(238 days)
No
The description focuses on the chemical composition and intended use of a culture medium, with no mention of AI/ML or related technologies.
No
The device is described as a medium for culturing embryos and is intended for use in assisted reproduction, not for treating a disease or condition in a patient.
No
Explanation: The device is a culture medium for human embryos (G-TL™), designed to support their growth from fertilization to transfer. Its intended use is for the culture of embryos, not for diagnosing any medical condition.
No
The device description clearly states it is a "bicarbonate-buffered physiological medium" contained within a bottle, indicating it is a physical substance and not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Medium for culture of embryos from fertilization to blastocyst stage". This involves the manipulation and maintenance of biological material (human embryos) in vitro (outside the body) for diagnostic or therapeutic purposes (in this case, assisted reproduction).
- Device Description: The description clearly states it's a "physiological medium" designed for the "culture of human embryos". This is a classic description of a reagent or medium used in in vitro procedures.
- User: It's intended for "professionals within assisted reproduction", which aligns with the typical users of IVD products in a clinical setting.
- Predicate Device: The predicate device listed, "CSC™ Complete", is also a culture medium used in assisted reproduction, further supporting the classification as an IVD.
While the device doesn't involve image processing, AI, or analyze patient samples directly in the traditional sense of a diagnostic test, the definition of an IVD includes reagents and media used in in vitro procedures that provide information about a physiological state or condition. In this case, the ability of the medium to support embryo development is crucial for the success of the assisted reproduction procedure, which is a form of in vitro manipulation with a diagnostic and therapeutic outcome.
N/A
Intended Use / Indications for Use
Medium for culture of embryos from fertilization to blastocyst stage
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professionals within assisted reproduction
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)
The shelf life of G-TL has been validated in stability studies measuring the specifications to 21 weeks.
G-TL™ was compared to CSC™ Complete using the one-cell mouse embryo assay (MEA). There were no differences in embryo development or viability. Therefore, G-TL is considered substantially equivalent to the predicate device CSC™ Complete (K121572).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K033462, K034063, K022244, K021890, K081114, K081117, K080473, K080172
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Name: G-TL™ K133568
K133568
pg 1 of 5
Vitrolife
510(k) Summary
JUL 1 6 2014
Submitted by:
Vitrolife, Inc.
3601 South Inca Street Englewood, CO 80110
USA
Contact Person:
Mark Larman, Ph.D.
Vitrolife, Inc
3601 South Inca Street
Englewood, CO 80110
USA
Phone: (303) 762-1933
(303) 762-7084 Fax:
Email:
Date Prepared:
07/14/2014 ·
Device Identification:
| Trade Name: | G-TL TM |
|---|---|
| Common Name: | IVF Media |
| Classification: | Class II Reproductive Media and Supplements (CRF 844.6180; |
| Product Code MQL) |
Predicate Device:
CSC™ Complete (K121572)
1
Image /page/1/Picture/1 description: The image shows the word "Vitrolife" in a stylized font. Above the word, there is the text "K133568" and "pg. 2 of 5". To the right of the word, there is a black curved line.
Description of the device:
G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.
Indication for Use:
G-TL™ is a medium for culture of embryos from fertilization to blastocyst stage.
Technical Characteristics:
CSC™ Complete and G-TL™ are aseptically filtered, physiological salt solutions containing pharmaceutical grade Gentamicin as an antibacterial agent and therapeutic human serum albumin (HSA). The predicate and new device are bicarbonate-buffered media for human embryo culture and are ready to use after warming to 37 ℃ and equilibration in a CO2 environment. The predicate and new device have the same sterility level (SAL 10 3), endotoxin level ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4 177.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.