(127 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a cryopreservation medium, with no mention of AI or ML technologies.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used during assisted reproductive procedures for sperm cryopreservation, which is not a treatment for a disease or condition.
No
Explanation: The device is a cryopreservation medium used in assisted reproductive procedures for sperm storage, not for diagnosing a disease or condition. Its purpose is to preserve biological material, as indicated by "Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm."
No
The device description clearly states it is a "defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin," and is supplied in "sterilized vials." This indicates a physical, chemical substance, not software.
Based on the provided information, the Arctic™ Sperm Cryopreservation Medium is likely considered an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm." This involves handling and processing human biological material (sperm) in vitro (outside the body) for a medical purpose (assisted reproduction).
- Device Description: The description details a "defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin." This is a reagent or solution specifically designed to interact with biological samples in vitro.
- Testing: The product is tested for various parameters like pH, osmolality, sperm cryosurvival, endotoxin, and sterility. These are quality control tests relevant to a product used for in vitro procedures involving biological samples.
- Predicate Device: The predicate device is "Sperm Maintenance Medium with Glycerol," which is also a medium used for in vitro handling of sperm. This further supports the classification as an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and testing all align with the definition and characteristics of an IVD device used in a clinical laboratory or healthcare setting for in vitro procedures.
N/A
Intended Use / Indications for Use
Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.
Product codes
MQL
Device Description
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.
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:
- 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
- Endotoxin testing (≤1.0 EU/ml) per USP
- 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)
- Sterility - No microbiological growth
Key Metrics
- pH: 7.25-7.54
- Osmolality: 2300-2600 mOsm/kg
- Sperm Cryosurvival Assay: ≥80% of control motility
- Endotoxin: ≤1.0 EU/ml (subject device), ≤3.0 EU/ml (predicate device)
- Sterility: No microbiological growth
- Shelf-life: 18 months
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font.
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
1
Image /page/1/Picture/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with no facial details.
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.
2
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
ll.
lll.
510(k) Summary
l. General Information on Submitter
| Submitter/Address: | Irvine Scientific Sales Co., Inc.
2511 Daimler Street
Santa Ana, CA 92705
Telephone: 800-437-5706
Facsimile: 949-261-6522 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jayme Yamaguchi-Owens
Senior Manager Regulatory Affairs
Irvine Scientific
2511 Daimler Street
Santa Ana, CA 92705
Tel: 949-261-7800 ext. 254
Fax: 949-261-6522
Email: 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.
5
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 Cryopreservation | |
| Medium is intended for use in | ||
| assisted reproductive procedures | ||
| involving the cryopreservation and | ||
| storage of human sperm. | Sperm Maintenance Medium with | |
| Glycerol is intended for use in | ||
| assisted reproductive procedures | ||
| involving the cryopreservation and | ||
| storage 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 ●
6
- Endotoxin testing (≤1.0 EU/ml) per USP 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.