V-HEPES PLUS

• K Number: K213293
• Device Name: V-HEPES PLUS
• Manufacturer: Vitromed Langenfeld
• Date Cleared: 2022-09-14 ( 348 days)
• Product Code: MQL
• Regulation Number: 884.6180

Intended Use

V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.

Device Description

V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months when stored at 2-8°C and can be used for up to seven days after bottle opening.

Predicate Devices

K142991

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a cell culture medium and does not mention any computational or analytical capabilities, let alone AI/ML.

Therapeutic

No.
The device is a medium used for handling and transferring oocytes and embryos, not a device that treats or cures a disease or condition.

Diagnostic

No

Explanation: The device is a medium used for oocyte collection, fertilization, washing, handling, and transfer of embryos. Its purpose is to facilitate reproductive procedures, not to diagnose a disease or condition. The performance studies focus on biocompatibility, sterility, and shelf-life, not diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "medium" provided in "bottles," indicating a physical substance and container, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states "oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures." These are all procedures performed in vitro (outside the body) involving human biological materials (oocytes and embryos).
• Device Description: The description confirms it's a "medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures." This medium is used to support and manipulate these biological materials in vitro.
• MEA Testing: The performance studies include "MEA testing (1-Cell MEA: ≥80% developed to expanded blastocysts at 96 h after 120-minute exposure)." MEA (Mouse Embryo Assay) is a common test used to assess the suitability of media for supporting embryo development in vitro. This directly relates to the in vitro diagnostic nature of the product.

While the device is also used for embryo transfer to the uterine cavity (an in vivo step), its primary function and the procedures it supports are clearly in vitro. The medium itself is used to handle and prepare the biological materials before the transfer.

Therefore, V-HEPES PLUS fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.

Product codes (comma separated list FDA assigned to the subject device)

MQL

Device Description

V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months 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

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 (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 embryo transfer procedures. Testing was conducted in accordance with the 2020 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 10993-10:2010, Vaginal Irritation per ISO 10993-23:2021. The testing demonstrated the device formulation to be non-cytotoxic, nonsensitizing, and non-irritating.
• Sterile filtration and aseptic fill validation, per ISO 13408-1:2008 and ISO 13408-2:2018.
• Shelf-life testing was conducted to support the 12-month shelf-life for the subject device through demonstration that the product specifications were met at time 0 and after accelerated aging in accordance with ASTM F1980-16.
• MEA testing, in accordance with the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices: One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 120-minute exposure to the subject device.
• Sterility, per USP : No growth.
• Transportation testing per ASTM D4169-16.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Cytotoxicity: non-cytotoxic
• Sensitization: non-sensitizing
• Irritation: non-irritating
• Shelf-life: 12 months
• Appearance: Pink rose color, no precipitates
• pH: 7.0—7.4
• Osmolality: 257-273 mOsm/kg
• Endotoxin, per USP : : No growth

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.

K142991

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

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2022

Vitromed Langenfeld c/o Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606

Re: K213293

Trade/Device Name: V-HEPES PLUS Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: August 15, 2022 Received: August 16, 2022

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. You must comply with all the Act's

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K213293

Device Name V-HEPES PLUS

Indications for Use (Describe)

V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K213293

510(k) Owner	VITROMED GmbH
	Raiffeisenstr. 15a
	40764 Langenfeld
	Germany
	Ines Diener
	Phone: [phone]
	Facsimile: [phone]

Submission Correspondent Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared

September 9, 2022

Trade Name V-HEPES PLUS Common Name Assisted Reproduction Media Requlation Name Reproductive Media and Supplements Regulation Number 21 CFR 884.6180 Class Class II Product Code MQL (Media, Reproductive) K142991 Predicate Device LifeGlobal Group, LLC LifeGlobal Global Total W/HEPES W/HSA

The predicate device has not been subject to a design-related recall.

Device Description

V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months 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-HEPES PLUS are provided in the Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics section of this summary.

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Indications for Use

V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.

