WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE

K040490 · Welch Allyn, Inc. · DXN · Aug 18, 2004 · Cardiovascular

Device Facts

• Record ID: K040490
• Device Name: WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
• Applicant: Welch Allyn, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 18, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

Device Story

Spot Vital Signs Ultra is a clinical-grade, non-handheld vital signs monitor for use by trained clinicians. It inputs physiological signals via blood pressure cuffs, temperature probes (SureTemp Plus or Braun 4000 IR), and pulse oximetry sensors (Nellcor or Masimo). The device processes these inputs using an oscillometric algorithm for blood pressure and standard thermometry/SpO2 sensing modules to produce digital readouts of vital signs. It also supports manual entry of patient metrics (height, weight, respiration, pain) to calculate BMI. The device stores the last 50 readings and supports data communication via wireless (802.11b), USB, or RS232. Clinicians use the output to assess patient status; it is not intended for continuous monitoring, patient transport, or use in MRI environments. The device benefits patients by providing rapid, accurate spot-check measurements in clinical settings.

Clinical Evidence

Bench testing only. Performance verified against AAMI SP10-2002 for blood pressure, ASTM E1112-00 for temperature, and EN12470 for IR temperature. Accuracy specifications for SpO2 and heart rate are consistent with established OEM modules (Nellcor/Masimo). No clinical trial data presented.

Technological Characteristics

Oscillometric BP algorithm; temperature modules (SureTemp Plus, Braun 4000 IR); SpO2 modules (Nellcor MP506, Masimo NCT-11). Connectivity: 802.11b wireless, USB 1.1, RS232. Power: Lead-acid battery. Form factor: 25x15x10 cm, 6.5 lbs. Standards: AAMI SP10-2002 (BP), ASTM E1112-00 (Temp), EN12470 (IR Temp).

Indications for Use

Indicated for adult and pediatric patients for the automatic measurement of systolic/diastolic blood pressure, MAP, pulse rate, temperature (oral, axillary, rectal, ear), and SpO2. Allows manual entry of height, weight, respiration, and pain level; calculates BMI. Contraindicated for neonatal patients (28 days or less if born at term; otherwise up to 44 gestational weeks).

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 Spot Vital Signs (K002530)
• Welch Allyn Spot Vital Signs (K024005)

Submission Summary (Full Text)

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KC4C49C
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#### 510(k) Summary II.

[As described in CFR 807.92]

| Submitted by: | Welch Allyn Inc.<br>4341 State Street Road<br>Skaneateles, New York 13153 |
|----------------------|---------------------------------------------------------------------------|
| Contact Person: | David Klementowski<br>Regulatory Affairs Manager |
| Date Prepared: | 20 February 2004 |
| Proprietary Name: | Welch Allyn Spot Ultra Vital Signs |
| Common Name: | Vital Signs Measurement Device |
| Classification Name: | Class II 870.1130 Noninvasive Blood Pressure<br>System |
| Predicate Device: | Welch Allyn Spot Vital Signs |

AUG 1 8 2004

Welch Allyn, Inc. 510(k) Document Control Number K002530 and K024005

# Description of the Device:

### Indications For Use of the Device:

The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry.

The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

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# Contraindication For Use of the Device:

SPOT VITAL SIGNS ULTRA IS NOT INTENDED TO MEASURE BLOOD PRESSURE ON NEONATAL PATIENTS. Welch Allyn defines neonates as children 28 days or less of age if born at term (37 weeks gestation or more); otherwise up to 44 gestational weeks. This definition comes from the AAMI SP10:2002 standard.

Spot Vital Signs Ultra is designed for medical clinician use. Although this manual may illustrate medical spot check techniques, only a trained clinician who knows how to take and interpret a patient's vital signs should use this system. Spot Vital Signs Ultra is not intended for use in environments that are without health care practitioner supervision.

Spot Vital Signs Ultra is not intended for continuous monitoring and is therefore not defibrillator proof. Do not leave the device unattended while taking measurements on a patient.

Spot Ultra is not intended for use during the transport of a patient. WARNING: This device is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. An explosion may result.

#### Blood Pressure Warnings

To ensure pediatric blood pressure accuracy and safety, the Small Child Durable One-Piece Cuff (5082-203-4) and the Small Child Disposable One-Piece Cuff (5083-93-4) are the smallest cuffs approved for use with young children and infants. The child's arm must fit within the range markings on the cuff.

You may experience inaccurate blood pressure measurements if cuffs and/or hoses other than those provided for Spot Vital Signs Ultra by Welch Allyn are used. To ensure patient safety, use only accessories and supplies (i.e., cuffs, hoses, temperature probes, SpO2 sensors, etc.) recommended for or supplied with Spot Vital Signs Ultra.

