Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) is intended for use in the vitrification of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) is intended for use in the thawing and recovery of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Device Description

The five (5) media that comprise the two (2) kits, Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and the Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are all based upon the modified formulation of Medium 199. The Medium 199 is HEPES buffered and contains 20% (v/v) DSS, 35ug/mL gentamicin and varying concentrations of DMSO, EG and sucrose. The two (2) freeze, ES and VS, media in the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) are intended to be used sequentially, for the preparation for, and cryopreservation of, PN, day 3 cleavage stage embryos and blastocyst stage embryos. ES is used in preparation for freezing and contains 7.5 % (v/v) DMSO and EG. VS is to be used during cryostorage and contains 15% (v/v) DMSO and EG and 0.5M sucrose.

The three (3) thaw, TS, DS and WS, media in the Vit Kit®- Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, TS, contains 1.0M sucrose. The second medium, DS, contains 0.5M sucrose. The third medium, WS, contains no sucrose.

AI/ML Overview

The provided document is a 510(k) summary for the Vit Kit® - Freeze and Vit Kit® - Thaw products, which are media used for the vitrification and thawing of human embryos. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and a rigorous study proving the device meets those specific acceptance criteria in the manner of a clinical trial for a diagnostic device.

However, based on the information provided, we can infer the acceptance criteria and the study design used to support the substantial equivalence claim. The primary acceptance criteria appear to be the successful outcome of assisted reproductive procedures (ARP) after using the vitrification and thawing kits, specifically focusing on births and ongoing pregnancies.

Here's an analysis based on the available text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical outcomes presented to demonstrate substantial equivalence to predicate devices. The study results focus on successful pregnancies and live births following the use of vitrified/thawed embryos.

Acceptance Criteria (Implied)	Reported Device Performance (Aggregate from various studies/predicates)
Successful births from vitrified pronuclear stage zygotes	10 healthy births (19 babies = 1 singleton and 9 deliveries = 18 babies) for the specific use of Irvine Scientific's Vit Kit® for pronuclear zygotes, as reported in studies by Kumasako, et. al. and Al-Hasani, et. al. Aggregate: Total of thirty (30) births (10 singletons; 9 deliveries = 2 singletons, 7 twins, 2 triplets; 11 deliveries = number of children from the deliveries not known) for vitrified pronuclear stage zygotes and day 3 embryos.
Ongoing pregnancies from vitrified pronuclear stage zygotes	52 ongoing pregnancies (37 for Kumasako, et. al.; 15 for Al-Hasani, et. al.) from vitrified pronuclear stage zygotes and day 3 embryos.
Ongoing pregnancies from vitrified 2PN embryos (general)	52 ongoing pregnancies (37 pregnancies for Kumasako, et. al.; 15 pregnancies for Al-Hasani, et. al) reported following use of 2PN embryos.
Ongoing pregnancies from vitrified blastocysts (general)	137 ongoing pregnancies (136 pregnancies for Kuwayama, et. al. ; 1 pregnancy for Oakes, et. al. 11).
Births from predicate device (RapidVit™ Cleave and RapidWarm™)	8 births (2 sets of twins and 6 singletons). This is presented to show that the proposed device, based on similar technology, is suitable for its intended use, implying comparable outcomes.

Note: The document presents clinical data in an aggregate form, citing various publications. It asserts that the proposed device is "substantially equivalent" to predicate devices based on this summarized clinical data, rather than presenting a direct comparative study of the new device against a predefined set of acceptance criteria. The underlying assumption is that if the predicate devices demonstrate these outcomes, and the new device is functionally and compositionally similar, it will achieve similar outcomes.

