(127 days)
Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.
The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin. The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.
This document describes the Arctic™ Sperm Cryopreservation Medium, a device intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm. The regulatory submission (K171224) demonstrates its substantial equivalence to a predicate device (Sperm Maintenance Medium with Glycerol, K991337).
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Arctic™ Sperm Cryopreservation Medium) | Reported Performance/Results (Arctic™ Sperm Cryopreservation Medium) |
|---|---|---|
| pH | 7.25 - 7.54 | Met (same as predicate) |
| Osmolality | 2300 - 2600 mOsm/kg | 2300 - 2600 mOsm/kg (within range, comparable to predicate's 2362-2532 mOsm/kg) |
| Appearance | Clear, free of particulate | Clear, free of particulate (comparable to predicate's clear, light yellow, free of particulate) |
| Formulation | 21 Ingredients | 21 Ingredients (modified from predicate's 20 ingredients) |
| Aseptic Processing Validation | Per ISO 13408-1:2008 and ISO 13408-2:2003 | Performed |
| Sterility | No microbiological growth (per USP <71>) | Met |
| Endotoxin | ≤1.0 EU/ml (per USP <85>) | ≤1.0 EU/ml (more stringent than predicate's ≤3.0 EU/ml) |
| Sperm Cryosurvival Assay (Post-thaw motility relative to control) | ≥80% of control motility | Met |
| Shelf-life (accelerated study for pH, osmolality, sperm cryosurvival, endotoxin, sterility) | pH: 7.25-7.54; Osmolality: 2300-2600 mOsm/kg; Sperm Cryosurvival: ≥80% of control motility; Endotoxin: ≤1.00 EU/ml; Sterility: No microbiological growth | Met for all criteria at time zero and end of shelf-life |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific number of samples for each test (e.g., pH, osmolality, endotoxin, sterility). For the Sperm Cryosurvival Assay, it states "Donor semen was mixed with the test medium and control (predicate device)". This suggests a comparative test using an unspecified number of donor semen samples. The data provenance is not specified regarding country of origin or whether it's retrospective or prospective; however, it is part of a regulatory submission for a medical device, implying prospective testing for the purpose of demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a cryopreservation medium, and its performance is assessed through laboratory tests (e.g., pH, osmolality, microbiological growth, sperm motility), not through expert interpretation of images or clinical outcomes that require human ground-truthing in the typical sense of diagnostic AI.
4. Adjudication method for the test set
Not applicable. The tests are laboratory-based and yield objective measurements (e.g., pH values, osmolality values, presence/absence of growth, percentage motility) which do not require an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone medical product (a cryopreservation medium). The performance tests described (e.g., pH, osmolality, sperm cryosurvival) are standalone evaluations of the product's physical, chemical, and biological properties, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for this device's performance is established by objective, quantitative laboratory measurements and established scientific standards/methods (e.g., USP <71> for sterility, USP <85> for endotoxin, specified pH and osmolality ranges, and a minimum percentage of control motility for cryosurvival).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that involves a "training set." The product is a chemical formulation.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device does not involve a training set.
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January 13, 2022
Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens Senior Manager Regulatory Affairs 2511 Daimler Street Santa Ana, CA 92705
Re: K171224
Trade/Device Name: ArcticTM Sperm Cryopreservation Medium 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 August 31, 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
August 31, 2017
Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens Senior Manager Regulatory Affairs 2511 Daimler Street Santa Ana, CA 92705
K171224 Re:
Trade/Device Name: Arctic™ Sperm Cryopreservation Medium Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: July 31, 2017 Received: August 1, 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 (DICE) 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 (DICE) 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.
Charles Viviano -S
For 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) K171224
Device Name Arctic™ Sperm Cryopreservation Medium
Indications for Use (Describe)
Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
l. 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-OwensSenior Manager Regulatory AffairsIrvine Scientific2511 Daimler StreetSanta Ana, CA 92705Tel: 949-261-7800 ext. 254Fax: 949-261-6522Email: jfy@irvinesci.com |
| Date Prepared: | August 29, 2017 |
| General Information | |
| Device Name: | Arctic™ Sperm Cryopreservation Medium |
| Common Name: | Sperm Cryopreservation Medium |
| Classification Name: | Reproductive Media and Supplements (21 CFR884.6180) |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | II |
IV. Predicate Device:
Sperm Maintenance Medium with Glycerol (K991337) manufactured by Irvine Scientific Sales, Co., Inc. This predicate device has not been subject to any design related recalls.
V. Description of the Device:
The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin.
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The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.
VI. Indications for Use
Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.
VII. Comparison of Intended Use and Technological Characteristics with the Predicate Device
| Device/Predicate Device | K171224 (subject device) | K991337 (predicate device) |
|---|---|---|
| Indications for Use | Arctic™ Sperm CryopreservationMedium is intended for use inassisted reproductive proceduresinvolving the cryopreservation andstorage of human sperm. | Sperm Maintenance Medium withGlycerol is intended for use inassisted reproductive proceduresinvolving the cryopreservation andstorage of human sperm. |
| Appearance | Clear, free of particulate | Clear, light yellow, free of particulate |
| pH | Same as predicate | 7.25-7.54 |
| Osmolality | 2300-2600 mOsm/kg | 2362-2532 mOsm/kg |
| Formulation | 21 Ingredients | 20 Ingredients |
The subject and predicate devices have the same indication - cryopreservation and storage of human sperm.
The subject and predicate devices have the same or comparable appearance, pH, and osmolality. The only differences in formulation are the replacement of L-glutamine with L-alanyl glutamine, addition of MOPS buffer, and minor modifications in concentrations of certain ingredients in the subject device. The differences noted are minor and do not raise different questions of safety andeffectiveness.
In addition to pH and osmolality, the subject and predicate devices have the same acceptance criteria for the sperm cyrosurvival assay and sterility testing, and the subject device has a more stringent acceptance criterion for endotoxin testing (≤1.0 EU/ml vs. ≤3.0 EU/ml).
VIII. Summary of Non-Clinical Performance Testing:
The following studies have been performed to support substantial equivalence to the predicate device:
- pH (7.25-7.54) ●
- Osmolality (2300-2600 mOsm/kg) ●
- Aseptic Processing Validation testing per ISO 13408-1:2008 and ISO 13408-● 2:2003
- Sterility testing (no microbiological growth) per USP <71> ●
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- Endotoxin testing (≤1.0 EU/ml) per USP <85> o
- Sperm Cryosurvival Assay
Donor semen was mixed with the test medium and control (predicate device) and cryopreserved in liquid nitrogen. After thawing, sperm motility was determined at three time points: post thaw, post gradient separation, and two (2) hours post wash. Success of this test was based on ≥80% of control motility.
- Shelf-life testing (accelerated) was conducted to ensure that the following . acceptance criteria for product characteristics are met at time zero and the end of shelf-life:
- √ pH 7.25-7.54
-
Osmolality - 2300-2600 mOsm/kg
-
Sperm Cryosurvival Assay - ≥80% of the control motility
- Endotoxin ≤1.00 EU/ml (LAL) V
- V Sterility - No microbiological growth
XI. Conclusion:
The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.
§ 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.