(161 days)
Not Found
No
The description focuses on the electrochemical sensor and basic electronic voltage output, with no mention of AI or ML terms or functionalities.
Yes.
The device is used in the diagnosis of alcohol intoxication, which indicates a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description explicitly mentions hardware components like an electrochemical fuel cell sensor, battery, and DC input, indicating it is a physical device, not software-only.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained are used in the diagnosis of alcohol intoxication. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The device measures alcohol in human breath, which is a specimen derived from the human body.
While the device description focuses on the technical aspects of the breathalyzer, the crucial factor for determining if it's an IVD is its intended use in diagnosis.
N/A
Intended Use / Indications for Use
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Product codes
DJZ
Device Description
The AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The result of bench and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.005% at 0.05%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
NOV 1 8 2009
Skyfine Inc. Limited 5 İÖ(k) Notification
AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579
510(k) Summary
This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.)
Prepared: May 22, 2009
Revised: Sep 9, 2009
Traditional 1.1 Type of Submission:
Skyfine Inc. Limited 1.2 Submitter: Flat A, 10/F., Block A, Tung Chun Industrial Building, 9-11 Address: Cheung Wing Road, Kwai Chung, N.T., HONG KONG (852) 6827-6600 Phone: (852) 2448-8918 Fax: Jason Chiang, President Contact: Establishment Registration Number: 3007776657
1.3 Identification of the Device:
Proprietary/Trade name: AlcoDigital Breathalyzer, Model AT576, AT577, AT578,
AT579 Breath Alcohol Test System Common Name: Devices, Breath Trapping, Alcohol Classification Name: Device Classification: I 862.3050 Regulation Number: Panel: Toxicology Product Code: DJZ
1.4 Identification of the Predicate Device:
Predicate Device Name:
AlcoHAWK PT500 Digital Alcohol Detector
Manufacturer:
Q3 INNOVATIONS LLC
510(k) Number or Clearance Information: K080848
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AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579 Skyfine Inc. Limited 510(k) Notification
1.5 Intended Use and Indications for Use of the subject device.
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
1.6 Device Description
The AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.
1.7 Safety and Effectiveness
The result of bench and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device.
1.8 Substantial Equivalence Determination
2
AlcoDigital Breathalyzer
odel AT576, AT577, AT578, AT578, AT575
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Skyfine Inc. Limited
510(k) Notification
1
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Similarit
| Feature | Shape | AlcoDigital Breathalyzer AT576 | AlcoDigital Breathalyzer AT577 | AlcoDigital Breathalyzer AT578 | AlcoDigital Breathalyzer AT579 |
|---|---|---|---|---|---|
| Construction | Plastic case with internal circuit board | Same | Same | Same | |
| Type of Sensor | Fuel Cell Sensor | Same | Same | Same | |
| Accuracy | $±0.005%$ at 0.05% | Same | Same | Same | |
| Blowing time | 6 seconds | Same | Same | Same | |
| Blowing flow | 10L/min | Same | Same | Same | |
| Warm up Time | 15 seconds | Same | Same | Same | |
| Testing Time | 10 seconds | Same | Same | Same | |
| Repeat test | less than 60 seconds | Same | Same | Same | |
| Audible sound alarm if above 0.05%BAC | Yes | Same | Same | Same | |
| Show "HI" if above the display range | Yes | Same | Same | Same | |
| Anatomical Site | Mouth | Same | Same | Same | |
| Mouthpiece | Replaceable | Same | Same | Same | |
| Power supply | 9V battery or DC 12V | Same | Same | Same | |
| Battery for standard testing | about 500 times | Same | Same | Same | |
| Low battery indication and auto power off function | Yes | Same | Same | Same | |
| Feature | AlcoDigital Breathalyzer AT576 | AlcoDigital Breathalyzer AT577 | AlcoDigital Breathalyzer AT578 | AlcoDigital Breathalyzer AT579 | |
| Shape | Image: AlcoDigital Breathalyzer AT576 | Image: AlcoDigital Breathalyzer AT577 | Image: AlcoDigital Breathalyzer AT578 | Image: AlcoDigital Breathalyzer AT579 | |
| Operation | 10°C~40°C | Same | Same | Same | |
| Store: | -10°C~60°C | Same | Same | Same | |
| Recalibration interval | 12 months | Same | Same | Same | |
| Blowing pressure and interrupt detection | Yes | Same | Same | Same | |
| Size | 115x60x23mm | Same | Same | Same | |
| Display range | 0.000-0.200%BAC | Same | Same | Same |
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Skyfine Inc. Limited
510(k) Notification
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Similarity
| Differences | ||
|---|---|---|
| 4 digits display with status | Image: 4 digits display with date and time | Image: 4 digits display |
| Temperature/Date/Time display | YES | NO |
| Print/Download | YES | NO |
| Memory | 1000 records | 5 records |
| Buttons | 3 buttons: Test, Set Up, Print | 2 buttons: Test, Memory |
| Weight | 110g | 100g |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
NOV 1 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Skyfine Inc. Ltd. c/o Michael Lee Acmebiotechs Co. Ltd. No.45, Minsheng Rd., Danshui Town (Innovation and Incubation Center of Mackey Memorial Hospital) Taipei County, TW 251
Re: K091714
Trade Name: Skyfine Inc. AlcoDigital Breathalyzer Models AT576, AT577, AT578, AT579 Regulation Number: 21 CFR §862.3050 Regulation Name: Breath-Alcohol Test System Regulatory Class: Class I, reserved Product Codes: DJZ Dated: October 30, 2009 Received: November 5, 2009
Dear Mr Lee .:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Skyfine Inc.Limited 510(k) Notification
AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579
510(k) Number (if known): K091714
Device Name: AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579
Indications for Use:
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
OR
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 807 Subpart C)
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091714