K Number
K240605
Device Name
Ultra RapidWarm™ Blast
Date Cleared
2024-08-07

(156 days)

Product Code
Regulation Number
884.6180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.
Device Description
Ultra RapidWarm Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose. The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.
More Information

No
The device description and performance studies focus on a chemical solution and warming protocol, with no mention of AI or ML.

Yes.

The device is intended for warming of vitrified human blastocyst stage embryos, which is a medical procedure aimed at achieving pregnancy.

No

The device is intended for warming vitrified human blastocyst stage embryos, which is a therapeutic or preparatory function, not a diagnostic one. The performance metrics listed are related to the success of the warming process (embryo survival, pregnancy, live birth rates), not the detection or diagnosis of a condition.

No

The device description explicitly states the device consists of a "single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose," which is a chemical composition, not software.

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "warming of vitrified human blastocyst stage embryos." This process is performed in vitro (outside the living body) on biological material (human embryos).
  • Device Description: The device is a "single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose." This is a reagent or medium used in a laboratory setting for a diagnostic or therapeutic procedure performed in vitro.
  • Context of Use: The device is used in the context of warming embryos, which is a crucial step in assisted reproductive technology (ART) procedures like IVF. These procedures involve handling and manipulating biological samples in vitro.

While the device itself is a solution and not a complex instrument, its intended use and composition clearly align with the definition of an In Vitro Diagnostic device, which includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems used in vitro for the examination of specimens derived from the human body. In this case, the "specimen" is the vitrified human blastocyst.

N/A

Intended Use / Indications for Use

Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

Product codes

MQL

Device Description

Ultra RapidWarm™ Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose.

The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

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Intended User / Care Setting

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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

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Summary of Performance Studies

The following studies have been performed to support substantial equivalence to the predicate device:

  • Aseptic filtration and filling validation testing that met the requirements of ISO 13408-. 1:2008/Amd1:2013 and ISO 13408-2:2018.
  • Shelf-life testing was conducted to support a 9-week shelf-life for the subject device through demonstration that the product specifications were met at time 0 and after realtime aging. Testing was also included on aged samples demonstrating that medium in bottles can maintain their specifications after 14 days of simulated use conditioning after bottle opening. Testing conducted is shown below:
    • Sterility testing per USP (acceptance criterion: no microbial growth)
    • Bacterial endotoxins testing per USP (acceptance criterion: (acceptance criterion: 7.30 ± 0.10)
    • Osmolality per USP (acceptance criterion: 547 ± 20 mOsm/kq)
    • Mouse embryo assay One-cell system: ≥80% embryos developed to expanded blastocyst at -96 hours after 2 minutes of exposure.
  • Transportation testing was conducted according to ASTM D4169-22 (DC-13) and cap/seal leak testing according to USP .

A clinical evidence summary providing information to support the safety and performance of the subject device was included in this submission. The evaluation covers literature review and data from a study on a single step warming protocol identical to the subject device. The literature review summarized research conducted with single-step warming versus multi-step standard warming procedures, and the results showed comparable embryo survival rate, clinical pregnancy rate, and live birth rate between blastocysts warmed with the single-step and multi-step warming procedures, indicating that a single-step warming procedure is equivalent to multi-step warming procedures. The clinical study used the Warm 1 Blast (K101003) as a surrogate for the subject device and compared the effectiveness of warming using a simplified warming protocol (2 minutes of warming in Warm 1 Blast) compared to standard warming protocol using RapidWarm Blast (K101003). The study was conducted in a university-based IVF center in France. A prospective pilot study with 86 cycles (52 blastocysts in the control group and 42 blastocysts in the treatment group) was conducted, followed by a cohort study including 868 cycles (578 blastocysts in the control group and 336 blastocysts in the treatment group). The results from the cohort study showed that embryo survival rate after warming (97.8%), clinical pregnancy rate (38.2% vs. 39.2%), and live birth rate (28.3% vs. 29.6%) obtained with the single-step warming and with the conventional standard warming protocol, respectively, were comparable.

Key Metrics

Embryo survival rate after warming (97.8%), clinical pregnancy rate (38.2% vs. 39.2%), and live birth rate (28.3% vs. 29.6%)

Predicate Device(s)

K101003

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 7, 2024

Vitrolife Sweden AB Nina Arvidsson Official Applicant Gustaf Werners gata 2 Vastra Frolunda, 42132 SWEDEN

Re: K240605

Trade/Device Name: Ultra RapidWarm™ Blast Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Received: July 9, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240605

Device Name Ultra RapidWarm™ Blast

Indications for Use (Describe) Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/2 description: The image shows the word "Vitrolife" in blue font, with a stylized blue wave-like graphic to the right of the word. The font is a serif font, and the wave graphic is a simple, curved line. The overall design is clean and modern. The color is a dark blue.

