(240 days)
No
The device is a semen wash medium, a chemical solution, and the description focuses on its composition, sterilization, testing, and shelf-life. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for washing sperm and for sperm swim-up procedures, and it can also be used for Intra Uterine Insemination (IUI), which are all therapeutic procedures aimed at assisting fertility.
No.
The device is a medium for washing sperm and for sperm swim-up procedures, and it can also be used for IUI (intrauterine insemination). These are therapeutic/preparatory procedures, not diagnostic ones.
No
The device description clearly states it is a liquid medium composed of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water, provided in glass bottles. This is a physical substance, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic), although it's not explicitly stated in the "Intended Use" or "Device Description" sections.
Here's why:
- Intended Use: The primary intended uses are "washing of sperm and for sperm swim-up procedures." These procedures are typically performed in a laboratory setting to prepare sperm for assisted reproductive technologies (ART). While the medium is also used for IUI (which involves direct patient contact), the initial steps of sperm preparation are in vitro.
- Device Description: The description details the composition of the medium, which is a solution used to manipulate biological material (sperm) outside of the body. It also mentions testing for parameters like pH, osmolality, endotoxin, sterility, and sperm toxicity, which are relevant to the in vitro handling of sperm.
- Testing: The performance studies include a "Human Sperm Survival Assay (% motility compared with control)." This is a direct measurement of the device's effect on sperm viability in vitro.
- Predicate Device: The predicate device listed, K212410 VitaVitro® Sperm Washing Medium, is also a sperm washing medium, and such products are generally classified as IVDs.
However, it's important to note the ambiguity:
- The "Intended Use" also includes IUI, which is a procedure involving direct patient contact. This aspect could potentially lead to classification as a medical device with a different regulatory pathway.
- The document doesn't explicitly use the term "In Vitro Diagnostic" in the key sections where it would typically be found.
In conclusion, while the document doesn't definitively label it as an IVD, the nature of its intended use (sperm preparation outside the body) and the testing performed strongly suggest that it falls under the category of an In Vitro Diagnostic device. The IUI use adds a layer of complexity, but the core function of preparing sperm in vitro is characteristic of an IVD.
N/A
Intended Use / 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).
Product codes
MQL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use Only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 : 7.2-7.6 -
- Osmolality, per USP : 270-300 mOsm/kg -
- Endotoxin, per USP : : No growth -
- Transportation testing per ASTM D4169-22 (DC-13) and cap/seal leak testing using a ● method equivalent to USP on transportation-conditioned devices.
Key Metrics
- Appearance: Clear and particulate free
- pH, per USP : 7.2-7.6
- Osmolality, per USP : 270-300 mOsm/kg
- Endotoxin, per USP : : No growth
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
3
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 Semen | |||
| Wash Medium | VitaVitro® Sperm | ||
| Washing Medium | |||
| 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). | VitaVitro® Sperm | ||
| Washing Medium is | |||
| intended for preparation | |||
| and washing of sperm | |||
| for use in assisted | |||
| reproduction | |||
| procedures. VitaVitro® | |||
| Sperm Washing Medium | |||
| is also intended for use | |||
| in intrauterine | |||
| insemination | |||
| procedures. | The subject device | ||
| indications for use | |||
| statement is not | |||
| identical to the predicate | |||
| device. However, the | |||
| intended use of the | |||
| subject and predicate | |||
| device is the same (i.e., | |||
| for sperm washing, | |||
| preparation, and | |||
| intrauterine | |||
| insemination | |||
| procedures). | |||
| Conditions | |||
| for Use | Prescription Use Only | Prescription Use Only | Same |
| Formulation | Gentamicin sulphate | ||
| Glucose | |||
| HEPES | |||
| Human Serum Albumin | |||
| Sodium pyruvate | |||
| Sodium bicarbonate | |||
| Calcium chloride | |||
| Magnesium sulphate | |||
| Magnesium chloride | |||
| Potassium chloride | |||
| Sodium chloride | |||
| Potassium phosphate | |||
| Calcium lactate | |||
| Insulin | |||
| Sodium selenite | |||
| Ethanolamine | |||
| Water | Gentamicin sulphate | ||
| Glucose | |||
| HEPES | |||
| Human Serum Albumin | |||
| Sodium Pyruvate | |||
| Sodium Lactate | |||
| Taurine | |||
| Alanyl Glutamine | |||
| EDTA | |||
| Water | 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). | |||
| 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 |
| Human | |||
| Sperm | |||
| Survival | |||
| Assay (% | |||
| motility | |||
| compared | |||
| with control | |||
| after 24 | |||
| hours) | ≥ 80% | ≥ 80% | Same |
| Endotoxin | |||
| (EU/ml) | : 7.2-7.6 - |
- Osmolality, per USP : 270-300 mOsm/kg -
- Endotoxin, per USP : : No growth -
- Transportation testing per ASTM D4169-22 (DC-13) and cap/seal leak testing using a ● method equivalent to USP 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.