VIT KIT - FREEZE AND THAW
Device Facts
| Record ID | K093273 |
|---|---|
| Device Name | VIT KIT - FREEZE AND THAW |
| Applicant | Irvine Scientific Sales Co., Inc. |
| Product Code | MQL · Obstetrics/Gynecology |
| Decision Date | Mar 3, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6180 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K093273 · Mar 3, 2010 | VIT KIT - FREEZE AND THAW | Irvine Scientific Sales Co., Inc. | Published clinical literature (Kumasako et al., Al-Hasani et al., Kuwayama et al., Oakes et al.) | The sponsor utilized clinical outcomes data from published literature describing routine clinical vitrification procedures to demonstrate the safety and effectiveness of the device by comparing it to predicate devices. | Clinical literature; Routine clinical practice; Pregnancy outcomes; Vitrification |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Literature review of clinical vitrification outcomes; Retrospective analysis of clinical outcomes from published literature | Patients undergoing vitrification of pronuclear (PN) zygotes, day 3 embryos, and blastocysts; Sample Size: Not specified (reported as 30 births and 189 ongoing pregnancies across multiple studies) | Not applicable for this study | Clinical pregnancy and birth rates |
Indications for Use
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 Story
Media kits for cryopreservation of human embryos; includes Vit Kit®-Freeze (ES, VS media) and Vit Kit®-Thaw (TS, DS, WS media). Media based on modified Medium 199; contains HEPES buffer, human serum albumin (HSA), gentamicin, and cryoprotectants (DMSO, ethylene glycol, sucrose). Used in IVF laboratories by embryologists. Sequential exposure to media prepares embryos for vitrification (ultra-rapid cooling) or thawing. Protects embryo viability during storage for future implantation. Does not contact patient directly. Output is cryopreserved or thawed embryo ready for clinical transfer.
Clinical Evidence
Clinical evidence provided via literature review and retrospective data. Reported outcomes include 30 births (singletons, twins, triplets) and 189 ongoing pregnancies following vitrification/thawing of PN zygotes and day 3 embryos. Data sources include studies by Kumasako et al., Al-Hasani et al., Kuwayama et al., and Oakes et al. Bench testing includes endotoxin, sterility (10^-3 SAL), and mouse embryo assay (MEA) for performance validation.
Technological Characteristics
Media composition: Modified Medium 199, HEPES buffered. Components: DMSO, ethylene glycol, sucrose, 20% (v/v) human serum albumin (HSA), 35ug/mL gentamicin. Sequential usage protocol. Sterility assurance level 10^-3. Non-patient contacting. No electronic or software components.
Indications for Use
Indicated for vitrification and subsequent thawing/recovery of human pronuclear (PN) zygotes, day 3 cleavage stage embryos, and blastocyst stage embryos for use in assisted reproductive technology (ART) procedures.
Regulatory Classification
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.).
Special Controls
*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.
Predicate Devices
- RapidVit™ Cleave (K080446)
- RapidWarm™ Warm (K080446)
- Vit Kit® - Freeze (K060168)
- Vit Kit® - Thaw (K060168)
Reference Devices
Submission Summary (Full Text)
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K093273
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MAR - 3 2010
# 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
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| Submitted by: | Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705-5588<br>Telephone: (800) 437-5706<br>Facsimile: (949) 261-6522 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jayme Yamaguchi-Owens<br>Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705-5588<br>Telephone: (800) 437-5706<br>Facsimile: (949) 261-6522<br>Email: ify@irvinesci.com |
| Date Prepared: | 26 February 2010 |
| Trade Name: | Vit Kit® - Freeze<br>Vitrification Freeze Kit for Embryos (PN<br>through Blastocyst Stage) |
| | Vit Kit® - Thaw<br>Vitrification Thaw Kit for Embryos (PN through<br>Blastocyst Stage) |
| Common Name: | Embryo (PN zygotes to day 3 cleavage stage<br>and blastocyst stage embryos) Vitrification<br>cryopreservation media |
| | Embryo (PN zygotes to day 3 cleavage stage<br>and blastocyst stage embryos) Vitrification<br>thawing 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:
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.
#### Intended Use:
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.
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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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K093273
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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.
<sup>1</sup> 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 | Freezing<br>Method | Cryoprotectant | | | | Media Components | | | |
|------------------------------------------|--------------------|-----------------|------|---------|---------------------|------------------|-------|------------|-----------------|
| | | Ethylene Glycol | DMSO | Sucrose | Other | Amino<br>Acids | NEAA³ | Gentamicin | Protein<br>HSA⁴ |
| RapidVit™ Cleave<br>(K080446) | Vitrification | + | - | + | 1,2-<br>propanediol | + | + | + | + |
| Vit Kit® - Freeze<br>(K060168) | Vitrification | +⁵ | +⁵ | +⁶ | | + | + | + | + |
| Vitrification Kit<br>(K073522) | Vitrification | +⁵ | +⁵ | +⁷ | | + | + | + | + |
| Cook IVF<br>Freeze/Thaw Kit<br>(K011157) | Slow Freeze | - | - | + | 1,2 propanediol | + | + | + | + |
| Vit Kit®- Freeze<br>(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 | Amino<br>Acids | NEAA3 | Lactate | Pyruvate | Glucose | Gentamicin | Protein<br>HSA4 |
| RapidVit™ Warm<br>(K080446) | + | + | + | + | + | + | + | + |
| Vit Kit® - Thaw (K060168) | +8 | + | + | + | + | + | + | + |
| Vitrification Warming Kit<br>(K073522) | +9 | + | + | + | + | + | + | + |
| Cook IVF Freeze/Thaw<br>Kit<br>(K011157) | + | + | + | + | + | + | + | + |
| Vit Kit® - Thaw<br>(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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K093273
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# 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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K093273
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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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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:
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.
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
