(150 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a cryopreservation storage device, with no mention of AI or ML capabilities.
No.
The device is described as a cryopreservation storage device for human embryos and does not mention treating or diagnosing any medical condition.
No
Explanation: The device is described as a "cryopreservation storage device" used to "contain and maintain human 4-8 cell and blastocyst stage embryos" during vitrification procedures. Its purpose is storage and maintenance, not the diagnosis of any condition or disease.
No
The device description explicitly states it is a physical cryopreservation storage device made of polystyrene and ABS, not software.
Based on the provided information, the iVitri®Straw is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "contain and maintain human 4-8 cell and blastocyst stage embryos" during vitrification procedures. This describes a device used for storage and handling of biological material, not for performing a diagnostic test on that material.
- Device Description: The description focuses on the physical characteristics of the device (stick, cap, seal, markings) and its function in containing and protecting the embryos. It does not mention any components or processes related to analyzing or testing the embryos.
- Performance Studies: The performance studies listed (cooling/warming rates, durability, endotoxin, MEA, sterilization, package integrity, shelf-life) are all related to the functionality and safety of the storage device itself, not to the diagnostic properties of the embryos or any test performed on them.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, or any other elements typically associated with an IVD device that would be used to diagnose a condition or provide information about the embryos' health or characteristics.
In summary, the iVitri®Straw is a medical device used in assisted reproductive technology (ART) procedures for the cryopreservation of embryos. Its function is to provide a safe and effective environment for storing the embryos, not to perform a diagnostic test on them.
N/A
Intended Use / Indications for Use
The iVitri®Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MOK, MQK
Device Description
The iVitri® Straw device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
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)
Non-Clinical Characteristics Performance Data:
- Cooling/warming rate testing: Evaluated the cooling and warming rates of the subject device. Temperature recording equipment was used to document the temperature profile of devices when used as prescribed in the Instructions for Use throughout the cooling and warming portions of the vitrification process. Results showed a cooling rate of -3,022°C/min, and a warming rate of +40,976°C/min.
- Durability and closure integrity testing: Assessed the integrity of the device following exposure to liquid nitrogen and subsequent 37℃ temperatures. The acceptance criteria were that devices must not exhibit any leakage, damage (breaks, etc.), deformation or discoloration. Test samples met the acceptance criteria.
- Endotoxin testing per USP:
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2018
Reprobiotech Corp. Huai L. Feng, Ph.D. Director 42-31 Colden Street. Suite 202 Flushing, NY 11355
Re: K172751
Trade/Device Name: iVitri® Straw Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MOK Dated: January 8, 2018 Received: January 16, 2018
Dear Huai L. Feng:
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 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.
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.
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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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172751
Device Name iVitri® Straw
Indications for Use (Describe)
The iVitri®Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and 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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510(K) Summary K172751 - iVitri® Straw
1. Submission Sponsor:
Reprobitech Corp.
42-31 Colden St., Suite 202 Flushing, New York 11355 Tel: (516) 301-6171 Email: Reprobiotech@gmail.com
2. Contact Person:
Dr. Huai L. Feng Director of Reprobiotech Corp. 42-31 Colden Street, Suite 202 Flushing, NY 11355 Doctorf99@gmail.com Tel: (516) 301-6171
3. Date Prepared: February 8, 2018
4. Device Information:
| Name of Device | iVitri® Straw |
|---|---|
| Common Name | Cryopreservation Storage Device |
| Classification Name | Assisted Reproduction Labware |
| Regulation | 21 CFR 884.6160 |
| Product Code | MQK (Labware, Assisted Reproduction) |
| Predicate | K162640-iVitri® EZ |
| Regulatory Class | II |
5. Predicate Device Information:
iVitri® EZ (K162640) manufactured by Reprobiotech Corp. This device has not been subject to a design-related recall.
Device Description: 6.
The iVitri® Straw device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only. Product specifications are listed in the table below:
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| Parameter | Specification |
|---|---|
| Cooling Rate | -3,022°C/min |
| Warming Rate | +40,976°C/min |
| Sterility Assurance Level (SAL) | 10-6 |
| Endotoxin | ≤0.5 EU/device |
| Mouse Embryo Assay (MEA) | 1-Cell MEA ≥80% expanded blastocyst formation at 96 hours |
7. Indication for Use:
The iVitn® Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
8. Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices:
| Parameter | K172751 (subject device) | K162640 (predicate device) |
|---|---|---|
| Indications for Use | Same as the predicate device | The iVitri® EZ is a cryopreservation storage device that is |
| intended for use in vitrification procedures to contain and | ||
| maintain human 4-8 cell and blastocyst stage embryos. | ||
| Fundamental design | Same as the predicate device | Consists of two components: a body with a tip, where the |
| embryos are loaded, and a cap. The device is closed by | ||
| surface friction of the body and cap. | ||
| Body | Same as the predicate device | Consists of a single molded polystyrene stick that |
| incorporates a curved sample loading area. | ||
| Cap | Weighted, straw-like cap | Non-weighted, stick-like cap |
| Dimensions | Overall length: 130 mm | |
| Body length: 105 mm | ||
| Cap length: 90 mm | ||
| Tip length:16 mm | Overall length: 130 mm | |
| Body length: 116 mm | ||
| Cap length: 45.5 mm | ||
| Tip length:16 mm | ||
| Loading capacity | Same as the predicate device | Maximum of 3 embryos in ≤1 μl of medium |
| Mode of action | Same as the predicate device | The device is closed prior to freezing in liquid nitrogen |
| and opened during warming (i.e., the embryos have direct | ||
| contact with warming media). | ||
| Cooling rate | -3,022°C/min | -3,020°C/min |
| Warming rate | +40,976°C/min | +40,694°C/min |
| Embryo contacting | ||
| material | Same as the predicate device | Polystyrene including colorant (blue, orange, yellow, |
| green, pink) |
The subject and predicate devices have Indications for Use, fundamental design, mode of action, material used in the embryo-contacting component, and embryo loading capacity. They also have comparable cooling and warming rates. There are differences in dimensions and design of the cap between the subject and predicate devices. However, these differences do not raise different questions of safety and effectiveness.
9. Non-Clinical Characteristics Performance Data:
As part of demonstrating substantial equivalence to the following non-clinical performance tests were conducted. The iVitri® Straw passed all of the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:
- . Cooling/warming rate testing: The purpose of this testing was to evaluate the cooling and warming rates of the subject device. Temperature recording equipment was used to document the temperature profile of devices when used as prescribed in the Instructions for Use throughout the cooling and warming portions of the vitrification process. Results showed a cooling rate of -3,022°C/min, and a warming rate of +40,976°C/min.
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- . Durability and closure integrity testing: The purpose of this testing was to assess the integrity of the device following exposure to liquid nitrogen. The samples were assembled as described in the Instructions for Use and submerged in liquid nitrogen. The samples were then exposed to 37℃ temperatures. Samples were then assessed for signs of leakage, damage (breaks, ctc.), deformation or discoloration. The acceptance criteria were that devices must not exhibit any of the failure modes described above. Test samples met the acceptance criteria.
- . Endotoxin testing per USP: