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.

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.

AI/ML Overview

This document describes the SAGE Vitrification Kit and SAGE Vitrification Warming Kit, which are used in assisted reproductive technology (ART) for the ultra-rapid freezing and warming of human blastocysts.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary includes a comparison table between the subject device (K170560) and its predicate device (K073522), which also serves to outline the acceptance criteria for various parameters. The "reported device performance" is implicitly stated as meeting these criteria for the subject device.

Parameter	Acceptance Criteria (from K170560 column)	Reported Device Performance (Implicitly stated as meeting criteria in "Stability and Shelf-life" section)
Indication for use	SAGE Vitrification Kit: Ultra-rapid freezing and containment of human blastocysts. Used with Warming Kit. SAGE Vitrification Warming Kit: Recovery of human blastocysts after ultra-rapid freezing and containment using Vitrification Kit.	Met (Same intended use as predicate)
Formulation	Ethylene Glycol, DMSO, Sucrose, Human Serum Albumin, Gentamicin, MOPS-Buffered, Amino Acids, Normal Salts	Met (Same as predicate)
Cryoprotectants in Vitrification Solutions	Equil. Sol. 7.5% DMSO/7.5% Ethylene Glycol Vit. Sol.15% DMSO/15% Ethylene Glycol/0.6M Sucrose	Met (Same as predicate)
Cryoprotectants in Warming Solutions	0-1.0 M Sucrose as identified by solution name (1.0 M Sucrose Sol., 0.5 M Sucrose Sol, MOPS Sol. (no sucrose))	Met (Same as predicate)
MEA (Mouse Embryo Assay)	≥80% blastocysts at 96h	Met (Same as predicate)
Endotoxin	<0.5 EU/ml	Met (Same as predicate)
Osmolality (mOsm/Kg)	Equil. Sol. 2331-2849 Vit. Sol. 5603-6849 1.0 M Sucrose 1255-1535 0.5M Sucrose 745-911 MOPS 257-273	Met (Subject 1.0 M Sucrose Solution specification noted as tighter but within acceptable limits)
pH	7.2-7.4	Met (Same as predicate)
Sterilization	Membrane filtration SAL 10-3 USP<71>	Met (Same as predicate)
Single-Use	Single	Met (Same as predicate)
Shelf-Life	52 Weeks	Met (Real-time shelf-life testing demonstrated this)
Device Packaging	Polypropylene vials, Gamma irradiated, 10-6	Met (New packaging type, validated)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., MEA, endotoxin, osmolality, pH, sterility, stability). It refers to "All devices tested" in the context of stability and "Samples tested" for transportation testing.

The data provenance is not specified regarding country of origin or explicit retrospective/prospective design. However, the tests (MEA, endotoxin, etc.) are standard laboratory tests for reproductive media, usually conducted under controlled laboratory conditions rather than with human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The "ground truth" here relates to the chemical, physical, and biological properties of the media, which are measured against established scientific and regulatory standards (e.g., USP<71> for sterility, MEA for toxicity). Expert consensus in the clinical sense (e.g., radiologists interpreting images) is not relevant for proving the performance of vitrification media.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used for studies involving human interpretation (e.g., medical image reading) where there might be disagreement among experts. This is not applicable to the type of performance testing described for this device, which relies on objective, quantifiable laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This type of study assesses how human readers' diagnostic performance changes with or without AI assistance, which is for devices involving diagnostic or interpretive tasks. The SAGE Vitrification Kit and Warming Kit are chemical media, not a diagnostic AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. A standalone algorithm performance study is not applicable as this is not an algorithm-based device. The "performance" refers to the chemical and biological integrity of the media.

7. The Type of Ground Truth Used

The ground truth used for performance assessment consists of:

Established scientific and regulatory specifications: These are the predefined ranges and limits for parameters like pH, osmolality, endotoxin levels, sterility assurance level (SAL), and acceptable MEA blastocyst development rates (e.g., ≥80% at 96h).
Predicate device characteristics: The predicate device K073522's established specifications also served as a benchmark for comparison and "ground truth" equivalence.

8. The Sample Size for the Training Set

This concept is not applicable. This device is not an AI/ML algorithm that requires training data. The "training set" for physical devices could loosely refer to the initial development and optimization batches, but the document does not provide details on this. The studies mentioned are primarily for validation and verification.

9. How the Ground Truth for the Training Set Was Established

As per point 8, this is not applicable for a chemical media product.

Summary

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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.

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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

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Expiration Date: January 31, 2017

See PRA Statement below.

