Continuous Single Culture-NX Complete (CSCM-NXC)

K170602 · Irvine Scientific Sales Co., Inc. · MQL · Jun 7, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K170602
• Device Name: Continuous Single Culture-NX Complete (CSCM-NXC)
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jun 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

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 Story

CSCM-NXC is a liquid culture medium for human gametes and embryos; used in IVF laboratories by embryologists. Input: gametes/embryos; Output: culture environment supporting development from fertilization to blastulation and subsequent uterine transfer. Device provides necessary salts, energy substrates, amino acids, buffering agents, nutrients, antibiotics, and human serum albumin. Used in clinical IVF settings; supports embryo development in vitro. Healthcare providers use the medium to maintain embryo viability during culture and transfer, potentially improving IVF success rates. Supplied as single-use, aseptically filled 20 mL bottles.

Clinical Evidence

Bench testing only. Performance supported by pH, osmolality, and sterility testing (USP <71>). Aseptic processing validated per ISO 13408-1/2. Endotoxin testing per USP <85>. Mouse embryo assay (MEA) demonstrated ≥80% development to blastocyst stage at 96 hours. Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization, and intracutaneous reactivity (ISO 10993-10). Human sperm survival assay (HSSA) showed ≥70% motility at 24 hours. Shelf-life and stability testing confirmed performance criteria met after repeated opening.

Technological Characteristics

Liquid culture medium containing salts, energy substrates, amino acids, buffering agents, nutrients, antibiotics, and human serum albumin. pH 7.25-7.54 (at 5% CO2); osmolality 260-270 mOsm/kg. Aseptically filled in 20 mL bottles; SAL 10^-3. Storage 2-8°C; 4-month shelf-life; 4-week stability after opening. Non-electronic, non-software device.

Indications for Use

Indicated for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro, including transfer of embryos to the uterus.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Continuous Single Culture Complete (K121572)

Submission Summary (Full Text)

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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, [phone], [e-mail].

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 [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,

# 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)

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.

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.<br>2511 Daimler Street<br>Santa Ana, CA 92705<br>Telephone: [phone]<br>Facsimile: 949-261-6522 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jayme Yamaguchi-Owens<br>Regulatory Affairs Manager<br>Irvine Scientific<br>2511 Daimler Street<br>Santa Ana, CA 92705<br>Tel: [phone] ext 254<br>Fax: [phone]<br>Email: [e-mail] |
| 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),<br>manufactured by Irvine Scientific Sales Co., Inc. This<br>predicate device has not been subject to any design related |

#### V. Description of the Device:

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.

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## VI. Indication for Use:

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.

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