(415 days)
The zIVF-AIRe Photo Catalytic Air Purification System models are 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.
zIVF-AIRe Photo-Catalytic Air Purification System
The provided text is a 510(k) clearance letter for the ZIVF-AIRe Photo-Catalytic Air Purification System, Model 100C. This document primarily focuses on the regulatory clearance process and does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that for regulatory purposes, the FDA has determined the device is as safe and effective as a previously cleared device. However, this letter does not provide details on specific performance acceptance criteria or a study to demonstrate its performance.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's technical specifications, performance metrics, and the results of testing conducted to support its claims.
Based on the provided text, I can only state the following:
- Acceptance Criteria and Reported Device Performance: Not available in this document. The letter indicates "substantially equivalent," implying it meets the performance characteristics of predicate devices, but no specific metrics are mentioned.
- Sample Size (Test Set) and Data Provenance: Not available in this document.
- Number and Qualifications of Experts for Ground Truth: Not available in this document.
- Adjudication Method: Not available in this document.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not available in this document. This typically applies to diagnostic or interpretative devices, not air purification systems.
- Standalone Performance Study: Not available in this document.
- Type of Ground Truth Used: Not available in this document.
- Sample Size for Training Set: Not available in this document.
- How Ground Truth for Training Set was Established: Not available in this document.
The document indicates the device is an "Air Purification System" designed to "improve indoor air quality" in settings like IVF laboratories. Performance studies for such devices typically involve measuring the reduction of specific airborne contaminants (e.g., volatile organic compounds, particulates) under controlled conditions, with acceptance criteria defined by industry standards or established benchmarks for air quality in sensitive environments. However, these specific details are not present in this 510(k) clearance letter.
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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.xxxx21 CFR 884.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115(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
Page 1 of 1
§ 884.6120 Assisted reproduction accessories.
(a)
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.
(b)
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.