(254 days)
K-SIBV-5000,K-SIBW-5000
No
The device description and performance studies focus on the chemical composition and physical process of vitrification and warming, with no mention of AI or ML for analysis, decision-making, or image processing.
Yes
This device is used for the vitrification and warming of human blastocysts in ART procedures, which is a therapeutic intervention aimed at helping patients achieve pregnancy.
No
Explanation: The device is for the vitrification (freezing) and warming of human blastocysts, which are procedures for preservation and recovery in ART (Assisted Reproductive Technology). It does not appear to diagnose a disease or condition. The performance studies focus on the safety and efficacy of the kits for preserving and recovering blastocysts, not for diagnostic purposes.
No
The device description clearly states the kits are comprised of HEPES buffered solutions containing physiological salts and cryoprotectants, which are chemical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "vitrification" and "warming" of human blastocysts for ART (Assisted Reproductive Technology) procedures. This involves preserving and recovering biological material (embryos) for future use in a clinical procedure.
- Device Description: The device is described as "HEPES buffered solutions containing physiological salts and the cryoprotectants ethylene glycol, DMSO and trehalose." These are media used to facilitate the freezing and thawing process of the blastocysts.
- Lack of Diagnostic Purpose: The text does not mention any intention for this device to be used to diagnose a disease, condition, or state of health. It is a tool used in a therapeutic procedure (ART).
- Performance Studies: The performance studies focus on the safety and efficacy of the media in terms of pH, osmolality, mouse embryo assay, and bacterial endotoxin. These are tests related to the quality and safety of the media for handling biological material, not diagnostic performance metrics.
- Predicate Device: The predicate device is "Irvine Scientific Vitrification," which is also a vitrification media, further supporting the classification as a device used in a procedure rather than a diagnostic test.
In summary, the Cook Sydney IVF Blastocyst Vitrification and Warming Kits are tools used in the process of preserving and recovering human embryos for ART, which is a therapeutic procedure. They do not perform any diagnostic function.
N/A
Intended Use / Indications for Use
'Cook Sydney IVF Blastocyst Vitrification Kit' is intended for the vitrification of Human blastocysts for ART procedures. This kit is designed for use with Cook Sydney IVF Blastocyst Vitrification Warming Kit
'Cook Sydney IVF Blastocyst Warming Kit' is intended for the recovery of Human blastocysts that have undergone vitrification using Cook Sydney IVF Blastocyst Vitrification Kit for ART procedures.
Blastocyst Warming Kit is intended for the recovery of human blastocysts that have undergone vitrification using Cook Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) for ART procedures.
Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction procedures. This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).
Product codes
MQL
Device Description
Cook Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification, containment and re-warming of human blastocysts as part of human ART procedures. Vitrification involves the rapid freezing of the embryo and is defined as the solidification of a solution at a temperature below its glass transition temperature by extreme elevation in viscosity using high cooling rates (15 000 to 30 000 °C/min) rather than crystallisation. The Cook Sydney IVF Vitrification and Warming Kits are comprised of HEPES buffered solutions containing physiological salts and the cryoprotectants ethylene glycol, DMSO and trehalose.
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)
Clinical Efficacy:
The vitrification media and warming kits have been used in clinical practice at Sydney IVF, Sydney, Australia. The results in clinical practice support the safety and efficacy of the product, returning a suitable pregnancy rate.
Bench Testing:
Satisfactory safety of the product has been determined through the following tests:
- pH testing
- osmolality
- two-cell mouse embryo assay (MEA)
- bacterial endotoxin (LAL)
The vitrification and warming media passed all the requirements of these tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
K0r2363
APR 2 9 2009
510(k) SUMMARY
Date:
15th December 2008
Submitted By:
- Ms Milica Talic QA/RA Manager Cook Australia 12 Electronics Street Brisbane Technology Park Eight Mile Plains Queensland, Australia. 4113
Device:
COOK Sydney IVF Blastocyst Vitrification Kit Trade Name: COOK Sydney IVF Blastocyst Warming Kit
Common name: Blastocyst Vitrification & Warming Kits
Proposed Classification Name:
Reproductive media & supplements 21 CFR Part 884.6180 (87MQL)
Class II
1
Predicate Devices:
Cook Sydney IVF Blastocyst Vitrification & Warming Kits are comparable to predicate devices described by criteria set forth in the final rule [63 FR 48428]. The predicate device used as the basis for this application is Vit Kit Freeze/Vit Kit Thaw (K060168) manufactured by Irvine Scientific Sales, Santa Ana, California.
Device Description:
Cook Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification, containment and re-warming of human blastocysts as part of human ART procedures. Vitrification involves the rapid freezing of the embryo and is defined as the solidification of a solution at a temperature below its glass transition temperature by extreme elevation in viscosity using high cooling rates (15 000 to 30 000 °C/min) rather than crystallisation. The Cook Sydney IVF Vitrification and Warming Kits are comprised of HEPES buffered solutions containing physiological salts and the cryoprotectants ethylene glycol, DMSO and trehalose.