Avoid compression of the cuff tubing or pressure hose of Spot Vital Signs Ultra. Compression of the cuff tubing or pressure hose may cause system errors to occur in the device.

Take care to prevent water or other fluid from entering any connectors on the device. Should this occur, dry the connectors with warm air. Check all operating functions.

A qualified service person should check any Spot Vital Signs Ultra that has been dropped or damaged to ensure proper operation prior to use.

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Every three months, inspect the temperature probe, SpO2 cord, and accessories for fraying or other damage. Replace as necessary.

Do not use Spot Vital Signs Ultra on patients who are linked to heart/lung machines.

There are no user-serviceable parts inside the device other than battery replacement.

Spot Vital Signs Ultra does not operate effectively on patients who are experiencing convulsions or tremors.

This device complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices.

As a precaution, avoid using this device in close proximity to other equipment.

This device is not intended for hand-held use during operation.

Welch Allyn recommends that the battery is left in the device, regardless if the device is not used for long periods of time. There is no hazard of leaving the battery in the device.

Using unapproved Welch Allyn accessories with Spot Vital Signs Ultra can affect patient and/or operator safety.

Do not autoclave.

Welch Allyn is NOT responsible for the integrity of any wall-mounting interface. Welch Allyn recommends that the customer contact their Biomedical Engineering Department or maintenance service to ensure professional installation for safety and reliability of any mounting accessory

Patients that are experiencing moderate to severe arrhythmias may give inaccurate blood pressure measurements.

When several blood pressure measurements are taken on the same patient, regularly check the cuff site and extremity for possible ischemia, purpura, and/or neuropathy.

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### SpO2 Warnings

The operation of the SpO2 sensor in MRI environments is specifically not recommended.

Only use Spot Vital Signs Ultra with Nellcor or Masimo pulse oximetry option with Nellcor or Masimo brand sensors and accessories, respectively. Using the wrong or unapproved sensors or cables may cause improper performance.

The SpQ2 sensor and extension cables are intended for use only for pulse oximetry measurements. Do not attempt to connect these cables to a PC or any similar device.

Before using, carefully read the sensor Operator's Manual, including all warnings, cautions, and instructions.

Do not use a damaged sensor or pulse oximetry cable or a sensor with exposed optical components.

Incorrect application or a long duration of use of an SpO2 sensor may cause tissue damage. Inspect the sensor site periodically as directed in the sensors' direction for use.

SpO2 readings and pulse signal is affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions.

Do not immerse or wet the sensor.

Do not use the pulse oximetry cable or power cord to lift the pulse oximeter because the cable or cord may disconnect from the pulse oximeter, causing the pulse oximeter to drop on the patient.

The SpO2 is NOT intended for use as an apnea monitor.

Consider the pulse oximeter an early warning device. As a trend toward patient hypoxemia is indicated, use laboratory instruments to analyze blood samples to completely understand the patient's condition.

Carefully route patient cabling to reduce the possibility of patient enlargement or strangulation.

Severe anemia may cause erroneous SpO2 readings.

Always remove the sensor from the patient and completely disconnect the patient from the pulse oximeter before bathing the patient.

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# Temperature Warnings

SureTemp Plus™

Use single-use, disposable probe covers to limit patient cross-contamination. The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings.

Do not take a patient's temperature without using a disposable probe cover. Doing so can cause patient discomfort, patient cross-contamination, or erroneous temperature readings.

Long-term continuous monitoring beyond three to five minutes is not recommended in any mode.

Biting the probe tip while taking a temperature may result in damage to the probe.

Oral/axillary probes (blue ejection button at top of probe) and blue oral/axillary removable probe wells are used for taking oral and axillary temperatures only. Rectal probes (red ejection button) and red rectal removable probe wells are used for taking rectal temperatures only. Use of the probe at the wrong site will result in temperature errors. Use of the incorrect removable probe well could result in patient cross-contamination.

The thermometer connectors and probe are not waterproof. Do not immerse or drip fluids on these items. Should this occur, dry the device with warm air. Check all functions for proper operation.

Do not take an axillary temperature through patient's clothing. Direct probe cover to skin contact is required.

The SureTemp Plus thermometer consists of high-quality precision parts. Protect it from severe impact and shock. A qualified service technician must check any SureTemp Plus thermometer that is dropped or damaged to ensure proper operation prior to further use. Do not use the thermometer if you notice any signs of damage to the probe. Contact the Welch Allyn Customer Service Department for assistance.

Do not autoclave.

### General Cautions

If the accuracy of any measurement is in question, check the patient's vital sign(s) with an alternate method, then check to make sure the device is functioning properly.

Place the device on a secure surface or use one of the optional mounting accessories.

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Do not place fluids on or near the device.

# Blood Pressure Cautions

Minimize extremity and cuff motion during blood pressure determinations.

