247 BP DEVICE

K070750 · Suntech Medical, Inc. · DXN · May 2, 2007 · Cardiovascular

Device Facts

• Record ID: K070750
• Device Name: 247 BP DEVICE
• Applicant: Suntech Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: May 2, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

Device Story

The 247 is a microprocessor-based vital signs monitor measuring noninvasive blood pressure (NIBP), temperature, and pulse oximetry (SpO2). NIBP is determined via oscillometric signals using an internal electric pump and two-valve deflation system. Temperature is measured using oral, rectal, or auxiliary probes; SpO2 is measured via an optical finger sensor. The device incorporates OEM modules for SpO2 and temperature. Used in hospitals, clinics, and subacute settings by healthcare professionals to display vital signs for clinical assessment. It does not provide continuous patient monitoring. The device aids clinicians in evaluating patient status through spot-check measurements.

Clinical Evidence

Bench testing only. The device was validated against AAMI SP10:2002 for blood pressure, ISO 9919:1992 for pulse oximetry, and ASTM E1112-00:2006 for temperature. Compliance with IEC 60601-1, 60601-1-2, and 60601-1-4 was confirmed. No clinical trial data was required for this submission.

Technological Characteristics

Microprocessor-controlled NIBP, temperature, and SpO2 measurement system. Uses oscillometric NIBP sensing, optical finger sensors for SpO2, and thermistor-based probes for temperature. Internal electric pump and dual-valve system for cuff inflation/deflation. Powered by electrical source. Complies with AAMI SP10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 9919, and ASTM E1112 standards.

Indications for Use

Indicated for adult and pediatric patients in hospitals, clinics, physician offices, and subacute environments for measurement and display of systolic/diastolic blood pressure, heart rate, temperature, 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

• Welch Allyn's Spot Vital Signs (K002530)

Submission Summary (Full Text)

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K07075D

SunTech Medical, Inc. Abbreviated 510(k) Submission 247 510(k) Summary March 16, 2007

Page :

MAY - 2 2007

## (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 16, 2007 |

#### (2) Name of Device

| Trade Name: | 247 |
|----------------------|---------------------------------------------------------|
| Common Name: | NIBP Monitor |
| Classification name: | Noninvasive blood pressure measurement system, 870.1130 |

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

Sun Tech Medical has identified Welch Allyn's Spot Vital Signs, K002530, as the predicate device for the 247.

The 247 is substantially equivilent to this device.

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# (4) Description

The 247 BP, Temperature and Pulse Oximeter device, a microprocessor based noninvasive blood pressure, predictive temperature and oxygen saturation measurement system, uses oscillometric signals to determine blood pressure, oral, rectal or auxiliary probes to determine temperature and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff. Deflation of the cuff is controlled by two valves. Implementation of Pulse Oximetry and temperature is achieved through the incorporation of OEM devices from companies with currently marketed products and accessories.

## (5) Intended Use

The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

## (6) Comparison to Predicate Devices

The 247 has the same basic construction as the predicate device. Both devices are microprocessor controlled and the devices utilize similar circuitry. Both devices measure NIBP, SpO2, and body temperature. Neither device is intended to monitor the patient's vital signs. Both devices utilize the same measurement ranges for the various vital signs parameters being measured. Both devices are intended for adult and pediatric populations.

### (7) Testing and Validations

The 247 has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.

- AAMI SP10: 2002 .
- IEC 60601-1:1996 .
- IEC 60601-1-2:2001 ●
- IEC 60601-1-4:2000 .
- ISO 9919:1992 .
- E1112-00:2006 .
- Functional Specification, (SunTech document # 99-0049-XX-FS) .

### (8) Conclusion

The 247 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

MAY - 2 2007

SunTech Medical, Inc. c/o Mr. Chuck Setzer Regulatory Manager 507 Airport Blvd., Suite 117 Morrisville, NC 27560-8200

Re: K070750

> Trade Name: 247 BP Device Regulation Number: 21 CFR 870.1130, 21 CFR 870.2700, and 21 CFR 880.2910 Regulation Name: Noninvasive Blood Pressure Measurement System; Oximeter; and, Clinical Electronic Thermometer Regulatory Class: Class II (two) Product Code: DXN, MUD, and FLL Dated: March 16, 2007 Received: March 19, 2007

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,

Blymmumor 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

K070750 510(k) Number (if known):

Device Name: 247

#### Indications for Use:

The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenta
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

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