(130 days)
Not Found
No
The device description and intended use clearly define the product as a culture media for sperm preparation, with no mention of AI or ML technologies.
No
The device is described as "Sperm Preparation Media," which is a culture media used for preparing sperm for IUI procedures. It is explicitly labeled "For In Vitro Use Only," indicating it does not directly interact with the patient as a therapeutic agent.
No
The device is a culture media used for preparing sperm, which involves washing and separation. It does not perform any diagnostic function.
No
The device description clearly states it is a "culture media" provided in "sterile bottles," indicating a physical, chemical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's used to prepare sperm prior to a medical procedure (IUI). This preparation involves in vitro manipulation (washing and separation) of a biological sample (sperm/semen).
- Device Description: The description states it's a "culture media" and is labeled "For In Vitro Use Only." Culture media are commonly used in in vitro procedures to maintain or manipulate biological samples.
- Predicate Device: The listed predicate device (K861188; Irvine Sperm Capacitation Media) is also a sperm preparation media, which are typically classified as IVDs.
The combination of the intended use involving in vitro manipulation of a biological sample and the explicit "For In Vitro Use Only" labeling strongly indicates that this device falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
Sperm Preparation Media is a mineral essential media with glucose and penicillin. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
-
- 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.
1
- 2-SMDA 510 (K) Summary
11962816
2
-
- 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.