ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

K241132 · Artsmedia Denmark Aps · MQL · Dec 18, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K241132
• Device Name: ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
• Applicant: Artsmedia Denmark Aps
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

Device Story

ARTSMedia Oocyte Aspiration Medium is a sterile, single-use liquid medium used during assisted reproductive technology procedures. It consists of physiological salts, energy substrates, buffering agents, Human Serum Albumin, and Gentamicin Sulphate. The medium is used by clinicians in a clinical setting to facilitate the retrieval of human oocytes via follicular aspiration or flushing, and for subsequent washing of the retrieved oocytes. The device is provided in pre-sterilized glass bottles. By providing a controlled physiological environment, the medium supports oocyte viability during the retrieval and washing process, which is a critical step in the IVF workflow. The healthcare provider uses the medium as a tool to maintain oocyte health before further laboratory processing.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity ISO 10993-5, sensitization ISO 10993-10, vaginal irritation ISO 10993-23) confirmed the formulation is non-cytotoxic, non-sensitizing, and minimally irritating. Shelf-life validation (18 months) performed per ASTM F1980-21 confirmed specifications for appearance, pH (7.2-7.6), osmolality (270-300 mOsm/kg), endotoxin (<0.25 EU/mL), sterility, and 1-cell Mouse Embryo Assay (≥80% blastocyst development). Transportation testing performed per ASTM D4169-22.

Technological Characteristics

Physiological salt solution containing Calcium chloride, Gentamicin sulphate, Glucose, HEPES, Human Serum Albumin, Sodium pyruvate, Sodium bicarbonate, Magnesium sulphate, Magnesium chloride, Potassium chloride, Potassium phosphate, Calcium lactate, Insulin, Sodium selenite, Ethanolamine, and water. Aseptically filtered. Provided in 20 mL, 50 mL, 100 mL glass bottles with Fluorotec-coated stoppers. Shelf-life 18 months at 2-8°C. Standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 13408-1/2, ASTM F1980-21, ASTM D4169-22, USP <791>, USP <785>, USP <85>, USP <71>, USP <1207.2>.

Indications for Use

Indicated for the retrieval of human oocytes by follicular aspiration or flushing, and for the washing of oocytes.

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

• Medi-Cult Flushing Medium (K991327)

Submission Summary (Full Text)

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December 18, 2024

ARTSMedia Denmark ApS Tina Andersen Executive Director RA/QA Kongeveien 149 Virum, 2830 DENMARK

K241132 Re:

> Trade/Device Name: ARTSMedia Oocyte Aspiration Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: November 21, 2024 Received: November 22, 2024

Dear Tina Andersen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Michael T. Bailey -S

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

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# Indications for Use

510(k) Number (if known) K241132

Device Name

ARTSMedia Oocyte Aspiration Medium

Indications for Use (Describe)

ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

| 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 K241132

510(k) Owner/Contact details

ARTSMedia Denmark ApS Kongevejen 149 2830 Virum Denmark Tina Andersen Phone: [phone]

Date Prepared

Trade Name Common Name Classification Name Requlation Number Product Code

Predicate Device

December 12, 2024

ARTSMedia Oocyte Aspiration Medium Assisted Reproduction Media Reproductive media and supplements 21 CFR 884.6180 MQL

K991327 Medi-Cult Flushing Medium

The predicate device has not been subject to a designrelated recall.

### Device Description

ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

ARTSMedia Oocyte Aspiration Medium consists of physiological salts, energy substrates, buffering agents, Human Serum Albumin, Gentamicin Sulphate, and water.

Furthermore, ARTSMedia Oocyte Aspiration Medium is aseptically filtered and provided in a volume of 20 mL, 50 mL, and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Oocyte Aspiration Medium is tested for pH, osmolality, embryotoxicity, endotoxin, and sterility, before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.

