NEO-STAT CO2 <KG

K083056 · Mercury Medical · CCK · Feb 23, 2009 · Anesthesiology

Device Facts

• Record ID: K083056
• Device Name: NEO-STAT CO2 <KG
• Applicant: Mercury Medical
• Product Code: CCK · Anesthesiology
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.

Device Story

Neo-StatCO2 <Kg is a colorimetric breath indicator for verifying proper endotracheal tube placement. Device connects between endotracheal tube and breathing circuit (manual resuscitator or ventilator). Exhaled gas passes through chemical indicator, causing rapid color change corresponding to approximate end-tidal CO2 ranges. Used in hospital, sub-acute, pre-hospital, and transport settings by clinicians. Provides visual feedback to confirm airway placement; used alongside standard clinical assessment. Benefits include rapid, real-time verification of intubation in neonates and infants (250g to 6 kg). Operates up to 24 hours in relative humidity up to 100%.

Clinical Evidence

Bench testing only. Performance testing demonstrated the indicator's ability to change color for the intended patient population (250g to 6 kg), tidal volumes, and respiratory rates (up to 100 bpm). No clinical data provided.

Technological Characteristics

Chemical colorimetric indicator for CO2 detection. Patient-contact materials identical to predicate. Internal volume: 1 cc. Weight: 3 g. Resistance to flow: 1.86 cm H2O at 10 Lpm; 15.6 cm H2O at 30 Lpm. Operating range: -10°C to +50°C. Duration: up to 24 hours. Standalone device; no software or electronics.

Indications for Use

Indicated for semi-quantitative visualization of CO2 in patient airway as an adjunct in patient assessment. Intended for neonate and infant patients weighing 250g to 6 kg. Contraindicated for detection of hypercapnia, main-stem bronchial intubation, mouth-to-tube ventilation, or oropharyngeal tube placement.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Mercury Medical - Mini-StatCO₂ - K031411
• Nellcor - Pedi-CAP™ - K944400
• Oridion - MicroCan - K024300

Submission Summary (Full Text)

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L083056
P. 1 of 3

## 510(k) Summary Page 1 of 3 11-Feb-09

# FEB 2 3 2009

| 11300 - 49th St. North<br>Clearwater, FL 33762-4800 | Tel - [phone]<br>Fax - [phone] |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Official Contact: | Jeff Ratner - VP Engineering and Quality Assurance |
| Proprietary or Trade Name: | Neo-StatCO2 |
| Common/Usual Name: | CO₂ detector |
| Classification Name/Code: | CCK - carbon dioxide gas analyzer |
| Device: | Neo-StatCO2 |
| Predicate Devices: | Mercury Medical - Mini-StatCO₂ - K031411<br>Nellcor - Pedi-CAP™ - K944400<br>Oridion - MicroCan - K024300 |

## Device Description:

Mercury Medical, Inc.

Neo-StatCO2 <Kg is a colorimetric breath indicator for visualization of exhaled CO2. It is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. Color change is rapid and the detector has the ability to show color changes with 1 ml tidal volume and up to a respiratory rate of 100 breaths per minute. The detector may be used during patient transport or in locations when intubations are performed. While the indicator functions at relative humidity (RH) of up to 100%, it is not recommended for use below 10% RH. It may be used for up to 24 hours.

Use only ET tubes and connectors and gas source devices, i.e. manual resuscitators and ventilators, which are intended for use with neonates and infants.

#### Indications for Use:

The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.

| Patient Population: | Neonate and infant - 250 g to 6 Kg |
|---------------------|------------------------------------------------------------|
| Environment of Use: | Hospital, sub-acute facilities, pre-hospital and transport |

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! 510(k) Summary Page 2 of 3 11-Feb-09

## Summary of substantial equivalence

| | Predicate<br>Mini-StatCO2TM<br>K031411<br>Or other predicates as indicated | New Model<br>Neo-StatCO2<KgTM |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Indications for Use | The Mini-StaCO2 is indicated to<br>provide a semi-quantitative<br>visualization of the CO2 in the patient<br>airway. It is an adjunct in patient<br>assessment to be used in conjunction<br>with other methods to determine clinical<br>signs and symptoms by or on the order<br>of a physician. | Same as predicate device |
| Environment of use | Hospital, sub-acute facilities, pre-<br>hospital and transport | Same as predicate |
| Patient Population | Neonate and pediatric<br>Oridion MicroCap - K024300 | Neonate and infant (250g to 6 kg) |
| | Indications as listed in 510(k) Summary<br>and Instructions for Use: | |
| | Include “The monitor is intended for use<br>on adult, pediatric, and infant/neonatal<br>patients.” | |
| Physical and Performance Characteristics | | |
| Weight | 5 g | 3 g |
| Internal volume | 3 cc | 1 cc |
| Resistance to flow | 1.23 cm H2O @ 10 Lpm<br>8.8 cm H2O @ 30 Lpm | 1.86 cm H2O @ 10 Lpm<br>15.6 cm H2O @ 30 Lpm |
| Duration of CO2 detection | Up to 24 hours | Up to 24 hours |

.

:

Effectiveness of color change for the intended population

Performance testing to demonstrate ability of indicator to change color for the intended body weight, tidal volume and breath rate under conditions of use

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## 510(k) Summary Page 3 of 3

| | 11-Feb-09 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| | Predicate<br>Mini-StatCO₂ TM<br>K031411<br>Or other predicates as indicated | New Model<br>Neo-StatCO₂ <KgTM |
| Operating Conditions | Operating range -<br>-10°C to +50°C | Operating range -<br>-10°C to +50°C |
| Storage Conditions | Color change function after storage at<br>0°C and 60°C | Color change function after storage at<br>0°C and 60°C |
| Contraindications and Warnings | | |
| Contraindications and<br>Warnings | Do not use for detection of hypercapnia<br>Do not use for the detection of main-<br>stem bronchial intubation<br>Do not use during mouth to tube<br>ventilation<br>Do not use the CO₂ detector to detect<br>oropharyngeal tube placement<br>Standard clinical assessment must be<br>used | Same |

The Neo-StatCO2 <Kg™ is viewed as substantially equivalent to the predicate device because:

#### Indications -

- Identical to predicate Mercury Mini-StatCO2™ K031411 .
#### Patient Population -

- Expanded from predicate Mercury Mini-StatCO2TM K031411 .
- . Similar to - Oridion MicroCap - K024300

#### Technology -

- Chemical indicator technology for detection of the presence of CO2 Mercury Mini-StatCO2™ -. K031411
#### Materials -

- The materials in patient contact are identical to predicate devices ●
#### Environment of Use -

- Identical to predicate Mercury Mini-StatCO2IM K031411 .
#### Differences -

The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mercury Medical C/o Mr. Paul Dryden Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

FEB 2 3 2009

K083056 Re:

> Trade/Device Name: Neo-StatCO2<Kg Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: February 11, 2009 Received: February 12, 2009

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Snette y. Michie Dmd.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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## Indications for Use Statement

Page 1 of 1

510(k) Number: K083056

Device Name: Neo-StatCO2 <Kg

## Indications for Use:

The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.

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)

Zuz M. Z.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083056

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