Study Information

The document describes clinical data that was "presented in the Comparison to Predicate Device summary presented on page 68" (which is not included in the provided text). This indicates a review of existing literature and clinical outcomes associated with the predicate devices and potentially similar vitrification technologies. It is not a prospective clinical trial specifically designed to test the new device against stringent acceptance criteria.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not a single "test set" in the traditional sense. The data points mentioned are aggregated from various published clinical studies regarding vitrification techniques and predicate devices.
  - "thirty (30) births" from vitrified pronuclear stage zygotes and day 3 embryos.
  - "fifty-two (52) ongoing pregnancies" from 2PN embryos (37 from one study, 15 from another).
  - "one hundred-thirty seven (137) ongoing pregnancies" from blastocysts (136 from one study, 1 from another).
  - Specifically for the new device's intended use for pronuclear zygotes: "ten (10) healthy births (19 babies = 1 singleton and 9 deliveries = 18 babies)" and "fifty-two (52) ongoing pregnancies."
  - For the predicate device (RapidVit™ Cleave and RapidWarm™ Cleave K080446): "resulted in the births of two (2) sets of twins and six (6) singletons, a total of eight (8) births."
- Data Provenance: Retrospective, as the data is summarized from existing published articles (e.g., Al-Hasani, Kumasako, Kuwayama, Oakes). The countries of origin are not specified for each study but are implied to be international given the nature of scientific publications in this field.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify a number of experts or their qualifications for establishing ground truth for the summarized clinical data. The data is drawn from published scientific literature, where the ground truth (e.g., live birth, ongoing pregnancy) would have been established by the clinical teams conducting those studies (e.g., reproductive endocrinologists, embryologists).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned as this is a summary of existing clinical outcome data, not a prospective study where independent review of specific cases would be performed for the purpose of the 510(k). The "adjudication" would have occurred as part of the internal processes of the original studies cited.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is a medical media kit for embryo vitrification, not an imaging diagnostic device assisted by AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemical media kit, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used is primarily outcomes data, specifically clinical outcomes such as live births and ongoing pregnancies, which are definitive endpoints in fertility treatments.
The sample size for the training set:
- Not applicable in the context of device approval for a chemical media kit. There isn't a "training set" for an algorithm. The development of the media formulation would have involved internal R&D experiments and optimization, but not in the sense of a machine learning "training set".
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an algorithmic device. The formulation of the media would have been based on scientific principles, prior research, and experimental validation in vitro to optimize cryoprotective properties, which are then ultimately validated by clinical outcomes data as presented.

Summary

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K093273
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MAR - 3 2010

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Submitted by:	Irvine Scientific Sales Co., Inc.2511 Daimler StreetSanta Ana, CA 92705-5588Telephone: (800) 437-5706Facsimile: (949) 261-6522
Contact Person:	Jayme Yamaguchi-OwensIrvine Scientific Sales Co., Inc.2511 Daimler StreetSanta Ana, CA 92705-5588Telephone: (800) 437-5706Facsimile: (949) 261-6522Email: ify@irvinesci.com
Date Prepared:	26 February 2010
Trade Name:	Vit Kit® - FreezeVitrification Freeze Kit for Embryos (PNthrough Blastocyst Stage)
	Vit Kit® - ThawVitrification Thaw Kit for Embryos (PN throughBlastocyst Stage)
Common Name:	Embryo (PN zygotes to day 3 cleavage stageand blastocyst stage embryos) Vitrificationcryopreservation media
	Embryo (PN zygotes to day 3 cleavage stageand blastocyst stage embryos) Vitrificationthawing and recovery media
Classification Name:	Reproductive Media (21 CFR § 884.6180)
Predicate Device:	RapidVit™ Cleave (K080446)
	RapidWarm™ Warm (K080446)
	Vit Kit® - Freeze (K060168)
	Vit Kit® - Thaw (K060168)

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Vitrification Kit (K073522) Vitrification Warming Kit (K073522) Cook IVF Freeze/Thaw Kit (K011157)

Description of the Device:

Intended Use:

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Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) is intended for use in the thawing and recovery of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Technological Characteristics:

Embryos are routinely stored for use in future assisted reproductive procedures. In some instances, excess eggs will be retrieved from the patient, and fertilized. If development of these fertilized eggs indicates a potential for viability during implantation, they may be frozen for future use. In the event that the current transfer is unsuccessful, and does not result in a clinical pregnancy, the patient has embryos in reserve that may be used for implantation in future procedures. Embryos are also routinely frozen when patients have a history of unsuccessful implantation procedures, and also for those patients who desire multiple children. Media to protect the embryos during the preparation for cryopreservation, during storage, and ultimate thawing and recovery are, therefore, different in composition from media used for gamete retrieval, during fertilization and implantation.

The media in the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) ES and VS, are designed to be used sequentially for the preparation of vitrified PN zygotes, day 3 cleavage stage embryos and blastocyst stage embryos for cryopreservation, as the protective media during cryostorage.

The media in the Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) TS, DS and WS, are also designed for sequential use, in the thawing and recovery of cryopreserved vitrified PN zygotes, day 3 cleavage stage embryos and blastocyst stage embryos. None of the media are intended to contact the patient.

