K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

K013401 · K-Systems, Kivex Biotec , Ltd. · MQG · Dec 14, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013401
• Device Name: K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
• Applicant: K-Systems, Kivex Biotec , Ltd.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Indications for Use

The K-Systems Culture bag system is intended for use during Assisted Reproduction Technology (ART). The K-SYSTEMS Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microinvironment. The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag. When the K-Systems Culture Bags have been filled with the appropriate gas mixture the K-Systems Culture Bags are placed in a conventional incubator for maintaining the temperature. The K-Systems culture bag sytem is a closed system that reduces the risk of cross contamination within the incubator.

Device Story

K-Systems Culture Bag System comprises a benchtop sealer and specialized culture bags. Sealer inflates bags with specific gas mixtures and heat-seals them. Bags are flexible, transparent, and feature low gas permeability (O2/CO2) to maintain stable microenvironments for embryos and gametes. Used in clinical ART laboratories; operated by embryologists or lab technicians. Sealed bags are placed in conventional incubators for temperature control. System functions as a closed environment to minimize cross-contamination risk during incubation. Transparency allows visual evaluation of cells without opening the bag.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Benchtop sealer device; flexible, transparent culture bags with low O2/CO2 permeability. Closed system design. Mechanical inflation and heat-sealing mechanism.

Indications for Use

Indicated for use in Assisted Reproduction Technology (ART) for the storage of culture dishes containing embryos and gametes to provide a stable CO2 and pH microenvironment.

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

## DEC 1 4 2001

Mr. Jacob Møllenbach R & D Manager K-Systems, Kivex Biotec Ltd. Klintehøj Vænge 21 DK-3460 Birkerød DENMARK

Re: K013401

Trade/Device Name: K-Systems Culture Bag Sealer and Culture Bags Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG Dated: October 12, 2001 Received: October 15, 2001

Dear Mr. Møllenbach:

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.

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. 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 (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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdin

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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K013401

## Statement of Indications for Use

The K-Systems Culture bag system is intended for use during Assisted Reproduction Technology (ART).

The K-SYSTEMS Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microinvironment.

The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag.

When the K-Systems Culture Bags have been filled with the appropriate gas mixture the K-Systems Culture Bags are placed in a conventional incubator for maintaining the temperature.

The K-Systems culture bag sytem is a closed system that reduces the risk of cross contamination within the incubator.

David A. Seaman

Prescription Use

Please note new address and phone/fax number K-SYSTEMS KIVEX Blotec Ltd. Klintehøj Vænge 21 X Blotac Birkerad, Denmark Tel: [phone] Fax: [phone]

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