AIRSTRIP OB

K090061 · Airstrip Technologies, LP · HGM · Jan 23, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090061
• Device Name: AIRSTRIP OB
• Applicant: Airstrip Technologies, LP
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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.

Device Story

AirStrip OB is a remote data viewing software application for Windows-based handheld devices. It interfaces with hospital perinatal monitoring systems to receive real-time fetal heart rate and maternal contraction waveforms and numeric data. The software allows obstetricians to view this data remotely, facilitating rapid response to nurse calls, proactive patient monitoring, and remote consultation requests. It is intended for use by obstetricians to support clinical decision-making when they are off-site. The device does not perform diagnostic analysis but provides a visual representation of data generated by the primary bedside monitoring system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based remote viewing system; operates on Windows-based handheld devices; connects to hospital perinatal monitoring systems for real-time data display; no hardware components.

Indications for Use

Indicated for obstetricians to remotely monitor fetal heart tracings, maternal contraction patterns, and patient census data for patients in labor and delivery when the physician is unable to be physically present.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892 xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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

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## 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 <ul><li>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</li><li>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</li><li>To review the current Labor and Delivery patient census list</li><li>Provide a request for remote consultation regarding a fetal heart tracing</li><li>To remotely review other standard or critical real-time numeric data from Labor and Delivery</li></ul> |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

GE IF

Concurrence of CDRH, Office of Device Evaluation

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Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number RM DOG

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use

(Per 21 CFR 801 109)

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