(36 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of cryopreservation solutions, with no mention of AI or ML.
No.
The devices are designed for ultra-rapid freezing and warming of human blastocysts in ART procedures, focusing on preservation rather than direct therapy or treatment of a disease.
No
These kits are used for the ultra-rapid freezing, containment, and recovery of human blastocysts, which are procedures for preservation and handling in assisted reproductive technology, not for diagnosing a condition or disease.
No
The device description clearly states that the device is a kit containing solutions in vials, which are physical components, not software.
Based on the provided information, the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is for the ultra-rapid freezing, containment, and recovery of human blastocysts in assisted reproductive technology procedures. This is a process for preserving biological material, not for diagnosing a condition or providing information about a patient's health status.
- Device Description: The devices are solutions containing cryoprotectants and media components. They are used to facilitate the physical process of freezing and thawing blastocysts.
- Lack of Diagnostic Function: There is no mention of these devices being used to analyze a sample to provide diagnostic information. They are tools used in a procedure.
IVD devices are typically used to examine specimens (like blood, urine, tissue) from the human body to provide information for the diagnosis, treatment, or prevention of disease. The SAGE kits do not fit this description.
N/A
Intended Use / Indications for Use
SAGE Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts in assisted reproductive technology procedures. This kit is designed to be used in conjunction with the SAGE Virtification Warming Kit (ART-8031) for optimal recovery of specimens.
SAGE Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using SAGE Vitrification Kit (ART-8026) for assisted reproductive technology procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
SAGE Vitrification Kit:
This kit includes two solutions (Equilibration Solution and Vitrification Solution). Both solutions in the kit consist of a MOPS-buffered media containing non-essential amino acids, gentamicin suffate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:
Equilibration Solution: 7.5% (v/v) each of DMSO and ethylene glycol.
Vitrification Solution: 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose
SAGE Vitrification Warming Kit:
This kit includes three solutions (1.0 M Sucrose Warming Solution, 0.5 M Warming Solution, and MOPS Solution). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0 M, 0.5 M, or no sucrose).
Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in 2 ml polypropylene vials. The solutions in these kits are considered single-use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human blastocysts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The media are used in clinics working with assisted reproductive technology procedures
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)
Real-time shelf-life testing was conducted to demonstrate a 52-week shelf-life for the SAGE Vitrification Kit and SAGE Vitrification Warming Kit.
Stability testing included assessments of pH, osmolality, endotoxin, MEA, and sterility. All devices tested met the acceptance criteria described in the comparison table above.
Transportation testing on the SAGE Vitrification Kit and SAGE Vitrification Warming Kit was conducted in accordance with ASTM D4169-08, Standard Practice for Performance Testing of Shipping Containers and Systems. Samples tested did not show any signs of negative effects from simulated handling/transportation and met vial leakage acceptance specifications.
The results of the performance testing conducted on the subject device demonstrate that it is as safe and effective as the predicate device and supports substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MEA: >=80% blastocysts at 96h
Endotoxin:
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
CooperSurgical, Inc. % Tove Kiær Director Corporate Regulatory Affairs Origio a/s Knardrupvej 2 Måløv, 2760 Denmark
Re: K170560
Trade/Device Name: SAGE Vitrification Kit SAGE Vitrification Warming Kit Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: February 23, 2017 Received: March 6, 2017
Dear Tove Kjær:
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.
1
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 devicerelated 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170560
Device Name SAGE Vitrification Kit
SAGE Vitrification Warming Kit
Indications for Use (Describe)
SAGE Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts in assisted reproductive technology procedures. This kit is designed to be used in conjunction with the SAGE Virtification Warming Kit (ART-8031) for optimal recovery of specimens.
SAGE Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using SAGE Vitrification Kit (ART-8026) for assisted reproductive technology procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Expiration Date: January 31, 2017
See PRA Statement below.
