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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called ARTSMedia Oocyte Aspiration Medium. It primarily focuses on demonstrating the substantial equivalence of this new device to a legally marketed predicate device (K991327 Medi-Cult Flushing Medium).

The information provided does not include details about a study proving that a device (algorithm/AI) meets certain acceptance criteria. Instead, it describes non-clinical performance testing for a medical medium (a solution). Therefore, the requested information regarding AI/algorithm performance, such as sample sizes for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

The document discusses the physical and chemical properties of the medium and its biological effects on mouse embryos as part of its performance testing.

Here's a breakdown of the acceptance criteria and performance for the medical medium, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (for the medical medium)

Acceptance Criteria (Specification)	Reported Device Performance (ARTSMedia Oocyte Aspiration Medium)
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

The document states these specifications were met at Time 0 and Time 18 months for shelf-life testing.

Information Not Applicable or Not Provided in the Document:

The following points are either not applicable to a medical medium or the required details are not present in this 510(k) summary, which focuses on substantial equivalence rather than a full clinical trial for an AI/algorithm.

Sample size used for the test set and the data provenance: This refers to testing of a medical medium, not an AI/algorithm on a "test set" of patient data. The document mentions "testing" (e.g., biocompatibility on samples, shelf-life testing of the product itself) but does not delineate a "test set" in the context of diagnostic performance on patient data. No data provenance (country, retrospective/prospective) is relevant or provided for this type of device testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic algorithm is not relevant to testing a chemical medium.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/diagnostic algorithms.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the chemical and biological performance of the medium against established scientific/regulatory standards (e.g., USP monographs, ISO standards, specific MEA criteria).
The sample size for the training set: Not applicable. This is a medical medium, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the non-clinical performance testing for a medical medium (ARTSMedia Oocyte Aspiration Medium) to demonstrate its substantial equivalence to a predicate device, focusing on its physical, chemical, and certain biological properties. It does not describe a study for an AI/algorithm-based device.

Summary

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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 (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

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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: +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.

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	K241132ARTSMedia OocyteAspiration Medium	K991327Medi-Cult FlushingMedium	Comparison
Indicationsfor Use	ARTSMedia OocyteAspiration Medium (AM-Oocyte Aspiration) isintended for retrieval ofhuman oocytes byfollicular aspiration orflushing. The medium canalso be used for washingof oocytes.	Flushing Medium isused for oocyte retrievaland oocyte washing andfor holding throughoutoocyte recovery.	Same Intended Use
Conditionsfor Use	Prescription Use Only	Prescription Use Only	Same
Formulation	Calcium chlorideGentamicin sulphateGlucoseHEPESHuman Serum AlbuminSodium pyruvateSodium bicarbonateMagnesium sulphateMagnesium chloridePotassium chlorideSodium chloridePotassium phosphateCalcium lactateInsulinSodium seleniteEthanolamineMilli RX Water	Earl's Balances SaltSolution (EBSS)Sodium PyruvateAssisted ReproductionTechnology Supplement(ARTS)HEPESSodium BicarbonateHuman Serum Albumin(HAS)PenicillinStreptomycinPhenol Red	Different: Theformulations of thesubject and predicatedevices are not thesame. Differences indevice formulations donot raise differentquestions of safety andeffectiveness (S&E)
Sterility	No growth	No growth	Same
pH	7.2-7.6	Not known	Different: The pHacceptancespecification for thepredicate device is notknown; however, thisdifference does notraise different questionsof S&E.
Osmolality(mOsm/kg)	270 - 300	Not known	Different: Theosmolality acceptancespecification for thepredicate device is not
Parameters	K241132ARTSMedia OocyteAspiration Medium	K991327Medi-Cult FlushingMedium	Comparison
			known; however, thisdifference does notraise different questionsof S&E.
MouseEmbryoAssay(MEA)	1-Cell MEA ≥ 80%embryos developed toexpanded blastocystsat 96 hours following60 minutes exposureto ARTSMedia OocyteAspiration Medium.	Two cell assay ≥80% hatching	Different: The MEAmethods used for thesubject and predicateare different; however,this difference does notraise different questionsof S&E.
Endotoxin(EU/ml)	<0.25	Not know	Different: Theendotoxin acceptancespecification for thepredicate device is notknown; however, thisdifference does notraise different questionsof S&E.
Sterilization	Aseptic filtration	Aseptic filtration	Same
Shelf life	18 months	Not known	Different: The shelf-lifeof the predicate deviceis not known; however,this difference does notraise different questionsof 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.

Regulation Number and Section

§ 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.