(250 days)
Not Found
No
The device is a culture medium, and the description focuses on its chemical composition, physical properties, and performance in supporting embryo development. There is no mention of AI or ML.
No
The device is a culture medium used in assisted reproductive procedures for the development of gametes and embryos, not a therapeutic device meant to treat or cure a disease or condition.
No
This device is a culture medium used for growing gametes and embryos, not for diagnosing medical conditions.
No
The device description clearly states that the device is a culture media, which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the media are used "as culture media for gametes and embryos from fertilization through day 5/6 of development." This involves examining and manipulating biological samples (gametes and embryos) in vitro (outside the body) for the purpose of assisting in reproduction.
- Device Description: The description further clarifies that the media are "culture media used in assisted reproductive procedures" and are "designed for development of the embryo from fertilization through day 5/6." This reinforces the in vitro nature of the device's function.
- Predicate Device: The predicate device listed (K170681; Continuous Single Culture®-NX (CSCM-NX)) is also a culture medium used in assisted reproductive technology, which are typically classified as IVDs.
While the device doesn't perform diagnostic testing in the traditional sense (like detecting a disease), it is a critical component used in vitro to support the development of biological samples (gametes and embryos) for a medical purpose (assisted reproduction). This aligns with the definition of an IVD, which includes reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the "examination" is the process of culturing and observing the development of the gametes and embryos in vitro.
N/A
Intended Use / Indications for Use
iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.
Product codes
MQL
Device Description
The Kitazato iMedium Single Step media are culture media used in assisted reproductive procedures. The iMedium Single Step media are designed for development of the embryo from fertilization through day 5/6 until the embryo transfer, in a continuous and uninterrupted culture system without the need to change media.
The iMedium Single Step media are provided in three variants: without protein (Model: IM-S), with human serum albumin (HSA; Model: IM-SS), and with recombinant human albumin (rHA; Model: IM-SC). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each iMedium Single Step solution is offered in three volumes (10mL, 50mL and 100mL).
Each iMedium Single Step solution is a colorless and clear fluid. The product is single-use only, provided aseptically-filtered in a container sterilized by gamma irradiation.
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
To demonstrate safety and effectiveness of iMedium Single Step media and to show substantial equivalence to the predicate device, Kitazato completed the following non-clinical tests. Results confirm that the performance specifications for the iMedium Single Step media are met.
The device passed all testing in accordance with internal requirements, national standards, and international standards shown below:
- Appearance
- pH per USP
- Osmolarity testing using freezing point depression method
- Endotoxin testing per USP (Bacterial Endotoxins Test)
- 1-Cell MEA
- Sterility testing per USP (Sterility Tests)
Shelf-life performance testing was conducted at time 0 and at the end of shelf-life (4 months realtime aged samples) to ensure the product specifications listed above were met. Real-time aged samples also underwent transportation testing per ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) and passed all testing.
Sterilization validation was tested per ISO 13408-1: 2008 / A1:2013 (Aseptic processing of health care products - Part 1: General requirements) and ISO 13408-2: 2018 (Aseptic processing of health care products - Part 2: Sterilizing filtration). The samples passed all testing.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2020
Kitazato Corporation % Michael A. Siano, MA, RAC Regulatory Affairs Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K193522
Trade/Device Name: iMedium Single Step: iMedium Single Step with HSA: iMedium Single Step with rHA Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: July 21, 2020 Received: July 23, 2020
Dear Michael A. Siano:
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.
1
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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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.
Monica D. Garcia, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193522
Device Name
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
Indications for Use (Describe)
iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K193522 – iMedium Single Step Media
1. Submission Sponsor
| Applicant: | Kitazato Corporation |
|---|---|
| Contact: | Mr. Futoshi Inoue |
| President and Representative Director | |
| Address: | 81 Nakajima |
| Fuji Shizuoka | |
| JAPAN 416-0907 | |
| Phone: | +81-545-66-2202 |
2. Correspondent Information
| Contact: | Michael A. Siano
Regulatory Affairs Consultant |
|----------|--------------------------------------------------------------------------------------------------|
| Address: | Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746 |
| Phone: | (512) 327-9997 |
| Email: | LST.AUS.ProjectManagement@ul.com |
- August 24, 2020 3. Date Prepared:
Device Identification 4.
| Device Name: | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step
with rHA |
|--------------------|------------------------------------------------------------------------------------|
| Common Name: | Culture Medium |
| Regulation Number: | 21 CFR 884.6180 |
| Regulation Name: | Reproductive media and supplements |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | Class II |
5. Predicate Device(s)
| Device Name: | Continuous Single Culture®-NX (CSCM-NX) |
|---|---|
| 510(k) Number: | K170681 |
4
Irvine Scientific Sales Co., Inc. Manufacturer:
The predicate device has not been subject to a design-related recall.
