MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S

K071645 · Omron Healthcare, Inc. · MWI · Jul 2, 2007 · Cardiovascular

Device Facts

• Record ID: K071645
• Device Name: MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
• Applicant: Omron Healthcare, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring: . Pulse rate (via oximetry data) . Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP) . Temperature . Blood Oxygen Saturation (SpO2 via finger oximeter) This device is intended for use by qualified healthcare personnel trained in its use.

Device Story

HBP T-105 Series Vital Signs Monitor; monitors single patient vital signs including pulse rate, NIBP, temperature, and SpO2. Inputs: oscillometric pressure sensor, finger oximeter, electronic predictive thermometer. Operation: oscillometric NIBP measurement; SpO2 via Nellcor or Masimo modules; predictive temperature sensing. Output: LED display of vital sign data. Used in hospitals/clinics by qualified healthcare personnel. T-105S model performs manual BP activation; T-105 allows interval settings. Output informs clinical assessment of patient condition. Benefits: provides real-time physiological monitoring to support clinical decision-making.

Clinical Evidence

Bench testing only. Comparison of performance specifications (accuracy of pressure, pulse, SpO2, and temperature) against predicate devices. No clinical study data provided.

Technological Characteristics

Oscillometric NIBP measurement; semiconductor pressure sensor; DC rolling diaphragm pump; electromagnetic solenoid valve. SpO2 via Nellcor (NELL-1) or Masimo (MS-11) modules. Predictive electronic thermometer. LED display. Power: 12V 3.2Ah battery or AC adapter. Type BF defibrillator-protected. Dimensions: 239x239x150mm. Weight: 7.7 lbs.

Indications for Use

Indicated for monitoring vital signs (pulse rate, NIBP, temperature, SpO2) in adult, pediatric, and neonatal patients in clinical settings (hospitals, acute care, outpatient surgery, practitioner facilities) by qualified healthcare personnel. No contraindications.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Colin - Press-Mate PM-2100 (K022537)
• Omron - HEM 907 (K001848)
• Omron - HEM 757 (K001670)
• Nellcor - N595 (K012891)
• Nellcor - Oximax (K052186)
• Masimo - RAD 5 (K033296)
• Masimo - LNCS (K041815)

Submission Summary (Full Text)

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Omron

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 12-Jun-07

| Omron Healthcare, Inc.<br>1200 Lakeside Dr.<br>Bannockburn, IL 60015 | Tel - 847-247-5609<br>Fax - 847-680-6269 |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Ranndy Kellogg - VP Marketing & Product Development |
| Proprietary or Trade Name: | HBP T-105 Series Vital Signs monitor |
| Common/Usual Name: | Monitor, Physiological, Patient (without arrhythmia detection or<br>alarms) |
| Classification Name/Code: | MWI - Monitor, Physiological, Patient (without arrhythmia<br>detection or alarms) |
| Device: | Models HBP T-105 and T-105S |
| Predicate Devices: | Colin - Press-Mate PM-2100 - K022537<br>Omron - HEM 907 - K001848<br>Omron - HEM 757 - K001670<br>Nellcor - N595 – K012891<br>Nellcor - Oximax - K052186<br>Masimo - RAD 5 - K033296<br>Masimo - LNCS – K041815 |

### Device Description:

The Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100 and is intended to monitor a single patient's vital signs. The device is capable of monitoring:

- . Pulse rate (via oximetry data):
- Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP); .
- . Temperature; and
- . Blood Oxygen Saturation (SpO2 via finger oximeter)

### Indications for Use:

The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring:

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 12-Jun-07

- Pulse rate (via oximetry data) ◆
- Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP) .
- . Temperature
- . Blood Oxygen Saturation (SpO2 via finger oximeter)

This device is intended for use by qualified healthcare personnel trained in its use.

### Patient Population: Adult, pediatric, neonate

Hospital, acute care settings, outpatient surgery, healthcare practitioner Environment of Use: facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition.