510(k) Summary - K240605

1. Submitter Information

Submitted by: Vitrolife Sweden AB Gustaf Werners gata 2 SE - 421 32 Västra Frölunda Sweden

Contact Person:Nina Arvidsson
Vitrolife Sweden AB
Gustaf Werners gata 2
SE - 421 32 Västra Frölunda
Sweden
Phone:+46 31 721 80 00
Fax:+46 31 721 80 90
Email:narvidsson@vitrolife.com
    1. Date Prepared:
      August 6, 2024
    1. Device Identification
Trade Name:Ultra RapidWarm™ Blast
Common Name:Warming medium for vitrified blastocysts
Regulatory Class:Class II
Regulation Number:21 CFR 884.6180
Regulation Name:Reproductive media and supplements
Product Code:MQL (Media, Reproductive)
4. Predicate Device:RapidWarm™ Blast (K101003) manufactured by Vitrolife
Sweden AB

The predicate device has not been subject to a design related recall.

5. Device Description

Ultra RapidWarm Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose.

The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.

6. Indications for Use

Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

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Ultra RapidWarm™ Blast

Image /page/5/Picture/2 description: The image shows the word "Vitrolife" in blue font. To the right of the word is a blue swoosh symbol. The font is a serif font and the color is a dark blue.

7. Comparison of intended use and technological characteristics of the subject and predicate devices

A comparison of the indications for use and technological characteristics of the subject device and the predicate device is shown in the table below:

| | Subject Device
(K240605) | Predicate Device
(K101003) | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ultra RapidWarmTM Blast | RapidWarm Blast | N/A |
| Indications for
Use | Ultra RapidWarmTM Blast
is indicated for warming of
vitrified human blastocyst
stage embryos. | RapidWarmTM Blast is
indicated for warming of
vitrified human blastocyst
stage embryos. | Same |
| Warming
procedure | Ultra Warm Blast (250 mM
sucrose): 2 minutes | Warm 1 Blast (250 mM
sucrose): 2 minutes
Warm 2 Blast (125 mM
sucrose): 3 minutes
Warm 3 Blast: 5-10
minutes | Different: The
warming procesure
of the subject and
predicate devices
are not the same.
Differences in
warming procedure
do not raise
different questions
of safety and
effectiveness
(S&E). |
| Packaging | 5 mL PETG bottle with
HDPE closure | 10 mL PETG bottle with
HDPE closure | Different: The
packaging of the
subject and
predicate devices
are not the same.
Differences in
device packgaing
do not raise
different questions
of S&E. |
| Storage
conditions | Store dark at +2 to +8 °C | Store dark at +2 to +8 °C | Same |
| pH | 7.30 ± 0.10 | 7.30 ± 0.10 | Same |
| Osmolality
(mOsm/kg) | 547 ± 20 | 528 ± 20 / 394±12 / 261±5 | Different: The
osmolality of the
subject and
predicate devices
are not the same.
Differences in
osmolality do not
raise different
questions of S&E. |
| Bacterial
endotoxins
(LAL assay) | (acceptance criterion: no microbial growth) -
- Bacterial endotoxins testing per USP (acceptance criterion: (acceptance criterion: 7.30±0.10) -
- -Osmolality per USP (acceptance criterion: 547±20 mOsm/kq)
- Mouse embryo assay One-cell system: ≥80% embryos developed to expanded blastocyst at -96 hours after 2 minutes of exposure.

  • . Transportation testing was conducted according to ASTM D4169-22 (DC-13) and cap/seal leak testing according to USP .

9. Summary of Clinical Performance Testing

A clinical evidence summary providing information to support the safety and performance of the subject device was included in this submission. The evaluation covers literature review and data from a study on a single step warming protocol identical to the subject device. The literature review summarized research

7

Ultra RapidWarm™ Blast

Image /page/7/Picture/2 description: The image contains the word "Vitrolife" in blue font. To the right of the word is a blue swoosh. The font is a serif font.

conducted with single-step warming versus multi-step standard warming procedures, and the results showed comparable embryo survival rate, clinical pregnancy rate, and live birth rate between blastocysts warmed with the single-step and multi-step warming procedures, indicating that a single-step warming procedure is equivalent to multi-step warminq procedures. The clinical study used the Warm 1 Blast (K101003) as a surrogate for the subject device and compared the effectiveness of warming using a simplified warming protocol (2 minutes of warming in Warm 1 Blast) compared to standard warming protocol using RapidWarm Blast (K101003). The study was conducted in a universitybased IVF center in France. A prospective pilot study with 86 cycles (52 blastocysts in the control group and 42 blastocysts in the treatment group) was conducted, followed by a cohort study including 868 cycles (578 blastocysts in the control group and 336 blastocysts in the treatment group). The results from the cohort study showed that embryo survival rate after warming (97.8%), clinical pregnancy rate (38.2% vs. 39.2%), and live birth rate (28.3% vs. 29.6%) obtained with the single-step warming and with the conventional standard warming protocol, respectively, were comparable.

9. Conclusion

The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.