(130 days)
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.
Sperm Preparation Media is a mineral essential media with glucose and penicillin. This product is provided in sterile bottles. This products as indicated in the label is For In Vitro Use Only.
This document is a Premarket Notification (510(k)) for a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations that would typically be found in a clinical study report or a more detailed device performance section.
Therefore, I cannot extract the requested information from the provided text. The document focuses on the equivalence of the "GenX Sperm Preparation Media" to an existing product based on its ingredients and intended use, rather than presenting a detailed performance study with acceptance criteria.
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Premarket Notification [K962816]
GENX International, Inc. 1) 339 Bartlett Drive Madison, CT 06443 Tel: 203-421-8300 Fax: 203-421-8301
NOV 26 1996
1192
Contact Individual: Michael Cecchi
Date: July 15, 1996
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- DEVICE NAME: Sperm Preparation Media
Proprietary Name: GenX Sperm Preparation Media
- DEVICE NAME: 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 8312M CULTURE MEDIA, GENERAL NUTRIENT BROTH 831SC CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL 8318G CULTURE MEDIA, SUPPLEMENT 8312K
"Cervical cup of all procede prior to MAL procede
- This product is substantially equivalent to the Irvine Sperm Capacitation Media (product 3) code HDR and K861188). This product has the same intended use, the same original formula, and the same basic ingredients.
- Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine 4) 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 products as indicated in the label is For In Vitro Use Only.
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- 2-SMDA 510 (K) Summary
11962816
2
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- 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).
- Sperm Preparation Media has the same characteristics and the same chemical composition 6) 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.
§ 884.5300 Condom.
(a)
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.(b)
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.