(152 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological performance of a media supplement, with no mention of AI/ML or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a supplement for ART media used in assisted reproductive technology procedures which include gamete and embryo manipulation and culture. It is not directly applied to a patient for diagnosis, treatment, or prevention of disease.
No
The device is described as an assisted reproduction media supplement used in ART procedures for gamete and embryo manipulation and culture. Its performance studies focus on ensuring its sterility, shelf-life, and meeting certain physical and biological specifications for its intended use as a culture supplement, not on diagnosing any condition.
No
The device description clearly states it is a liquid solution consisting of human serum proteins in a saline solution, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture." This involves working with biological materials (gametes and embryos) in vitro (outside the body).
- Device Description: It's a "supplement for ART media," which is a substance added to a culture medium used to support the growth and development of cells or tissues in vitro.
- Nature of the Device: It's a "Serum Substitute Supplement" consisting of human serum proteins. While it's a supplement, its function is to provide essential components for the in vitro culture of gametes and embryos.
- Regulatory Context: The "Prescription Use (Part 21 CFR 801 Subpart D)" indicates it's a regulated medical device. While not all regulated medical devices are IVDs, the context of ART procedures strongly points towards an in vitro application.
- Performance Studies: The performance studies include testing like MEA (Mouse Embryo Assay), which is a common in vitro test used to assess the suitability of media and supplements for embryo culture.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the intended use, device description, and the nature of the procedures it supports (ART, gamete and embryo culture) clearly align with the definition of an IVD. It's a product used in vitro to support a diagnostic or therapeutic process (in this case, ART).
N/A
Intended Use / Indications for Use
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.
Product codes
MQL
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.
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 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: 7.2 7.6 O
- Osmolality, per USP: 272 288 mOsm/kg O
- Endotoxin, per USP : : No growth O
- Transportation testing per ASTM D4169-22 ●
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
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
3
Indications for Use
510(k) Number (if known) K233764
Device Name
SSS-NX (Serum Substitute Supplement-NX)
Indications for Use (Describe)
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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY K233764
| Submitter/Address | FUJIFILM Irvine Scientific, Inc.
2511 Daimler Street |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Santa Ana, CA 92705 |
| | Telephone: 949 261-7800 |
| Contact Person: | Cindy Kha
FUJIFILM Irvine Scientific, Inc.
2511 Daimler Street
Santa Ana, CA 92705
Telephone: 949 261-7800
Email:
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 a
design-related recall |
5
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.
Indications for Use
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.
Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Indications | |||
| for Use | SSS-NX (Serum | ||
| Substitute Supplement- | |||
| NX) | K983579 | ||
| Serum Substitute | |||
| Supplement (SSS) | Different - There are | ||
| differences in the subject | |||
| and predicate device | |||
| indications for use | |||
| statements; however, both | |||
| have the same intended | |||
| use (i.e., for manipulation | |||
| of gametes and embryos | |||
| and for culture use). | |||
| Intended | |||
| Use | SSS-NX is intended for | ||
| use in assisted | |||
| reproductive technology | |||
| (ART) procedures which | |||
| include gamete and | |||
| embryo manipulation and | SSS is intended for use in | ||
| assisted reproductive | |||
| procedures which include | |||
| gamete and embryo | |||
| manipulation. These | |||
| procedures include the | |||
| use of SSS as a | Same - The subject and | ||
| predicate devices include | |||
| gamete and embryo | |||
| manipulation and for | |||
| culture 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 procedures
include the use of SSS-NX
as a supplement for ART
media. | supplement for culture
medium. | |
|-----------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conditions
of Use | Rx Only | Rx Only | Same |
| Device
Materials | Plasma Protein Fraction | Plasma Protein Fraction
(mixture of separate
components on-site)
• Human Serum Albumin
(20% for use in
manufacturing
reproductive products)
• α-Globulin, Human,
Fraction IV (5% solution) | 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). |
| Aseptically
Filtered | Yes | Yes | Same |
| Sterility | Sterile (No Growth)
USP | Sterile (No Growth)
USP | 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 subject
device has a more
stringent endotoxin limit.
Differences in endotoxin
limit do not raise different
questions of safety and
effectiveness (S&E). |
| 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 | Same |
| Shelf Life | 8 months | 2 years | Different - The subject
device has a shorter shelf
life |
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: 7.2 7.6 O
- Osmolality, per USP: 272 288 mOsm/kg O
- Endotoxin, per USP : : 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.