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System, Water, Reproduction, Assisted, And Purification

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.6170
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.6170 Assisted reproduction water and water purification systems

§ 884.6170 Assisted reproduction water and water purification systems.

(a) 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.

(b) 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).

System, Water, Reproduction, Assisted, And Purification

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.6170
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.6170 Assisted reproduction water and water purification systems

§ 884.6170 Assisted reproduction water and water purification systems.

(a) 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.

(b) 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).