Who is the manufacturer of ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

Artsmedia Denmark Aps filed the 510(k) submission for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (K241132).

What is the FDA product code for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

Medi-Cult Flushing Medium (K991327).

Who can help prepare an FDA 510(k) submission like ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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)

Related Devices

K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50 · Genea Biomedx Pty, Ltd. · Sep 28, 2017
K192503 — GM501 Wash with Phenol Red and Gentamicin · Hamilton Thorne Incorporated · Nov 19, 2020
K213293 — V-HEPES PLUS · Vitromed Langenfeld · Sep 14, 2022
K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium · William A. Cook Australia Pty. , Ltd. · Jan 27, 2016
K200408 — VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium · Shenzhen Vitavitro Biotech Co., Ltd. · Oct 16, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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" {1}------------------------------------------------ (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 {2}------------------------------------------------ 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, 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 {3}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary K241132 510(k) Owner/Contact details ARTSMedia Denmark ApS Kongevejen 149 2830 Virum Denmark Tina Andersen Phone: +45 53535199 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. {5}------------------------------------------------ # 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 ARTSMedia Oocyte Aspiration Medium | K991327 Medi-Cult Flushing Medium | Comparison | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | Flushing Medium is used for oocyte retrieval and oocyte washing and for holding throughout oocyte recovery. | Same Intended Use | | Conditions for Use | Prescription Use Only | Prescription Use Only | Same | | Formulation | Calcium chloride Gentamicin sulphate Glucose HEPES Human Serum Albumin Sodium pyruvate Sodium bicarbonate Magnesium sulphate Magnesium chloride Potassium chloride Sodium chloride Potassium phosphate Calcium lactate Insulin Sodium selenite Ethanolamine Milli RX Water | Earl's Balances Salt Solution (EBSS) Sodium Pyruvate Assisted Reproduction Technology Supplement (ARTS) HEPES Sodium Bicarbonate Human Serum Albumin (HAS) Penicillin Streptomycin Phenol Red | Different: The formulations of the subject and predicate devices are not the same. Differences in device formulations do not raise different questions of safety and effectiveness (S&E) | | Sterility | No growth | No growth | Same | | pH | 7.2-7.6 | Not known | Different: The pH acceptance specification for the predicate device is not known; however, this difference does not raise different questions of S&E. | | Osmolality (mOsm/kg) | 270 - 300 | Not known | Different: The osmolality acceptance specification for the predicate device is not | | Parameters | K241132 ARTSMedia Oocyte Aspiration Medium | K991327 Medi-Cult Flushing Medium | Comparison | | | | | known; however, this difference does not raise different questions of S&E. | | Mouse Embryo Assay (MEA) | 1-Cell MEA ≥ 80% embryos developed to expanded blastocysts at 96 hours following 60 minutes exposure to ARTSMedia Oocyte Aspiration Medium. | Two cell assay ≥ 80% hatching | Different: The MEA methods used for the subject and predicate are different; however, this difference does not raise different questions of S&E. | | Endotoxin (EU/ml) | <0.25 | Not know | Different: The endotoxin acceptance specification for the predicate device is not known; however, this difference does not raise different questions of S&E. | | Sterilization | Aseptic filtration | Aseptic filtration | Same | | Shelf life | 18 months | Not known | Different: The shelf-life of the predicate device is not known; however, this difference does not raise different questions of S&E. | {6}------------------------------------------------ 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. {7}------------------------------------------------ - 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.