If the blood pressure cuff is not at heart level, note the difference in reading due to the hydrostatic effect. Add the value of 1.80 mmHg (.2 kPa) to the displayed reading for every inch (2.5 cm) above heart level. Subtract the value of 1.80 mmHg (.2 kPa) from the displayed reading for every inch (2.5 cm) below heart level.

Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure determination. See "Chart for Determining Cuff Size" on page 23 for cuff sizing information.

# Pulse Oximetry Cautions

The pulse oximeter is calibrated to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin such as carboy hemoglobin or methmoglobin may affect the accuracy of the measurement.

Some intravascular dyes, depending on the concentration, may affect the accuracy of the SpO2 measurement. Some sensors may not be appropriate for a particular patient. If at least 10 seconds of perfusion pulses cannot be observed for a given sensor, change sensor location or sensor type for perfusion to resume.

The sensor disconnect message indicates that the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor, pulse oximetry cable, or both.

NOTE: Physiological conditions, medical procedures, or external agents that may interfere with the pulse oximeter's ability to detect and display measurements include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents such as nail polish, dye, or pigmented cream.

When selecting a sensor, consider the patient's weight and activity level, the adequacy of perfusion, the available sensor sites, the need for sterility, and the anticipated duration of monitoring.

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# Technological Characteristics:

The Welch Allyn Spot Ultra Vital Signs Device utilizes an Oscillometric BP Algorithm and temperature technology, similar to Spot Vital Signs and utilizes the same SpO2 OEM as the Welch Allyn Spot Vital Signs. The new Spot Ultra Vital Signs will incorporate a new temperature module (Braun 4000) and a new SpO2 OEM module the Masimo SET as options. The FDA, under 510(k) numbers K002530 and K024005, approved Spot Vital Signs. The following table summarizes the similarities between the Welch Allyn Spot Vital Signs Device and the new Welch Allyn Spot Ultra Vital Signs Device.

### Table 1

Specifications & Technological Comparison Between the Welch Allyn Spot Vital Signs Device and the Welch Allyn Spot Ultra Vital Signs Device.

| | Welch Allyn Spot Vital Signs<br>Device | Welch Allyn Spot Ultra Vital<br>Signs Device |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Pressure | | |
| BP Determination Method | Oscillometric | Oscillometric |
| Auto Zero | Yes | Yes |
| Initial Cuff Inflation | 160 (Default). Operator may<br>change this default. Options are<br>120, 140, 160, 180, 200, 240<br>and 280. | Intelligent Target inflation,<br>(which can return a BP reading)<br>or 160 mmHg (Default).<br>Operator may change this<br>default. Options are 120, 140,<br>160, 180, 200, 240 and 280. |
| Measurement Range | | |
| Systolic | 60-250 mmHg | 60-250 mmHg |
| Diastolic | 30-160 mmHg | 30-160 mmHg |
| Heart Rate (Using<br>Oscillometric<br>measurement) | 40-200 bpm | 35-199 bpm |
| Measurement Accuracy | | |
| Cuff Pressure | +/- 3 mmHg | +/- 3 mmHg |
| Blood Pressure | AAMI SP10-1992 | AAMI SP10-2002 |
| Heart Rate | +/- 5% (BP Determination) | +/- 5% (BP Determination) |
| | Welch Allyn Spot Vital Signs<br>Device | Welch Allyn Spot Ultra Vital<br>Signs Device |
| BP Time Intervals (Min.) | NA | NA |
| Measurement time (sec.) | 20-45 typical, 165 max. | 15 to 30 typical, 150 max. |
| Mean Arterial Pressure | Calculated | Calculated |
| Nellcor® OEM SpO2 | | |
| SpO2 Measurement | Yes | Yes |
| OEM Model Used | MP506 | MP506 |
| Measurement Range | | |
| SpO2 | 40-100% | 40-100% |
| Heart Rate | 25-245 bpm | 25-245 bpm |
| Measurement Accuracy | | |
| SpO2 | 70-100% +/- 3%<br><70% unspecified | 70-100% +/- 3%<br><70% unspecified |
| Heart Rate | +/- 3 bpm | +/- 3 bpm |
| Massimo OEM SpO2 | | |
| Spo2 Measurement | No | Yes |
| OEM Model Used | NA | NCT-11 |
| Measurement Range | | |
| SpO2 | NA | 40-100% |
| Heart Rate | NA | 25-245 bpm |
| Measurement Accuracy | | |
| SpO2 | NA | 70-100% +/- 3%<br><70% unspecified |
| Heart Rate | NA | +/- 3 bpm |
| SureTemp® OEM | | |
| Temperature | | |
| Temperature | Yes | Yes |
| Measurement Range | 84°F (30°C) to 109.4°F (43.0°C) | 80.0° to 109.4° F (34.5°-43.0°C) |
| Measurement Accuracy | per ASTM E1112-86 (1991) | per ASTM E1112-00 (2000) |
| Temperature<br>Determination | Normal Mode: 4 sec (Oral), 10<br>sec (Axillary), 15 sec (Rectal)<br>Monitor Mode: 3 minutes | Normal Mode: 4 sec (Oral), 10<br>sec (Axillary), 15 sec (Rectal)<br>Monitor Mode: 3 minutes |
| Braun 4000 IR | | |
| Thermometer | | |
| Temperature | No | Yes |
| Measurement Range | NA | 68° to 108° F / 20° to 42.2° C |
| Measurement Accuracy | NA | Per EN12470 |
| Temperature<br>Determination | NA | Ear IR |
| HHP 3800PDF Bar | No | Yes |
| Code Scanner | | |
| | Welch Allyn Spot Vital Signs<br>Device | Welch Allyn Spot Ultra Vital<br>Signs Device |
| Overall System | | |
| Patient Population | Pediatric/Adult | Pediatric/Adult |
| Data Communications | IR wireless Capable<br>Communication | Wireless (802.11b) Capable<br>Communications, USB 1.1<br>Communications and/or RS232<br>Communications |
| Display Type | Custom LCD | Custom LCD |
| Low Battery Indicators | Symbol on LCD begins to flash<br>when low battery voltage is<br>detected | Symbol on LCD begins to flash<br>when low battery voltage is<br>detected |
| Number of readings stored<br>in memory | No readings are stored | Last 50 readings are stored |
| Battery Charge Time | 90% Capacity in 12 hours. Unit<br>will operate and charge the<br>battery simultaneously | 90% Capacity in 12 hours. Unit<br>will operate and charge the<br>battery simultaneously |
| Battery Life | 150 typical readings | 120 typical readings |
| Warranty | Two Years | Two Years |
| Height | 9.70 inches (24.64 cm) | 25 cm |
| Length | 5.72 inches (14.53 cm) | 15 cm |
| Depth | 4.73 inches (12.01 cm) | 10 cm |
| Weight | 4.25 lbs | 6.5 lbs |
| Operating Temperature | 10 to 40 °C (except temperature<br>which is 16 to 40 °C) | 10 to 40 °C |
| Humidity Range | 15 to 90% RH non-condensing | 15 to 90% RH non-condensing |
| Altitude Range | -170 m (557 ft) to +4877 m<br>(16,000 ft) | -170 m (557 ft) to +4877 m<br>(16,000 ft) |
| Storage Temperature | -20 to 50 °C | -25 to 55 °C |
| Battery | Lead Acid, with external<br>recharge capability | Lead Acid, with external<br>recharge capability |

