Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and biological outcomes of a cryopreservation device, with no mention of AI or ML.

Therapeutic

No

The device is designed for the cryopreservation and maintenance of human embryos, which is a method of preserving viability, not directly treating a disease or condition in a patient.

Diagnostic

No

The device is a cryopreservation device designed to contain, vitrify, and maintain human embryos. It is used for storage and preservation, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components (PMMA stick, Mediprene straw, stainless steel weight, stainless steel rod) and the performance studies focus on physical and biological characteristics (embryo development, endotoxin levels, sterilization, cooling/warming rates, dimensions, shelf-life), indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Rapid-i™ Kit is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos." This describes a device used for the physical preservation of biological material, not for performing a diagnostic test on a sample taken from the human body.
Device Description: The components (PMMA stick, Mediprene straw, stainless steel rod) are consistent with a cryopreservation device, not an IVD.
Lack of Diagnostic Elements: There is no mention of analyzing a sample, detecting a substance, or providing information for diagnosis, monitoring, or treatment decisions based on an in vitro test.
Performance Studies: The performance studies focus on the device's ability to successfully vitrify and maintain embryo viability (mouse embryo assay, clinical blastocyst survival rate), sterility, and endotoxin levels. These are relevant to the function of a cryopreservation device, not an IVD.

IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health status. The Rapid-i™ Kit is used to preserve embryos, which are not considered a specimen for diagnostic testing in this context.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.

Product codes (comma separated list FDA assigned to the subject device)

MOK

Device Description

Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos, consists of the following three items:
• 80 mm PMMA stick (Rapid-iTM)
• 135 mm Mediprene straw equipped with a stainless steel weight, (RapidStraw)
• 115 mm stainless steel rod inserted in the RapidStraw

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Effects of sealing before and after vitrification- the purpose of the study was to evaluate different non-liquid nitrogen (LN2) contact vitrification methods of previously frozen day 1 embryos. The methods were: (a) post-seal Rapid-iTM (i.e., the predicate device); (b) pre-seal Rapid-i™; and (c) the HSV straw. A non-vitrified group was used as control. The methods were evaluated with respect to expanded blastocyst development, cell count of expanded blastocysts on day 5, and ease of use and time in the final solution prior to vitrification. The study showed that the three methods did not differ from each other significantly in terms of expanded blastocyst development.
A comparative mouse study- similar to the study above, the purpose was to evaluate different non-LN2 contact vitrification methods of fresh F1 mouse embryos. The methods were: (a) post-seal Rapid-i™ (i.e., the predicate device); (b) pre-seal Rapid-i™; and (c) the HSV straw. A non-vitrified group was used as control. The methods were evaluated with respect to blastocyst development on day 4 and 5 and cell count of expanded blastocysts on day 5. The study showed that the three methods did not differ from each other significantly in terms of blastocyst development on day 4 and 5.
A comparative Swiss outbred study- similar to the studies above, the purpose was to evaluate different non-LN2 contact vitrification methods of Swiss outbred mice. The methods were: (a) post-seal Rapid-i™ (i.e., the predicate device); and (b) pre-seal Rapid-i™. A non-vitrified group was used as control. The methods were evaluated with respect to blastocyst development on day 4 and 5 and cell count of expanded blastocysts on day 5. The study showed that method (a) showed a significantly higher blastocyst development rate on day 5 and cell count of expanded blastocysts compared to method (b).
A vitrification study- the purpose of the study was to visually verify that the post-seal Rapid-i™ and pre-seal Rapid-i™ vitrification methods result in total vitrification of the media. The methods were: (a) post-seal Rapid-i™ (i.e., the predicate device) loaded with the final vitrification media: (b) pre-seal Rapid-i™ loaded with the final vitrification media: and (c) pre-seal Rapid-i™ loaded with the an intermediate vitrification media with lower osmolality. No embryo was used. The methods were evaluated by capturing images of the media in the device under LN2. The study showed that methods (a) and (b) resulted in transparent media indicating that vitrification had taken place and method (c) resulted in opaque media indicating that freezing had occurred.

