WATER FOR TISSUE CULTURE, MODELS 1500

K993140 · Conception Technologies · MTW · Aug 2, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993140
• Device Name: WATER FOR TISSUE CULTURE, MODELS 1500
• Applicant: Conception Technologies
• Product Code: MTW · Obstetrics/Gynecology
• Decision Date: Aug 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6170
• Device Class: Class 2

Intended Use

Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures. It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.

Device Story

Water for Assisted Reproduction Procedures is a sterile, high-purity water product used in clinical laboratory settings for assisted reproductive technology (ART) procedures. It serves as a solvent for reconstituting culture media and as a final rinse for laboratory equipment that comes into direct contact with gametes or embryos. By providing a controlled, non-toxic aqueous environment, it supports the viability of gametes and embryos during aspiration, incubation, transfer, or storage. The device is intended for professional use by embryologists and laboratory technicians in fertility clinics. It ensures that media and labware are free from contaminants that could adversely affect reproductive cells, thereby facilitating successful IVF and related procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-purity water for laboratory use in ART. Sterile, non-pyrogenic, and formulated to be compatible with gamete and embryo culture environments. No electronic, software, or mechanical components.

Indications for Use

Indicated for use in assisted reproduction procedures, including IVF, for the reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos, and as a final rinse for labware or devices contacting gametes or embryos.

Regulatory Classification

Identification

Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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2 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Conception Technologies c/o Greg Holland Regulatory Consultant Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606

Re: K993140

Water for Tissue Culture, Model 1500 Dated: March 27,2000 Received: May 11, 2000 Regulatory Class: II 21CFR 884.6170/Procode: 85 MTW

Dear Mr. Holland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have devices We have reviewed your Section 510(k) hourcelion of market the enclosmed to feet it market bredicate devices
device is substantially equivalent (for the indications for use a device is substantially equivalent (for the natural not be of the Medical Device Andreinendments, or to evices that market in interstate commerce pror to May 26, 1976, the ender someth someth on the may therefore,
have been reclassified in accordance with the provisions of the Peders on th have been reclassified in accordance with the provisions of the Act. The general of the Act includes of the Act include matket the device, subject to the general controls of the Act. "The general control of the nown of the nown of the broading and adulteration.

If your device is classified (see above) into either class III (Fremated Approval). It may be subject to lf your device is classified (see above) into emericas) of class in in the Code of Federal Regulations, Title 21,
such additional controls. Existing major regulations artic such additional controls. Existing major tegulations and be Touth to Current God Manufacting Pradice
Parts 800 to 895. A substantially equivalent determination (AC) for Ce Parts 800 to 895. A substantaliy equivalent delection (GS) for Medical Devices: Cerech negulation (21 CFR Pat 820) and requirements, as set forth in the Quality (QS) in Reducer Colour roganding. Forlue to onnply with that, through periodic OS inspections, the Food and Internet of the rannoncements concerning your device in
the GMP regulation may result in regulator, In addition, EDA not m the GMP regulation may result in regulation in the position indicsion submission on affect any might of you might
the Federal Register. Please note this response of sinceres the Federal Register. Please note inis response to your premation a do work of the order of the order Federal laws or regulations.

This letter will allow you to begin marketing your device as described in the FDA finding of This letter will allow you to begin marketed predicale 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 Pat 801 and additionally for questions on the progri If you desire specific advice for your device of Or I at documly for ender matrially, for ensultion and the promotion and diagnostic devices), please contact the Office of Conplice at (301) 594-459. Also, please note the regulation entiled
advertising of your device, please contact the of Conpl advertising of your device, please contact to Childer (2017). Other general information on our respibilities under the "Misbranding by reference to premaker noticalidation in Arian Manufactor of John Manaton on Jose Cop 1 or [phone]
Act may be obtained from the Division of Small Manufa / to they be obtainouses "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

David S. Gold, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page

510(k) Number (if known):_ K993140

Device Name:Water for Assisted Reproduction Procedures

Indications For Use:

Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures.

It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K993140 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div>✓</div> |
|----------------------|--------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

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