6. Device Description
The Kitazato iMedium Single Step media are culture media used in assisted reproductive procedures. The iMedium Single Step media are designed for development of the embryo from fertilization through day 5/6 until the embryo transfer, in a continuous and uninterrupted culture system without the need to change media.
The iMedium Single Step media are provided in three variants: without protein (Model: IM-S), with human serum albumin (HSA; Model: IM-SS), and with recombinant human albumin (rHA; Model: IM-SC). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each iMedium Single Step solution is offered in three volumes (10mL, 50mL and 100mL).
Each iMedium Single Step solution is a colorless and clear fluid. The product is single-use only, provided aseptically-filtered in a container sterilized by gamma irradiation.
7. Indications for Use Statement
iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.
8. Substantial Equivalence Discussion
A detailed comparison of the intended use and technological features of the subject and predicate device are described in the tables below:
| Attribute | K193522
Subject Device:
iMedium Single Step Media | K170681
Predicate Device
Continuous Single Culture-
NX | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Kitazato Corporation | Irvine Scientific Sales Co., Inc. | Different |
| Product Code | MQL | MQL | Same |
| Indications for Use | iMedium Single Step media
are intended to be used as
culture media for gametes
and embryos from
fertilization through day 5/6
of development. iMedium
Single Step media are not
intended for embryo transfer
procedures. | The Continuous Single
Culture®-NX (CSCM-NX) is
intended for use as a culture
medium for human gametes
and embryos from
fertilization through day 5/6
of development in vitro. | Different |
Table 1: Comparison of Intended use and Technological Characteristics
5
| Rx/OTC | Rx | Rx | Same |
|---|---|---|---|
| Ingredients | Sodium Chloride, Potassium | ||
| chloride, Potassium | |||
| dihydrogen phosphate, | |||
| Magnesium sulphate | |||
| heptahydrate, Sodium DL- | |||
| lactate solution, Sodium | |||
| pyruvate, D-glucose, Sodium | |||
| hydrogen carbonate, Calcium | |||
| chloride dihydrate, Alanyl- | |||
| glutamine, Polyvinyl alcohol | |||
| (30,000), Gentamicin, Non- | |||
| essential amino acid, | |||
| Essential amino acid, r- | |||
| Insulin, HSA (in IM-SS | |||
| models), rHA (in IM-SC | |||
| models) | Salts, energy substrates, | ||
| buffer, nutrients | |||
| supplements, amino acids, | |||
| antibiotic | Different | ||
| Volumes | 10, 50, 100 mL | 20, 60 mL | Different |
| pH | 7.2-7.6 | 7.25–7.54 | Similar |
| Endotoxin | ≤ 0.25 EU/mL | ≤ 0.25 EU/mL | Same |
| 1-Cell Mouse Embryo | |||
| Assay (MEA) | ≥ 80 % embryos developed | ||
| to expanded blastocyst at 96 | |||
| hours | ≥ 80 % developed to the | ||
| blastocyst stage at 96 hours | Same | ||
| Sterility | No growth | No growth | Same |
| Storage Condition | 2 – 8 °C | 2 – 8 °C | Same |
| Shelf Life | 4 months | 4 months | Same |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Single-Use | Yes | Yes | Same |
The subject and predicate device have similar indications for use statements and have the same intended use – to culture gametes and embryos through day 5/6 of development prior to use in assisted reproductive technology procedures. The subject and predicate device have different technological characteristics, including differences in formulation, pH, specifications, and package volumes. These differences do not raise different questions of safety and effectiveness as compared to the predicate device.
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of iMedium Single Step media and to show substantial equivalence to the predicate device, Kitazato completed the following non-clinical tests. Results confirm that the performance specifications for the iMedium Single Step media are met.
6
The device passed all testing in accordance with internal requirements, national standards, and international standards shown below:
- O Appearance
- pH per USP O
- O Osmolarity testing using freezing point depression method
- Endotoxin testing per USP (Bacterial Endotoxins Test) O
- O 1-Cell MEA
- Sterility testing per USP (Sterility Tests) o
Shelf-life performance testing was conducted at time 0 and at the end of shelf-life (4 months realtime aged samples) to ensure the product specifications listed above were met. Real-time aged samples also underwent transportation testing per ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) and passed all testing.
Sterilization validation was tested per ISO 13408-1: 2008 / A1:2013 (Aseptic processing of health care products - Part 1: General requirements) and ISO 13408-2: 2018 (Aseptic processing of health care products - Part 2: Sterilizing filtration). The samples passed all testing.
10. Conclusion
The results of the performance testing described above demonstrate that iMedium Single Step media are as safe and effective as the predicate device and supports a determination of substantial equivalence.