### Indications for Use

ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

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# Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics

A comparison of the intended use and technological features of the subject and predicate devices are described in the table below:

| Parameters | K241132<br>ARTSMedia Oocyte<br>Aspiration Medium | K991327<br>Medi-Cult Flushing<br>Medium | Comparison |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | ARTSMedia Oocyte<br>Aspiration Medium (AM-<br>Oocyte Aspiration) is<br>intended for retrieval of<br>human oocytes by<br>follicular aspiration or<br>flushing. The medium can<br>also be used for washing<br>of oocytes. | Flushing Medium is<br>used for oocyte retrieval<br>and oocyte washing and<br>for holding throughout<br>oocyte recovery. | Same Intended Use |
| Conditions<br>for Use | Prescription Use Only | Prescription Use Only | Same |
| Formulation | Calcium chloride<br>Gentamicin sulphate<br>Glucose<br>HEPES<br>Human Serum Albumin<br>Sodium pyruvate<br>Sodium bicarbonate<br>Magnesium sulphate<br>Magnesium chloride<br>Potassium chloride<br>Sodium chloride<br>Potassium phosphate<br>Calcium lactate<br>Insulin<br>Sodium selenite<br>Ethanolamine<br>Milli RX Water | Earl's Balances Salt<br>Solution (EBSS)<br>Sodium Pyruvate<br>Assisted Reproduction<br>Technology Supplement<br>(ARTS)<br>HEPES<br>Sodium Bicarbonate<br>Human Serum Albumin<br>(HAS)<br>Penicillin<br>Streptomycin<br>Phenol Red | Different: The<br>formulations of the<br>subject and predicate<br>devices are not the<br>same. Differences in<br>device formulations do<br>not raise different<br>questions of safety and<br>effectiveness (S&E) |
| Sterility | No growth | No growth | Same |
| pH | 7.2-7.6 | Not known | Different: The pH<br>acceptance<br>specification for the<br>predicate device is not<br>known; however, this<br>difference does not<br>raise different questions<br>of S&E. |
| Osmolality<br>(mOsm/kg) | 270 - 300 | Not known | Different: The<br>osmolality acceptance<br>specification for the<br>predicate device is not |
| Parameters | K241132<br>ARTSMedia Oocyte<br>Aspiration Medium | K991327<br>Medi-Cult Flushing<br>Medium | Comparison |
| | | | known; however, this<br>difference does not<br>raise different questions<br>of S&E. |
| Mouse<br>Embryo<br>Assay<br>(MEA) | 1-Cell MEA ≥ 80%<br>embryos developed to<br>expanded blastocysts<br>at 96 hours following<br>60 minutes exposure<br>to ARTSMedia Oocyte<br>Aspiration Medium. | Two cell assay ≥<br>80% hatching | Different: The MEA<br>methods used for the<br>subject and predicate<br>are different; however,<br>this difference does not<br>raise different questions<br>of S&E. |
| Endotoxin<br>(EU/ml) | <0.25 | Not know | Different: The<br>endotoxin acceptance<br>specification for the<br>predicate device is not<br>known; however, this<br>difference does not<br>raise different questions<br>of S&E. |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Shelf life | 18 months | Not known | Different: The shelf-life<br>of the predicate device<br>is not known; however,<br>this difference does not<br>raise different questions<br>of S&E. |

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As shown in the table above, there are differences in the indications for use statements of the subject and predicate device; however, the intended use of the subject and predicate device is the same. In addition, the table reflects differences in technological features of the subject and predicate devices. However, the differences do not raise different questions of safety and effectiveness.

# Summary of Non-Clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate device:

- . Biocompatibility testing was conducted in support of the subject device that will have direct contact with the patient during retrieval of human oocytes by follicular aspiration or flushing. Testing was conducted in accordance with the 2023 FDA guidance Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Testing included:
- -Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2021 -
- -Vaginal Irritation per ISO 10993-23:2021

The testing demonstrated the device formulation to be non-cytotoxic, non-sensitizing, and indicating minimally irritating according to irritation index calculation.

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- Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 & A1:2013 and ISO . 13408-2:2018.
- . Shelf-life testing was conducted under accelerated aging conditions per ASTM F1980-21 to support the 18-month shelf-life for the subject device through demonstration that the product specifications (shown below) were met at time 0and time 18 months.
- Appearance: Clear and particulate free -
- pH, per USP <791>: 7.2-7.6
- Osmolality, per USP <785>: 270-300 mOsm/kg -
- Endotoxin, per USP <85>: < 0.25 EU/mL -
- 1-cell Mouse Embryo Assay (MEA): ≥ 80% embryos developed to expanded blastocysts at 96 hours following 60 minute exposure to ARTSMedia Oocyte Aspiration Medium
- Sterility, per USP <71>: No growth -
- Transportation testing per ASTM D4169-22 (DC-13) and cap/seal leak testing using a . method equivalent to USP <1207.2> on transportation-conditioned devices.

### Conclusions

The results of the performance testing described above demonstrate that AM Occyte Aspiration is as safe and effective as the predicate device and supports a determination of substantial equivalence.