(240 days)
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.
Furthermore, ARTSMedia Semen Wash 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 Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
The provided text describes a 510(k) premarket notification for a medical device called "ARTSMedia Semen Wash Medium." It compares the new device to a predicate device and presents non-clinical performance testing. However, the document does NOT contain information about a study involving an AI/Machine Learning enabled device, human readers, or the establishment of ground truth for such a study. Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device performance for an AI/ML device.
The document is solely about a reproductive media and supplements device and its substantial equivalence based on physical and chemical properties and biocompatibility, not an AI/ML diagnostic or assistive device.
Therefore, for all the requested information, the answer will be "Not applicable / No information provided in the given text."
Here's a breakdown of why based on the input text:
- A table of acceptance criteria and the reported device performance: The document provides a table comparing characteristics like pH, Osmolality, Human Sperm Survival Assay, and Endotoxin for the subject and predicate devices. These are "performance" metrics for a biological solution, but not for an AI/ML device's diagnostic accuracy or similar.
| Parameter | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ARTSMedia Semen Wash Medium) |
|---|---|---|
| Human Sperm Survival Assay (% motility compared with control after 24 hours) | ≥ 80% | ≥ 80% |
| Endotoxin (EU/ml) | < 0.25 | < 0.25 |
| pH | 7.2-7.6 | 7.2-7.6 |
| Osmolality (mOsm/kg) | 270 - 300 | 270 - 300 |
| Sterility | No growth | No growth |
- Sample sized used for the test set and the data provenance: Not applicable. The "testing" here refers to chemical, biological, and sterility tests on the medium itself, not a test set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant here.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance with and without an AI assistant, which is not relevant to this product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This product is a physical medium, not an algorithm.
- The type of ground truth used: Not applicable. The performance metrics are direct measurements from laboratory tests (e.g., pH meter, osmolality meter, sperm survival assays).
- The sample size for the training set: Not applicable. This is not an AI/ML product.
- How the ground truth for the training set was established: Not applicable.
The provided document is a 510(k) clearance letter for a non-AI/ML medical device. Your request pertains specifically to AI/ML device performance and testing.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 18, 2024
ARTSMedia Denmark ApS Tina Andersen Executive Director RA/QA Kongevejen 149 Virum. 2830 DENMARK
Re: K241095
Trade/Device Name: ARTSMedia Semen Wash 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.
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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" (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 QS 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 Rule"). 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) K241095
Device Name ARTSMedia Semen Wash Medium
Indications for Use (Describe)
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
Type of Use (Select one or both, as applicable):
| ☒ Remediation Use (Part 21 CFR 601 Subpart E) |
|---|
| ☐ Same Therapeutic Use (21 CFR 314.54) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K241095
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 18, 2024
ARTSMedia Semen Wash Medium Reproductive media and supplements Media, Reproductive 21 CFR 884.6180 MQL
K212410 VitaVitro® Sperm Washing Medium
This predicate device has not been subject to a design related recall.
Device Description
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.
Furthermore, ARTSMedia Semen Wash 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 Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity 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 Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
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:
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| Parameters | K241095 | K212410 | Comparison |
|---|---|---|---|
| ARTSMedia SemenWash Medium | VitaVitro® SpermWashing Medium | ||
| Indicationsfor Use | ARTSMedia SemenWash Medium (AMSemen Wash) is intendedfor washing of sperm andfor sperm swim-upprocedures. The mediumcan also be used for IUI(Intra UterineInsemination). | VitaVitro® SpermWashing Medium isintended for preparationand washing of spermfor use in assistedreproductionprocedures. VitaVitro®Sperm Washing Mediumis also intended for usein intrauterineinseminationprocedures. | The subject deviceindications for usestatement is notidentical to the predicatedevice. However, theintended use of thesubject and predicatedevice is the same (i.e.,for sperm washing,preparation, andintrauterineinseminationprocedures). |
| Conditionsfor Use | Prescription Use Only | Prescription Use Only | Same |
| Formulation | Gentamicin sulphateGlucoseHEPESHuman Serum AlbuminSodium pyruvateSodium bicarbonateCalcium chlorideMagnesium sulphateMagnesium chloridePotassium chlorideSodium chloridePotassium phosphateCalcium lactateInsulinSodium seleniteEthanolamineWater | Gentamicin sulphateGlucoseHEPESHuman Serum AlbuminSodium PyruvateSodium LactateTaurineAlanyl GlutamineEDTAWater | Different: Theformulations of thesubject and predicatedevices are not thesame. Differences indevice formulations donot raise differentquestions of safety andeffectiveness (S&E). |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Sterility | No growth | No growth | Same |
| pH | 7.2-7.6 | 7.2-7.6 | Similar |
| Osmolality(mOsm/kg) | 270 - 300 | 270 – 300 | Same |
| HumanSpermSurvivalAssay (%motilitycomparedwith controlafter 24hours) | ≥ 80% | ≥ 80% | Same |
| Endotoxin(EU/ml) | <0.25 | <0.25 | Same |
| StorageCondition | 2-8°C | 2-8°C | Same |
| Shelf life | 18 months | 2 years | Different: The shelf-lifeof the subject andpredicate device is notthe same. Differences inshelf-life do not raisedifferent questions ofS&E. |
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As shown in the table above, there are differences in the indications for use statements and technological characteristics of the subject and predicate devices. However, as stated in the table, the differences in indications for use do not represent a new intended use and the differences in technological characteristics 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 IUI (Intra Uterine Insemination). 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.
- 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 0 and at 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 -
- Human Sperm Survival Assay (% motility compared with control): ≥ 80% -
- 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.
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Conclusions
The results of the performance testing described above demonstrate that AM Semen Wash is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.