs (K071885)
• Ultracuff Blood Pressure Cuff (K954282)

Submission Summary (Full Text)

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## 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

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#### 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<br>UltraCheck®<br>Curve Cuffs | UltraCheck®<br>Cuffs in<br>K954282 | Philips<br>K071885 | Philips<br>K071885 |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models | Adult Bariatric<br>BRUS3854<br>BRUD3854 | Adult Large<br>US3544 &<br>UD3544 | Adult Large<br>M4557B | Adult X-Large<br>for Thigh<br>M4559B |
| Intended use- as<br>listed in 510(k)<br>which may<br>include other<br>cuff sizes in the<br>case of the<br>predicates.. | "cuffs are to be<br>used with<br>identified<br>devices<br>intended for<br>use by, or<br>under the<br>supervision of,<br>a licensed<br>physician or<br>other<br>healthcare<br>provider for the<br>non-invasive<br>measurement<br>of adult human | cuffs are to be<br>used with<br>identified<br>devices<br>intended for<br>use by, or<br>under the<br>supervision of,<br>a licensed<br>physician or<br>other<br>healthcare<br>provider for the<br>non-invasive<br>measurement<br>of infant. | "cuffs are to be<br>used with<br>identified<br>devices<br>intended for<br>use by, or<br>under the<br>supervision of,<br>a licensed<br>physician or<br>other<br>healthcare.<br>provider for the<br>non-invasive<br>measurement<br>of infant. | cuffs are to be<br>used with<br>identified<br>devices<br>intended for<br>use by, or<br>under the<br>supervision of,<br>a licensed<br>physician or<br>other<br>healthcare<br>provider for the<br>non-invasive<br>measurement<br>of infant. |

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| | | blood pressure | pediatric<br>and adult<br>human blood<br>pressure | pediatric<br>and adult<br>human blood<br>pressure." | pediatric<br>and adult<br>human blood<br>pressure." | |
|--|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--|
| | Base Cuff<br>Material | Nylon Fabric<br>w/polyurethane<br>backing | Nylon Fabric<br>w/polyurethane<br>backing | Nylon with<br>polyurethane<br>backing | Nylon with<br>polyurethane<br>backing | |
| | Antimicrobial<br>Additive | Micropel -<br>same as<br>Phillips<br>Predicate | None | Micropel | Micropel. | |
| | Tube Material | Dynaflex<br>G2709-100-00 | Dynaflex<br>G2709-100-00 | Black unknown | Black unknown | |
| | Number of<br>adapter tubes | BRUS3854-<br>single<br>BRUD3854-<br>dual | US3544-single<br>UD3544-Dual | Option of<br>either 1 or 2<br>with adapter | Option of<br>either 1 or 2<br>with adapter | |
| | Sizes and<br>Dimensions | 38cm to 54 cm | 35cm to 44cm | 35cm to 44cm | 42cm to 54cm | |
| | Shape | Conical | Rectangular | Rectangular | Rectangular | |
| | Method of<br>attachment<br>Storage/Ambient<br>Temperature<br>Range: | Velcro | Velcro | Velcro | Velcro | |
| | Compatible<br>Monitors | Welch Allen<br>Draeger<br>Colin<br>Datascope<br>Spacelabs<br>Mindray<br>Siemens<br>GE | Welch Allen<br>Draeger<br>Colin<br>Datascope<br>Spacelabs<br>Mindray<br>Siemens<br>GE | Welch Allen<br>Draeger<br>Colin<br>Datascope<br>Spacelabs<br>Mindray<br>Siemens<br>GE | Welch Allen<br>Draeger<br>Colin<br>Datascope<br>Spacelabs<br>Mindray<br>Siemens<br>GE | |
| | | (Marquette)<br>Datex/Ohmeda<br>Criticon<br>Criticare<br>Phillips<br>Zoll<br>CAS<br>Physio<br>Invivo | (Marquette)<br>Datex/Ohmeda<br>Criticon<br>Criticare<br>Phillips<br>Zoll<br>CAS<br>Physio<br>Invivo | (Marquette)<br>Datex/Ohmeda<br>Criticon<br>Phillips | (Marquette)<br>Datex/Ohmeda<br>Criticon<br>Phillips | |

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#### 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.

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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

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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 [phone] or [phone] 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):

Device Name:

Indications for Use:

K122365

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)

# Bram D. Zuckerman -S 2013.06.04 16:11:07 -04'00'