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The predicate devices, RapidVit™ Cleave and RapidWarm™ Cleave (K080446), RapidVit™ Cleave and RapidWarm™ Cleave (K080446), and the Irvine Scientific Vit™ - Freeze and Vit™ - Thaw (K060168) are all designed for vitrification. The Cook IVF Freeze/Thaw Kits (K011157) was designed as a slow freeze kit.

The predicate devices referenced above are all similar in that they incorporate a basal media (Modified HTF, Medium 199) that contain amino acids, non-essential amino acids that is buffered (HEPES, MOPs), permeating (1.5 M Propainediol, Ethylene Glycol (EG), DMSO), a non-permeating cryoprotectant (Sucrose), protein (human serum albumin), and antibiotic (Gentamicin). The basal media that comprise the predicate devices are not intended for the culture of the specimens that are vitrified or cryopreserved by slow freezing. However, the basal media are all similar in that they contain energy substrates such as lactate, pyruvate and glucose.

The predicate devices each incorporate a stepwise method for exposing specimen(s) to the media to prepare them for slow-freezing or vitrification. Likewise, each of the predicate devices are comprised of a stepwise method for thawing the slow-frozen or vitrified specimen(s).

The type of permeating cryoprotectants that encompass each of the predicate devices have been used for many years for varying types of cryopreservation. The cryoprotectant used is dependent on the method of cryopreservation. Vitrification media are comprised of a combination of permeating cryoprotectants such as ethylene glycol, propanediol and DMSO. Slow freezing media are typically comprised of one cryoprotectant. It has been published in an article by

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Al-Hasani, et. al.1 that cryoprotectant mixtures might have better results than solutions containing one permeable cyroprotectant, Vajta, et. al.2

The predicate devices, RapidVit™ Cleave and RapidWarm™ Cleave (K080446), were cleared in November 2008 with the intended use for vitrification of day 3 cleavage stage embryos and warming of vitrified day 3 cleavage stage embryos respectively. The predicate device for the RapidVit™ Cleave and RapidWarm™ Cleave (K080446) was the Irvine Scientific Vit™ - Freeze and Vit™ - Thaw (K060168) cleared in April 2006 with the intended use in the assisted reproductive procedure of vitrification and thawing blastocysts.

The predicate device, Cook IVF Freeze/Thaw Kits (K011157) were cleared in May 2001 with the intended for use in the cryopreservation, slow freezing, of zygotes or embryos and thawing of cryopreserved zygotes or embryos, respectively, that are intended for use during in vitro fertilization procedures.

The predicate devices, RapidVit™ Cleave and RapidWarm™ Cleave (K080446) and Vit Kit® - Freeze and Vit Kit® - Thaw (K060168), like the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and Vit Kit® -Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are comprised of embryo-physiological solutions that are supplemented with permeable and non-permeable cryoprotectants. Both the predicate devices and the Vit Kit® - Freeze. Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are subjected to the same methods of control and to a significant degree are comprised of the same components. The storage conditions and manner in which the products are used are similar. All the devices have a sterility assurance level of 10-3.

1 Al-Hasani, Safaa, et. al., Three years of routine vitrification of human zygotes: is it still fair to advocate slow-rate freezing?, Reproductive BioMedicine Online, Vol. 14, No. 3, 2007, p. 288-293. 2 Vaita G., Nagy, ZP, Are programmable freezers still needed in the embryo laboratory? Review on vitrification, Reproductive BioMedicine Online, Vol. 12, 2006, 779 - 796.

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apidVit™ Cleave (K080446), Vit Kit® - Freeze (K060168), Vitrification Kit (K073522), the Cook IVF Freeze/Thaw composition of the media and their concentrations, where available, that comprise each of the predicate dev 011157) and the proposed device, Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blast are presented in Table 1 below