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Image /page/9/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized design of what appears to be an eagle or bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2004

Welch Allyn, Inc. c/o Mr. Christopher Klaczyk Senior Regulatory Engineer 4341 State Street Road P.O. Box. 220 Skaneateles Falls, NY 13153-0220

Re: K040490

Trade Name: Welch Allyn Spot Ultra Vital Signs Device Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 22, 2004 Received: July 23, 2004

Dear Mr. Klaczyk:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your SC-2001 - 10(x) premained is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrossio) to tegains and the Medical Device Amendments, or to commerce provide to May 20, 1976, the enational with the provisions of the Federal Food, Drug, devices that have been recatismed in assessment of a premarket approval application (PMA). alle Cosment Act (Act) that do not requent of the general controls provisions of the Act. The You may, therefore, market the dovres, basyer to the counter for annual registration, listing of general controls provisions of the 110 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 If your device is classified (500 a0070) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional consections, 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. Christopher Klaczyk

Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA s issualles of a substaints of the requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a determination that Journation administered by other Federal agencies. You must light of any Pederal Statutes and regulations animations on of limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: ret comply with an the Act 3 requirements, moreally, which and and and and and and as a least of each as a leater CFR Part 807), labeling (21 CFR Part 800); good management of applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on device as described in your Section 510(k) I his letter will anow you to oegin manceing your antial equivalence of your device to a legally prematket nothication. The PDA inding of backanian requested 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 If you desire specific acrice 101 your ac 1) 594-4646. Also, please note the regulation entitled, Contact the Office of Comphanee w (s ) >> (21CFR Part 807.97) you may obtain. Misolanding by release to premarker no hittens and read on the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil RE Ogden

Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Welch Allyn, Inc. Spot Ultra Vital Signs Pre-Market Notification _____________________________________________________________________________________________________________

#### Indications for Use Statement VII.

| 510(k) Number: | Unknown |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Welch Allyn Spot Ultra Vital Signs Device |
| Indications for use: | The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. |

Prescription Use X
Or
Over-The-Counter Use
(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Kropla

(Division Sign-Off) Division of Cardiovascular Devices

302

Division of Cardiovascular Devices
K14116

**510(k) Number** K040490