The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus.

Device Description

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

This product is a single-use device supplied in a fill volume of 20 mL. It is aseptically filled into the sterilized bottle and has a sterility assurance level (SAL) of 10-3. 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 open/close of bottle, when it is stored at 2-8°C.

AI/ML Overview

This document describes the Continuous Single Culture®-NX Complete (CSCM-NXC), a culture medium for human gametes and embryos, and outlines the non-clinical performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists acceptance criteria for various tests but does not explicitly provide the reported device performance values for each test. It states that the "performance data also demonstrate that the subject device is substantially equivalent to the predicate device," implying the criteria were met. For some tests (pH, Osmolality, Endotoxin, Sterility), it states "Same as predicate" or provides a pass/fail criterion without a specific measured value from the study.

Test / Characteristic	Acceptance Criteria	Reported Device Performance (as stated in document)
pH (under 5% CO2)	Same as predicate (7.25-7.54)	Met acceptance criteria (implied, no specific value)
Osmolality	Same as predicate (260-270 mOsm/kg)	Met acceptance criteria (implied, no specific value)
Mouse Embryo Assay (MEA)	≥80% developed to the blastocyst stage at 96 hours	Met acceptance criteria (implied, no specific value)
Human Sperm Survival Assay (HSSA)	≥70% of original motility at 24 hours	Met acceptance criteria (implied, no specific value)
Endotoxin	≤0.25 EU/ml (LAL)	Met acceptance criteria (implied, no specific value)
Sterility	No microbiological growth	Met acceptance criteria (implied, no specific value)
Cytotoxicity	Per 10993-5:2009 (presumably pass/fail)	Met acceptance criteria (implied)
Guinea Pig Maximization Sensitization	Per ISO 10993-10:2010 (presumably pass/fail)	Met acceptance criteria (implied)
Intracutaneous Reactivity	Per ISO 10993-10:2010 (presumably pass/fail)	Met acceptance criteria (implied)
Shelf-life stability	Acceptance criteria for pH, Osmolality, 1-cell MEA, HSSA, Endotoxin, Sterility met at end of shelf-life	Met acceptance criteria (implied)
Opened bottle stability	Acceptance criteria for product characteristics met after repeated opening/closing for four weeks	Met acceptance criteria (implied)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not specify the sample size for the biological assays (MEA, HSSA) or the chemical/physical tests. It mentions "One-cell mouse embryos" were exposed for MEA, but not the number of embryos or replicates.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a premarket notification for a medical device in the US, it's highly likely the studies were conducted to US regulatory standards, but the geographical origin of the samples (e.g., human gametes for HSSA) is not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable or not provided in the context of this device. The tests described are laboratory-based, quantitative assays (e.g., pH, osmolality, embryo development percentages, bacterial growth, endotoxin levels). These are typically assessed by trained laboratory technicians against defined quantitative acceptance criteria, rather than by human experts establishing a "ground truth" through interpretation (as would be the case for an imaging AI device).

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective, quantitative measurements or established pass/fail biological assays, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. This document concerns an in vitro culture medium, and such a study design is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This is a medical device (culture medium), not an AI algorithm. Its performance is evaluated through direct laboratory testing of its effect on biological samples (mouse embryos, human sperm) and its physical/chemical properties.

7. Type of Ground Truth Used:

The ground truth used for performance evaluation is objective laboratory measurements and established biological outcomes.

For MEA: Percent development to expanded blastocyst stage.
For HSSA: Percent of original motility at 24 hours.
For chemical/physical tests: Measured values (pH, osmolality) compared to specified ranges.
For sterility/endotoxin: Absence of growth/LAL assay results compared to limits.

These are not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather quantifiable and verifiable laboratory results.

8. Sample Size for the Training Set:

Not applicable. This is a manufactured product (culture medium), not an AI/machine learning model that requires a training set. The "formulation modified from the predicate device" implies chemical engineering and biological optimization, not algorithm training.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device. The formulation would have been developed and optimized through R&D experiments guided by scientific principles and previous experience with culture media, evaluated against biological performance targets.

Summary

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January 13, 2022

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

Re: K170602

Trade/Device Name: Continuous Single Culture®-NX Complete (CSCM-NXC) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL

Dear Jayme Yamaguchi-Owens:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 7, 2017. Specifically, FDA is updating this SE Letter to include the correct version of the 510(k) Summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Monica Garcia, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-2791, monica.garcia@fda.hhs.gov.

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

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

June 7, 2017

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

Re: K170602

Trade/Device Name: Continuous Single Culture®-NX Complete (CSCM-NXC) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: May 18, 2017 Received: May 19, 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.

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.

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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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Benjamin R. Fisher -S

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) K170602

Device Name

Continuous Single Culture®-NX Complete (CSCM-NXC)

Indications for Use (Describe)

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 StreetSanta Ana, CA 92705Telephone: 800-437-5706Facsimile: 949-261-6522
Contact Person:	Jayme Yamaguchi-OwensRegulatory Affairs ManagerIrvine Scientific2511 Daimler StreetSanta Ana, CA 92705Tel: 949-261-7800 ext 254Fax: 949-261-6522Email: jfy@irvinesci.com
II. Date Prepared:	June 6, 2017

recalls.

III. General Information on Device

Device Name:	Continuous Single Culture®-NX Complete (CSCM-NXC)
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. Thispredicate device has not been subject to any design related

V. Description of the Device:

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VI. Indication for Use:

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

Device & Predicate	K170602	K121572
Device(s):	(subject device)	(predicate device)
Indications for Use	The Continuous Single Culture®-NX Complete (CSCM-NXC) isintended for use as a culturemedium for human gametes andembryos from fertilization throughday 5/6 of development in vitro.This device can be used fortransfer of embryos to the uterus.	Continuous Single Culturecomplete is intended for useas a culture medium forhuman gametes andembryos from fertilizationthrough day 5/6 ofdevelopment in vitro.
pH (under 5% CO2)	Same as predicate	7.25-7.54
Osmolality	Same as predicate	260-270 mOsm/kg
Formulation	Same ingredients as in predicate	36 ingredients

The subject and predicate devices have the same indication - culture of embryos from fertilization to blastulation. The subject device is also indicated for embryo transfer, while predicate device does not have this indication. This difference does not represent a new intended use as both devices are intended for in vitro fertilization (IVF) procedures that require transfer of embryos into the uterus, and is in-line with other devices cleared under the same regulation/product code that are used for both culture and embryo transfer.

The subject and predicate devices are composed of the same ingredients and have the same pH and osmolality specifications. The only difference is that the concentrations of certain ingredients are modified in the subject device. The difference noted is minor and does not raise different questions of safety and effectiveness.

In addition to pH and osmolality, the acceptance criteria for mouse embryo assay (MEA), human sperm survival assay (HSSA), endotoxin testing, and sterility testing for the subject device 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 ●
o Aseptic Processing Validation testing per ISO 13408-1:2008 and ISO 13408-2:2003
Sterility testing per USP <71> ●

Continuous Single Culture®-NX Complete (CSCM-NXC)

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o Endotoxin testing per USP <85>
Mouse embryo assay (MEA) o

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.

Biocompatibility studies, as follows: o
- ★ Cytotoxicity testing per 10993-5:2009
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 *
- ★ Intracutaneous Reactivity testing per ISO 10993-10:2010
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 characteristics are met after repeated opening/closing of bottles for four 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.

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.