(242 days)
RapidVit™ Blast is indicated for vitrification of human blastocyst stage embryos
RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos
RapidVit™ Blast and RapidWarm™ Blast is a device used for vitrification and warming of human blastocysts. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation.
RapidVit™ Blast consists of three different solutions with increasing concentrations of cryoprotectants intended to prepare the human blastocysts for vitrification by reducing the intracellular water content and increasing the osmolality. Also RapidWarm™ Blast consists of three different solutions with decreasing concentrations of sucrose to restore the water content and osmolality in embryo during warming after vitrification storage.
The provided text describes the 510(k) summary for Vitrolife Sweden AB's RapidVit™ Blast and RapidWarm™ Blast devices, intended for the vitrification and warming of human blastocysts.
No explicit acceptance criteria are stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and presenting nonclinical and clinical study results without defining specific performance thresholds for acceptance.
However, based on the nonclinical and clinical study results that "showed good survival, development and hatching rate of the blastocysts" and that "the majority of the blastocysts survive vitrification," we can infer the implied acceptance criteria: demonstrated equivalent or improved survival, development, and hatching rates of vitrified/warmed blastocysts compared to predicate devices or established clinical norms, with no adverse effects.
Here's an analysis of the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Good survival, development, and hatching rate of vitrified blastocysts. | Nonclinical Studies: "All studies showed good survival, development and hatching rate of the blastocysts." One study also included fluorescence in situ hybridization analysis for chromosomal abnormalities and reported "no significant differences in abnormal cells than non vitrified fresh blastocysts." Clinical Studies: "the majority of the blastocysts survive vitrification" using RapidVit™ Blast and RapidWarm™ Blast. |
| Can be used with good results in the daily treatment of IVF patients. | Clinical Studies: "vitrification using RapidVit™ Blast and RapidWarm™ Blast can be used with good results in the daily treatment of IVF patients." |
| Pregnancy rate with vitrified and warmed blastocysts. | Clinical Studies: "Reported pregnancy rate is 43.0% per embryo transfer." |
| Live births from vitrified and warmed blastocysts. | Clinical Studies: "So far 43 healthy babies have been born from vitrified and warmed blastocysts after the use of RapidVit™ Blast." |
| No adverse effects or complications. | Clinical Studies: "No adverse effects or complications were reported during the Study." |
| Results similar to other FDA-approved devices. | Clinical Studies: "Reports are similar to results with other FDA approved devices." |
| Safe, efficient, and performs as well as similar FDA-approved devices (Conclusion on Nonclinical and Clinical studies). | Conclusions: "RapidVit™ Blast and RapidWarm™ Blast has showed to be as safe, efficient and performs as well as similar FDA approved devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Nonclinical studies: "Three studies have been performed with vitrified surplus human blastocysts using RapidVit™ Blast and RapidWarm™ Blast." The exact number of blastocysts in these three studies is not specified. The data provenance is human blastocysts, implying clinical or research settings where surplus embryos were available. It is inferentially retrospective for the samples. The country of origin is not explicitly stated.
- Clinical studies: "All patients undergoing IVF and included in the data analysis." The exact number of patients or blastocysts included in the clinical study is not specified, but it yielded "43 healthy babies." This appears to be a prospective clinical investigation. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth in either the nonclinical or clinical studies. The assessment of survival, development, hatching rates, and pregnancy outcomes would typically be performed by trained embryologists, clinicians, and medical staff.
4. Adjudication Method for the Test Set
The document does not detail any specific adjudication methods (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned, nor is there any discussion of human readers improving with or without AI assistance. This device is a cryopreservation solution, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a cryopreservation medium, not an algorithm or software. It does not operate without human intervention.
7. The Type of Ground Truth Used
- Nonclinical Studies: The ground truth for blastocyst survival, development, and hatching rates was established through direct observation and laboratory analysis of the blastocysts. Additionally, one study used "fluorescence in situ hybridisation analysis for chromosomal abnormalities" as a ground truth for genetic integrity.
