(199 days)
No
The device description and performance studies focus on the chemical composition and physical properties of the vitrification and thawing solutions, not on any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
No
The device is described as a vitrification and thaw kit for oocytes and embryos, which are used in assisted reproductive technologies like IVF. While these procedures are medical, the device itself acts as a medium for preserving and thawing biological materials, not directly treating a disease or condition in a patient. It facilitates a laboratory process rather than providing therapeutic intervention.
No
This device is a vitrification and thaw kit used for preserving and unfreezing oocytes and embryos, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (solutions in vials) and their chemical composition, indicating it is a physical medical device, not software-only.
Based on the provided information, the CryoX™ Vitrification Freeze Kit and CryoX™ Vitrification Thaw Kit are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that the kits are for the vitrification and thawing of biological materials (oocytes and embryos) in vitro (outside of the living body). This is a key characteristic of IVDs.
- Device Description: The description details the chemical composition of the solutions used to interact with the biological samples in vitro for the purpose of preservation and recovery.
- Performance Studies: The performance studies include tests like Mouse Embryo Assay (MEA), which is a common test for devices used in assisted reproduction technology (ART), a field that heavily relies on in vitro procedures.
- Predicate Device: The predicate device (K190152; Vit Kit- Freeze NX and Vit Kit- Warm NX) is also a vitrification and warming kit for oocytes and embryos, which are typically classified as IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use, device description, and the context of assisted reproduction technology strongly indicate that these kits are designed for in vitro use and would be regulated as IVDs.
N/A
Intended Use / Indications for Use
CryoXTM Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. CryoXTM Vitrification Thaw Kit is intended for use in the thawing of virified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
Product codes
MQL
Device Description
CryoX™ Vitrification Freeze Kit is designed to facilitate dehydration of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos before vitrification via rapid cooling in liquid nitrogen. CryoX™ Vitrification Freeze Kit contains two solutions to be used sequentially during vitrification. Both solutions consist of Medium 199 (M199), human serum albumin (HSA) and gentamicin sulfate. They also contain varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose.
CryoX™ Vitrification Thaw Kit contains three solutions to be used sequentially during oocyte and embryo thawing procedures. All three solutions contain M199, HSA, and gentamicin sulfate. They also contain decreasing concentrations of cryoprotectant.
The five solutions in the CryoX™ Vitrification Freeze Kit and Thaw Kit are aseptically filtered and provided in 4.5 mL PETG vials. The solutions in these kits are single-use only. They have a shelf-life of 6 months when stored at 2-8℃.
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
The following studies have been conducted in support of the substantial equivalence to the predicate device:
- Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 & A1:2013 and ISO 13408-2:2018.
- Shelf-life testing was conducted to support a 6-month shelf-life for the subject device through demonstration that the product specifications (Appearance, pH, Osmolality, Sterility, Bacterial endotoxin, MEA) were met at time 0 and after accelerated aging in accordance with ASTM F1980-16.
- Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP on transportation-conditioned devices.
Key Results: The results of the performance testing described above demonstrate that CryoX™ Vitrification Freeze Kit / Thaw Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics
- Appearance: Clean, transparent, pink; no impurities
- pH per USP : 7.2-7.6
- Osmolality per USP : 855
1042 mOsmol/kg for ES (1:2 dilution); 1916-2477 mOsmol/kg for VS (1:2 dilution); 16532430 mOsmol/kg for TS; 871~1025 mOsmol/kg for DS; 307-318 mOsmol/kg for WS - Sterility per USP : No microbial growth
- Bacterial endotoxin per USP : = 80% embryos developed to expanded blastocyst at 96 hours.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION". The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
May 11, 2023
Zhejiang Horizon Medical Technology Co., Ltd Wu Tang RA Supervisor Rom 219, 2nd floor, Building 9, 1303 Asia-Pacific Road, Dagiao Town. Nanhu District Jiaxing, Zhejiang 314006 China
Re: K223265
Trade/Device Name: CryoX™ Vitrification Freeze Kit / Thaw Kit Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: April 7, 2023 Received: April 7, 2023
Dear Wu Tang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael T. Bailey -S
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223265
Device Name CryoX™ Vitrification Freeze Kit / Thaw Kit
Indications for Use (Describe)
CryoXTM Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
CryoXTM Vitrification Thaw Kit is intended for use in the thawing of virified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst 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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510(k) Summary K223265
I. SUBMITTER
| Applicant: | Zhejiang Horizon Medical Technology Co., Ltd. |
|---|---|
| Address: | Room 219, 2nd floor, Building 9, 1303 Asia-Pacific Road, Daqiao Town, |
| Nanhu District, Jiaxing City, Zhejiang Province, P. R. China. | |
| Phone: | +86-21-38954600-59403 |
| Fax: | +86-21-50801305 |
| Contact Person: | Wu Tang, RA Supervisor |
| Email: | Wu.Tang@microport.com |
Date Prepared: May 8, 2023
II. DEVICE
| Trade Name: | CryoX™ Vitrification Freeze Kit / Thaw Kit |
|---|---|
| Common Name: | Assisted Reproduction Media |
| Regulation Name: | Reproductive Media and Supplements |
| Regulation Number: | 884.6180 |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | II |
III. PREDICATE DEVICE
Vit Kit- Freeze NX and Vit Kit- Warm NX (K190152) from FUJIFILM Irvine Scientific, Inc.
