AIRSTRIP OB

K042082 · Mp4 Solutions, LP · HGM · Jan 21, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K042082
• Device Name: AIRSTRIP OB
• Applicant: Mp4 Solutions, LP
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 waveforms. To view 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.

Device Story

AirStrip OB® is a remote monitoring system for obstetricians; it captures real-time fetal heart rate and maternal contraction waveforms from hospital labor and delivery monitoring systems. Data is transmitted to mobile devices (PDAs or smartphones) allowing physicians to view waveforms, patient census, and numeric data remotely. The system facilitates rapid response to nurse calls and enables proactive patient review when the physician is off-site. It supports remote consultation requests. The device benefits patients by providing continuous physician oversight and faster clinical decision-making during labor and delivery, even when the obstetrician is not physically present in the hospital.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based remote monitoring system; operates on mobile platforms (PDA/Smart Phone); transmits real-time waveforms and numeric data from hospital labor and delivery systems.

Indications for Use

Indicated for obstetricians to remotely monitor fetal heart rate and maternal contraction waveforms, review patient census, and request consultations for patients in labor and delivery settings.

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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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.

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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

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## 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)