- Clinical Studies: The ground truth for effectiveness was established by clinical outcomes: survival of blastocysts post-warming, successful embryo transfer, reported pregnancy rates, and the birth of healthy babies.
8. The Sample Size for the Training Set
The concept of a "training set" is not relevant here, as this device is a medical solution for cryopreservation, not an AI/machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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X. THE 510(k) SUMMARY
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| Submitted by: | Vitrolife Sweden ABBox 9080SE-40092 GöteborgSWEDEN | DEC 10 2010 |
|---|---|---|
| Contact Person: | Mr Kjell KjörkVitrolife Sweden ABBox 9080SE-40092 GöteborgSWEDENPhone +46 31 721 80 77Fax +46 31 721 80 90Mail kkjork@vitrolife.com | |
| Date Prepared: | 3 December 2010 | |
| Trade Name: | RapidVit™ BlastRapidWarm™ Blast | |
| Common Name: | Vitrification freeze kit for blastocystsVitrification thaw kit for blastocysts | |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. § 884.6180) | |
| Predicate Devices: | RapidVit™ Cleave and RapidWarm™ Cleave(K080446) from Vitrolife, andVit Kit™ - Freeze and Vit Kit™ - Thaw from IrvineScientific Co., Inc. (K060168) | |
| Description of the Device: | RapidVit™ Blast and RapidWarm™ Blast is adevice used for vitrification and warming of humanblastocysts. The cryoprotectants 1,2-propanediol andethylene glycol are used together with sucrose fordehydration of the embryo before cryopreservation.RapidVit™ Blast consists of three different solutionswith increasing concentrations of cryoprotectantsintended to prepare the human blastocysts forvitrification by reducing the intracellular watercontent and increasing the osmolality. AlsoRapidWarm™ Blast consists of three differentsolutions with decreasing concentrations of sucroseto restore the water content and osmolality in embryoduring warming after vitrification storage. |
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Intended Use:
RapidVit™ Blast is intended for vitrification of human blastocyst stage embryos
RapidWarm™ Blast is intended for warming of vitrified human blastocyst stage embryos
Technological Characteristics:
RapidVit™ Blast and RapidWarm™ Blast are devices used for vitrification of blastocysts. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation.
For RapidVit™ Blast and RapidWarm™ Blast two predicate devices have been utilized:
Rapid Vit™ Cleave and RapidWarm™ Cleave as predicate device
The Rapid Vit™ Blast and RapidWarm™ Blast device is a modification of the RapidVit™ Cleave and RapidWarm™ Cleave device (K080446) currently marketed by Vitrolife Sweden AB for the vitrification of day 3 cleavage stage embryos.
Rapid Vit™ Blast and RapidWarm™ Blast is similar to the predicate device in most respects. However, the predicate device RapidVit™ Cleave and RapidWarm™ Cleave (K080446) is intended for vitrification of day 3 cleavage stage embryos. RapidVit™ Blast and RapidWarm™ Blast and the predicate device consist of the same components but in somewhat different proportions as they are tailor-made for blastocysts and for cleavage stage embryos respectively.
Vit Kit™ - Freeze/Vit Kit™ - Thaw as predicate device
Vit Kit™ - Freeze/Vit Kit™ - Thaw and RapidVit™ Cleave/RapidWarm™ Cleave are embryo-physiological solutions supplemented with permeable and non-permeable cryoprotectants.
