iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

K193522 · Kitazato Corporation · MQL · Aug 25, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K193522
• Device Name: iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
• Applicant: Kitazato Corporation
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended 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.

Device Story

iMedium Single Step is a culture medium for assisted reproductive technology (ART). It supports gamete and embryo development from fertilization through day 5/6 in a continuous, uninterrupted system. The device is provided in three variants: protein-free, with human serum albumin (HSA), or with recombinant human albumin (rHA). All variants contain gentamicin. It is a clear, colorless, single-use liquid supplied in 10mL, 50mL, or 100mL containers. The product is aseptically filtered and stored at 2-8°C. It is used by embryologists in clinical laboratory settings to maintain optimal environmental conditions for embryo development prior to transfer. The medium provides necessary nutrients and energy substrates to support viability and growth, allowing for continuous culture without media changes, which minimizes embryo handling and potential stress.

Clinical Evidence

Bench testing only. Performance validated via 1-cell Mouse Embryo Assay (MEA) (≥80% development to expanded blastocyst at 96 hours), pH testing (USP <791>), endotoxin testing (USP <85>, ≤0.25 EU/mL), and sterility testing (USP <71>). Shelf-life and transportation testing (ASTM D4169-16) confirmed stability over 4 months.

Technological Characteristics

Aqueous solution containing salts, energy substrates, buffers, amino acids, and gentamicin. Variants include HSA or rHA. pH 7.2-7.6. Aseptically filtered; container sterilized by gamma irradiation. Single-use. Storage 2-8°C. Shelf life 4 months. Complies with ISO 13408-1 and ISO 13408-2 for aseptic processing.

Indications for Use

Indicated for use as culture media for human gametes and embryos from fertilization through day 5/6 of development in vitro. Not for embryo transfer procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Continuous Single Culture®-NX (CSCM-NX) (K170681)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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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# 510(k) Summary

# K193522 – iMedium Single Step Media

## 1. Submission Sponsor

| Applicant: | Kitazato Corporation |
|------------|------------------------------------------------------------|
| Contact: | Mr. Futoshi Inoue<br>President and Representative Director |
| Address: | 81 Nakajima<br>Fuji Shizuoka<br>JAPAN 416-0907 |
| Phone: | [phone] |

# 2. Correspondent Information

| Contact: | Michael A. Siano<br>Regulatory Affairs Consultant |
|----------|--------------------------------------------------------------------------------------------------|
| Address: | Emergo Global Consulting, LLC<br>2500 Bee Cave Road<br>Building 1, Suite 300<br>Austin, TX 78746 |
| Phone: | [phone] |
| Email: | [e-mail] |

- August 24, 2020 3. Date Prepared:
#### Device Identification 4.

| Device Name: | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step<br>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 |

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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<br>Subject Device:<br>iMedium Single Step Media | K170681<br>Predicate Device<br>Continuous Single Culture-<br>NX | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Kitazato Corporation | Irvine Scientific Sales Co., Inc. | Different |
| Product Code | MQL | MQL | Same |
| Indications for Use | iMedium Single Step media<br>are intended to be used as<br>culture media for gametes<br>and embryos from<br>fertilization through day 5/6<br>of development. iMedium<br>Single Step media are not<br>intended for embryo transfer<br>procedures. | The Continuous Single<br>Culture®-NX (CSCM-NX) is<br>intended for use as a culture<br>medium for human gametes<br>and embryos from<br>fertilization through day 5/6<br>of development in vitro. | Different |

# Table 1: Comparison of Intended use and Technological Characteristics

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| Rx/OTC | Rx | Rx | Same |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------|
| Ingredients | Sodium Chloride, Potassium<br>chloride, Potassium<br>dihydrogen phosphate,<br>Magnesium sulphate<br>heptahydrate, Sodium DL-<br>lactate solution, Sodium<br>pyruvate, D-glucose, Sodium<br>hydrogen carbonate, Calcium<br>chloride dihydrate, Alanyl-<br>glutamine, Polyvinyl alcohol<br>(30,000), Gentamicin, Non-<br>essential amino acid,<br>Essential amino acid, r-<br>Insulin, HSA (in IM-SS<br>models), rHA (in IM-SC<br>models) | Salts, energy substrates,<br>buffer, nutrients<br>supplements, amino acids,<br>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<br>Assay (MEA) | ≥ 80 % embryos developed<br>to expanded blastocyst at 96<br>hours | ≥ 80 % developed to the<br>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.

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The device passed all testing in accordance with internal requirements, national standards, and international standards shown below:

- O Appearance
- pH per USP <791> O
- O Osmolarity testing using freezing point depression method
- Endotoxin testing per USP <85> (Bacterial Endotoxins Test) O
- O 1-Cell MEA
- Sterility testing per USP <71> (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.