Rapid-i™ Kit
Device Facts
| Record ID | K181461 |
|---|---|
| Device Name | Rapid-i™ Kit |
| Applicant | Vitrolife Sweden AB |
| Product Code | MQK · Obstetrics/Gynecology |
| Decision Date | Jan 4, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6160 |
| Device Class | Class 2 |
Indications for Use
Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MII).
Device Story
Rapid-i™ Kit is a sterile, single-use cryopreservation storage device for human embryos and oocytes. System components include a PMMA stick with a 0.4 mm hole for sample loading via surface tension, a Mediprene straw with a stainless steel weight for orientation in liquid nitrogen (LN), and a stainless steel rod for pre-cooling. Used in assisted reproduction laboratories by embryologists. Samples are loaded into the stick, inserted into the pre-cooled straw, and sealed using an ultrasonic device. The straw protects samples from direct LN contact. The device facilitates vitrification and subsequent maintenance of embryos/oocytes in LN storage. Clinical benefits include successful cryopreservation and post-warming survival for future transfer, supporting infertility treatment and fertility preservation.
Clinical Evidence
Clinical data from multiple studies demonstrated device efficacy. For 2PN embryos (n=1618), 90.1% survival rate; clinical pregnancy rates 25.1% (1-3 day culture) and 36.3% (4-5 day culture). For oocytes, three studies reported survival rates of 94%, 93.7%, and 90.5%, with clinical pregnancy rates ranging from 40% to 50% post-transfer. Data confirms the device effectively vitrifies and maintains oocytes and embryos.
Technological Characteristics
Materials: Polymethyl methacrylate (PMMA), Mediprene, stainless steel. Components: 80mm stick, 130mm straw, 115mm rod. Principle: Vitrification via surface tension loading in a 30 nL drop, protected by a sealed straw in liquid nitrogen. Sterilization: ISO 11135:2014. Standards: USP <85>, ANSI/AAMI ST72:2002/(R)2010 (endotoxins); ASTM F1929-15, F88/F88M-15, F1886/F1886M-16 (packaging).
Indications for Use
Indicated for cryopreservation of human embryos and oocytes (MII) for patients undergoing infertility treatment or fertility preservation.
Regulatory Classification
Identification
Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, 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
- Rapid-i™ Kit (K140207)
Reference Devices
- Gook et al. (2016) Closed vitrification of human oocytes and blastocysts: outcomes from a series of clinical cases. J Assist Reprod Genet 33:1247-1252
Submission Summary (Full Text)
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January 4, 2019
Vitrolife Sweden AB Nina Arvidsson Regulatory Affairs Manager Gustaf Werners gata 2 SE-421 32 Västra Frölunda Sweden
Re: K181461 Trade/Device Name: Rapid-i™ Kit Regulation Number: 21 CFR& 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: December 4, 2018 Received: December 7, 2018
Dear Nina Arvidsson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Michael T. Bailey -S
for
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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# Indications for Use
510(k) Number (if known) K181461
Device Name Rapid-i™ Kit
Indications for Use (Describe)
Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MI).
Type of Use (Select one or both, as applicable)
| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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Image /page/3/Picture/1 description: The image shows the word "Vitrolife" in blue font. The font is a serif font, and the letters are all capitalized. To the right of the word is a blue swoosh that curves upward. The logo is simple and modern.
# 510(k) Summary - K181461
#### 1. Submitter Information
| Submitter: | Vitrolife Sweden AB<br>Gustaf Werners gata 2<br>SE-421 32 Västra Frölunda<br>Sweden |
|-----------------|-------------------------------------------------------------------------------------|
| Contact Person: | Nina Arvidsson |
| Phone: | +46 31 721 80 00 |
| Fax: | +46 31 721 80 90 |
| Email: | narvidsson@vitrolife.com |
- 2. Date Prepared:
January 3, 2019
#### 3. Device Identification
| Trade Name: | Rapid-i™ Kit |
|----------------------|--------------------------------------|
| Common Name: | Cryopreservation Storage Device |
| Classification Name: | Assisted Reproduction Labware |
| Regulation Number: | 21 CFR 884.6160 |
| Product Code: | MQK (Labware, Assisted Reproduction) |
| Regulatory Class: | II |
## 4. Predicate Device:
Rapid-i™ Kit (K140207) manufactured by Vitrolife Sweden AB. This predicate device has not been subject to any design related recalls.
## 5. Device description:
Rapid-i™ Kit is a modified version of the predicate device (K140207). This device is a cryopreservation storage device intended for embryo/oocyte vitrification. Rapid-i™ Kit is provided sterile and is for single-use only. This device consists of the following items:
- . Rapid-i Stick – A 80 mm long Polymethyl methacrylate (PMMA) stick with a 0.4 mm diameter hole located near the distal tip of the device. The hole on the stick is used to hold one to five embryos or oocytes for vitrification in a 30 nL drop of vitrification medium. Users suspend samples across the hole via surface tension. Therefore, the medium containing the samples only touches the periphery of the hole. The stick has one flat side that aids in correct orientation of the device during oocyte/embryo loading procedures.
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- RapidStraw A 130 mm long Mediprene straw equipped with a stainless steel weight to . maintain device orientation in liquid nitrogen (LN). The straw has a flared open end to allow for insertion of the Rapid-i Stick. This component functions as a protective sleeve around the Rapid-i Stick to prevent direct contact with LN during loading and after sealing the open end with an ultrasonic sealing device.
- . Stainless steel rod - This 115 mm long stainless steel rod resides within RapidStraw during pre-cooling procedures in LN. It aids in keeping RapidStraw straight in LN during pre-cooling. Rod removal occurs 20-30 seconds prior to Rapid-i Stick loading into the RapidStraw.
