(69 days)
The VEO Multigas Monitor for Pocket PC is intended to provide monitoring of carbon dioxide and oxygen 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 and pediatric patients.
The VEO Multigas Monitor for Pocket PC combines a miniature mainstream infrared gas analysis bench with an ultra-fast response oxygen fuel cell. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the K051857 device, the VEO Multigas Monitor for Pocket PC:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria (e.g., "accuracy must be within ±X%"). Instead, it broadly compares the device's performance to its predicate devices in several key areas. The acceptance criteria are implicitly defined as being "equivalent or superior" to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (VEO Multigas Monitor for Pocket PC) |
|---|---|
| Performance equivalent or superior to predicate devices | Demonstrated performance equivalent or superior to its predicates in all characteristics. |
| Response time equivalent or superior to predicate devices | Demonstrated superior performance in response time. |
| Accuracy equivalent or superior to predicate devices | Demonstrated superior performance in accuracy. |
| Precision equivalent or superior to predicate devices | Demonstrated superior performance in precision. |
| Reliability equivalent or superior to predicate devices | Demonstrated superior performance in reliability. |
| Safety equivalent to predicate devices | Demonstrated safety equivalent to its predicates. |
| Effectiveness equivalent to predicate devices | Demonstrated effectiveness equivalent to its predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Non-clinical testing in direct comparison to predicates throughout the operating range was conducted." It doesn't provide specific numbers of tests or gas samples used.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. It was a "non-clinical" study, implying laboratory testing rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for the non-clinical testing was established using "calibrated gas samples and legally marketed anesthesia and ventilation devices," not human experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the testing involved calibrated gas samples and established devices, there would be no need for expert adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The study was a non-clinical comparison against predicate devices using calibrated gas samples and other medical equipment, not a human-reader study. Therefore, there's no reported effect size regarding human reader improvement with or without AI assistance.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
- Standalone Study Done: Yes. The described "Non-clinical testing in direct comparison to predicates throughout the operating range" is a standalone performance study. The device's performance (response time, accuracy, precision, reliability) was directly measured and compared against established standards (calibrated gas samples) and predicate devices.
7. Type of Ground Truth Used
- Type of Ground Truth: "Calibrated gas samples and legally marketed anesthesia and ventilation devices." This means the ground truth was based on precisely known concentrations of gases and the output from reference medical equipment.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware multigas monitor, not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" would involve calibration and engineering design, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as it's not an AI/ML device that uses a "training set" in the context of data. The device's accuracy and performance are established through calibration and engineering validation using known physical standards.
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510(k) SUMMARY
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510(k) Owner Name and Address: 1. PHASEIN AB Svärdvägen 15 182 33 Danderyd Sweden Telephone: 46-8-544-98-150 Fax: 46-8-544-98-169
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Contact Person: 2. David Weissburg Weissburg Associates Madison, Wisconsin Telephone: 1-608-770-0223
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Date: 6 September 2005 ന്
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Trade Name: VEO Multigas Monitor for Pocket PC 4.
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Common Name: Multigas Monitor 5.
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Classification Names: 6.
- a. Carbon dioxide gas analyzer (21 CFR 868.1400, Product Code CCK)
- Oxygen gas analyzer (21 CFR 868.1720, Product Code CCL) ﺗﻘ
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Substantially equivalent to: 7.
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Device description: The VEO Multigas Monitor for Pocket PC combines a miniature 8. mainstream infrared gas analysis bench with an ultra-fast response oxygen fuel cell. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.
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Intended Use: The VEO Multigas Monitor for Pocket PC is intended to provide monitoring ത inflenced ooor the not oxygen 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 and pediatric patients.
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- Comparison to predicates: The VEO Multigas Monitor for Pocket PC combines the gas monitoring capabilities of two predicate devices into one device. The VEO Multigas Monitor for Pocket PC 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 and its predicates are the same. All the devices consume equivalent amounts of electric power produce disposable single-patient-use airway adapters to interface with gases in the breathing circuit. Labeling and materials used are equivalent, except that the VEO Multigas Monitor for Pocket PC displays numeric and graphic information on an off-theshelf Pocket PC. PHASEIN-approved Pocket PCs have been tested and validated as reliable components of the VEO Multigas Monitor device.
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- Testing vs. predicates: Non-clinical testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
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- Conclusions from testing: The VEO Multigas Monitor for Pocket PC demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics. The VEO Multigas Monitor for Pocket PC demonstrated superior performance in response time, accuracy, precision, and reliability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare. The symbol consists of three curved lines that converge at the top and bottom, with a wavy line at the bottom.
Public Health Service
SEP 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Phasein AB C/O Mr. David Weissburg Weissburg Associates 4213 Winnequah Drive Madison, Wisconsin 53716
Re: K051857
R021857
Trade/Device Name: VEO Multigas Monitor For Pocket PC, Model 400221 Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon dioxide gas analyzer Regulatory Class: II Product Code: CCK, CCL Dated: June 30, 2005 Received: July 8, 2005
Dear Mr. Weissburg:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becaon 310(t) person is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the Chelosure) to regard cate of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food Drya commerce proof to May 20, 1976, the excordance with the provisions of the Federal Food. Drug, devices that have been recalised in access approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, manse the devices, belyer to the .
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 aborb) and existing major regulations affecting your device can Inay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I cases on one one on the Federal Register.
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Page 2 -- Mr. Weissburg
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substitive complies with other requirements of the Act
that FDA has made a determination that your device Force agemains. You mus that FDA has made a determination that your arres over Federal agencies. You must and listing or any Federal statutes and regulations administered of one of existing and listing (21
comply with all the Act's requirements, including, but not asseting securements as set comply with all the Act s requirements, menames caring practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as a CFR Part 807); labeling (21 CFR Part 001); good manager (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 100); 21 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Act); vous Section S product radiation confor provisions (Scetions 95 %) on and on the more of the may of the may of This letter will allow you to begin marketing your avries as walnec of your device to a legally premarket notification. The PDA intallig of substantial equively .
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 If you desire specific advice for your as the sees, please not the regulation entitled, a contact the Office of Compliance at (210) 276 : 1265, Part 807.97). You may obtain "Misbranding by reference to premarket notified.com the Division of Small
other general information on your responsibilities under the Act from worker (800) 638-200 other general information on your responsion.res-ander at its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Assistance of the economic of consisted on the many of the world index. html.
Sincerely yours,
Clive, Ph.D.
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
Enclosure
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Indications for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: VEO Multigas Monitor for Pocket PC Indications for Use:
The VEO Multigas Monitor for Pocket PC is intended to provide monitoring of The VEO Multigas Monitor for Postor of Is interespiratory and respiratory care. It
carbon dioxide and oxygen during anesthesia, recovery and respiration one Carbon dioxide and oxygon daning intensive care unit, patient room and may be used in the operaings for adult and pediatric patients.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cure Julion
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Onetral Dental Devices Division of Anesthoolorships Devices
510(k) Number _
Page __ of ___
§ 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).