(301 days)
Not Found
No
The device description focuses on chemical solutions and their intended use in cryopreservation and warming of blastocysts. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
This device is a vitrification and warming kit used for the cryopreservation and recovery of human blastocysts, which are for Assisted Reproductive Technology (A.R.T.) procedures. While A.R.T. is a medical procedure, the device itself is for handling biological specimens rather than providing direct therapeutic treatment to a patient.
No
The device is intended for the ultra-rapid freezing and containment, and subsequent warming and recovery, of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. It is a tool for cryopreservation and recovery, not for diagnosing any condition.
No
The device description clearly states that the device consists of five solutions, which are physical components (liquids) used in a cryopreservation process. This is not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kits are for "ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures" and "recovery of human blastocysts that have undergone ultra-rapid freezing and containment... for Assisted Reproductive Technology (A.R.T.) procedures." While not a direct diagnostic test on a patient sample, these procedures are integral to the process of assessing and preparing biological material (blastocysts) for a medical procedure (A.R.T.).
- Device Description: The kits consist of solutions used to process biological material (human blastocysts) outside of the body. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the information is related to the viability and suitability of the blastocysts for A.R.T.
- Predicate Devices: The listed predicate devices (K060168 Vit Kit - Freeze and Vit Kit - Thaw; K032154 G-FreezeKit Blast; K032155 G-ThawKit Blast) are also cryopreservation and warming kits for biological samples used in A.R.T. procedures. These are typically regulated as IVDs.
While the kits themselves don't directly diagnose a disease, they are essential components in a process that involves the manipulation and assessment of human biological material (blastocysts) for a medical purpose (A.R.T.). This places them within the scope of IVD regulation.
N/A
Intended Use / Indications for Use
Vitrification Kit: These products are 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 Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens.
Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
There are five (5) solutions that comprise the two kits, Vitrification Kit and Vitrification Warming Kit.
Vitrification Kit: Consists of two solutions, Equilibration Solution (ES) and Vitrification Solution (VS) that are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts.
Equilibration Solution is used in preparation for freezing and contains dimethyl sulfoxide (DMSO) and ethylene glycol (EG).
Vitrification Solution is to be used during cryostorage and contains DMSO and EG and sucrose.
Vitrification Warming Kit: The three (3) warming solutions, 1.0 M Sucrose Warming Solution, 0.5 M Sucrose Warming Solution and MOPS Solution, are also intended for sequential use in the warming and recovery of cryopreserved human blastocysts.
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)
Not Found
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
5. 510(k) Summary
073522
OCT 1 0 2008
Image /page/0/Picture/4 description: The image shows a logo with the word "SAGE" inside of a circle. The circle is not fully complete, as there is a break in the lower right quadrant. To the right of the circle and the word "SAGE" is the word "As" but only a portion of the word is visible.
Assisted Reproduction Products TM
SAGE In-Vitro Fertilization, Inc. a CooperSurqical Company 95 Corporate Drive Trumbull, CT 06611 (203) 601-5200 FAX (203) 601-4737
Submitter's name: Address:
Phone: Fax number:
Name of contact person:
SAGE In-Vitro Fertilization 95 Corporate Drive Trumbull, CT 09911 203-601-5200 203-601-4737
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821 Email: grace@regulatoryspecialists.com
Date the summary was prepared: December 11, 2007
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Equilibration Solution Equilibration Solution Equilibration Solution Reproductive media
Vitrification Solution Vitrification Solution Vitrification Solution Reproductive media
1.0 M Sucrose Warming Solution 1.0 M Sucrose Warming Solution 1.0 M Sucrose Warming Solution Reproductive media
0.5 M Sucrose Warming Solution 0.5 M Sucrose Warming Solution 0.5 M Sucrose Warming Solution Reproductive media
MOPS Solution MOPS Solution
1
Common or usual name: Classification name:
MOPS Solution Reproductive media
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| Device | Ref# | Decided |
|---|---|---|
| Vit Kit - Freeze and Vit Kit - Thaw | K060168 | 04/24/2006 |
| G-FreezeKit Blast | K032154 | 05/07/2004 |
| G-ThawKit Blast | K032155 | 05/07/2004 |
Description of the devices:
There are five (5) solutions that comprise the two kits, Vitrification Kit and Vitrification Warming Kit.
Vitrification Kit: Consists of two solutions, Equilibration Solution (ES) and Vitrification Solution (VS) that are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts.
Equilibration Solution is used in preparation for freezing and contains dimethyl sulfoxide (DMSO) and ethylene glycol (EG).
Vitrification Solution is to be used during cryostorage and contains DMSO and EG and sucrose.
Vitrification Warming Kit: The three (3) warming solutions, 1.0 M Sucrose Warming Solution, 0.5 M Sucrose Warming Solution and MOPS Solution, are also intended for sequential use in the warming and recovery of cryopreserved human blastocysts.
Summary of the technological characteristics of both the Sage products and the Irvine Scientific products:
The technological characteristics of the Sage products as compared to the predicate products are similar in the following areas and do not compromise the safety or efficacy of the device.
- . Indications For Use
- . Formulae
- t Performance testing
- . Sterility
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 eagle with three lines representing its wings and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the eagle. The text is arranged in a circular fashion, following the curve of the border.
OCT 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SAGE In-Vitro Fertilization, Inc. c/o Ms. Grace Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K073522
Trade Name: Vitrification Kit & Vitrification Warming Kit Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: September 29, 2008 Received: September 30, 2008
Dear Ms. Holland:
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 (2) CFR Parison 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 tad tion 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 legal]y marketed predicate device results in a classification for your device and thus, permits a 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 mmber 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 24/0276-3474. 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 potain 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Joppu 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
4. Indications for Use Statement Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Vitrification Kit & Vitrification Warming Kit
Indications for Use:
Vitrification Kit: These products are 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 Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens.
Vitrification Warming Kit:_These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.
Prescription Use _ X _ X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Torn A. Why
Division of Reproductive, Abdominal, and Radiological Devi
510(k) Number K073522
Page __ 1_ of __1 __