(270 days)
No
The device is a chemical medium for enzymatic removal of cells, and the summary does not mention any computational or algorithmic components, let alone AI/ML.
No
The device is an assisted reproduction medium used to prepare oocytes for an ICSI procedure, which is a laboratory step, not a direct therapeutic intervention on a patient.
No
V-HYADASE is an assisted reproduction medium used for the enzymatic removal of cumulus and corona radiata cells from oocytes. It is a treatment medium, not a device that diagnoses a condition or disease.
No
The device is described as an "assisted reproduction medium" provided in "pre-sterilized 2 mL polypropylene copolymer (PPCO) bottles with PPCO caps." This indicates a physical substance and container, not software. The performance studies also focus on physical and chemical properties, sterility, and biological activity, not software validation.
Based on the provided information, V-HYADASE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the enzymatic removal of cells from oocytes prior to a procedure (ICSI). This is a preparatory step for a medical procedure, not a test performed in vitro to diagnose a condition or provide information about a patient's health status.
- Device Description: The description clearly states it is an "assisted reproduction medium" intended for a specific processing step of biological material.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample, detect a substance, or provide any diagnostic information. Its function is purely enzymatic processing.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. V-HYADASE does not fit this description.
N/A
Intended Use / Indications for Use
V-HYADASE is intended for the enzymatic removal of cumulus and corona radiata cells from oocytes prior to intracytoplasmic sperm injection (ICSI) procedures.
Product codes
MQL
Device Description
V-HYADASE is an assisted reproduction medium intended for the enzymatic removal of cumulus and corona radiata cells from oocyte prior to Intracytoplasmic Sperm Injection (ICSI) procedures. The medium is aseptically filtered and provided in a volume of 1 mL in pre-sterilized 2 mL polypropylene copolymer (PPCO) bottles with PPCO caps. V-HYADASE has a shelf-life of one-year when stored at 2-8°C and can be used for up to seven days after bottle opening.
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
The following studies have been performed to support substantial equivalence to the predicate device:
- Sterile filtration and aseptic fill validation, per ISO 13408-1:2008 Aseptic . Processing of Health Care Products – Part 1 General Requirements (including Amendment 1 (2013)) and ISO 13408- 2:2018 – Aseptic Processing of Health Care Products - Part 2 Sterilizing Filtration.
- Shelf-life testing was conducted to support the 12-month shelf-life for the subject . device through demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging in accordance with ASTM F1980-21. Testing was also included on aged samples demonstrating that medium in bottles can maintain their specifications after seven days of simulated use conditioning after bottle opening. Testing conducted is shown below:
- Clarity/Color: Pink rose color, no precipitates O
- pH, per USP: 7.2-7.4 O
- Osmolality, per USP: 257-273 mOsm/kg O
- Endotoxin, per USP : : No growth o
- Hyaluronidase Activity: 50-120 IU/mL
- Transportation testing per ASTM D4169-22 and USP ●
Key Metrics
Clarity/Color: Pink rose color, no precipitates
pH: 7.2-7.4
Osmolality: 257-273 mOsm/kg
Endotoxin:
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 26, 2023
VITROMED GmbH % Greg Holland Consultant Regulatory Specialists. Inc. 3722 Ave. Sausalito Irvine, CA 92606
Re: K222606
Trade/Device Name: V-HYADASE Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: April 21, 2023 Received: April 24, 2023
Dear Greg Holland:
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 (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 located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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,
Monica D. Garcia -S
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
2
Indications for Use
510(k) Number (if known) K222606
Device Name V-HYADASE
Indications for Use (Describe)
V-HYADASE is intended for the enzymatic removal of cumulus and corona radiata cells from oocytes prior to intracytoplasmic sperm injection (ICSI) procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K222606
| 510(k) Owner | VITROMED GmbH |
|---|---|
| Raiffeisenstr. 15a | |
| 40764 Langenfeld | |
| Germany | |
| Phone: +49 2173-20041-30 | |
| Facsimile: +49 2173-20041-58 |
Submission Correspondent
Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949.262.0411 Fax: 949.552.2821 Email: greq@requlatoryspecialists.com
Submission Date
Regulation Number
Product Code
Class
Predicate
Trade Name Common Name Regulation Name V-HYADASE
May 23, 2023
Assisted Reproduction Media Reproductive Media and Supplements 884.6180 MQL (Media, Reproductive) Class II
Origio A/S Synvitro Hyadase K200680
The predicate device has not been subject to a design-related recall.
