MINI-LOGGER SERIES 2000

K991045 · Mini-Mitter Co., Inc. · GWK · Sep 21, 1999 · Neurology

Device Facts

• Record ID: K991045
• Device Name: MINI-LOGGER SERIES 2000
• Applicant: Mini-Mitter Co., Inc.
• Product Code: GWK · Neurology
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1845
• Device Class: Class 2

Indications for Use

The Mini-Logger® is an ambulatory logging device that enables out-patient data collection for clinical and research applications. The Mini-Logger® is a compact, lightweight, physiological data logger for monitoring heart rate or inter-beatinterval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, obesity/weight loss studies, behavioral and addiction studies. The device can be used for any assement of human heart rate or inter-beat-interval, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger may be used in any instance where quantifiable analysis of physiological data is desirable.

Device Story

Mini-Logger Series 2000 is a compact, battery-powered ambulatory physiological data logger; worn in shirt pocket or on belt. Inputs: thermistor probes (temperature), chest band ECG electrodes (heart rate/IBI), motion-sensitive switches (gross motor activity), and photoconductive sensors (ambient light). Device logs digital data and resistances representing signal amplitudes; stores data in internal memory (128KB or 1MB). Used in clinical/research settings for behavioral, sleep, and circadian studies. Data downloaded to IBM-compatible PC for analysis. Provides longitudinal physiological monitoring; enables quantifiable analysis of human physiological parameters over time.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-state data logger; 65x120x22 mm; 125g. Powered by two 3.6V lithium cells. Inputs: thermistor, ECG electrodes, motion switch, photoconductor. Memory: 128KB or 1MB. Connectivity: direct-wired probes; PC download via cable. Operating temperature: 0-40°C. Not water resistant.

Indications for Use

Indicated for monitoring heart rate, inter-beat-interval (IBI), temperature, ambient light, and activity in humans. Used for behavioral, circadian rhythm, sleep, occupational health, sports medicine, and obesity/weight loss research or clinical assessments requiring longitudinal data logging and analysis.

Regulatory Classification

Identification

A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

Predicate Devices

• Vitalog HMS-5000 (K914085)

Submission Summary (Full Text)

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510(k) Premarket Notification Mini-Logger® June 22, 1999

K991045

#### 10.0 510(K) SUMMARY

### 10.1 Summary Information

#### Submitter's Name and Address 10.1.1

Jack E. McKenzie, Ph.D. Mini-Mitter Co., Inc. P.O. Box 3386 56885 Enterprise Dr. Sunriver, Oregon 97707

June 22, 1999 Date summary was prepared:

#### 10.1.2 Name of Device

Mini-Logger® Series 2000 Trade Name: Physiological Data Logging Device Common Name: Classification Name: Physiological signal conditioner (Product Code GYE)

#### Identification of predicate device 10.1.3

Vitalog HMS-5000 510(k) Number : K914085

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### 10.1.4 Device Description

### 10.1.4.1 Functions of the device

The Mini-Logger® Series 2000 is a compact physiological data logger whose physical size and appearance are similar to a small TV remote control. The Mini-Logger® is powered from two replaceable, non-rechargeable lithium cells. The Mini-Logger® is generally worn in the shirt pocket or on a belt using its optional soft pouch. Direct-wired probes used to sense the physiological data are plugged into one or more of the four available data input channels.

### 10.1.4.2 Basic scientific concepts

The device acquires and logs digital data and resistances whose values represent the amplitudes of physiological signals. The physiological signals are temperature, heart inter-beat-interval (IBI), counts representing gross motor activity, and resistance representing ambient light intensity. The scientific concepts and technologies that are used to sense the signals are summarized in Table 10.

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## TABLE 10. BASIC TECHNOLOGIES USED FOR PHYSIOLOGICAL SIGNAL RECORDING IN MINI-LOGGER®SENSOR PROBES.

| Physiological Parameter | Sensor Used | Sensor Technology | Signal Obtained |
|----------------------------------------|-------------------------|-----------------------------------------------------------------------------|--------------------------------------------------|
| Skin, ear canal, rectal<br>temperature | Thermistor probe | Thermistor resistance<br>varies uniquely with<br>temperature. | Resistance. |
| Heart rate | Polar chest band | Low-impedance ECG skin<br>electrode and high-<br>impedance signal amplifier | Digital pulse for each heart<br>beat. |
| Heart IBI | Polar chest band | Low-impedance ECG skin<br>electrode and high-<br>impedance signal amplifier | Digital pulse for each heart<br>beat. |
| Gross motor activity | Motion-sensitive switch | Hermetically-sealed and<br>encapsulated switch | Switch closures which<br>provide digital pulses. |
| Ambient light | Photoconductive sensor | Photoconductor whose<br>resistance varies with<br>changing light levels. | Resistance. |

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### 10.1.4.3 Physical characteristics

Pertinent physical characteristics of the Mini-Logger® data logger are shown in Table 11.

| Parameter | Value |
|-------------------------|------------------------------------------|
| Size | 65x120x22 mm |
| Weight | 125 grams |
| Battery type | 3.6 volt lithium cells (2 each) |
| Moisture susceptibility | Not water resistant |
| Memory | 128 Kilobyte or<br>1 Megabyte |
| Storage Temperature | -10 C to 50 C at 0-95% relative humidity |
| Operating Temperature | 0 C to 40 C |

TABLE 11. PHYSICAL CHARACTERISTICS OF MINI-LOGGER®.

### Statement of the intended use of the device. 10.1.5

The Mini-Logger® is an ambulatory logging device that enables out-patient data collection for clinical and research applications. The Mini-Logger® is a compact, lightweight, physiological data logger for monitoring heart rate or inter-beatinterval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, obesity/weight loss studies, behavioral and addiction studies. The device can be used for any assement of human heart rate or inter-beat-interval, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger may be used in any instance where quantifiable analysis of physiological data is desirable.

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### How the technological characteristics of the device compare to 10.1.6 those of the predicate device:

The Mini-Logger® and theVITALOG HMS-5000 Pocket Polygraph (FDA 510(k) Number: K914085) are both diagnostic test systems based upon the concept of a portable, unattended physiological monitor that logs sensor-input physiological data to the logging device. The device communicates the data with an IBM-compatible computer. These devices are both solid-state monitors with user-definable data collection algorithms, numbers of channels, types of channels, and with the ability to store data until it is down-loaded into the PC. The Mini-Logger® and theVITALOG HMS-5000 Pocket Polygraph are of similar size and weight. Both devices have an internal clock and event marker to time-stamp and mark data for later interpretation. . The Mini-Logger® has five specific types of data that can be input: temperature, gross motor activity, heart rate, heart inter-beat-interval (IBI) and ambient light. The VITALOG HMS-5000 Pocket Polygraph has the potential for twenty-three sensor inputs to include temperature, gross motor activity, heart rate, and ambient light.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 1999

Jack E. McKenzie, Ph.D. Vice President of Market Development Mini Mitter Co., Inc. P.O. Box 3386 Sunriver, Oregon 97707

K991045 Re: Trade Name: Mini-Logger® Series 2000 Regulatory Class: II Product Code: GWK Dated: June 22, 1999 Received: June 24, 1999

Dear Dr. McKenzie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Jack E. McKenzie, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

Salim McWitt, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Mini Mitter Co, Inc.

510(k) Premarket Notification Mini-Logger® June 22, 1999

### INDICATIONS FOR USE 2.0

510(k) Number (if known):

K991045

Mini-Logger® Series 2000

# Device Name:

Indications for Use:

The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, interbeat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assement of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

baséat

eral Restorative De