K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L

K991229 · Henning Knudsen Engineering A/S · MQG · Jun 29, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991229
• Device Name: K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
• Applicant: Henning Knudsen Engineering A/S
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Jun 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

The K-SYSTEMS Work Station is intended for maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with steribenair.

Device Story

K-SYSTEMS Work Station provides controlled environment for gametes/embryos; maintains temperature near body levels; regulates humidity and pH; utilizes steribenair flushing. Used in clinical laboratory settings by embryologists/technicians. Device ensures stable conditions for sensitive biological samples during handling; supports viability of gametes/embryos during IVF procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Workstation platform; temperature control system; humidification system; pH maintenance system; steribenair flushing mechanism.

Indications for Use

Indicated for maintaining temperature, humidity, and pH environment for gametes and/or embryos during clinical procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1999

Mr. Jacob Møllenbach Sales Manager Henning Knudsen Engineering Ltd. A/S Klintehøj Vænge 1 DK-3460 Birkerød DENMARK

Re: K991229 Henning Knudsen Engineering Ltd. A/S K-SYSTEMS Work Station Dated: April 7, 1999 Received: April 12, 1999 Regulatory Class: Il 21 CFR §884.6120/Procode: 85 MQG

Dear Mr. Møllenbach:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiiance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

[signature]

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: K-SYSTEMS Work Station_(K991229)

Indications For Use:

The K-SYSTEMS Work Station is intended for maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with steribenair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-88)

Once-The-Counter

Prescription

David G. Styzma
(Division Sign-Off)

Division of Reproductive, Abdominal, E and Radiological De 510(k) Number