CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060

K060820 · Suntech Medical, Inc. · DXN · Jun 7, 2006 · Cardiovascular

Device Facts

• Record ID: K060820
• Device Name: CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
• Applicant: Suntech Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 7, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

Device Story

Microprocessor-based ambulatory blood pressure monitor and pulse oximeter; compatible with ergometer stress-test systems. Inputs: Korotkoff sounds via cuff for blood pressure; optical finger sensor for SpO2. Internal electric pump inflates cuff; two valves control deflation. Operates at physician-scheduled intervals or on-demand. SpO2 measurements updated once per second. Used in hospitals, medical facilities, and subacute environments by clinicians. Output displayed for provider review to monitor patient hemodynamic status during stress testing or routine care.

Clinical Evidence

Bench testing only. Device validated against AAMI SP10:2002, IEC 60601-1:1996, IEC 60601-2-30:1999, ISO 9919:1992, IEC 60601-1-2:2001, IEC 60601-1-4:2000, and IEC 60601-2-49:2001. All tests indicated passing results.

Technological Characteristics

Microprocessor-controlled NIBP and pulse oximetry system. Materials identical to predicate. Sensing: Korotkoff sound detection (no R-wave gating) and optical finger sensor. Energy: Internal electric pump. Connectivity: Compatible with ergometer stress-test systems. Standards: AAMI SP10:2002, IEC 60601-1, IEC 60601-2-30, ISO 9919, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-49.

Indications for Use

Indicated for adult and pediatric patients in hospitals, medical facilities, and subacute environments for measurement and display of systolic/diastolic blood pressure, heart rate, and SpO2.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Tango+ (K053209)

Submission Summary (Full Text)

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K060820

SunTech Medical®

SunTech Medical, Inc. Abbreviated 510(k) Submission Cycle BP Monitor and Pulse Oximeter 510(k) Summary March 22, 2006

JUN - 7 2006

#### (1) Submitter information

:

| Name: | SunTech Medical, Inc |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 507 Airport Boulevard<br>Suite 117<br>Morrisville, North Carolina 27560-8200 |
| Telephone:<br>FAX: | 919.654.2332<br>919.654.2301 |
| Contact person: | David Gallick (Official Correspondent).<br><br>SunTech Medical<br>507 Airport Boulevard<br>Suite 117<br>Morrisville, North Carolina 27560-8200<br>Tel: [phone]<br>Fax: [phone] |
| Date prepared: | March 22, 2006 |

#### (2) Name of Device

!

| Trade Name: | Cycle BP Monitor and Pulse Oximeter |
|----------------------|------------------------------------------------------------|
| Common Name: | NIBP Monitor |
| Classification name: | Noninvasive blood pressure measurement system.<br>870.1130 |

#### (3) Legally-marketed predicate devices

Sun Tech Medical has identified its Tango+, K053209, as the predicate device for the Cycle BP Monitor and Pulse Oximeter.

The Cycle BP Monitor and Pulse Oximeter is substantially equivilent to this device.

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#### SunTech Medical Cycle Blood Pressure Monitor and Pulse Oximeter 510(k)

## (4) Description

The Cycle BP Monitor and Pulse Oximeter, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system compatible with ergometer stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. The Cycle has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

## (5) Intended Use

The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

## (6) Comparison to Predicate Devices

The Cycle BP Monitor and Pulse Oximeter has the same basic construction as the predicate device. Both devices are microprocessor controlled and the devices utilize similar circuitry. The Cycle is made from the same materials as the Tango+. It uses the same BP cuffs and SpO2 sensors as the Tango+. The Cycle utilizes the same BP measurement range and the same SpO2 range as the Tango+. The Cycle includes Pediatrics in the patient population. The Cycle BP monitor identifies the Korotkoff signals without the use of R-wave gating as used by the Tango+.

### (7) Testing and Validations

The Cycle BP Monitor has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results.

- AAMI SP10: 2002
- . IEC 60601-1:1996
- IEC 60601-2-30:1999 .
- ISO 9919:1992 .
- IEC 60601-1-2:2001 ●
- IEC 60601-1-4:2000 .
- IEC 60601-2-49:2001 ●
- Functional Specification, (SunTech document # 99-0049-XX-FS) ●

### (8) Conclusion

The Cycle BP Monitor and Pulse Oximeter is equivalent in safety and efficacy to the legally-marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2006

SunTech Medical, Inc. c/o Mr. David Gallick Vice President, Engineering 507 Airport Blvd., Suite 117 Morrisville, NC 27560-8200

Re: K060820

> Trade Name: Cycle BP Monitor and Pulse Oximeter, Model 1060 Regulation Number: 21 CFR 870.1130, and 21 CFR 870.2700 Regulation Name: Noninvasive Blood Pressure Measurement System, and Oximeter Regulatory Class: Class II (two) Product Code: DXN and MUD Dated: May 25, 2006 Received: May 26, 2006

Dear Mr. Gallick:

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. David Gallick

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 (OS) 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.

Blyminima for

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): K060820

Device Name: Cycle BP Monitor and Pulse Oximeter

Indications for Use:

The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying systolic and diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

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)

amminn

Visión Slan-Off) Division of Cardlovascular Devices 510(k) Number

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