(14 days)
Not Found
None
No
The summary focuses on remote viewing and review of real-time waveforms and data, with no mention of AI or ML terms, image processing, or descriptions of training/test sets typically associated with AI/ML development.
No
The device is intended for remote viewing and review of patient data, not for direct diagnosis, treatment, or prevention of disease or medical conditions.
No.
The device allows for remote viewing and review of existing data (fetal heart tracings, contraction patterns, numeric data). It does not generate new physiological data or provide a diagnosis itself, but rather facilitates the obstetrician's ability to respond to and review information. Its purpose is to aid in monitoring and consultation, not to perform a diagnostic test.
Unknown
The provided text describes the intended use of the device, which is software-based (viewing data remotely on a Windows-based handheld device). However, the "Device Description" section is "Not Found," which is crucial for definitively determining if the device is solely software or if it includes any hardware components or interfaces that are part of the regulated device. Without a device description, we cannot confirm the absence of hardware.
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.
- AirStrip OB's intended use: The intended use of AirStrip OB is to allow Obstetricians to remotely view and review real-time fetal heart tracings, maternal contraction patterns, patient census lists, and other numeric data from Labor and Delivery. This involves accessing and displaying data that is already being generated by other medical devices (like fetal monitors).
- No sample analysis: The description does not mention any analysis of biological samples from the patient. The device is focused on the display and review of existing physiological data.
Therefore, AirStrip OB functions as a remote viewing and communication tool for existing patient data, not as a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
AirStrip OB® is intended to be used by Obstetricians for the following purposes To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time To review the current Labor and Delivery patient census list Provide a request for remote consultation regarding a fetal heart tracing To remotely review other standard or critical real-time numeric data from Labor and Delivery
Product codes
HGM
Device Description
Not Found
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
Not Found
Intended User / Care Setting
Obstetricians; Labor and Delivery
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2009
Airstrip Technologies, LP c/o Mr Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, N W BUFFALO MN 55313
Re K090061
Trade/Device Name AirStrip OB Remote Data Viewing software Regulation Number 21 CFR §884 2740 Regulation Name Perinatal monitoring system and accessories Regulatory Class II Product Code HGM Dated January 8, 2009 Received January 9, 2009
Dear Mr Job
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 pror 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 mclude 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
1
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 (OS) 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 os 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter
| 21 CFR 876 xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892 xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notrfication" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, 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.suppot/index.html.
Sincerely yours,
Laura M. Norris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
| 510(k) Number | K090061 |
|---|---|
| Device Name | AirStrip OB® Remote Data Viewing software |
| Indications for Use | AirStrip OB® is intended to be used by Obstetricians for the following purposes To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld deviceTo proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that timeTo review the current Labor and Delivery patient census listProvide a request for remote consultation regarding a fetal heart tracingTo remotely review other standard or critical real-time numeric data from Labor and Delivery |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
GE IF
Concurrence of CDRH, Office of Device Evaluation
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number RM DOG
Prescription Use
(Per 21 CFR 801.109)
バブ
Over-The-Counter Use
(Per 21 CFR 801 109)
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OR