3
510(k) Summary
| 510(k) Number: | K170560 |
|---|---|
| Submitted on behalf of | Mr. James Keller |
| Vice President, Regulatory Affairs and Quality Assurance | |
| CooperSurgical, Inc | |
| 95 Corporate Drive | |
| Trumbull, CT 06611 | |
| USA | |
| e-mail: James.Keller@coopersurgical.com | |
| Phone: +1 (203) - 601 - 5200 | |
| Contact person | Ms. Tove Kjaer |
| Corporate Director Regulatory Affairs | |
| Origio a/s | |
| Knardrupvej 2 | |
| DK-2760 Måløv | |
| Denmark | |
| e-mail: tkjaer@origio.com | |
| phone: +45 46790200 | |
| Date prepared | April 3, 2017 |
| Device identification: | |
| Trade name | SAGE Vitrification Kit |
| SAGE Vitrification Warming Kit | |
| Common name | Vitrification Kit and Vitrification Warming Kit |
| Classification number | 21 CFR 884.6180, Reproductive Media and Supplements |
| Product code | MQL, Media, Reproductive |
| Regulatory class | Class II |
| Predicate device |
SAGE In-Vitro Fertilization, Inc. - Vitrification Kit and Vitrification Warming Kit (K073522)
The predicate devices have not been subject to any design-related recall.
4
Device description:
SAGE Vitrification Kit:
This kit includes two solutions (Equilibration Solution and Vitrification Solution). Both solutions in the kit consist of a MOPS-buffered media containing non-essential amino acids, gentamicin suffate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:
Equilibration Solution: 7.5% (v/v) each of DMSO and ethylene glycol.
Vitrification Solution: 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose
SAGE Vitrification Warming Kit:
This kit includes three solutions (1.0 M Sucrose Warming Solution, 0.5 M Warming Solution, and MOPS Solution). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0 M, 0.5 M, or no sucrose).
Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in 2 ml polypropylene vials. The solutions in these kits are considered single-use devices.
Use environment:
The media are used in clinics working with assisted reproductive technology procedures
Device function:
The SAGE Vitrification Kit is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentration of cryprotectants in the SAGE Vitrification Kit, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.
The SAGE Vitrification Warming Kit is designed to facilitate the re-hydration (warming) of blastocysts after the cells have been vitrified. In the warming process, sucrose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.
Modification of existing devices:
This submission covers two modifications to the currently marketed predicate device cleared under K073522. The first modification was a change in the primary packaging from a Type I borosilicate vial with a siliconized rubber stopper and an aluminum seal to polypropylene copolymer vials. The second modification was an extension of the shelf-life from 26 weeks to 52 weeks.
Indication for Use
SAGE Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts in assisted reproductive technology procedures. This kit is designed to be used in conjunction with the SAGE Vitrification Warming Kit (ART-8031) for optimal recovery of specimens.
5
SAGE Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using SAGE Vitrification Kit (ART-8026) for assisted reproductive technology procedures.
| Parameter | K170560 | K073522 | Comments |
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Indication for use | SAGE Vitrification Kit: | ||
| These products are | |||
| intended for ultra-rapid | |||
| freezing and containment | |||
| of human blastocysts in | |||
| assisted reproductive | |||
| technology procedures. | |||
| This kit is designed to be | |||
| used in conjunction with | |||
| the SAGE Vitrification | |||
| Warming Kit (ART-8031) for | |||
| optimal recovery of | |||
| specimens. | Vitrification Kit: These | ||
| products are intended for | |||
| ultra-rapid freezing and | |||
| containment of human | |||
| blastocysts for Assisted | |||
| Reproductive Technology | |||
| (A.R.T.) procedures. This kit | |||
| is designed for use with | |||
| Sage IVF's Vitrification | |||
| Warming Kit (Ref # ART- |
- for optimal recovery
of specimens. | Similar: The indications
for use for the subject
device are similar to the
predicate device;
however, they are not
identical. Although
minor differences in
text exist, the
underlying use in
vitrifying and warming
human blastocyst stage
embryos is the same.
