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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the UltraCheck® Curve Blood Pressure Cuff meets them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
Clinical Accuracy	- Manual, electronic, automated sphygmomanometers (AAMI/ANSI SP10: 2002, Am1: 2003): Clinical accuracy study showed the accuracy of the cuff is unchanged from the predicate device when used with manual or electronic sphygmomanometer. Results were compared to measurements collected using predicate cuffs.
Biocompatibility	- ISO 10993-1: 2009 Biological evaluation of medical devices: A biocompatibility study indicated no biocompatibility issues for the cuff material.
Shelf Life	- Not explicitly tied to a standard, but a specific test: A shelf life study indicated the cuff's performance did not degrade over a three-year shelf life.
Antimicrobial Efficacy	- FDA guidance on Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents: A textile test performed per Mil Std 810E 508.4 indicated the antimicrobial agent inhibited fungal growth in the cuff material.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Clinical Accuracy Study (for the cuff): The document does not specify the exact sample size for the clinical accuracy study. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
Biocompatibility Study: Not applicable (material testing).
Shelf Life Study: Not applicable (product testing over time).
Antimicrobial Efficacy (Textile Test): Not applicable (material testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number or qualifications of experts used to establish ground truth for any of the studies mentioned. For a blood pressure cuff, the "ground truth" for accuracy is typically derived from direct measurement methods and comparisons to established, validated devices rather than expert consensus on interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method. This type of adjudication is typically relevant for studies involving human interpretation of medical images or diagnostic tests, which is not the primary focus for a blood pressure cuff's performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This is not applicable to a blood pressure cuff, as it is a physical medical device for measurement, not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a "standalone algorithm performance" study was not done. The device tested is a blood pressure cuff, which is a hardware component used in conjunction with a sphygmomanometer (manual or electronic) to measure blood pressure. Its performance is inherent to its design and how it interacts with the patient and the measurement device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Clinical Accuracy Study: The ground truth for the clinical accuracy study would have been established by comparing the measurements from the UltraCheck® Curve Cuffs against measurements collected using the predicate cuffs and a reference method (likely a mercury sphygmomanometer or another highly validated method as per AAMI/ANSI SP10 standards). The standard typically defines the acceptable differences in mean and standard deviation of blood pressure measurements.
Biocompatibility Study: Ground truth established through standardized material testing procedures and chemical analysis per ISO 10993-1.
Shelf Life Study: Ground truth established by testing the device performance (e.g., accuracy, material integrity) at different time points across the claimed shelf life using established test methods.
Antimicrobial Efficacy: Ground truth established by laboratory testing for the inhibition of fungal growth using standardized microbial testing methods (Mil Std 810E 508.4).

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are validated through engineering and clinical testing.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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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

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.

	NewUltraCheck®Curve Cuffs	UltraCheck®Cuffs inK954282	PhilipsK071885	PhilipsK071885
Models	Adult BariatricBRUS3854BRUD3854	Adult LargeUS3544 &UD3544	Adult LargeM4557B	Adult X-Largefor ThighM4559B
Intended use- aslisted in 510(k)which mayinclude othercuff sizes in thecase of thepredicates..	"cuffs are to beused withidentifieddevicesintended foruse by, orunder thesupervision of,a licensedphysician orotherhealthcareprovider for thenon-invasivemeasurementof adult human	cuffs are to beused withidentifieddevicesintended foruse by, orunder thesupervision of,a licensedphysician orotherhealthcareprovider for thenon-invasivemeasurementof infant.	"cuffs are to beused withidentifieddevicesintended foruse by, orunder thesupervision of,a licensedphysician orotherhealthcare.provider for thenon-invasivemeasurementof infant.	cuffs are to beused withidentifieddevicesintended foruse by, orunder thesupervision of,a licensedphysician orotherhealthcareprovider for thenon-invasivemeasurementof infant.

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a marka marka katika katika katika katika katika katika ke mana mana mana Ki22365 milikan ka

	blood pressure	pediatricand adulthuman bloodpressure	pediatricand adulthuman bloodpressure."	pediatricand adulthuman bloodpressure."
Base CuffMaterial	Nylon Fabricw/polyurethanebacking	Nylon Fabricw/polyurethanebacking	Nylon withpolyurethanebacking	Nylon withpolyurethanebacking
AntimicrobialAdditive	Micropel -same asPhillipsPredicate	None	Micropel	Micropel.
Tube Material	DynaflexG2709-100-00	DynaflexG2709-100-00	Black unknown	Black unknown
Number ofadapter tubes	BRUS3854-singleBRUD3854-dual	US3544-singleUD3544-Dual	Option ofeither 1 or 2with adapter	Option ofeither 1 or 2with adapter
Sizes andDimensions	38cm to 54 cm	35cm to 44cm	35cm to 44cm	42cm to 54cm
Shape	Conical	Rectangular	Rectangular	Rectangular
Method ofattachmentStorage/AmbientTemperatureRange:	Velcro	Velcro	Velcro	Velcro
CompatibleMonitors	Welch AllenDraegerColinDatascopeSpacelabsMindraySiemensGE	Welch AllenDraegerColinDatascopeSpacelabsMindraySiemensGE	Welch AllenDraegerColinDatascopeSpacelabsMindraySiemensGE	Welch AllenDraegerColinDatascopeSpacelabsMindraySiemensGE
	(Marquette)Datex/OhmedaCriticonCriticarePhillipsZollCASPhysioInvivo	(Marquette)Datex/OhmedaCriticonCriticarePhillipsZollCASPhysioInvivo	(Marquette)Datex/OhmedaCriticonPhillips	(Marquette)Datex/OhmedaCriticonPhillips

Page 3 of 4

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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 (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):

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'

Regulation Number and Section

§ 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).