(238 days)
Not Found
No
The device is a chemical medium for oocyte aspiration and washing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is a medium used for the retrieval and washing of human oocytes, which is a key step in assisted reproductive procedures. This direct involvement in a medical treatment process for a patient qualifies it as a therapeutic device.
No
The device is a medium used for the retrieval and washing of human oocytes, which is a procedural aid, not a diagnostic device.
No
The device description clearly states it is a medium consisting of physiological salts, energy substrates, buffering agents, Human Serum Albumin, Gentamicin Sulphate, and water, provided in pre-sterilized glass bottles. This is a physical substance, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the retrieval and washing of human oocytes. This is a procedure performed on the patient (or the biological material directly from the patient) as part of an assisted reproductive technology process.
- Device Description: The description details the composition of a medium used in a clinical procedure. It's a solution for handling biological material outside the body, but the purpose is to facilitate a clinical intervention (oocyte retrieval and preparation), not to perform a diagnostic test on the biological material to determine a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, sterility, shelf-life, and physical properties of the medium itself, ensuring its safety and suitability for the intended clinical use. They do not describe studies evaluating the medium's ability to diagnose a condition or provide information about a patient's health status.
- Key Metrics: The key metrics are quality control parameters for the medium (pH, osmolality, endotoxin, sterility, embryotoxicity), not diagnostic performance metrics like sensitivity or specificity.
IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a medium used in conjunction with a clinical procedure to obtain and handle biological material, not to perform a diagnostic test on that material.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQL
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.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
-
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 time 18 months.
- Appearance: Clear and particulate free
- pH, per USP : 7.2-7.6
- Osmolality, per USP : 270-300 mOsm/kg
- Endotoxin, per USP : = 80% embryos developed to expanded blastocysts at 96 hours following 60 minute exposure to ARTSMedia Oocyte Aspiration Medium
- Sterility, 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.
The results of the performance testing described above demonstrate that AM Oocyte Aspiration is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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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) | : 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.
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.