#### Contraindications: None

| Specification | Predicate<br>PM2100 - K022537 | New Models<br>HBP-T105 T-105S |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power source | Battery (Tin acid) or AC | Battery(Lead-acid) or AC adapter |
| Power range | AC : 100-120V,220-240V,50/60Hz<br>Battery6V 5Ah | AC : 100-115V,220-240V,50/60Hz<br>Battery12V 3.2Ah |
| Display | Monocolor LCD and LED | LED |
| Operating conditions | 0 to 50 ℃, 30 to 85 %RH | 0 to 40 °C, 30 to 85 %RH |
| Storage conditions | -20 to 70 °C, 30 to 85 %RH | -20 to 60 ℃, 10 to 95 %RH |
| Dimensions (mm) | 240 (W) × 250 (D) × 238 (H) mm | 239 (W) × 239 (D) × 150 (H) mm |
| Weight (without batteries) | 7.5 lbs | 7.7 lbs |
| BP module | M2600 | M3600 |
| Measurement method | Oscillometric method | same as predicate device |
| Patient target | Adult/Pediatric/Neonatal | same as predicate device |
| Measurement range | Pressure: 0 to 300 mmHg<br>Pulse rate: 40 to 240 beats/min. | Pressure: 0 to 299 mmHg<br>Pulse rate: 40 to 240 beats/min. |
| Pressure sensor | Semiconductor pressure sensor | same as predicate device |
| Air Control Valve | Electromagnetic solenoid | Omron HEM907 - K001848 |
| Applicable cuff | Regular sized cuff | Omron HEM907 - K001848 |
| Specification | Predicate<br>PM2100 - K022537 | New Models<br>HBP-T-105 / T-105S |
| Accuracy of pressure indicator | Within ±3 mmHg or 1 % of reading | same as predicate device |
| Accuracy of pulse rate | Within ±2 beats/min or ±2% of reading | same as predicate device |
| Inflation method | DC Rolling diaphragm pump | same as predicate device |
| Deflation method | Dynamic linear deflation | same as predicate device |
| Quick measurement function of<br>Blood Pressure | No algorithm | Omron algorithm<br>HEM-757 - K001670 |
| SpO2 Measurement method | 2 wave length pulse wave type | same as predicate device |
| SpO2 display range | 0 to 100 % | same as predicate device |
| SpO2 module | Nellcor NELL-3(MP-506) | Nellcor NELL-1<br>N-595 - K012891<br>same technology as NELL-1.<br>Masimo MS-11<br>RAD-5 - K033296<br>same technology as MS-11.<br>User can select which one |
| Accuracy of SpO2 | D-25 disposable sensor<br>SpO2:70-100% ±2%<br>other ranges unspecified<br>N-25 disposable sensor<br>SpO2:70-95% ±2%<br>other ranges<br>unspecified | Nellcor - Same as predicate<br>OXIMAX Sensors - K052186<br>Add option of - Masimo<br>SpO2:70-100% ±2%<br>LNCS sensors - K041815 |
| Pulse rate display range | 20 - 250 beats/min | Nellcor -same as predicate device<br>Masimo -25 - 240 beats/min |
| Accuracy of pulse rate | Within ±3 beats/min | Nellcor - same as predicate device<br>Masimo - Within ±3 beats/min |
| Temperature<br>Measurement method | TURBO TEMP electronic<br>predictive thermometer | same as predicate device |
| TEMP display range | Predictive mode: 35.6 - 41.1℃ / 96-<br>106°F<br>Monitor mode: 26.7 - 41.1º / 80 - 106ºF | same as predicate device |
| Accuracy of TEMP | ±0.1°C / ±0.2°F | same as predicate device |
| Scale | Selectable from °C to °F | same as predicate device |
| Shock protection | Type BF(Defibrillator protected) | same as predicate device |

### Summary of substantial equivalence

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# Non-Confidential Summary of Safety and Effectiveness Page 3 of 4
12-Jun-07

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K071645
Omron p4/4

# Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 12-Jun-07

### Differences Between Other Legally Marketed Predicate Devices

The Model HBP T-105 Series is viewed as substantially equivalent to the following predicate device - Colin Press-Mate PM-2100 - K022537.

The difference between the Model T-105 and T-105S is that the T-105S model does not have the ability to set the time interval of the BP measurement. The T-105S model BP is done on an as needed / manual activation basis. All other features, specifications, etc. are otherwise identical.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

Omron Healthcare, Inc. c/o Mr. Paul Dryden, ProMedic, Inc. 3460 Pointe Creek Court # 102 Bonita Springs, FL 34134-2015

Re: K071645

HBP-105 and T-105S Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: June 12, 2007 Received: June 15, 2007

Dear Mr. Dryden:

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. Paul Dryden

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,

Ashley B. Brown

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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Omron

Page 1 of 1

Device Name: HBP T-105 and T-105S

## Indications for Use:

The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring:

- . Pulse rate (via oximetry data)
- . Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
- . Temperature
- . Blood Oxygen Saturation (SpO2 via finger oximeter)

This device is intended for use by qualified healthcare personnel trained in its use.

Prescription Use XX (Part 21 CFR 801 Subpart D) Or

Over-the-counter use (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)

Antilu Bvanu An BDZ

**510(k) Number** K071645