SSS-NX is intended for use in assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for ART media.

Device Description

SSS-NX (Serum Substitute Supplement-NX) is an assisted reproduction media supplement consisting of a combination of human serum proteins (approximate protein content 50 mg/mL, 5% w/v) in a saline solution. Of this, ≥83% is albumin and ≤17% is globulins. The product is supplied as a ready to use liquid in 10 mL containers distributed in a twelve (12) x 10 mL kit and a 100 mL liquid packaged in a 125 mL container.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SSS-NX (Serum Substitute Supplement-NX)
Device Type: Assisted reproduction media supplement
Predicate Device: Serum Substitute Supplement (SSS)
510(k) Number: K233764

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Predicate Device Performance	Subject Device Performance (SSS-NX)
Sterility	Sterile (No Growth) USP <71>	Sterile (No Growth) USP <71>
pH	7.2 – 7.6	7.2 – 7.6
Osmolality	272 – 288 mOSM/kg	272 – 288 mOsm/kg
Endotoxin	≤ 3.0 EU/mL	≤ 0.5 EU/mL
Mouse Embryo Assay (MEA)	1-cell: ≥ 80% embryos developed to expanded blastocyst at 96 hours	1-cell: ≥ 80% embryos developed to expanded blastocyst at 96 hours
Clarity/Color	(Not explicitly stated for predicate; expected to be similar based on "general requirements")	Amber, Clear, Free of particulate matter
Shelf Life	2 years	8 months

Note: While the "Indications for Use" statement differs between the subject and predicate devices, the "Intended Use" is considered the same: for manipulation of gametes and embryos and for culture use. The differences in device materials do not raise different questions of safety and effectiveness. The subject device has a more stringent endotoxin limit than the predicate, which is considered an improvement and does not raise different safety and effectiveness concerns. The shorter shelf life for the subject device is noted but not presented as a failure of acceptance criteria, as it was supported by testing.

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

The provided document describes testing for a reproductive media supplement, not a diagnostic or AI-powered device. Therefore, the concept of a "test set" in the context of imaging or algorithm performance is not applicable here.

Sample Size: The document does not specify the exact sample size for each test (e.g., how many batches for sterility, how many embryos for MEA). It implies that testing was performed on sufficient samples to meet the specified criteria.
Data Provenance: Not applicable in the traditional sense for this type of product. The data is generated through laboratory testing of the manufactured product (SSS-NX). There is no mention of country of origin of data or retrospective/prospective clinical data for human subjects because it is a manufacturing component, not a device directly used in a patient.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As this is a reproductive media supplement, the "ground truth" is established through standardized laboratory assays and physical/chemical property measurements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for this product is determined by objective laboratory tests and adherence to specified ranges (e.g., pH, osmolality, sterility) and biological performance (MEA). There would be no expert adjudication in the manner of diagnostic interpretation.

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

Not applicable. This type of study is relevant for AI-assisted diagnostic devices involving human readers interpreting medical images or data. SSS-NX is a laboratory reagent.

6. Standalone Performance Study (Algorithm Only)

Not applicable. SSS-NX is a physical product (a liquid supplement), not an algorithm or software. Its performance is measured directly by laboratory tests.

7. Type of Ground Truth Used

The ground truth for this device is based on:

Laboratory Assay Results:
- Sterility (absence of microbial growth per USP <71>)
- Endotoxin levels (per USP <85>)
- pH (per USP <791>)
- Osmolality (per USP <785>)
- Mouse Embryo Assay (MEA) performance (percentage of 1-cell embryos developing to expanded blastocyst at 96 hours). This is a biological performance test to ensure the media supports embryo development.
Physical/Chemical Properties: Clarity and Color.
Standards Adherence: ISO 13408-1:2008, ISO 13408-2:2018, ASTM F1980-21, ASTM D4169-22.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this product.

Summary

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April 24, 2024

FUJIFILM Irvine Scientific Cindy Kha Regulatory Affairs Specialist II 2511 Daimler Street Santa Ana, California 92705

Re: K233764

Trade/Device Name: SSS-NX (Serum Substitute Supplement-NX) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media And Supplements Regulatory Class: II Product Code: MQL Dated: November 22, 2023 Received: November 24, 2023

Dear Cindy Kha:

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" (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).

