(142 days)
No
The device description and performance studies focus on the chemical composition and biological performance of culture media, with no mention of AI/ML or image processing.
No
The devices are solutions used for the fertilization and culture of oocytes and embryos, not directly for treating a disease or condition in a patient.
No
The device description indicates that ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are solutions for fertilizing oocytes and culturing embryos, which are used in assisted reproduction. Their function is to facilitate biological processes, not to diagnose a disease or condition.
No
The device description clearly states that the device is a "non viscous solutions" contained in "bottles," indicating it is a physical product (culture media) and not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the products are for "fertilization of oocytes in vitro" and "culture of embryos in vitro." These are procedures performed outside of the human body to obtain information about the reproductive process and the viability of embryos.
- Device Description: The description details solutions used in these in vitro procedures.
- Context of Use: The products are used by "professionals within assisted reproduction," which aligns with the use of IVDs in a clinical or laboratory setting.
While the device doesn't involve image processing, AI, or analyze patient samples directly in the traditional sense of a diagnostic test, the definition of an IVD includes reagents, instruments, and systems intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for diagnosis, monitoring, or treatment. In this case, the "specimens" are oocytes and embryos, and the information gained from their fertilization and culture in vitro is crucial for the diagnosis and treatment of infertility.
The predicate devices listed (Cook IVF Fertilization Medium and Cook IVF Cleavage Medium) are also commonly classified as IVDs in the context of assisted reproductive technology.
N/A
Intended Use / Indications for Use
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
ORIGIO® Sequential Fert™ is intended for in vitro fertilization of human oocytes.
Two versions of ORIGIO® Sequential Fert™ are available:
- Catalogue no. 8301: ORIGIO® Sequential Fert™.
- Catalogue no. 8302: ORIGIO® Sequential Fert™ with phenol red.
ORIGIO® Sequential Cleav™ is intended for in vitro culture of human embryos until the 2-8 cell stage. The medium can also be used for transfer.
Two versions of ORIGIO® Sequential Cleav™ are available:
- Catalogue no. 8303: ORIGIO® Sequential Cleav™
- Catalogue no. 8304: ORIGIO® Sequential Cleav™ with phenol red
Both ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.
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
professionals within assisted reproduction.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The product specifications for ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ and the predicates are similar regarding sterility, pH, and Mouse Embryo Assay (MEA) test. The endotoxin level for ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ is lower (
§ 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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a CooperSurgical Company
K133912 Page 1 of 5
K133912
MAY 1 4 2014
510(K) SUMMARY
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Submitted by: | ORIGIO a/s
Knardrupvej 2,
2760 Måløv,
Denmark |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Tove Kjær
Director Corporate Regulatory Affairs
ORIGIO a/s |
| | Phone: +45 4679 0220
Fax: +45 4679 0300 |
| | Date Submitted: May 12, 2014 |
| Device Identification
Trade name: | ORIGIO® Sequential FertTM
ORIGIO® Sequential FertTM with phenol red
ORIGIO® Sequential CleavTM
ORIGIO® Sequential CleavTM with phenol red |
| Common name: | ORIGIO® Sequential FertTM
ORIGIO® Sequential CleavTM |
| Classification name: | Reproductive media and supplements (21 CFR 884.6180, Product
Code MQL) |
| Predicate devices:
Cook Medical: | Cook IVF Fertilization Medium and Cook IVF Cleavage Medium
(K002385). |
Description
ORIGIO® Sequential Fert™ is intended for in vitro fertilization of human oocytes.
Two versions of ORIGIO® Sequential Fert™ are available:
- Catalogue no. 8301: ORIGIO® Sequential Fert™ .
- Catalogue no. 8302: ORIGIO® Sequential Fert™ with phenol red .
ORIGIO® Sequential Cleav™ is intended for in vitro culture of human embryos until the 2-8 cell stage. The medium can also be used for transfer.
Two versions of ORIGIO® Sequential Cleav™ are available:
1
- Catalogue no. 8303: ORIGIO® Sequential Cleav™
- Catalogue no. 8304: ORIGIO® Sequential Cleav™ with phenol red
Both ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.
Indication for use
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
Technological characteristics
The design of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ as well as the predicates listed in this submission is based on each medium containing the appropriate nutrients for the embryo development stage it is intended for. Table 1 compares the technological characteristics of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ to the predicates Cook IVF Fertilization Medium and Cook IVF Cleavage Medium. Both similarities and differences are illustrated.
ORIGIO® Sequential Fert™ is for the fertilization of oocvtes in vitro. Cook IVF Fertilization Medium is intended for use during in vitro fertilization procedures for insemination and incubation of ocytes. The in vitro fertilization procedure includes insemination and incubation of the oocytes. Thus, the indication for use for ORIGIO® Sequential Fert™ is considered comparable to the predicate and the differences are not considered to represent a new intended use nor do they pose any safety or effectiveness issues.
ORIGIO® Sequential Cleav™ is for culture and transfer of embryos as the predicate Cook IVF Cleavage Medium. Thus, the intended use of ORIGIO® Sequential Cleav™ is considered identical to the predicate.
| Product | ORIGIO®
Sequential Fert™ | Cook IVF
Fertilization
Medium | ORIGIO®
Sequential Cleav™ | Cook IVF Cleavage
Medium |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | ORIGIO® Sequential
Fert™ is for the
fertilization of
oocytes in vitro. | Cook IVF
Fertilization Medium
is intended for use
during in vitro
fertilization
procedures for
insemination and
incubation of
oocytes. | ORIGIO® Sequential
Cleav™ is for the
culture of embryos
until the 2-8 cell
stage.
ORIGIO® Sequential
Cleav™ can also be
used for embryo
transfer at day 2 or
3. | Cook IVF Cleavage
Medium is intended
for use during in
vitro fertilization
procedures for
culture and transfer
of embryos. |
| Product
specification | | | | |
| Product | ORIGIO®
Sequential Fert™ | Cook IVF
Fertilization
Medium | ORIGIO®
Sequential Cleav™ | Cook IVF Cleavage
Medium |
| pH | 7.3-7.5 | 7.5-7.8 (in air)
7.3-7.5 (in 6% CO₂) | 7.2-7.4 | 7.5-7.8 (in air)
7.3-7.5 (in 6% CO₂) |
| Osmolality
(mOsm/kg) | 277-293 | 285-295 | 272-288 | 285-295 |
| Endotoxin (EU/mL) | Trade/Device Name: ORIGIO® Sequential Fert™ ORIGIO® Sequential Fert™ with phenol red ORIGIO® Sequential CleayTM ORIGIO® Sequential Cleav™ with phenol red Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: April 8, 2014 Received: April 11, 2014
Dear Tove Kjacr,
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.
6
Page 2 - Tove Kjaer
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Image /page/6/Picture/7 description: The image shows the text "Benjamin Asher-S". The text is written in a bold, sans-serif font. The letters "FDA" are stylized with a pattern of lines and shapes. The text is arranged horizontally, with "Benjamin" on the left, "FDA" in the middle, and "Asher-S" on the right.
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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133912
Device Name
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Feri™ with phenol red
Indications for Use (Describe)
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
ーズ : 【 : 【 : 【 : 】 : 】 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
156 Productions Services (101) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
8
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."
FORM FDA 3881 (9/13)
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133912
Device Name
ORIGIO& Sequential Cleavi™ and ORIGIO® Sequential Cleav™ with phenol red
Indications for Use (Describe)
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIOR Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR USE ONLY 2 2 2 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
"SC" Mublisheng Scrivace (303) +43-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
10
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."