(281 days)
Not Found
No
The summary describes a cryopreservation kit and process, with no mention of AI, ML, image processing, or data-driven algorithms.
No
This device is for vitrification and warming of embryos, which are laboratory procedures, not a direct treatment for a patient's disease or condition.
No
The device description indicates that it is used for vitrification and warming of embryos, which are procedures for preserving and retrieving biological material, not for identifying the presence or absence of a disease or condition. Its purpose is to facilitate assisted reproductive technologies through embryo handling, not diagnosis.
No
The device description explicitly details the use of cryoprotectants and plunging embryos into liquid nitrogen, indicating a physical process involving chemical substances and cryogenic equipment, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The intended use of RapidVit™ Cleave and RapidWarm™ Cleave is for the vitrification and warming of embryos, which are not considered specimens derived from a human body in the context of an IVD.
- The process described is a cryopreservation technique for biological material (embryos), not a diagnostic test performed on a patient sample.
- The device description focuses on the chemical composition and process for preserving and reviving embryos. This aligns with a device used in assisted reproductive technology (ART) procedures, not an IVD.
While the device is used in a clinical setting and requires a physician's order, its function is not to diagnose or provide information about a patient's health status based on a bodily specimen.
N/A
Intended Use / Indications for Use
Rapid Vit™ Cleave is intended for vitrification of day 3 cleavage stage embryos
RapidWarm™ Cleave is intended for warming of vitrified day 3 cleavage stage embryos
RapidVit™ Cleave is indicated for vitrification of day 3 cleavage stage embryos
RapidWarm™ Cleave is indicated for warming of vitrified day 3 cleavage stage embryos
RapidVit™ Cleavage and RapidWarm™ Cleavage are restricted to sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
RapidVit™ Cleave is used for vitrification of day 3 cleavage stage embryos. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation. Then the embryos are immediately plunged into liquid nitrogen in order to prevent intracellular and extracellular ice crystal formation.
RapidWarm™ Cleave is used for the subsequent warming of vitrified day 3 cleavage embryos
RapidVit™ Cleave and RapidWarm™ Cleave are devices used for vitrification of day 3 cleavage stage embryos. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation. Then the embryos are immediately plunged into liquid nitrogen in order to prevent intracellular and extracellular crystal formation.
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
restricted to sale by or on the order of a physician.
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)
Successful vitrification of human cleavage stage embryos by use of RapidVit™ Cleave and RapidWarm™ Cleave has been clinically proven (Balaban et al. 2008).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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.
0
K 080446
X. PREMARKET NOTIFICATION SUMMARY
.
1
NOV 2 6 2008
:
| NOV 26 2008 | |
|---|---|
| Submitted by: | Vitrolife Sweden AB |
| Box 9080 | |
| SE-400 92 Göteborg | |
| SWEDEN | |
| Contact Person: | Mr Kjell Kjörk |
| Vitrolife Sweden AB | |
| Box 9080 | |
| SE-400 92 Göteborg | |
| SWEDEN | |
| Phone +46 31 721 80 77 | |
| Fax +46 31 721 80 90 | |
| Mail kkjork@vitrolife.com | |
| Date Prepared: | 25 November 2008 |
| Trade Name: | RapidVit™ Cleave |
| RapidWarm™ Cleave | |
| Common Name: | Vitrification freeze kit for cleavage stage embryos |
| Vitrification warming kit for cleavage stage | |
| embryos | |
| Classification Name: | Reproductive Media and Supplements |
| (21 C.F.R. § 884.6180) | |
| Predicate Device: | Vit Kit™ - Freeze and Vit Kit™ - Thaw from Irvine |
| Scientific Co., Inc. (K060168) | |
| Description of the Device: | RapidVit™ Cleave is used for vitrification of day 3 |
| cleavage stage embryos. The cryoprotectants 1,2- | |
| propanediol and ethylene glycol are used together | |
| with sucrose for dehydration of the embryo before | |
| cryopreservation. Then the embryos are |
:
1
immediately plunged into liquid nitrogen in order to prevent intracellular and extracellular ice crystal formation.
RapidWarm™ Cleave is used for the subsequent warming of vitrified day 3 cleavage stage embryos
Intended Use:
Rapid Vit™ Cleave is intended for vitrification of day 3 cleavage stage embryos
RapidWarm™ Cleave is intended for warming of vitrified day 3 cleavage stage embryos
Technological Characteristics:
RapidVit™ Cleave and RapidWarm™ Cleave are devices used for vitrification of day 3 cleavage stage embryos. The cryoprotectants 1,2-propanediol and ethylene glycol are
used together with sucrose for dehydration of the embryo before cryopreservation. Then the embryos are immediately plunged into liquid nitrogen in order to prevent intracellular and extracellular crystal formation.
The predicate device Vit Kit™ - Freeze/Vit Kit™ - Thaw and RapidVit™ Cleave/RapidWarm™ Cleave are embryo-physiological solutions supplemented with permeable and non-permeable cryoprotectants. Both devices are subject to the same control methods and, to a significant degree, contain the same components. They have similar handling procedures and the same sterility assurance level (10") and storage conditions.
The main differences between RapidVit™ Cleave and RapidWarm™ Cleave and Vit Kit™ - Freeze and Vit Kit™ - Thaw are the following:
- Vit Kit™ Freeze and Vit Kit™ Thaw contain ethylene glycol, DMSO and . sucrose as cryoprotectants, while RapidVit™ Cleave and RapidWarm™ Cleave contain ethylene glycol, 1,2-propanediol and sucrose
- Vit Kit™ Freeze and Vit Kit™ Thaw is intended for blastocysts stage . embryos while RapidVit™ Cleave and RapidWarm™ Cleave is intended for cleavage stage embryos
Successful vitrification of human cleavage stage embryos by use of RapidVit™ Cleave and RapidWarm™ Cleave has been clinically proven (Balaban et al. 2008).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three overlapping shapes resembling a person with outstretched arms, positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
NOV 26 2006
K080446 Re:
Trade/Device Name: RapidVit™ Cleave RapidWarm" Cleave Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: November 10, 2008 Received: November 12, 2008
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jozpu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K080446
XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
RapidVit™ Cleave RapidWarm™ Cleave
Indications for Use:
RapidVit™ Cleave is indicated for vitrification of day 3 cleavage stage embryos
RapidWarm™ Cleave is indicated for warming of vitrified day 3 cleavage stage embryos
RapidVit™ Cleavage and RapidWarm™ Cleavage are restricted to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. § 801.109)
OR
Over-the Counter Use
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number