Therefore, the subject
and predicate devices
have the same Intended
Use. |
| | SAGE Vitrification Warming
Kit: These products are
intended for the recovery
of human blastocysts that
have undergone ultra-rapid
freezing and containment
using SAGE Vitrification Kit
(ART-8026) for assisted
reproductive technology
procedures. | Vitrification Warming Kit:
These products are
intended for the recovery
of human blastocysts that
have undergone ultra-rapid
freezing and containment
using Sage IVF's
Vitrification Kit (Ref # ART- - for Assisted
Reproductive Technology
(A.R.T.) procedures. | |
| Formulation | Ethylene Glycol
DMSO
Sucrose
Human Serum Albumin
Gentamicin
MOPS-Buffered
Amino Acids
Normal Salts | Ethylene Glycol
DMSO
Sucrose
Human Serum Albumin
Gentamicin
MOPS-Buffered
Amino Acids
Normal Salts | Same |
| Cryoprotectants in
Vitrification Solutions | Equil. Sol. 7.5%
DMSO/7.5% Ethylene
Glycol
Vit. Sol.15% DMSO/15%
Ethylene Glycol/0.6M
Sucrose | Equil. Sol. 7.5%
DMSO/7.5% Ethylene
Glycol
Vit. Sol.15% DMSO/15%
Ethylene Glycol/0.6M
Sucrose | Same |
| Cryoprotectants in
Warming Solutions | 0-1.0 M Sucrose as
identified by solution name | 0-1.0 M Sucrose as
identified by solution name | Same |
| | 1.0 M Sucrose Sol.
0.5 M Sucrose Sol
MOPS Sol. (no sucrose) | 1.0 M Sucrose Sol.
0.5 M Sucrose Sol
MOPS Sol. (no sucrose) | |
| MEA | ≥80% blastocysts at 96h | ≥80% blastocysts at 96h | Same |
| Endotoxin | | Membrane filtration
SAL 10-3
USP | Same |
| Single-Use | Single | Single | Same |
| Shelf-Life | 52 Weeks | 26 Weeks | Different - The shelf-life
is longer in the subject
device. Differences in
shelf-life do not raise
different questions of
S&E. |
| Device Packaging | Polypropylene vials
Gamma irradiated, 106 | Glass vial with a siliconized
rubber stopper and
aluminum seal.
Steam sterilized, 10-6 | Different - Packaging
has moved from steam-
sterilized glass vials to
gamma irradiated
polypropylene vials.
Differences in vial
materials/sterilization
methods do not raise
different questions of
S&E. |
Comparison of Intended Use and Technological Characteristics
6
7
As noted in the table above, the devices have the same intended use and are technologically comparable. Differences in technological characteristics noted included a minor difference in the osmolality specification for one media, and differences in shelf-life length and device packaging. As noted in the table, these differences do not raise different questions of safety or effectiveness.
Sterilization
Solutions in these kits are aseptically filtered, and have a Sterility Assurance Level of 10 °. Validation of the media sterilization process was not re-assed in the current submission as the aseptic filtration process is the same as that provided in the predicate submission (K073522).
Stability and Shelf-life:
Real-time shelf-life testing was conducted to demonstrate a 52-week shelf-life for the SAGE Vitrification Kit and SAGE Vitrification Warming Kit.
Stability testing included assessments of pH, osmolality, endotoxin, MEA, and sterility. All devices tested met the acceptance criteria described in the comparison table above.
Transportation testing:
Transportation testing on the SAGE Vitrification Kit and SAGE Vitrification Warming Kit was conducted in accordance with ASTM D4169-08, Standard Practice for Performance Testing of Shipping Containers and Systems. Samples tested did not show any signs of negative effects from simulated handling/transportation and met vial leakage acceptance specifications.
Conclusion:
The results of the performance testing conducted on the subject device demonstrate that it is as safe and effective as the predicate device and supports substantial equivalence.