(90 days)
Not Found
No
The document describes a standard gas analysis monitor and does not mention any AI or ML capabilities.
No
The device is described as a monitor and analyzer for gases and does not mention any therapeutic function; its purpose is to provide information, not deliver treatment.
No
The VEO Multigas Monitor is intended to provide monitoring of various gases and respiratory rate, which is a measurement function, not a diagnostic one. It gathers data but does not interpret it to diagnose a condition.
No
The device description explicitly states it is a "miniature mainstream infrared gas analysis bench" contained within a "transducer," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VEO Multigas Monitor measures gases directly in the breathing circuit of a patient. It analyzes the composition of inhaled and exhaled gases (CO2, N2O, anesthetic agents) and respiratory rate. This is a direct measurement of physiological parameters related to respiration and anesthesia, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states monitoring during anesthesia, recovery, and respiratory care, which involves real-time measurement of gases in the breathing circuit.
Therefore, the VEO Multigas Monitor is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VEO Multigas Monitor for Pocket PC, model 400601 is intended to provide monitoring of CO2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult, pediatric and infant patients.
Product codes (comma separated list FDA assigned to the subject device)
CCK, CBR, CBS, NHQ, CBQ, NHO, NHP
Device Description
The VEO Multigas Monitor for Pocket PC, model 400601 is a miniature mainstream infrared gas analysis bench. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and infant patients.
Intended User / Care Setting
operating suite, intensive care unit, patient room and emergency medicine settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The VEO Multigas Monitor for Pocket PC, model 400601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
SEP - 4 2008
510(k) SUMMARY, K [081601
-
- 510(k) Owner Name and Address: PHASEIN AB Svärdvägen 15 182 33 Danderyd Sweden Telephone: 46-8-544-98-150 Fax: 46-8-544-98-169
-
- Contact Person: David Weissburg Weissburg Associates Madison, Wisconsin, USA Telephone: 1-608-770-0223
-
- Date: June 3, 2008
-
Trade Name: VEO Multigas Monitor for Pocket PC, model 400601 র্ব
-
- Common Name: Multigas Monitor
-
Classification Names: 6.
- a. Carbon-dioxide gas analyzer (21 CFR 868.1400. Product Code CCK)
- Nitrous-oxide gas analyzer (21 CFR 868.1700, Product Code CBR) b.
- Halothane gas analyzer (21 CFR 868.1620, Product Code CBS) C.
- Isoflurane gas analyzer (21 CFR 868.1500, Product Code NHQ) d.
- Enflurane gas analyzer (21 CFR 868.1500, Product Code CBQ) e.
- ﺘﻬ Desflurane gas analyzer (21 CFR 868.1500, Product Code NHO)
- ு. Sevoflurane gas analyzer (21 CFR 868.1500, Product Code NHP)
-
- Substantially equivalent to:
-
- Device description: The VEO Multigas Monitor for Pocket PC, model 400601 is a miniature mainstream infrared gas analysis bench. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.
-
- The VEO Multigas Monitor for Pocket PC, model 400601 is intended to provide monitoring of CO2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult, pediatric and infant patients.
-
- Comparison to predicates: The VEO Multigas Monitor for Pocket PC, model 400601 combines the gas monitoring capabilities of two predicate devices into one device. The VEO Multigas Monitor for Pocket PC, model 400601 uses the same basic technology concepts used in the predicate devices, while adding improvements derived from advanced electronics and miniaturization. The intended uses of the VEO Multigas Monitor for Pocket PC, model 400601 and its predicates are the same. All the devices consume equivalent amounts of electric power and utilize disposable single-patient-use airway adapters to interface with gases in the breathing circuit. Labeling and materials used are equivalent.
-
- Testing vs. predicates: Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
-
- Conclusions from testing: The VEO Multigas Monitor for Pocket PC, model 400601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Phasein AB C/O Mr. David Weissburg Principal Weissburg Associates 4213 Winnequah Drive Madison, Wisconsin 53716
SEP - 4 2008
Re: K081601
Trade/Device Name: VEO Multigas Monitor for Pocket PC, Model 400601 Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: June 3, 2008 Received: June 6, 2008
Dear Mr. Weissburg:
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.
2
Page 2 - Mr. Weissburg
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
TKamueli-Lendimo D. for 11
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number: _____________________
Device Name: VEO Multigas Monitor for Pocket PC, model 400601.
Indications for Use:
The VEO Multigas Monitor for Pocket PC, model 400601 is intended to provide monitoring of CO2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult, pediatric and infant patients.
| Prescription Use _____________________________________________________________________________________________________________________________________________________________
(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 | | |
| IF NEEDED) | | |
| | | |
| | | |
| RH, Office of Device Evaluation (ODE)
(Division Sign-Off) | | |
| Division of Anesthesiology, General Hospital | | |
| Infection Control, Dental Devices | | Page 1 of 1 |
| | | |
510(k) Number:_ Ko8160 |