Clinical Testing:
The indication was modified to expand use with blastocyst stage embryos, and additional testing was performed to assess the ability to vitrify blastocyst stage embryos using the device, as discussed below. All laboratory procedures including embryo assessment were performed according to standard procedures. For vitrification and warming, respectively, Vitrolife's RapidVit Blast and RapidWarm Blast solutions were used while the Rapid-i™ Kit was used as a carrier device. During the vitrification and warming procedures, the instructions for use for the respective procedures were followed. After vitrification, blastocysts were stored in liquid nitrogen until the time of warming. After warming, cultured and surviving embryos were transferred into the uterus using standard procedures.
The use of the Rapid-i™ Kit as carrier device for clinical blastocyst vitrification provides good results. The clinical pregnancy rates range between 32% and 47%, and to date, birth of 124 children. Clinical blastocyst vitrification was conducted at four sites, including 426 patients with embryo transfer. The average blastocyst survival rate was 91% and the average clinical pregnancy rate was 42%.
When compared with the most recent Assisted Reproductive Technology ("ART") National Summary Report, published by the Centers for Disease Control and Prevention (“CDC"), the success rates with the Rapid-i™ Kit are comparable to the 2011 ART success rates. For example, in 2011, CDC reported a mean of 36.6% of frozen embryos from nondonor eggs transferred (all ages combined) resulted in pregnancy. By comparison, the clinical pregnancy rates for the Rapid-i™ Kit ranged between 32% and 47%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical pregnancy rates: range between 32% and 47%
Birth of 124 children (to date)
Average blastocyst survival rate: 91%
Average clinical pregnancy rate: 42%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090832

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.6160 Assisted reproduction labware.

(a)
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.(b)
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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is black and white.

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

December 18, 2014

Vitrolife Sweden AB % Anthony T. Pavel Regulatory Counsel Morgan, Lewis & Bockius LLP 1111 Pennsylvania Avenue NW Washington, DC 20004

Re: K140207

Trade/Device Name: Rapid-i™ Kit Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: November 24, 2014 Received: November 25, 2014

Dear Anthony T. Pavel,

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 (reporting of medical device

1

related 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 yours,

Herbert P. Lerner -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

2

Indications for Use

510(k) Number (if known) K140207

Device Name Rapid-i™ Kit

Indications for Use (Describe)

The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary

| Submitted by: | Vitrolife Sweden AB
Box 9080
SE-400 92 Göteborg
SWEDEN | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Date: | December 16, 2014 | |
| Manufacturing
Sites: | Vitrolife Sweden AB
Box 9080
SE-400 92 Göteborg
SWEDEN | Vitrolife Inc.
3601 Inca Street
Englewood, CO 80110
USA |
| Contact
Person: | Nina Arvidsson
Regulatory Affairs Manager
Vitrolife Sweden AB
Box 9080
SE-400 92 Göteborg
SWEDEN
Tel: +46 31 721 80 77
Fax: +46 31 721 80 90
E-mail: narvidsson@vitrolife.com | |
| Establishment
Registration
Numbers: | 3003995932
Vitrolife Sweden AB | 9037178
Vitrolife Inc., Englewood, CO |
| Device Trade
Name: | Rapid-iTM Kit | |
| 510(k)
Number: | K140207 | |
| Device
Common
Name: | Cryopreservation container and microtool | |
| Device
Classification: | Regulation: 21 C.F.R. § 884.6160
Classification Name: Assisted Reproduction Labware
Product Code: MQK
Classification: Class II (special controls) | |
| Device
Classification: | Class II | |

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| Predicate

Device:	Vitrolife Rapid-iTM (K090832)
Indications for
Use:	The Rapid-iTM Kit is a cryopreservation device designed to contain, vitrify and
maintain 4-8 cell and blastocyst stage human embryos.
Device
Description
and Principles
of Operation:	Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and
maintain 4-8 cell and blastocyst stage human embryos, consists of the following
three items:
	• 80 mm PMMA stick (Rapid-iTM)
	• 135 mm Mediprene straw equipped with a stainless steel weight,
(RapidStraw)
	• 115 mm stainless steel rod inserted in the RapidStraw
Substantial
Equivalence to
Predicate
Devices:	4-8 cell and blastocyst stage embryos are vitrified using the Rapid-iTM Kit by
pre-cooling the RapidStraw (steel rod inserted) with the open end extending
from the liquid nitrogen. A 30 nanoliter drop of vitrification solution holding
embryos is placed in a capillary sized hole in the Rapid-iTM. The stainless steel
rod is removed 20-30 seconds before the Rapid-iTM is inserted in the pre-cooled
RapidStraw in liquid nitrogen to effect vitrification of the embryos. The open
end of the straw is then sealed.

The Rapid-iTM Kit is substantially equivalent to the Rapid-iTM, as previously
cleared by FDA (K090832).