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:

	K213293	K142991	Comparison
	V-HEPES PLUS	LifeGlobal Global Total
		w/HEPES w/HSA
Indications for
Use	V-HEPES PLUS is intended
for oocyte collection,
intracytoplasmic sperm
injection (ICSI) fertilization,
and oocyte and embryo
washing and handling
procedures. V-HEPES
PLUS is also intended for
transfer of embryos to the
uterine cavity.	Oocyte and embryo
washing, manipulation,
fertilization by
intracytoplasmic sperm
injection (ICSI), and
embryo transfer.	There are differences in
the indications for use
statements for the
subject and predicate
device, including use of
the subject device for
collection of aspirated
oocytes; however, the
intended uses of the
subject and predicate
devices are the same.
Conditions for
Use	Prescription Use Only	Prescription Use Only	Same
Formulation	Water; Sodium Bicarbonate;
Calcium Lactate; Potassium
Chloride; Sodium Chloride;
Magnesium Sulfate;
Potassium Phosphate;
EDTA; Phenol Red, Sodium;
Taurine; Sodium Citrate; D-
Calcium Pantothenate;
Alanyl-Glutamine; Glucose;
Sodium Pyruvate;
Gentamicin Sulfate; L-
Aspartic Acid; L-Glutamic
acid; Glycine; L-Proline; L-
Asparagine; L-Serine; L-
Arginine Hydrochloride; L-
Cystine; L-Histidine
Hydrochloride; L-Isoleucine;
L-Leucine; L-Lysine
Hydrochloride: L-
Methionine; L-
Phenylalanine; L-Threonine;
L-Tryptophan; L-Tyrosine; L-
Valine; HEPES; Human
Serum Albumin (HSA)	Sodium Chloride;
Potassium Chloride;
Calcium Chloride;
Potassium Phosphate;
Magnesium Sulfate;
Sodium Bicarbonate;
Glucose; Sodium Lactate;
Sodium Pyruvate; L-
Arginine; L-Cystine; L-
Histidine; L-Isoleucine; L-
Leucine; L-Lysine; L-
Methionine; L-
Phenylalanine; L-
Threonine; L-Tryptophan;
L-Tyrosine; L-Valine; L-
Alanine; L-Asparagine; L-
Aspartic Acid; L-Glutamic
Acid; Glycine; L-Proline; L-
Serine: Glycyl-L-
glutamine; EDTA; Phenol
Red; Gentamicin Sulfate;
Water; Human Serum
Albumin (HSA); HEPES	Different: The
formulations of the
subject and predicate
devices include the
same types of chemical
constituents; however,
the formulations are not
the identical.
Differences in device
formulations do not
raise different
questions of safety and
effectiveness (S&E).
	K213293
V-HEPES PLUS	K142991
LifeGlobal Global Total
w/HEPES w/HSA	Comparison
Sterility	No growth	Sterile (SAL 10-3)	Different: The subject
and predicate devices
are both provided
sterile; however, their
specifications are
different. This
difference in sterility
specification does not
raise a different
question of S&E.
pH	7.0-7.4	7.2-7.4	Different: The subject
device has a lower pH
range than the
predicate device. This
difference in pH range
does not raise different
questions of S&E.
Osmolality
(mOsm/kg)	257-273	260-270	Similar
Mouse Embryo
Assay (MEA)	1-Cell MEA:≥80%
developed to expanded
blastocysts at 96 h after
120-minute exposure	1-Cell MEA: ≥80%
developed to expanded
blastocysts at 96 h after
one-hour exposure	Different: The duration
of exposure of the
subject and predicate
devices to mouse
embryos are not the
same. This difference
in MEA method due to
expected worst-case
exposure of media to
oocytes/embryos
during use does not
raise different
questions of S&E.
Endotoxin
(EU/mL)	: : No growth -

• Transportation testing per ASTM D4169-16 .

Conclusions

The results of the performance testing described above demonstrate that V-HEPES PLUS is as safe and effective as the predicate device and support a determination of substantial equivalence.