(257 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological effects of the solutions used for embryo freezing and thawing. There is no mention of any computational or algorithmic components, let alone AI/ML.
No
This device is for the freezing and thawing of embryos, which directly facilitates the IVF procedure but does not inherently treat a disease or condition itself.
No
The device description and intended use state that FreezeKit™ Cleave and ThawKit™ Cleave are used for the freezing and thawing of embryos in IVF procedures. This is a therapeutic or procedural support function, not a diagnostic one. Diagnostic devices are typically used to identify or characterize a disease, condition, or physiological state.
No
The device description clearly states that the devices are "two separate kits, containing two and three solutions respectively," which are physical components, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "freezing of pronuclear (2PN) and cleavage-stage embryos" and "thawing of frozen pronuclear (2PN) and cleavage-stage embryos." These are procedures performed in vitro (outside the body) on biological samples (embryos).
- Device Description: The device consists of solutions used for these in vitro procedures.
- Clinical Testing: The clinical testing section describes evaluating the "survival and development of frozen and thawed human 2PN embryos and cleavage-stage embryos." This is a direct assessment of the device's performance on biological samples in vitro.
While the device itself is a kit of solutions and not a diagnostic test in the traditional sense (like a blood test for a disease), the regulatory definition of an IVD includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In the context of IVF, the ability to successfully freeze and thaw embryos is crucial for the overall process, which is related to addressing infertility (a "condition").
Therefore, based on the intended use and the nature of the device as described, it falls under the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FreezeKit™ Cleave is intended for freezing of pronuclear (2PN) and cleavage-stage embryos.
ThawKit™ Cleave is intended for thawing of frozen pronuclear (2PN) and cleavage-stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
FreezeKit™ Cleave and ThawKit™ Cleave are devices used for freezing of pronuclear (2PN) and cleavage-stage embryos, and thawing of frozen pronuclear (2PN) and cleavage-stage embryos during in vitro fertilization (IVF) procedures.
The proposed devices are two separate kits, containing two and three solutions respectively. The two kits are marketed separately, yet are recommended to be used together to perform freezing and thawing. All solutions in both kits contain MOPS buffered solution, gentamicin as an antibacterial agent, human serum albumin and hyaluronan. The cryoprotectants 1,2 - propanediol and sucrose are included in the freezing solution, and only sucrose is included as a cryoprotectant in the thawing solutions.
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
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)
A clinical evaluation was performed to assure satisfactory performance of FreezeKit™ Cleave and ThawKit™ Cleave. The testing assessed survival and development of frozen and thawed human 2PN embryos and cleavage-stage embryos after being cryopreserved with the subject devices as compared to the predicates. Results for the subject device demonstrated satisfactory survival and development of treated 2PN embryos.
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.
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
Vitrolife Sweden AB % Brett Sonet Glazar Vitrolife, Inc. Embryologist & MEA Laboratory Manager 3601 South Inca Street Englewood, CO 80110
Re: K150950
Trade/Device Name: Freezekit™ Cleave, Thawkit™ Cleave Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: Class II Product Code: MOL Dated: November 9, 2015 Received: November 10, 2015
Dear Brett Sonet Glazar,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a large, bold font. The text is arranged horizontally, with the name "Herbert P. Lerner" appearing prominently. The "-S" is slightly smaller and set off to the right. The background is plain and does not distract from the text.
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150950
Device Name FreezeKit™ Cleave and ThawKit™ Cleave
Indications for Use (Describe)
FreezeKit™ Cleave is intended for freezing of pronuclear (2PN) and cleavage-stage embryos.
ThawKit™ Cleave is intended for thawing of frozen pronuclear (2PN) and cleavage-stage embryos.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "Vitrolife" in blue font, with a blue curved line to the right of the word. The word "Vitrolife" is written in a serif font, and the curved line is thick and smooth. The image is simple and clean, with a white background.
510(k) Summary
| Submitted by: | Vitrolife Sweden AB
Box 9080
SE-40092 Göteborg
SWEDEN |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brett Sonet Glazar, M.S.
Embryologist & MEA Laboratory Manager
Vitrolife Inc.
