DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100

K080854 · Suntech Medical, Inc. · DXQ · Oct 20, 2008 · Cardiovascular

Device Facts

• Record ID: K080854
• Device Name: DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
• Applicant: Suntech Medical, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 20, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Disposable blood pressure cuff; comprises soft inelastic sleeve with integrated inflatable bladder; tubing with connectors for manual or automated sphygmomanometers. Wrapped around patient limb; secured via hook and loop closure. Used in clinical settings to facilitate non-invasive blood pressure measurement. Output is pneumatic pressure transmission to measurement system; enables clinician to obtain blood pressure readings. Benefits include patient-specific sizing (15 configurations) and disposable design to support hygiene.

Clinical Evidence

Bench testing only. Device tested against AAMI SP10:2002 and IEC 60601-2-30:1999 requirements with passing results.

Technological Characteristics

Soft inelastic sleeve; integrated inflatable bladder; hook and loop closure. Available in 15 sizes (neonate to adult). Single/dual tubing configurations. Standards: AAMI SP10:2002, IEC 60601-2-30:1999. Non-electronic, passive pneumatic component.

Indications for Use

Indicated for determination of blood pressure parameters in neonate, pediatric, and adult patients using non-invasive blood pressure measurement systems.

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

• CRITIKON Soft Cuff (K974080)

Submission Summary (Full Text)

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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 Boulevard<br>Suite 117<br>Morrisville, 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

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

| 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 [phone]. 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 [phone] or [phone] 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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