Manufacturer	Vitrolife Sweden AB	Vitrolife Sweden AB
Trade Name	Rapid-iTM Kit	Rapid-iTM
510(k) Number	K140207	K090832
Product Code	MQK	MQK
Regulation Number	884.6160	884.6160
Regulation Name	Assisted Reproduction
Labware	Assisted Reproduction
Labware
Indications for Use	The Rapid-iTM Kit is a
cryopreservation device
designed to contain,
vitrify and maintain 4-8
cell and blastocyst stage
human embryos.	Rapid-iTM is a
cryopreservation device
that is intended to be
used to contain, vitrify
and maintain 4-8 cell
stage embryos.
Manufacturer	Vitrolife Sweden AB	Vitrolife Sweden AB
Method of Action
(vitrification)	Precool a straw with the
open end extending
from the liquid
nitrogen. A 30 nanoliter
drop of vitrification
solution holding
embryos is placed in a
capillary sized hole in
the stick. The stick in
turn is inserted in the
pre cooled straw in
liquid nitrogen to effect
vitrification of the
embryos. Subsequently,
the open end of the
straw is sealed.	Precool a straw with the
open end extending
from the liquid
nitrogen. A 30 nanoliter
drop of vitrification
solution holding
embryos is placed in a
capillary sized hole in
the stick. The stick in
turn is inserted in the
pre cooled straw in
liquid nitrogen to effect
vitrification of the
embryos. Subsequently,
the open end of the
straw is sealed.
Cooling Rate	1400°C/min at -50°C	1400°C/min at -50°C
Method of Action
(rewarming)	While the distal end of
the straw remains in
liquid nitrogen, cut the
sealed proximal end of
the straw. Withdraw
the stick and directly
immerse the
stick/vitrified drop in
warming media.	While the distal end of
the straw remains in
liquid nitrogen, cut the
sealed proximal end of
the straw. Withdraw
the stick and directly
immerse the
stick/vitrified drop in
warming media.
Rewarming Rate	10,000°C/min at -50°C	10,000°C/min at -50°C
Warming: Contact
With the Warming
Medium	Direct immersion of
sample in the warming
solution for
simultaneous thawing
and dilution.	Direct immersion of
sample in the warming
solution for
simultaneous thawing
and dilution.
Materials in Contact
With Tissue (embryos)	Polymethyl
methacrylate (PMMA)
stick with hole, 2x80
mm	Polymethyl
methacrylate (PMMA)
stick with hole, 2x80
mm
Straw	Mediprene straw with
funnel and weight, OD
3.45 mm, ID 2.5 mm,
wall thickness 0.47 mm,
length 135 mm	Poly vinyl chloride
(PVC) straw with
funnel and weight, OD
3.3 mm, ID 2.6 mm,
wall thickness 0.35 mm,
and length 165 mm
Stainless Steel Rod	Stainless steel, 2.2 x
115 mm	----
Manufacturer	Vitrolife Sweden AB	Vitrolife Sweden AB
Sterility Assurance
Level	Sterilized by ethylene
oxide. SAL is 10-6	Sterilized by ethylene
oxide. SAL is 10-6
MEA Specification	Mouse Embryo Assay
(1 -cell)
% expanded blastocyst,
within 96h ≥80	Mouse Embryo Assay
(1 -cell)
% expanded blastocyst
on day 5 ≥80
Endotoxin
Specification	Bacterial endotoxins
(LAL assay) Bacterial Endotoxins Test.
	C. Sterilization Validation
	Sterility of the device is assured through the use of ethylene oxide sterilization.
	Specification: Sterilized using ethylene oxide SAL 10-6.
	Sterilization validation was performed according to ISO 11737-2:2009
Sterilization of Medical devices – Microbiological Methods, Part 2: Tests of
Sterility Performed in the Validation of the Sterilization Process.
	D. Design Validation
	As part of the design validation process, the following tests were conducted on
the Rapid-i™ (K090832) (which is substantially similar to the Rapid-i™ Kit):
	The design validation testing on the post-seal Rapid-i™ described below is
valid for Rapid-i™ Kit as well. The minimal physical differences between the
post-seal Rapid-i™ and the Rapid-i™ Kit are only in the straw material and the

5

6

Discussion of Similarities and Differences

The indication for the cleared Rapid-i™ is "a cryopreservation device that is intended to be used to contain, vitrify and maintain 4-8 cell stage embryos." The addition of blastocyst stage embryos to the proposed device's indication does not represent a new intended use. Both the proposed and predicate devices are intended to cryopreserve embryos from patients undergoing assisted reproductive procedures for later use. Blastocyst stage embryos and 4-8 cell stage embryos are similar in size and morphology and therefore the same carrier devices may be used for the vitrification of embryos in both of these stages. Therefore, addition of blastocyst vitrification does not represent a new intended use as it does not raise different questions of safety or effectiveness.