3601 South Inca Street
Englewood, Co. 80110
USA
Tel: +1 720 473 5577
Fax: +1 303 781 5615
E-mail: bglazar@vitrolife.com |
| Date Prepared: | November 21, 2014 |
| Trade Name: | FreezeKit™ Cleave and ThawKit™ Cleave |
| Common Name: | Assisted Reproduction Media for
cryopreservation |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Devices: | Cook IVF Cryopreservation Kit and Cook IV
Thawing Kit (K011157) |
Devices Description:
FreezeKit™ Cleave and ThawKit™ Cleave are devices used for freezing of pronuclear (2PN) and cleavage-stage embryos, and thawing of frozen pronuclear (2PN) and cleavage-stage embryos during in vitro fertilization (IVF) procedures.
The proposed devices are two separate kits, containing two and three solutions respectively. The two kits are marketed separately, yet are recommended to be used together to perform freezing and thawing. All solutions in both kits contain MOPS buffered solution, gentamicin as an antibacterial agent, human serum albumin and hyaluronan. The
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Image /page/4/Picture/0 description: The image shows the word "Vitrolife" in blue font. To the right of the word is a blue swoosh design. The word and design are on a white background.
cryoprotectants 1,2 - propanediol and sucrose are included in the freezing solution, and only sucrose is included as a cryoprotectant in the thawing solutions.
Indications for Use:
FreezeKit™ Cleave is intended for freezing of pronuclear (2PN) and cleavage stage embryos.
ThawKit™ Cleave is intended for thawing of frozen pronuclear (2PN) and cleavage-stage embryos.
The subject device indications for use are slightly different from the predicate device, which is indicated more generally for cryopreservation and thawing of zygotes and embryos. However, this difference does not alter the intended use of the subject device from that of the predicate. The intended use of the subject and predicate devices are comparable.
Technological Characteristics Comparison
The formulation of the subject devices are similar to that of the predicates. The compositions of the proposed devices and predicate devices contain antibiotics (gentamicin) and human serum albumin (HSA), as well as the same cryoprotectants (sucrose and 1,2 -propanediol). However, hyaluronan is included only in the proposed devices. In addition, the subject devices have a different buffer base compared to the predicate devices. The addition of hyaluronan in the subject device and the different buffer base do not raise any different types of safety and effectiveness questions.
The subject and predicate devices have similar specifications, including pH, osmolality, endotoxin levels and MEA performance. In addition, both the subject and predicate devices are sterilized by aseptic filtration. The subject device includes one additional specification for the MEA analysis is evaluated for the proposed devices. However, this does not represent a difference in technological characterisicts and does not raise any different types of safety and effectiveness questions.
Non-Clinical Bench Testing
The following parameters were measured and evaluated to assure satisfactory operating performance of FreezeKit™ Cleave and ThawKit™ Cleave:
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- pH at +20°C and ambient atmosphere
- Osmolality in mOsm/kg ●
- . Sterility
- Bacterial Endotoxins (LAL assay) in EU/mL
- Mouse embryo assay (1-cell MEA) [% expanded blastocyst within 96h|
- Mouse embryo assay (1-cell MEA) [blastocyst cell number within 96h]
All bench tests performed met the predefined acceptance criteria.
Clinical Testing
A clinical evaluation was performed to assure satisfactory performance of FreezeKit™ Cleave and ThawKit™ Cleave. The testing assessed survival and development of frozen and thawed human 2PN embryos and cleavage-stage embryos after being cryopreserved with the subject devices as compared to the predicates. Results for the subject device demonstrated satisfactory survival and development of treated 2PN embryos.
Conclusions
The comparison of indications for use / intended purposes, product characteristics, specifications, composition and performance between the predicate devices (Cook IVF Cryopreservation Kit and Cook IVF Thawing Kit) and the proposed devices (FreezeKit™ Cleave and ThawKit™ Cleave) demonstrates that they are substantially equivalent. Although there are differences in the terminology of the indications for use, as well as minor differences in the composition, none of these differences render the subject device not substantially equivalent.
Pre-clinical and clinical evaluation studies demonstrate that the subject device performs comparably to the predicate device and support a determination of substantial equivalence.
Therefore, FreezeKit™ Cleave and ThawKit™ Cleave are as safe and effective as Cook IVF Cryopreservation Kit and Cook IVF Thawing Kit. FreezeKit™ Cleave and ThawKit™ Cleave are substantially equivalent to Cook IVF Cryopreservation Kit and Cook IVF Thawing Kit.