Device	FreezingMethod	Cryoprotectant				Media Components
		Ethylene Glycol	DMSO	Sucrose	Other	AminoAcids	NEAA³	Gentamicin	ProteinHSA⁴
RapidVit™ Cleave(K080446)	Vitrification	+	-	+	1,2-propanediol	+	+	+	+
Vit Kit® - Freeze(K060168)	Vitrification	+⁵	+⁵	+⁶		+	+	+	+
Vitrification Kit(K073522)	Vitrification	+⁵	+⁵	+⁷		+	+	+	+
Cook IVFFreeze/Thaw Kit(K011157)	Slow Freeze	-	-	+	1,2 propanediol	+	+	+	+
Vit Kit®- Freeze(K073522)	Vitrification	+⁵	+⁵	+⁶	-	+	+	+	+

able 1: Vitrification Kits Predicate Device Component Compari

NEAA - non-essential amino acid
HSA - human serum albumin

HSA-Human serum albumin

EAA – non-essential amin acids
SA – human seum albumin
Sed at two (2) concentrations, 7.5% (v/y) in the Equilibration Solution and 15% (v/v) in the Vitrification
SM sucrose

V. SUCROSE AND VITAMIN SOLUTION

Do not Success in the Verification Solution.

K093273
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eeze/Thaw Kit (K011157), and the proposed device, Vit Kit® - Thaw, Vitrification Thaw Kit for Embyros (PN through composition of the media and their concentrations, where available, that comprise each of the predicate devi t™ Warm (K080446), Vit Kit® - Thaw (K060168), Vitrification Warming Kit (K073522), the Cook lastocyst Stage) are presented in Table 2 below

Vitrification Warm/Thaw/Warming Kits
Device	Media Components
	Sucrose	AminoAcids	NEAA3	Lactate	Pyruvate	Glucose	Gentamicin	ProteinHSA4
RapidVit™ Warm(K080446)	+	+	+	+	+	+	+	+
Vit Kit® - Thaw (K060168)	+8	+	+	+	+	+	+	+
Vitrification Warming Kit(K073522)	+9	+	+	+	+	+	+	+
Cook IVF Freeze/ThawKit(K011157)	+	+	+	+	+	+	+	+
Vit Kit® - Thaw(K073522)	+8	+	+	+	+	+	+	+

able 2: Vitrification Warm/Thaw/Warming Kits Predicate Device Component Comparis

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Sucrose in the Thawing Solution and 0.5M Sucrose in the Dilution Solution

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pg. 8 of 9

Additional Information:

Endotoxin, mouse embryo freezing and recovery assay performance and sterility tests will be performed as a condition of release for these products. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.

Conclusion:

In the clinical data that was presented in the Comparison to Predicate Device summary presented on page 68 there have been a total of thirty (30) births (10 singletons; 9 deliveries = 2 singletons, 7 twins, 2 triplets; 11 deliveries = number of children from the deliveries not known) for vitrified pronuclear stage zygotes and day 3 embryos. In addition, at the time of publication of the articles there are fifty-two (52) ongoing pregnancies (37 pregnancies for Kumasako, et. al. 12; 15 pregnancies for Al-Hasani, et. al') reported following use of 2PN embryos and one hundred-thirty seven (137) ongoing pregnancies (136 pregnancies for Kuwayama, et. al ; 1 pregnancy for Oakes, et. al. 11).

With regards to the intended use of the Invine Scientific the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and Vit Kit® -Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) for pronuclear zygotes (PN) also presented in the Comparison to Predicate Device Summary presented on page 68 there specifically have been ten (10) healthy births (19 babies = 1 singleton and 9 deliveries = 18 babies) and fifty-two (52) ongoing pregnancies (37 pregnancies for Kumasako, et. al.12; 15 pregnancies for Al-Hasani, et. al1).

Based upon the clinical data that was summarized it has been demonstrated that the Irvine Scientific the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) device are substantially equivalent to the

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predicate device, RapidVit™ Cleave and RapidWarm™ Cleave (K080446) in which the study resulted in the births of two (2) sets of twins and six (6) singletons, a total of eight (8) births and are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

MAR ~ 3 2010

Ms. Jayme Yamaguchi-Owens Regulatory Affairs Manager Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K093273

Trade/Device Name: VitKit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage), VitKit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: February 3, 2010 Received: February 12, 2010

Dear Ms. Yamaguchi-Owens:

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 of medical device-related

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Page 2 -

adverse events) {21 CFR 803}; good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: Kog 3273

Device Name: Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage)

Indications for Use:

Prescription Use × (Part 21 CFR § 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR § 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

J. Remus

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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INDICATIONS FOR USE STATEMENT (page 1 of 1)

Ko9327 3 510(K) Number:

Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN · Device Name: through Blastocyst Stage)

Indications for Use:

Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage Embryos) is intended for use in the thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Prescription Use × (Part 21 CFR § 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR § 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _/

Hald Levin

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.