The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

Device Description

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers

AI/ML Overview

This submission describes a disposable blood pressure cuff. The relevant information related to acceptance criteria and performance studies is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against two recognized standards and an internal marketing specification. The submission states, "These tests have indicated passing results." However, specific numerical acceptance criteria and the detailed performance results for each criterion are not provided in this document.

Acceptance Criteria Standard/Document	Reported Device Performance
AAMI SP10: 2002	Passing results
IEC 60601-2-30:1999	Passing results
Marketing Specification (SunTech document # 98-00162-XX-MS)	Passing results

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "The Disposable Blood Pressure Cuff has been tested to... standards and requirements."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the type of device and testing described. The device is a physical medical device (blood pressure cuff), and its performance is assessed against technical standards for accuracy and safety, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a physical device like a blood pressure cuff, performance is measured objectively against technical standards.

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

An MRMC comparative effectiveness study is not applicable as this device is a disposable blood pressure cuff, not an AI-powered diagnostic tool that assists human readers.

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

This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified industry standards (AAMI SP10: 2002 and IEC 60601-2-30:1999) and an internal marketing specification. These standards define the acceptable range of accuracy for blood pressure measurements and other physical and safety features of the cuff. The device's performance is measured against these objective criteria.

8. The sample size for the training set

This information is not applicable. The development and testing of a physical blood pressure cuff do not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications, prototyping, and validation testing.

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

This information is not applicable, as there is no "training set" in the context of this device. The "ground truth" for general design and safety parameters would be established by relevant engineering principles, material science, and regulatory requirements that predate the specific device being developed.

Summary

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Tech Medical®

100085 11

OCT 20 2008

SunTech Medical, Inc. Abbreviated 510(k) Submission Disposable Blood Pressure Cuff 510(k) Summary March 25, 2008

Page 5-2

(1) Submitter information

Name:	SunTech Medical, Inc
Address:	507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200
Telephone:	919.654.2332
FAX:	919.654.2301
Contact person:	David Gallick (Official Correspondent).
Date prepared:	March 25, 2008

(2) Name of Device

Trade Name:	Disposable Blood Pressure Cuff
Common Name:	Blood Pressure Cuff
Classification name:	Blood Pressure Cuff, DXQ 870.1120

(3) Legally-marketed predicate devices

Sun Tech Medical has identified the CRITIKON Soft Cuff, K974080, as the predicate device for the Disposable Cuff.

The Disposable Blood Pressure Cuff is substantially equivilent to this device.

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SunTech Medical

Disposable blood pressure cuff 510(k)

(4) Description

· 15 sizes (five neonate, ten pediatric/adult)

· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers

Pediatric
Size	Range	Available tail length	Artwork Color
1	3-6 cm	Normal	Orange
2	4-8 cm	Normal	Turquoise
3	6-11 cm	Normal	Green
4	7-13 cm	Normal	Royal Blue
5	8-15 cm	Normal	Burgundy
Adult
Size	Range	Available tail length	Artwork Color
Infant	8-13 cm	Normal	Orange
Child	12-19 cm	Normal and Long	Green
Sm Adult	17-25 cm	Normal and Long	Turquoise
Adult	23-33 cm	Normal and Long	Royal Blue
Lg Adult	31-40 cm	Normal and Long	Burgundy
Thigh	38-50 cm	Normal	Brown

(5) Intended Use

The Disposable Blood Pressure Cuff is intended to be used with a non- invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

(6) Comparison to Predicate Devices

The device has the same basic construction as the predicate device. Both devices are wrapped around the patients limb and secured by means of a hook and loop type fastener. The devices are manufactured from the same type of material, are available in the same size/ranges and are intended for the same patient populations.

(7) Testing and Validations

The Disposable Blood Pressure Cuff has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.

· AAMI SP10: 2002
· IEC 60601-2-30:1999

· Marketing Specification (SunTech document # 98-00162-XX-MS)

(8) Conclusion

In accordance with the Federal Food. Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, SunTech Medical concludes that the Disposable Blood Pressure Cuff is safe, effective and substantially equivalent to the predicate device described herein

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 2008

SunTech Medical, Inc c/o Mr. Chuck Setzer Regulatory Manager 507 Airport Blvd. Suite 117 Morrisville, NC 27560

Re: K080854

SunTech Medical Disposable Pressure Cuff, Model DC100 Regulation Number: 21 CFR 870.1120 Regulation Name: Cuff, Blood Pressure Regulatory Class: Class II (two) Product Code: DXQ Dated: October 9, 2008 Received: October 14, 2008

Dear Mr. Setzer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Chuck Setzer

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

uma R. bochner

\ 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

Ko 80854 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Disposable Cuff

Indications for Use:

The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K080854

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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).