Continuous Single Culture -NX (CSCM-NX)

• K Number: K170681
• Device Name: Continuous Single Culture -NX (CSCM-NX)
• Manufacturer: Irvine Scientific Sales Co., Inc.
• Date Cleared: 2017-06-08 ( 94 days)
• Product Code: MQL MOL
• Regulation Number: 884.6180

Intended Use

The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

Device Description

The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics. This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10⁻⁶. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.

Predicate Devices

K121572

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a culture medium, and the description and performance studies focus on its chemical composition, sterility, and ability to support embryo development, with no mention of AI or ML.

Therapeutic

No.
The device is a culture medium for human gametes and embryos, which is a supportive environment for development, not a treatment or therapy itself.

Diagnostic

No

The device is a culture medium used for growing human gametes and embryos, not for diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device is a culture medium, which is a physical substance composed of various chemical components, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states it is a "culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro." The term "in vitro" is a key indicator of an IVD.
• Device Description: It is a culture medium used to support the development of human gametes and embryos outside of the body. This is a classic example of an in vitro application.
• Performance Studies: The performance studies focus on evaluating the medium's ability to support embryo development (Mouse embryo assay) and meet quality control specifications relevant to its use in a laboratory setting (pH, Osmolality, Sterility, Endotoxin, etc.). These are all tests performed in vitro to assess the performance of the medium.

While the device itself is a culture medium and not a diagnostic test that directly measures a substance or condition in a sample, it is a critical component used in an in vitro process (embryo culture) that is part of assisted reproductive technology (ART). Devices used in such in vitro procedures are typically classified as IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

Product codes

MOL

Device Description

The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics.

This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-6. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.

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

Summary of Non-clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate device:

• pH ●
• Osmolality
• . Aseptic Processing Validation testing per ISO 13408-1:2008 and ISO 13408-2:2003
• Sterility testing per USP ●
• Endotoxin testing per USP ●
• . Mouse embryo assay (MEA)

One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group.

• . Shelf-life studies (real-time and accelerated) were conducted to ensure that the following acceptance criteria for product characteristics are met at time zero and the end of shelf-life.
  • pH See table above *
  • • Osmolality - See table above
  • • 1-cell MEA - >=80% developed to the blastocyst stage at 96 hours
  • • HSSA - >=70% of original motility at 24 hours
  • Endotoxin =80% developed to the blastocyst stage at 96 hours
• HSSA: >=70% of original motility at 24 hours
• Endotoxin:

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 8, 2017

Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens Regulatory Affairs Manager 2511 Daimler Street Santa Ana, CA 92705

Re: K170681

Trade/Device Name: Continuous Single Culture® -NX (CSCM-NX) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: May 18, 2017 Received: May 23, 2017

Dear Jayme Yamaguchi-Owens:

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. 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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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170681

Device Name

Continuous Single Culture®-NX (CSCM-NX)

Indications for Use (Describe)

The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

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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510(k) Summary

-General Information on Submitter

| Submitter/Address: | Irvine Scientific Sales Co., Inc.
2511 Daimler Street
Santa Ana, CA 92705
Telephone: [phone]
Facsimile: 949-261-6522 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jayme Yamaguchi-Owens
Regulatory Affairs Manager
Irvine Scientific
2511 Daimler Street
Santa Ana, CA 92705
Tel: [phone] ext 254
Fax: [phone]
Email: [e-mail] |

II. Date Prepared: June 6, 2017

III. General Information on Device

Device Name:	Continuous Single Culture®-NX (CSCM-NX)
Common Name:	Embryo Culture Media
Classification Name:	Reproductive Media and Supplements (21 CFR 884.6180)
Product code:	MQL (Media, Reproductive)
Regulatory Class:	II
IV. Predicate Device:	Continuous Single Culture Complete (K121572) manufactured by Irvine Scientific Sales Co., Inc. This

V. Description of the Device:

The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics.

related recalls.

predicate device has not been subject to any design

This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10° The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.

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VI. Indication for Use:

The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

VII. Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices

| Device & Predicate
Device(s): | K170681
(subject device) | K121572
(predicate device) |
|----------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Same as predicate device | Continuous Single Culture complete
is intended for use as a culture
medium for human gametes and
embryos from fertilization through
day 5/6 of development in vitro. |
| pH (under 5% CO2) | Same as predicate device | 7.25-7.54 |
| Osmolality | Same as predicate device | 260-270 mOsm/kg |
| Formulation | Comparable to predicate device | 39 ingredients |

The subject and predicate devices have the same indication - culture of embryos from fertilization to blastulation. Therefore, they have the same intended use.

The subject and predicate devices have the same pH, osmolality and comparable formulations. Unlike the predicate device, the subject device does not contain human serum albumin (HSA), but needs addition of HSA before use. In addition, the concentrations of certain ingredients are modified in the subject device. The differences noted between the subject and predicate devices are minor and do not raise different questions of safety and effectiveness.

In addition to pH and osmolality, the acceptance criteria for other product characteristics of the subject device, including mouse embryo assay (MEA), human sperm survival assay (HSSA), endotoxin and sterility, are same to those of the predicate device.

VIII. Summary of Non-clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate device:

• pH ●
• Osmolality
• . Aseptic Processing Validation testing per ISO 13408-1:2008 and ISO 13408-2:2003
• Sterility testing per USP ●
• Endotoxin testing per USP ●
• . Mouse embryo assay (MEA)

Continuous Single Culture®-NX (CSCM-NX)

5

One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group.

• . Shelf-life studies (real-time and accelerated) were conducted to ensure that the following acceptance criteria for product characteristics are met at time zero and the end of shelf-life.
  • pH See table above *
  • • Osmolality - See table above
  • • 1-cell MEA - ≥80% developed to the blastocyst stage at 96 hours
  • • HSSA - ≥70% of original motility at 24 hours
  • Endotoxin ≤0.25 EU/ml (LAL) *
  • ★ Sterility - No microbiological growth
• . Stability testing was conducted to ensure that acceptance criteria for the product specifications are met after repeated opening/closing of bottles for four (4) weeks if handled appropriately.

XI. Conclusion:

The subject and predicate devices have the same intended use. Although there is a difference in formulation between the subject and predicate devices, this difference does not raise different questions of safety or effectiveness. The performance data also demonstrate that the subject device is substantially equivalent to the predicate device.