The operation of both devices is substantially similar, as both involve the precooling of a straw with the open end extending from the liquid nitrogen. The proposed device utilizes a stainless steel rod, which acts to keep the straw straight and also helps limit condensation in the straw during the cooling procedure, and is removed prior to insertion of the Rapid-i™ stick. The inclusion of the stainless steel rod does not raise any new questions of safety or effectiveness. A 30 nanoliter drop of vitrification solution holding embryos is placed in a capillary sized hole in the stick. The stick in turn is inserted in the pre-cooled straw in liquid nitrogen to effect vitrification of the embryos. Subsequently, the open end of the straw is sealed. The warming procedures are the same for both devices, and the cooling and warming rates of the devices are the same, as are the materials in contact with the embryos.

The straw in the proposed device is comprised of mediprene (straw with funnel and weight, 3.45 x 135 mm), whereas in the predicate, the straw is comprised of polyvinyl chloride (PVC) (straw with funnel and weight, 3.3 x 165 mm).

The change in material from PVC to mediprene has no impact on function and was made because of improved color properties of the material. The difference in material does not raise any new questions of safety or effectiveness.

The RapidStraw was shortened to fit better in devices used to hold samples in

7

straw thickness. Neither of these parameters affects the embryo, as the straw is

8

not in direct or indirect contact with the embryo. The changes do not affect cooling or warming rates. Hence, the differences do not affect vitrification. warming, or embryo development after vitrification.

Effects of sealing before and after vitrification- the purpose of the study ● was to evaluate different non-liquid nitrogen (LN2) contact vitrification methods of previously frozen day 1 embryos. The methods were: (a) post-seal Rapid-iTM (i.e., the predicate device); (b) pre-seal Rapid-i™; and (c) the HSV straw. A non-vitrified group was used as control. The methods were evaluated with respect to expanded blastocyst development, cell count of expanded blastocysts on day 5, and ease of use and time in the final solution prior to vitrification. The study showed that the three methods did not differ from each other significantly in terms of expanded blastocyst development.
A comparative mouse study- similar to the study above, the purpose was . to evaluate different non-LN2 contact vitrification methods of fresh F1 mouse embryos. The methods were: (a) post-seal Rapid-i™ (i.e., the predicate device); (b) pre-seal Rapid-i™; and (c) the HSV straw. A non-vitrified group was used as control. The methods were evaluated with respect to blastocyst development on day 4 and 5 and cell count of expanded blastocysts on day 5. The study showed that the three methods did not differ from each other significantly in terms of blastocyst development on day 4 and 5.
A comparative Swiss outbred study- similar to the studies above, the ● purpose was to evaluate different non-LN2 contact vitrification methods of Swiss outbred mice. The methods were: (a) post-seal Rapid-i™ (i.e., the predicate device); and (b) pre-seal Rapid-i™. A non-vitrified group was used as control. The methods were evaluated with respect to blastocyst development on day 4 and 5 and cell count of expanded blastocysts on day 5. The study showed that method (a) showed a significantly higher blastocyst development rate on day 5 and cell count of expanded blastocysts compared to method (b).
A vitrification study- the purpose of the study was to visually verify that ● the post-seal Rapid-i™ and pre-seal Rapid-i™ vitrification methods result in total vitrification of the media. The methods were: (a) post-seal Rapid-i™ (i.e., the predicate device) loaded with the final vitrification media: (b) pre-seal Rapid-i™ loaded with the final vitrification media: and (c) pre-seal Rapid-i™ loaded with the an intermediate vitrification media with lower osmolality. No embryo was used. The methods were evaluated by capturing images of the media in the device under LN2. The study showed that methods (a) and (b) resulted in transparent media indicating that vitrification had taken place and method (c) resulted in opaque media indicating that freezing had occurred.

9

E. Shelf-life Evaluation

The initial shelf-life report provided in the prior submission (K090832) for the Rapid-i™ device was based on sterile integrity of the packaging. A verifying stability study was also performed on the Rapid-i™ device. The testing included sterility testing according to USP Sterility Tests, bacterial endotoxins according to USP Bacterial Endotoxins Test, and Mouse Embryo Assay.

The data provided supports the proposed shelf-life for the updated version of the device because:

Sterility Testing (Negative, no growth): sterile integrity is dependent on . the primary packaging and the sealing procedure. This has not changed from the predicate.
. Endotoxin (