Intend use:
'Cook Sydney IVF Blastocyst Vitrification Kit' is intended for the vitrification of Human blastocysts for ART procedures. This kit is designed for use with Cook Sydney IVF Blastocyst Vitrification Warming Kit
'Cook Sydney IVF Blastocyst Warming Kit' is intended for the recovery of Human blastocysts that have undergone vitrification using Cook Sydney IVF Blastocyst Vitrification Kit for ART procedures.
The only difference in the intended use of the Cook product and that of the predicate device relates to some wording. Irvine (the predicate's manufacturer) uses the phrase "ultra-rapid freezing" instead of vitrification, however, the meaning is the same.
2
| Device | PREDICATE | |
|---|---|---|
| Element | Cook Sydney IVF Vitrification | Irvine Scientific Vitrification |
| (K060168) | ||
| Intended Use | Cook Sydney IVF Blastocyst Vitrification | |
| Kit is intended for the vitrification and | ||
| containment of Human blastocysts for ART | ||
| procedures. This kit is designed for use with | ||
| Cook Sydney IVF Blastocyst Vitrification | ||
| Warming Kit | Vit Kit - Freeze is intended for ultra-rapid | |
| freezing and containment of human blastocysts | ||
| for Assisted Reproductive Technology | ||
| (A.R.T.) procedures. This kit is designed for | ||
| use with Irvine Scientific's Blastocyst | ||
| Vitrification Thaw Kit | ||
| (Vit Kit - Thaw) for optimal recovery of | ||
| specimens. | ||
| Cook Sydney IVF Blastocyst Warming Kit | ||
| is intended for the recovery of Human | ||
| blastocysts that have undergone vitrification | ||
| and containment using Cook Sydney IVF | ||
| Blastocyst Vitrification Kit for ART | ||
| procedures. | Vit Kit - Thaw is intended for the recovery of | |
| human blastocysts that have undergone ultra- | ||
| rapid freezing and containment using Irvine | ||
| Scientific's Blastocyst Vitrification Freeze Kit | ||
| (Vit Kit - Freeze) for Assisted Reproductive | ||
| Technology (ART) procedures. | ||
| Principal of | ||
| Operation | Provides users with the ability to cryopreserve | |
| supernumerary embryos created during the in | ||
| vitro fertilization procedure and then to re- | ||
| warm them for use at a future point in time. | Provides users with the ability to cryopreserve | |
| supernumerary embryos created during the in | ||
| vitro fertilization procedure and then to re- | ||
| warm them for use at a future point in time. | ||
| Formulation | HEPES buffered physiologic media containing | |
| ethylene glycol, DMSO, trehalose, HSA & | ||
| gentamicin in addition to the normal | ||
| physiological salts. | Media 199 based physiologic media | |
| containing, ethylene glycol, DMSO and | ||
| sucrose in addition to the normal physiological | ||
| salts | ||
| Package | Borosilicate Class I vials packaged into a | |
| cardboard outer box | Borosilicate Class I vials |
Comparison to the predicate device:
Clinical Efficacy:
The vitrification media and warming kits have been used in clinical practice at Sydney IVF, Sydney, Australia. The results in clinical practice support the safety and efficacy of the product, returning a suitable pregnancy rate.
..
Bench Testing:
Satisfactory safety of the product has been determined through the following tests:
- . pH testing
- 미 osmolality
- two-cell mouse embryo assay (MEA) I
- bacterial endotoxin (LAL) 트
The vitrification and warming media passed all the requirements of these tests.
COOK Australia verify the following items have been met:
- This summary includes only information that is provided in the body of this . 510(k).
3
- This summary does not contain any puffery or unsubstantiated labelling claims. .
- This summary does not contain any raw data, it contains only summary data. .
- This summary does not contain any trade secret or confidential commercial . information.
- This summary does not contain any patient identification information. .
The device is similar with respect to intended use & technological characteristics to the FDA published predicate device description.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gus Taddeo Managing Director William A. Cook Australia PTY, Ltd. 12 Electronics Street Eight Mile Plains Queensland 4113 AUSTRALIA
APR 2 9 2009
Re: K082363
Trade/Device Name: Cook Sydney IVF Blastocyst Vitrification Kit Cook Sydney IVF Blastocyst Warming Kit Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product code: MQL Dated: March 26, 2009 Received: April 17, 2009
Dear Mr. Taddeo:
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 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-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.
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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 892.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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): K082363
Device Name: Cook Sydney IVF Blastocyst Warming Kit
Indications for Use:
Blastocyst Warming Kit is intended for the recovery of human blastocysts that have Diastooyst Warming This Internet Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) for ART procedures.
Prescription Use Y (Part 21 CFR 801 Subpart AND/OR D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1
Hula Peine
Division Sign-Off Division of Reproductive, Abdominal, and Radiological De 510(k) Number
7
INDICATIONS FOR USE
510(k) Number (if known): K082363
Device Name: Cook Sydney IVF Blastocyst Vitrification Kit
Indications for Use:
Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted Diastooyot . This sit is designed for use with Blastocyst Warming Kit (K-SIBW-5000)
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Hut Leinen
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number