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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.

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

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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

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Indications for Use

510(k) Number (if known) K233764

Device Name

SSS-NX (Serum Substitute Supplement-NX)

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY K233764

Submitter/Address	FUJIFILM Irvine Scientific, Inc.2511 Daimler Street
	Santa Ana, CA 92705
	Telephone: 949 261-7800
Contact Person:	Cindy KhaFUJIFILM Irvine Scientific, Inc.2511 Daimler StreetSanta Ana, CA 92705Telephone: 949 261-7800Email:cindy.kha@fujifilm.com
Date Prepared:	April 24, 2024
Trade Name:	SSS-NX (Serum Substitute Supplement-NX)
Common Name:	Assisted reproduction media supplement
Regulation Name:	Reproductive media and supplements
Regulation Number:	21 CFR 884.6180
Regulatory Class:	Class II
Product Code:	MQL (Media, Reproductive)
Predicate Device:	Serum Substitute Supplement (SSS)
	510(k): K983579
	Irvine Scientific Sales Co., Inc.
	The predicate device has not been subject to adesign-related recall

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Device Description

Indications for Use

Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices

	Subject Device	Predicate Device	Comparison
Indicationsfor Use	SSS-NX (SerumSubstitute Supplement-NX)	K983579Serum SubstituteSupplement (SSS)	Different - There aredifferences in the subjectand predicate deviceindications for usestatements; however, bothhave the same intendeduse (i.e., for manipulationof gametes and embryosand for culture use).
IntendedUse	SSS-NX is intended foruse in assistedreproductive technology(ART) procedures whichinclude gamete andembryo manipulation and	SSS is intended for use inassisted reproductiveprocedures which includegamete and embryomanipulation. Theseprocedures include theuse of SSS as a	Same - The subject andpredicate devices includegamete and embryomanipulation and forculture use.

A comparison of the intended use and technological characteristics of the subject device and the predicate device is shown in the table below:

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	culture. These proceduresinclude the use of SSS-NXas a supplement for ARTmedia.	supplement for culturemedium.
Conditionsof Use	Rx Only	Rx Only	Same
DeviceMaterials	Plasma Protein Fraction	Plasma Protein Fraction(mixture of separatecomponents on-site)• Human Serum Albumin(20% for use inmanufacturingreproductive products)• α-Globulin, Human,Fraction IV (5% solution)	Different - The formulasof the subject andpredicate devices are notthe same. Differences inmedia formulations do notraise different questions ofsafety and effectiveness(S&E).
AsepticallyFiltered	Yes	Yes	Same
Sterility	Sterile (No Growth)USP <71>	Sterile (No Growth)USP <71>	Same
pH	7.2 – 7.6	7.2 – 7.6	Same
Osmolality(mOSM/kg)	272 – 288	272 – 288	Same
Endotoxin(EU/ml)	≤ 0.5	≤ 3.0	Different - The subjectdevice has a morestringent endotoxin limit.Differences in endotoxinlimit do not raise differentquestions of safety andeffectiveness (S&E).
MouseEmbryoAssay(MEA)	1-cell: ≥ 80% embryosdeveloped to expandedblastocyst at 96 hours	1-cell: ≥ 80% embryosdeveloped to expandedblastocyst at 96 hours	Same
Shelf Life	8 months	2 years	Different - The subjectdevice has a shorter shelflife

As shown in the table above, there are differences in the Indications for Use statements and technological features of the subject and predicate devices. However, the subject and predicate device have the same Intended Use and the differences in technological features do not raise different questions of safety and effectiveness.

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Non-Clinical Performance Data

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 8-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 conducted is shown below:
- Clarity/Color: Amber, Clear, Free of particulate matter o
- pH, per USP<791>: 7.2 7.6 O
- Osmolality, per USP<785>: 272 288 mOsm/kg O
- Endotoxin, per USP <85>: < 0.5 EU/mL O
- O MEA: 1-Cell System: ≥80% of embryos developed to expanded blastocyst at 96h
- Sterility, per USP<71>: No growth O
Transportation testing per ASTM D4169-22 ●

Conclusions

The results of the testing described above provide demonstrate that the SSS-NX (Serum Substitute Supplement-NX) is as safe and effective as the predicate device and supports and determination of substantial equivalence.

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.