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510(k) Summary

510(k) Number:	K170560
Submitted on behalf of	Mr. James KellerVice President, Regulatory Affairs and Quality AssuranceCooperSurgical, Inc95 Corporate DriveTrumbull, CT 06611USAe-mail: James.Keller@coopersurgical.comPhone: +1 (203) - 601 - 5200
Contact person	Ms. Tove KjaerCorporate Director Regulatory AffairsOrigio a/sKnardrupvej 2DK-2760 MåløvDenmarke-mail: tkjaer@origio.comphone: +45 46790200
Date prepared	April 3, 2017
Device identification:
Trade name	SAGE Vitrification KitSAGE 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.

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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).

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.

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Parameter	K170560	K073522	Comments
	Subject Device	Predicate Device
Indication for use	SAGE Vitrification Kit:These products areintended for ultra-rapidfreezing and containmentof human blastocysts inassisted reproductivetechnology procedures.This kit is designed to beused in conjunction withthe SAGE VitrificationWarming Kit (ART-8031) foroptimal recovery ofspecimens.	Vitrification Kit: Theseproducts are intended forultra-rapid freezing andcontainment of humanblastocysts for AssistedReproductive Technology(A.R.T.) procedures. This kitis designed for use withSage IVF's VitrificationWarming Kit (Ref # ART-8030) for optimal recoveryof specimens.	Similar: The indicationsfor use for the subjectdevice are similar to thepredicate device;however, they are notidentical. Althoughminor differences intext exist, theunderlying use invitrifying and warminghuman blastocyst stageembryos is the same.Therefore, the subjectand predicate deviceshave the same IntendedUse.
	SAGE Vitrification WarmingKit: These products areintended for the recoveryof human blastocysts thathave undergone ultra-rapidfreezing and containmentusing SAGE Vitrification Kit(ART-8026) for assistedreproductive technologyprocedures.	Vitrification Warming Kit:These products areintended for the recoveryof human blastocysts thathave undergone ultra-rapidfreezing and containmentusing Sage IVF'sVitrification Kit (Ref # ART-8025) for AssistedReproductive Technology(A.R.T.) procedures.
Formulation	Ethylene GlycolDMSOSucroseHuman Serum AlbuminGentamicinMOPS-BufferedAmino AcidsNormal Salts	Ethylene GlycolDMSOSucroseHuman Serum AlbuminGentamicinMOPS-BufferedAmino AcidsNormal Salts	Same
Cryoprotectants inVitrification Solutions	Equil. Sol. 7.5%DMSO/7.5% EthyleneGlycolVit. Sol.15% DMSO/15%Ethylene Glycol/0.6MSucrose	Equil. Sol. 7.5%DMSO/7.5% EthyleneGlycolVit. Sol.15% DMSO/15%Ethylene Glycol/0.6MSucrose	Same
Cryoprotectants inWarming Solutions	0-1.0 M Sucrose asidentified by solution name	0-1.0 M Sucrose asidentified by solution name	Same
	1.0 M Sucrose Sol.0.5 M Sucrose SolMOPS Sol. (no sucrose)	1.0 M Sucrose Sol.0.5 M Sucrose SolMOPS Sol. (no sucrose)
MEA	≥80% blastocysts at 96h	≥80% blastocysts at 96h	Same
Endotoxin	<0.5EU/ml	<0.5EU/ml	Same
Osmolality (mOsm/Kg)	Equil. Sol. 2331-2849Vit. Sol. 5603-68491.0 M Sucrose 1255-15350.5M Sucrose 745-911MOPS 257-273	Equil. Sol. 2331-2849Vit. Sol. 5603-68491.0 M Sucrose 1235-15350.5M Sucrose 745-911MOPS 257-273	Similar —Thespecification for thesubject 1.0 M SucroseSolution is tighter thanthat of the prior cleareddevice. This minordifference does notraise differentquestions of safety oreffectiveness (S&E).
pH	7.2-7.4	7.2-7.4	Same
Sterilization	Membrane filtrationSAL 10-3USP<71>	Membrane filtrationSAL 10-3USP<71>	Same
Single-Use	Single	Single	Same
Shelf-Life	52 Weeks	26 Weeks	Different - The shelf-lifeis longer in the subjectdevice. Differences inshelf-life do not raisedifferent questions ofS&E.
Device Packaging	Polypropylene vialsGamma irradiated, 106	Glass vial with a siliconizedrubber stopper andaluminum seal.Steam sterilized, 10-6	Different - Packaginghas moved from steam-sterilized glass vials togamma irradiatedpolypropylene vials.Differences in vialmaterials/sterilizationmethods do not raisedifferent questions ofS&E.

Comparison of Intended Use and Technological Characteristics

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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.

Regulation Number and Section

§ 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.