(175 days)
Not Found
Not Found
No
The summary describes a physical cryopreservation storage device and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is described as a cryopreservation storage device intended to contain and maintain human oocytes or embryos, which is for storage and not for treating a disease or condition.
No
Explanation: The device is described as a "cryopreservation storage device" intended to "contain and maintain human oocytes" or "embryos" for vitrification procedures. Its purpose is storage and maintenance, not the diagnosis of a disease or condition.
No
The device is described as a "cryopreservation storage device" and "straw," which are physical hardware components used for storing biological material. There is no mention of software functionality.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for cryopreservation storage of human oocytes and embryos. This is a process of preserving biological material, not a diagnostic test performed in vitro (outside the body) to diagnose a condition or disease.
- Lack of Diagnostic Function: There is no mention of these devices being used to analyze samples, detect markers, or provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections (Not Found): The absence of information related to image processing, AI/ML, performance studies, and key metrics further supports that this is not a diagnostic device.
In summary, these devices are tools for preserving biological samples, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos.
The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.
Product codes
MQK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 4, 2021
Allwin Medical Devices, Inc. Digish Mehta Business Development Executive 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806
Re: K203626
Trade/Device Name: SureStrip Vitrification Straw, SureLock Vitrification Straw Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: April 30, 2021 Received: May 5, 2021
Dear Digish Mehta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203626
Device Name
SureStrip Vitrification Straw, SureLock Vitrification Straw
Indications for Use (Describe)
The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos.
The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell 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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