#### 6. Indications for use:
Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MII).
| Devices | Subject device (K181461) | Predicate device (K140207) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | A cryopreservation device intended to<br>be used to contain, vitrify and maintain<br>human embryos and/or oocytes (MII). | A cryopreservation device designed to contain,<br>vitrify and maintain 4-8 cell and blastocyst stage<br>human embryos. |
| Design | Same as the predicate device | The stick has a tip where the samples are loaded<br>in a 0.4 mm diameter hole. The stick is sealed<br>within in a straw that contains a stainless steel<br>weight to maintain device orientation in LN. |
| Dimension | - Rapid-i stick: 2mm×80mm<br>- RapidStraw: 3.40mm (OD)/2.40mm<br>(ID)×130mm<br>Stainless Steel Rod: 2.2mm × 115mm | - Rapid-i stick: 2mm×80mm<br>- RapidStraw: 3.45mm (OD)/2.45mm (ID)×<br>135mm<br>- Stainless Steel Rod: 2.2mm × 115mm |
| Cooling rate | Same as the predicate device | 1400°C/min (at -50°C) |
| Warming rate | Same as the predicate device | 10000°C/min (at -50°C) |
| Device<br>materials | Same as the predicate device | Polymethyl methacrylate (PMMA)<br>Mediprene<br>Stainless steel |
| Vitrification<br>and warming<br>methods | Same as the predicate device | Precool a straw (with steel rod inserted) with the<br>open end extending above the LN level. A 30 nL<br>drop of vitrification medium holding samples is<br>loaded in a sample hole in the stick. The stick is<br>then inserted into the pre-cooled straw (after<br>steel rod removal) to vitrify samples. The end of<br>the straw is sealed and the device is stored in<br>LN. |
#### 7. Substantial Equivalence Discussion
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The subiect device is indicated to contain. vitrify and maintain human embryos and oocytes (MII). whereas the predicate device is indicated to vitrify and maintain 4-8 cell and blastocyst stage embryos. Inclusion of the oocyte indication and expansion of the embryo indication to also include 2 PN embryos does not represent a new intended use because processing of the embryos or oocytes is applicable to same patient population with same clinical needs – infertility treatment or fertility preservation. Therefore, the subject and predicate devices have the same intended use.
The subject and predicate devices have similar technological characteristics. The only difference between the subject and predicate device is that the subject RapidStraw has a length of 130 mm and 3.40 mm OD/2.40 mm ID whereas the predicate RapidStraw has a length of 135 mm and 3.45 mm OD/2.45 mm ID. This difference is minor and does not raise different questions of safety and effectiveness as compared to the predicate device.
#### 8. Summary of Non-Clinical Performance Data
Non-clinical performance testing was conducted to support substantial equivalence to the predicate device. Rapid-i™ Kit passed all the tests shown below in accordance with internal requirements and/or applicable standards.
- Dimensional Testing per predefined design specifications. .
- . Bacterial Endotoxin Testing - < 1.0 EU/device per USP <85> and ANSI/AAMI ST72:2002/(R)2010
- Mouse Embryo Assay (MEA) - ≥80% of 1-cell embryos developed to blastocysts at 96 hours
- Shelf-life Testing: ●
- Package integrity testing:
- Dye penetration test of sterile packages per ASTM F1929-15 o
- Seal strength of sterile packages per ASTM F88/F88M-15 o
- Visual inspection per ASTM F1886/F1886M-16 o
- Dimensional testing, endotoxin testing and MEA in accordance with the methods and acceptance criteria mentioned above
In addition, information regarding cooling/warming rate testing and sterilization validation per ISO 11135:2014 and ISO 10993-7:2008 provided in K140207 was leveraged to support substantial equivalence.
#### 9. Summary of Clinical Performance Data
Data from clinical studies using the Rapid-i™ Kit were used to demonstrate the ability of the subject device to be used as a cryopreservation device for oocytes and 2 PN embryos.
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- Vitrification of 2PN embryos: .
Of 1618 2 PN embryos vitrified with Rapid-i™ Kit, 1458 (90.1%) survived after warming. Five hundred ten (510) embryo transfers were conducted using the embryos cultured for 1-3 days (418 transfers) or for 4-5 days (92 transfers). The clinical pregnancy rate resulting from the embryos cultured for 1-3 days was 25.1%. The clinical pregnancy rate resulting from the embryos cultured for 4-5 days was 36.3%.
- Vitrification of oocytes: .
- In one study, 94% (555/593) oocytes vitrified with Rapid-i™ Kit survived after warming. The fertilization rate, day 2 cleavage rate, day 5 blastulation rate were 78% (434/555), 95% (414/434) and 24% (102/434), respectively. Of the 54 blastocyst stage embryo transfers, 27 (50%) resulted in a clinical pregnancy.
- In another study, the survival rate and fertilization rate of oocytes vitrified with the Rapidi™ Kit were 93.7% and 58.5%, respectively. Of the 40 embryo transfers performed, 16 (40%) resulted in clinical pregnancy.
- In a published journal article, 90.5% (374/413) occytes vitrified with Rapid-i™ Kit survived after warming. The fertilization rate of survived oocytes was 64.2% (240/374). The cleavage rate on day 2 was 90.4% (217/240). Of the 44 embryo transfers performed, 18 (40.9%) resulted in clinical pregnancy. [Ref: Gook et al. (2016) Closed vitrification of human oocytes and blastocysts: outcomes from a series of clinical cases. J Assist Reprod Genet 33:1247-1252]
#### 10. Conclusions:
The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.