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Main differences between Vit Kit™ - Freeze/Vit Kit™ - Thaw and RapidVit™ Blast/RapidWarm™ Blast
Blast/Rapid Warni--- Diast
The main differences between RapidVit™ Blast and RapidWarm™ Blast and Vit Kit™ - Freeze and Vit Kit™ - Thaw are the following:
- Vit Kit™ Freeze and Vit Kit™ Thaw contain ethylene glycol, DMSO and . Vit Kit ---------------------------------------------------------------------------------------------------------------------------------------------------------------------contain ethylene glycol, 1,2-propanediol and sucrose
- Vit Kit™ Freeze and Vit Kit™ Thaw use an HEPES buffer, while . V It Kit --- Preczed and RapidWarm™ Blast use a MOPS buffer to keep the pH within physiological values during handling outside the incubator
Justification for use of different media composition
Justification for use of annoverison, in spite of the somewhat different media The Justification for this comparison, in Spice of and Vit Kit™ - Freeze/Vit Kit™ - Thaw, is as follows:
- Most ART centres are now using either 1,2-propanediol or DMSO as the � Most ANT contres are now asing online of embryos. 1,2-propanediol is considered less toxic for embryos and for users
- The MOPS buffer used in RapidVit™ Blast and RapidWarm™ Blast is similar . The MOPS buffer used in Napld vit - Diast and Nit Kit™ - Thaw In addition
to HEPES which is used in Vit Kit™ - Freeze and Vit Kit™ - Thaw of hear lo HEFES winch is used in VR Rt.
the MOPS buffer is used in most of the IVF Media from Vitrolife, and has been used clinically for a very long time with good results
Successful vitrification of animal and human blastocyst stage embryos by use of Successful Vitrification of animal and numan blast of bags
RapidVit™ Blast and RapidWarm™ Blast has been shown in the nonclinical and clinical studies referred to below.
Nonclinical studies
Nonclinical studies
Three studies have been performed with vitrified surplus human blastocysts using Three studies have been performed with volues showed good survival,
RapidVit" Blast and RapidWarm" Blast. All studies showed good survival, Rapid Vit Blast and Rapid Warm - Diast. An study also included fluorescence
development and hatching rate of the blastocysts. One study also included ambrios development and hatching fale of the blastery of a comalities and vitrified embryos
in situ hybridisation analysis for chromosomal abnormalities and vitrified embryos in situ hybridisation analysis for onformal cells then non vitrified fresh blastocysts.
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Clinical studies
Clinical studies
The clinical investigation of RapidVit™ Blast and RapidWarm™ Blast confirmed the The Chillcal findings, showing that the majority of the blastocysts survive vitrification precimical Indulings, snownig that the majority of that vitrification using RapidVit™ Blast and RapidWarm™ Blast can be used with good results in the daily treatment of IVF and Rapid Wallin - "Diast can oc used with good rooms vitrified and warmed blastocysts paticnes. An pations andergoing and included in the data analysis. The reported uuring the Study thire perfou have 0043% per embryo transfer. So far 43 health babies pregilancy falc 13 octiven 2 178 and in from vitrified and warmed blastocysts after the with nothlar outcomes have been obling of the Blast. No adverse effects or complications tise of Rapid Vit - - Diastana Reports are similar to results with other FDA approved devices.
Conclusions on Nonclinical and Clinical studies
Conclusions on Nonchinear and Chineal clinical investigations, RapidVit™ Bast and RapidWarm™ Blast has showed to be as safe, efficient and performs as well as similar FDA approved devices.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G605 Silver Spring, MD 20993-0002
Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
DEC 1 0 2010
Re: K101003
Trade Name: RapidVit™ Blast and RapidWarm™ Blast Regulation Number: 21 CER §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: November 23, 2010 Received: November 26, 2010
Dear Mr. Kjörk:
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 indictions 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, Isting 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 onlineer madend
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1/1 S809.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 (2) 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.nrcs.usda.gov/wps/portal/nrcs/detail/national/technical/ecs/resource/?cid=nrcs143_026847
Sincerely yours,
Hubert Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K101003
INDICATIONS FOR USE STATEMENT XI.
DEC 1 0 2010
510(k) Number (if known):
Device Name:
RapidVit™ Blast RapidWarm™ Blast
Indications for Use:
RapidVit™ Blast is indicated for vitrification of human blastocyst stage embryos
RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 C.F.R. § 801.109) |
OR
| Over-the Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Di sion of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number
§ 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.