Device Description
V-HYADASE is an assisted reproduction medium intended for the enzymatic removal of cumulus and corona radiata cells from oocyte prior to Intracytoplasmic Sperm Injection (ICSI) procedures. The medium is aseptically filtered and provided in a volume of 1 mL in pre-sterilized 2 mL polypropylene copolymer (PPCO) bottles with PPCO caps. V-HYADASE has a shelf-life of one-year when stored at 2-8°C and can be used for up to seven days after bottle opening. Additional information on the formulation and specifications of V-HYADASE are provided in the Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics section of this summary.
4
Indications for Use
V-HYADASE is intended for the enzymatic removal of cumulus and corona radiata cells from oocytes prior to intracytoplasmic sperm injection (ICSI) procedures.
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 device are described in the table below:
| | Subject Device
V-HYADASE
K222606 | Predicate Device
Origio A/S
SynVitro Hyadase
K200680 | Comparison |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | V-HYADASE is intended for
the enzymatic removal of
cumulus and corona radiata
cells from oocytes prior to
intracytoplasmic sperm
injection (ICSI) procedures. | SynVitro Hyadase is for the
removal of the cumulus
complex and corona radiata
surrounding the occyte in
preparation for ICSI. | There are differences in
the wording of the subject
and predicate device
indications for use
statements; however,
both have the same
intended use (i.e., for
removal of cumulus and
corona radiata cells from
oocytes prior to ICSI
fertilization). |
| Prescription Use
Only | Yes | Yes | Same |
| Formulation | Water
HEPES
Glucose, D- (+)
Calcium lactate
Gentamicin sulfate
HSA
Sodium Bicarbonate
Physiological Salts
Essential Amino Acids
Non-Essential Amino Acids
Phenol red
Hyaluronidase (Bovine
Source)
Vitamin
Citric Acid
Chelating agent
Sodium Pyruvate | Hyaluronidase (non-bovine
source)
Glucose
Sodium pyruvate
Calcium chloride
Magnesium sulphate
Sodium chloride
HEPES | Different - The formulas
of the subject and
predicate devices are not
the same. Differences in
media formulations do not
raise different questions
of safety and
effectiveness (S&E). |
| Sterilization | Aseptic Filtration, USP
- No Growth | Aseptic Filtration, USP
- No Growth | Same |
| pH | 7.20-7.40 | 7.150-7.449 | Similar |
| Osmolality
(mOSM/kg) | 257-273 | 272-288 | Similar |
| Mouse Embryo
Assay (MEA) | 1-Cell System: ≥80% of
embryos developed to
expanded blastocyst at 96h
after a 4-min exposure to V-
HYADASE | 1-Cell MEA
≥80% developed within 96
hours after a 15-second
exposure to SynVitro
Hyadase | Different - The subject
device specification
includes a longer
exposure of the medium
to mouse embryos. A
longer exposure does not
raise different questions
of S&E. |
| Endotoxin (EU/ml) | : 7.2-7.4 O- Osmolality, per USP: 257-273 mOsm/kg O
- Endotoxin, per USP : : No growth o
- Hyaluronidase Activity: 50-120 IU/mL
- Transportation testing per ASTM D4169-22 and USP ●
6
Conclusions
The results of the performance testing described above demonstrate that V-HYADASE is as safe and effective as the predicate device and support a determination of substantial equivalence.