(121 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological performance of a buffered saline solution, 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 a solution used for manipulating gametes and embryos in assisted reproductive procedures, not for treating a disease in a patient.
No
This device is a Phosphate Buffered Saline [PBS(-)], which is a solution used for manipulating gametes and embryos in assisted reproductive procedures. It facilitates procedures like oocyte retrieval and embryo handling, but it does not diagnose a condition or disease.
No
The device description clearly indicates it is a liquid solution (Phosphate Buffered Saline) packaged in a bottle, which is a physical product, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "assisted reproductive procedures that involve the manipulation of gametes and embryos." This involves working with biological samples (gametes and embryos) in vitro (outside the body).
- Device Description: The device is a solution used for handling and maintaining these biological samples.
- Performance Studies: The performance studies include testing like "1-cell MEA: ≥80% developed to blastocyst at 96 hrs," which is a biological assay performed in vitro to assess the suitability of the solution for supporting embryo development.
- Predicate Device: The predicate device listed (K991342 Irvine Scientific, PBS 1X) is also a solution used in assisted reproductive technologies, which are typically considered IVD procedures.
While the device itself is a simple buffer solution, its intended use and the context of its application in assisted reproductive procedures strongly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the solution is used to handle and maintain the biological specimens (gametes and embryos) during procedures that are part of a diagnostic and treatment process.
N/A
Intended Use / Indications for Use
PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.
Product codes
MOL
Device Description
Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60.
PBS(-) composition:
- Sodium Chloride
- · Potassium Chloride
- Monopotassium phosphate
- Di-sodium Hydrogen Phosphate Anhydrous
PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.
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
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Summary of Performance Studies
Non-clinical performance testing demonstrated that all product specifications were met as follows:
ASSAY: Color; SPECIFICATIONS: Clear, Particle Free
ASSAY: pH; SPECIFICATIONS: 7.20-7.60
ASSAY: Osmolality; SPECIFICATIONS: 279-295mOsm/kg
ASSAY: Endotoxin; SPECIFICATIONS: =80% developed to blastocyst at 96 hrs
Shelf-life testing demonstrated that PBS(-) maintained all specifications at the end of the sixmonth shelf-life period.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
KITAZATO BioPharma Co., Ltd. % Diane Sudduth Senior Regulatory Consultant Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701
Re: K160863
Trade/Device Name: PBS(-), Phosphate Buffered Saline Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: June 23, 2016 Received: June 27, 2016
Dear Diane Sudduth:
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 (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 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 vours.
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) K160863
Device Name PBS(-), Phosphate Buffered Saline
Indications for Use (Describe)
PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.
| 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 (K160863)
1. Submission Sponsor
KITAZATO BioPharma Co., Ltd. 81 Nakajima Fuji Shizuoka, 416-0907 Japan Phone number: +81-545-66-2202 Contact: Kyoko Izumi Title: Quality Assurance Manager
2. Submission Correspondent
Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561) 305.5075 Office Phone: (512) 327.9997 Contact: Diana Sudduth, Senior Regulatory Consultant Email: project.management@emergogroup.com
3. Date Prepared
07/27/2016
4. Device Identification
| Trade/Proprietary Name: PBS(-), Phosphate Buffered Saline | |
|---|---|
| Common/Usual Name: | Phosphate Buffered Saline |
| Classification Name: | Reproductive media and supplements |
| Regulation Number: | 21 CFR 884.6180 |
| Product Code: | MQL, Reproductive media and supplements |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Device(s)
Irvine Scientific, PBS 1X (K991342)
6. Device Description
Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60.
4
PBS(-) composition:
- Sodium Chloride
- · Potassium Chloride
- Monopotassium phosphate
- Di-sodium Hydrogen Phosphate Anhydrous
PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.
7. Indication for Use
PBS(-). Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.
8. Substantial Equivalence Discussion
Differences exist in the indications for use between the predicate and subject devices. Specifically, the predicate device is indicated for additional ART procedures (embryo transfer). This difference represents a narrower indication for use for the subject device and does not represent a new intended use as both devices are used for manipulation of gametes and embryos during ART procedures.
The subject and predicate devices have the same fundamental technological characteristics. Both are buffered solutions with similar pH and osmolality ranges meeting the physiological requirements of gametes and embryos. Although there are differences in the formulations of these devices, the differences do not represent a new technology as they do not raise different questions of safety and effectiveness.
9. Performance Data
Non-clinical performance testing demonstrated that all product specifications were met as follows:
| ASSAY | SPECIFICATIONS |
|---|---|
| Color | Clear, Particle Free |
| pH | 7.20-7.60 |
| Osmolality | 279-295mOsm/kg |
| Endotoxin |