(171 days)
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No
The summary focuses on remote viewing and access to real-time data, with no mention of AI/ML terms or functionalities like analysis, prediction, or automated interpretation.
No
The device aids in viewing and reviewing medical data remotely, but it does not directly treat or prevent a disease or condition. It is a communication and data display tool for medical professionals.
No
The device is intended for remote viewing and consultation regarding fetal heart tracings and maternal contractions, and for reviewing patient data. It aids in monitoring and communication but does not perform diagnostic analysis or provide a medical diagnosis on its own.
Yes
The intended use describes a software application running on mobile devices (PDA or Smart Phone) for viewing and reviewing medical data (fetal heart tracings, maternal contractions, patient census, numeric data). There is no mention of hardware components being part of the device itself, only the platform it runs on.
Based on the provided information, AirStrip OB® is not an IVD (In Vitro Diagnostic) device.
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® Function: The intended use of AirStrip OB® is to allow Obstetricians to remotely view and review real-time fetal heart tracings, maternal contractions, patient census lists, and other numeric data from Labor and Delivery. It facilitates remote monitoring and consultation based on data already being collected from the patient.
- Lack of Sample Analysis: There is no mention of AirStrip OB® performing any analysis on samples taken from the patient's body. Its function is to display and facilitate the review of data generated by other monitoring equipment.
Therefore, AirStrip OB® falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
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 vital tracings or maternal contraction status by viewing the real time waveforms remotely using a mobile device such as a PDA or Smart Phone.
- 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
85 HGM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Obstetricians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, possibly representing health, hope, and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Wm. Cameron Powell, M.D. President MP4 Solutions, LP 11 Lynn Batts Lane, Suite 100 SAN ANTONIO TX 78218
Re: K042082
Trade/Device Name: AirStrip OB® Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM Dated: November 26, 2004 Received: November 30, 2004
Dear Dr. Powell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776, the enactment date of the Medical Device Amendments, or to conniner or prior to 114) 2011-03-11 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 general controll providing 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rears of as nade 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 (21 CFR Part 801), assems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin harketing your antial equivalence of your device to a legally premarket notification. The PDA midning of Sacsamal Propor
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 tor your corres on on the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation childer, formation on your responsibilities under the Act from the 807.97). Tour may ootain only general international and Consumer Assistance at its toll-free number (800) DIVISION of Sillan Manufacturess Internet address http://www.fda.gov/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
AirStrip OB® is intended to be used by Obstetricians for the following purposes:
- To more rapidly and thoroughly respond to a nurse call . To more rapidly and theat tracings or maternal contraction regarding fotal vious the real time waveforms remotely using a mobile device such as a PDA or Smart Phone
- 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.
NancyC Brogdon
(Division Sign-Off) Division of Reproductive, Abd oming and Radiological Device 510(k) Number.
Prescription Use (Per 21 CFR 801.109)