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
CryoX™ Vitrification Freeze Kit is designed to facilitate dehydration of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos before vitrification via rapid cooling in liquid nitrogen. CryoX™ Vitrification Freeze Kit contains two solutions to be used sequentially during vitrification. Both solutions consist of Medium 199 (M199), human serum albumin (HSA) and gentamicin sulfate. They also contain varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose.
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CryoX™ Vitrification Thaw Kt contains three solutions to be used sequentially during oocyte and embryo thawing procedures. All three solutions contain M199, HSA, and gentamicin sulfate. They also contain decreasing concentrations of cryoprotectant.
The five solutions in the CryoX™ Vitrification Freeze Kit and Thaw Kt are aseptically filtered and provided in 4.5 mLPETG vials. The solutions in these kits are single-use only. They have a shelf-life of 6 months when stored at 2-8℃
INDICATIONS for USE V.
CryoX™ Vitrification Freeze Kt is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
CryoX™ Vitrification Thaw Kt is intended for use in the thawing of vitrified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH VL THE PREDICATE DEVICE
A comparison of the intended use and technological features of the subject and predicate devices are described in the table below:
| Comparison Item | K223265
Subject Device | K190152
Predicate Device | Comparison |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | CryoX™ Vitrification
Freeze Kit is intended for
use in the vitrification of
oocytes (MII), pronuclear
(PN) zygotes through day
3 cleavage stage embryos
and blastocyst stage
embryos.
CryoX™ Vitrification Thaw
Kit is intended for use in
the thawing of vitrified
oocytes (MII), pronuclear
(PN) zygotes through day
3 cleavage stage | Vit Kit - Freeze NX
(Vitrification Freeze Kit)
is intended for use in the
vitrification of oocytes
(MII) and pronuclear
(PN) zygotes through
day 3 cleavage stage
embryos and blastocyst
stage embryos.
Vit Kit - Warm NX
(Vitrification Warm Kit) is
intended for use in the
thawing of vitrified
oocytes (MII) and
pronuclear (PN) zygotes | There are differences in
the wording of the
indications for use
statements for the subject
and predicate device;
however, the intended
uses of the subject and
predicate devices are the
same. |
| Comparison Item | K223265
Subject Device | K190152
Predicate Device | Comparison |
| | embryos, and blastocyst
stage embryos. | through day 3 cleavage
stage embryos and
blastocyst stage
embryos. | |
| Conditions for Use | Prescription Use Only | Prescription Use Only | Same |
| Freeze Kit Formulation | M199 (HEPES buffer)
Sucrose (0.5M)
EG (7.5% 15%)
DMSO (7.5% 15%)
HSA
Gentamicin Sulfate | CSCM (HEPES and
MOPS buffer)
Trehalose (0.5M)
EG (7.5% 15%)
DMSO 7.5% 15%
HSA
Gentamicin
Dextran Substitute
Supplement
Sodium Bicarbonate | Different: The
formulations of the subject
and predicate devices are
not the same. Differences
in device formulations do
not raise different
questions of safety and
effectiveness (S&E). |
| Thaw Kit Formulation | M199 (HEPES buffer)
Sucrose (0.5 M, 1M)
HSA
Gentamicin Sulfate | CSCM (HEPES and
MOPS buffer)
Trehalose (0.5M, 1.0M)
HSA
Gentamicin
Dextran Substitute
Supplement
Sodium Bicarbonate | Different: The
formulations of the subject
and predicate devices are
not the same. Differences
in device formulations do
not raise different
questions of S&E. |
| pH | ES: 7.2-7.6
VS: 7.2-7.6
TS: 7.2-7.6
DS: 7.2-7.6
WS: 7.2-7.6 | ES: 7.05 - 7.44
VS: 7.05 - 7.44
TS: 7.05 - 7.45
DS: 7.05 - 7.45
WS: 7.05 - 7.45 | Different: The subject
device has a higher pH
range than the predicate
device. These differences
in pH specifications do not
raise different questions of
S&E. |
| Osmolality
(mOsmol/kg) | ES: 8551042 (1:22477 (1:2
dilution)
VS: 1916
dilution) | ES: 1150 - 1550
VS: 1220 - 1620
TS: 1550 - 1900
DS: 830 - 930 | Different: The subject
device and predicate
devices have differences in
osmolality specifications. |
| Comparison Item | K223265
Subject Device | K190152
Predicate Device | Comparison |
| | TS: 165324301025
DS: 871
WS: 307318 | WS: 265 - 300 | These differences in1042 mOsmoVkg for ES (1:2 dilution); 1916-2477 mOsmoVkg for VS (1:2 dilution); 1653
osmolality specifications
do not raise different
questions of S&E. |
| Bacterial Endotoxin | pH per USP : 7.2-7.6
- > Osmolality per USP : 8552430 mOsmoVkg for TS; 8711025 mOsmoVkg for DS; 307-318 mOsmol/kg for WS
- A Sterility per USP : No microbial growth
- > Bacterial endotoxin per USP : MEA per the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices: 1-Cell MEA: > 80%embryos developed to expanded blastocyst at 96 hours.
- . Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP on transportation-conditioned devices.
CONCLUSION VIII.
The results of the performance testing described above demonstrate that CryoX™ Vitrification Freeze Kit / Thaw Kt is as safe and effective as the predicate device and supports a determination of substantial equivalence.