← Product Code [MOL](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MOL) · K962816 # SPERM PREPARATION MEDIA (K962816) _Genx Intl., Inc. · MOL · Nov 26, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MOL/K962816 ## Device Facts - **Applicant:** Genx Intl., Inc. - **Product Code:** [MOL](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MOL.md) - **Decision Date:** Nov 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5300 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen. This product as indicated in the label is For In Vitro Use Only. ## Device Story Sperm Preparation Media; culture medium for sperm processing; used prior to Intrauterine Insemination (IUI). Functions by washing sperm and separating it from semen. Ingredients include sterile water, minerals, glucose, and penicillin. Provided in sterile bottles. Used in clinical laboratory settings by trained personnel. Output is processed sperm sample ready for clinical insemination. Benefits include standardized preparation of sperm for fertility procedures. ## Clinical Evidence No clinical data provided; substantial equivalence based on chemical composition and intended use comparison to predicate. ## Technological Characteristics Mineral essential media; ingredients: sterile water, minerals, glucose, penicillin. Provided in sterile bottles. No software or electronic components. ## Regulatory Identification A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility. ## Special Controls *Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document. ## Predicate Devices - Irvine Sperm Capacitation Media ([K861188](/device/K861188.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SMDA 510 (K) Summary -1- Prenarket Notification [K962816] K962816 1192 1) GENX International, Inc. 339 Bartlett Drive Madison, CT 06443 Tel: 203-421-8300 Fax: 203-421-8301 Contact Individual: Michael Cecchi Date: July 15, 1996 2) DEVICE NAME: Sperm Preparation Media Proprietary Name: GenX Sperm Preparation Media Common or Usual name: Culture Media Classification Name: Sperm Preparation Media According to the Classification Names for In Vitro Diagnostic Products (FDA 95-4246) we believe that this media belongs in one of the following classes: CULTURE MEDIA, NON PROPAGATING TRANSPORT 83JSM CULTURE MEDIA, GENERAL NUTRIENT BROTH 83JSC CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL 83JSG CULTURE MEDIA, SUPPLEMENT 83JSK > ~~"Cervical Cup" old procede prior to HQLprocede~~ 3) This product is substantially equivalent to the Irvine Sperm Capacitation Media (product code HDR and K861188). This product has the same intended use, the same original formula, and the same basic ingredients. 4) Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen. The basic ingredients of this products as described in the Formulation section of the submission are sterile water, minerals, glucose, and penicillin. This product is provided in sterile bottles. This product as indicated in the label is For In Vitro Use Only. {1} K962F16 ρ2012 SMDA 510 (K) Summary - 2- Premarket Notification [K962816] 5) The intended use of this media is for *in vitro* use only, the same as the Irvine Sperm Capacitation Media (product code HDR and K861188). 6) Sperm Preparation Media has the same characteristics and the same chemical composition as the predicate device Irvine Sperm Capacitation Media (product code HDR and K861188). Sperm Preparation Media is a mineral essential media with glucose and penicillin, which are the same basic ingredients as the Irvine Sperm Capacitation Media. --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MOL/K962816](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MOL/K962816) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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