← Product Code [MQG](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQG) · K041952

# ZIVF-AIRE (K041952)

_Zander Medical Supplies, Inc. · MQG · Sep 8, 2005 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQG/K041952

## Device Facts

- **Applicant:** Zander Medical Supplies, Inc.
- **Product Code:** [MQG](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQG.md)
- **Decision Date:** Sep 8, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.6120
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

The zIVF-AIRe Photo Catalytic Air Purification System models designed to improve indoor air quality. The manufacturer's models QA-20, SP-20, and SP-20C for residential and general office use were re-engineered for use in IVF laboratories, in Reproductive, Endocrinology, and Andrology laboratories, as well as for general hospital use.

## Device Story

The zIVF-AIRe Photo-Catalytic Air Purification System is an air purification device re-engineered from residential/office models (QA-20, SP-20, SP-20C) for use in clinical environments, specifically IVF, Reproductive, Endocrinology, and Andrology laboratories, and general hospital areas. The device utilizes photo-catalytic technology to improve indoor air quality. It is intended to be operated by laboratory or hospital staff to maintain air purity standards within these specialized clinical settings. The device functions as an environmental control system to mitigate airborne contaminants, thereby supporting the integrity of sensitive reproductive procedures.

## Technological Characteristics

Photo-catalytic air purification system; re-engineered from residential/office models (QA-20, SP-20, SP-20C) for clinical use in IVF and hospital laboratories.

## Regulatory 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem featuring a stylized depiction of an eagle or other bird-like figure, with three wave-like lines extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fred Zander President Zander IVF, Inc. 755-8th Court, Suite 4 P.O. Box 650790 VERO BEACH FL 32965-0790 Re: K041952

SEP - 8 2005

Trade/Device Name: zIVF-AIRe, Model 100C Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulation Class: II Product Code: MQG Dated: June 9, 2005 Received: June 10, 2005

## Dear Mr. Zander:

:

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 (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 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 Section 510(k) I his letter will anow you to ocgin manceing your and equivalence of your device to a legally premarket nothication: "The PDA maing or and this 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 for your as not of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx<br>21 CFR 884.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115<br>(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, prease note the regulation entired, " and on your responsibilities under the Act from the 807.97). Tou may obtain other general meetimes and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Nancy C. Hogdon

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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## RTTHCH NEW I

## Indications for Use

510(k) Number (if known): K041952

Device Name: ZIVF-AIRe Photo-Catalytic Air Purification System

Indications For Use:

The zIVF-AIRe Photo Catalytic Air Purification System models++++============================================================================================================== designed to improve indoor air quality.

The manufacturer's models QA-20, SP-20, and SP-20C for residential and general office use were re-engineered for use in IVF laboratories, in Reproductive, Endocrinology, and Andrology laboratories, as well as for general hospital use.

For Over-The-Counter Use

Prescription Use (Pan 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Nancy Croydon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K041952

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