XQ-1 INCUBATOR

K133742 · At Medical Uab · MQG · Apr 23, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133742
• Device Name: XQ-1 INCUBATOR
• Applicant: At Medical Uab
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Apr 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AT MEDICAL XQ-1 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature and CO2, O2, and N2 gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/ assisted reproduction technology (ART) treatments.

Device Story

AT Medical XQ-1 is an incubator for IVF/ART procedures. Device provides controlled environment for gamete and embryo development; regulates temperature, CO2, O2, N2, and humidity. Used in clinical laboratory settings by embryologists or trained laboratory personnel. Provides stable culture conditions to support embryo viability. Healthcare providers use the device to maintain optimal physiological conditions for in vitro development; benefits patient by supporting successful fertilization and embryo culture outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Incubator system for IVF/ART; provides controlled temperature, gas (CO2, O2, N2), and humidity. Class II device (21 CFR 884.6120).

Indications for Use

Indicated for use in IVF/ART treatments to provide a controlled environment (temperature, CO2, O2, N2, humidity) for the development of gametes and embryos.

Regulatory Classification

Identification

Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.

Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

April 23, 2014

AT Medical Ltd. Thomas Pedersen CEO Draugystes g. 19 Kaunas 51230 Lithuania

Re: K133742

> Trade/Device Name: AT Medical XO-1 Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: March 21, 2014 Received: March 27, 2014

Dear Thomas Pedersen,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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Page 2 - Thomas Pedersen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Herbert P. Lerner -S

for . . Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K133742

Device Name: · AT Medical XQ-1

The AT MEDICAL XQ-1 Incubator is intended to be used to Indications For Use: provide an environment with controlled temperature at or near body temperature and CO2, O2, and N2 gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/ assisted reproduction technology (ART) treatments.

.. : And/Or Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE _ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert P. Lerner -S 2014.04.23 13:36:29 -04'00'

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