ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
Device Facts
| Record ID | K093525 |
|---|---|
| Device Name | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE |
| Applicant | Ventlab Corp. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Dec 10, 2009 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The ACE/StatCheck II is intended for use as an adjunct assessment tool for verification of successful ventilation/intubation in patients >2.2 kilograms(51bs.).
Device Story
ACE/StatCheck II CO2 Indicator functions as adjunct assessment tool for verifying successful ventilation or intubation. Device used in clinical settings by healthcare professionals. Input consists of exhaled gas; device utilizes chemical CO2 indicator technology to provide visual feedback regarding presence of carbon dioxide. Output is colorimetric change indicating CO2 levels, assisting clinicians in confirming proper endotracheal tube placement and monitoring ventilation status. Benefits include rapid, non-invasive verification of airway management, reducing risk of unrecognized esophageal intubation.
Clinical Evidence
No clinical data provided; device relies on established chemical indicator technology for CO2 detection.
Technological Characteristics
Colorimetric CO2 indicator; chemical sensing principle; non-electronic; standalone device; intended for airway monitoring.
Indications for Use
Indicated for verification of successful ventilation/intubation in patients >2.2 kg.
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.
Related Devices
- K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 · Mercury Medical · Jul 30, 2003
- K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 · Mercury Medical · Nov 4, 2002
- K112840 — CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR · Seebreath AB · Jul 13, 2012
- K031814 — STATCO2METER, MODEL 10-55372 · Mercury Medical · Aug 14, 2003
- K203762 — Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector · Covidien · Sep 17, 2021
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. James A. Cochie Vice President, Quality Assurance Ventlab Corporation 155 Boyce Drive Mocksville, North Carolina 27028
DEC 1 0 2009
Re: K093525
Trade/Device Name: ACE/StatCheck II CO2 Indicator Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 13, 2009 Received: November 18, 2009
Dear Mr. Cochie:
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 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. Cochie
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ph for
Anthony D. Watson, BS, MS, MBA 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
510(k) Number (if known): JA 093525
Device Name: ACE/StatCheck II CO2 Indicator
Indications for Use:
The ACE/StatCheck II is intended for use as an adjunct assessment tool for verification of successful ventilation/intubation in patients >2.2 kilograms(51bs.).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) ·
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
L. Shelton
(Division Sign-Off) Pivision of Anesthesiology, General Hospital ifection Control, Dental Devices
11093525 510(k) Number:
