(133 days)
No
The description focuses on the chemical composition and physical properties of the culture medium, with no mention of AI or ML.
No
The device is described as a medium for in vitro fertilization and culture of human gametes and embryos, indicating it is used in a laboratory setting to facilitate reproduction rather than to treat a specific disease or condition in a patient.
No
The device is a medium used for in vitro fertilization and culture of human gametes and embryos, not for diagnosing a condition.
No
The device description clearly states it is a liquid medium contained in physical bottles, indicating it is a tangible product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro fertilization and culture of human gametes and embryos". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a "medium" used for the "in vitro fertilization and culture" process. Culture media used for biological samples outside the body are typically classified as IVDs.
- Anatomical Site: While the ultimate goal is implantation in the uterus, the device itself is used on biological material (gametes and embryos) outside the body.
- Intended User: The intended users are "professionals within assisted reproduction," which aligns with the use of specialized IVD products in a clinical or laboratory setting.
The device is used to perform a diagnostic or therapeutic procedure (in vitro fertilization and embryo culture) on biological samples (gametes and embryos) outside of the human body, which fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These products are intended for the in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The media can also be used for transfer.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
The SAGE 1-Step 11 medium is intended for in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The medium can also be used for transfer.
Two versions of the SAGE 1-Step™ medium are available:
- Catalogue no. 6701: SAGE 1-Step™ supplemented with Human Serum Albumin .
- Catalogue no. 6702: SAGE 1-Step™ supplemented with Serum Protein Supplement .
Both versions of SAGE 1-Step™ are aseptically filtered, light pink, non viscous solutions, which are ready to use by professionals within assisted reproduction.
The SAGE 1-Step™ media products are contained in 10 ml or 60 ml transparent Polyethylene Terephthalate Glvcol (PETG) bottles with high density polyethylene (HDPE) cap, available in a card boxes of 1 x 10 ml and 1 x 60 ml bottles. The bottles 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
human gametes and embryos, uterus
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 SAGE 1-Step™ and the predicate are similar regarding sterility, pH, and Mouse Embryo Assay (MEA) test. However, the endotoxin levels varies. Endotoxin is
§ 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
K133707 Page 1 of 4
APR 1 6 2014
K-133707 -- SAGE 1-Step™
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: April 10, 2014 |
| Device Identification
Trade name: | SAGE 1-Step™ supplemented with Human Serum Albumin |
| | SAGE 1-Step™ supplemented with Serum Protein Supplement |
| Common name: | SAGE 1-Step™ |
| Classification name: | Reproductive media and supplements (21 CFR 884.6180, Product
Code MQL) |
| Predicate device:
LifeGlobal: | LifeGlobal Global® Total® (K112083). |
Description
The SAGE 1-Step 11 medium is intended for in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The medium can also be used for transfer.
Two versions of the SAGE 1-Step™ medium are available:
- Catalogue no. 6701: SAGE 1-Step™ supplemented with Human Serum Albumin .
- Catalogue no. 6702: SAGE 1-Step™ supplemented with Serum Protein Supplement .
Both versions of SAGE 1-Step™ are aseptically filtered, light pink, non viscous solutions, which are ready to use by professionals within assisted reproduction.
The SAGE 1-Step™ media products are contained in 10 ml or 60 ml transparent Polyethylene Terephthalate Glvcol (PETG) bottles with high density polyethylene (HDPE) cap, available in a card boxes of 1 x 10 ml and 1 x 60 ml bottles. The bottles are individually labeled. The boxes also contain instruction for use provided as package insert.
1
Compositions:
The different types of components included in SAGE 1-Step™ supplemented with Human Serum Albumin and SAGE™ 1 step supplemented with Serum Protein Supplement are provided in table 1.
Indication for use
This product is intended for in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The medium can also be used for embryo transfer.
Technological Characteristics
The design of the SAGE 1-Step™ as well as the predicate listed in this submission, are based on the concept to offer the embryos various components at any time, from fertilization until blastocyst stage. Table 1 compares the technological characteristics of SAGE 1-Step™ with the predicate Global® Total®. Both similarities and differences are illustrated.
SAGE 1-Step™ is for fertilization: culture and embryo transfer. Global® Total @ is intended for culture of human embryos from zygote to blastocyst and embryo transfer. In vivo the gametes and zyqote are exposed to the same environment as the spermatozoa fertilizes the oocyte and forms the zyqote in the part of the fallopian tube called the ampulla. Thus, the intended use for the SAGE 1-StepTM is considered comparable to the predicate and the differences are not considered to represent a new intended use nor does it pose any safety or effectiveness issues.
| Product | SAGE 1-Step™
(REF 6701) | SAGE 1-Step™
(REF 6702) | Global® Total® |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Intended use | This product is
intended for the in vitro
fertilization and culture
of human gametes
and embryos from
fertilization until Day
5/6 of development.
The medium can also
be used for embryo
transfer. | This product is
intended for the in vitro
fertilization and culture
of human gametes
and embryos from
fertilization until Day
5/6 of development.
The medium can also
be used for embryo
transfer. | Culture of human
embryos from zygote
to blastocyst, and
embryo transfer. |
| Product specification | | | |
| pH | 7.2-7.4 | 7.2-7.4 | 7.2-7.4 |
| Osmolality (mOsm/kg) | 257-273 | 257-273 | 260-270 |
| Endotoxin (EU/mL) | 80% |
| Formulation | | | |
| Physiological salts | Magnesium Sulphate
Potassium Chloride
Potassium Phosphate
Sodium Chloride | Magnesium Sulphate
Potassium Chloride
Potassium Phosphate
Sodium Chloride | Calcium Chloride
Magnesium Sulphate
Potassium Chloride
Potassium Phosphate
Sodium Chloride |
| Amino Acids | Yes | Yes | Yes |
Table 1 Comparison of SAGE 1-Step™ with the predicate Global® Total®
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| Product | SAGE 1-Step™
(REF 6701) | SAGE 1-Step™
(REF 6702) | Global® Total® |
|----------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| Stable form of L-Glutamine | Alanyl-Glutamine | Alanyl-Glutamine | Glycyl-Glutamine |
| Energy sources | Glucose
Calcium-L-Lactate
Sodium Pyruvate | Glucose
Calcium-L-Lactate
Sodium Pyruvate | Glucose
Sodium-DL-Lactate
Sodium Pyruvate |
| EDTA | Yes | Yes | Yes |
| Buffer | Sodium Bicarbonate | Sodium Bicarbonate | Sodium Bicarbonate |
| Phenol Red | Yes | Yes | Yes |
| Sodium hyaluronate | 0.1 mg/mL | - | - |
| Protein source | | | |
| HSA (proteins: albumin) | 5 mg/mL | | - |
| PPF (proteins: albumin, α- and β-globulins) | - | 5 mg/mL | - |
| LGPS (proteins: albumin, α- and β-globulins) | - | - | 5 mg/mL |
| Drugs | | | |
| Gentamicin sulphate | 0.01 mg/mL | 0.01 mg/mL | 0.01 mg/mL |
The base medium of SAGE 1-Step™, as well as the predicate, is similar to the first single-step medium developed by Lawitts and Biggers (1991) and later supplemented with amino acids.
The technological characteristics of SAGE 1-Step™ are comparable to those of the predicate device. The main differences are:
- Protein supplementation: SAGE 1-Step™ is available in two ready-to-use formulations with . either Serum Protein Supplementation (REF 6702) or Human Serum Albumin (REF 6701) as protein source. The protein source of the predicate is LGPS which is similar to Serum Protein Supplementation as they both contain albumin and globulins. Human Serum Albumin is different from the protein source in the predicate, it is however a standard protein supplement used in other cleared devices for continuous culture such as Irvine Scientific Continuous Single Culture Complete (K121572).
- Sodium Hyaluronate: SAGE 1-Step™ supplemented with Human Serum Albumin is further . added Sodium Hyaluronate as a supplement to albumin. Sodium Hyaluronate is a well known component in other ART media (VitroLifes G-series (K081114, K081117, K031015)) and hyaluronan is naturally found in the female reproductive tract. Thus the addition of Sodium Hyaluronate in SAGE 1-Step™ supplemented with Human Serum Albumin (REF 6701) is not considered to represent a new technology when compared to the predicate.
- Lactate: SAGE 1-Step™ contains Ca-L-Lactate whereas the predicate contains Na-DL-. Lactate.. The concentration of L-lactate in SAGE 1-Step™ is comparable with the concentration of L-lactate in the predicate.
- Magnesium Sulphate is added in a higher concentration compared to the predicate. . However other culture media e.g Quinn 's Advantage media (K002836) also contain higher concentrations of Magnesium Sulphate and it is judged that it will not influence the performance or safety compared to the predicate device .
- Calcium: Calcium is added in the form of Ca-Lactate whereas the predicate contains Na-. Lactate. The Calcium concentration in SAGE 1-Step™ is similar to the predicate and therefore it has no impact.
3
- Stable L-Glutamine: Both SAGE 1-Step™ and the predicate contains a stable form of glutamine. Both Alanyl-Glutamine used in SAGE 1-STEP™ and Glycyl-Glutamine used in the predicate are widely used in ART media and have a history of safe use.
The differences in composition do not impact the substantial equivalence and do not raise any new types of safety or effectiveness concern.
Performance data
The product specifications for SAGE 1-Step™ and the predicate are similar regarding sterility, pH, and Mouse Embryo Assay (MEA) test. However, the endotoxin levels varies. Endotoxin is Trade/Device Name: SAGE 1-Step™ supplemented with Human Serum Albumin and SAGE 1-Step™ supplemented with Serum Protein Supplement Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: March 17, 2014 Received: March 19, 2014
Dear Tove Kjaer,
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 aboye) 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.
5
Page 2 - Tove Kjaer
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 (OS) 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/7 description: The image shows the word "Benjamin" followed by the letters "FDA" in a stylized font. The letters "FDA" are enclosed in a box-like shape. The word "sher-S" is written after the letters "FDA".
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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K 133707
Device Name
SAGE I-Step™ with Human Serum Albumin and SAGE 1-Step™ with Serum Protein Supplement
Indications for Use (Describe)
These products are intended for the in vitro fertilization and culture of human gametes and embryos from fertilization uni! Day 5/6 of development. The media can also be used for transfer.
Type of Use (Select one or both, as applicable)
D 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.
BARTER FOR FOR USE ONLY TO A WARRELLER FOR SELECT FOR A BEA 2017 11 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(· Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) [signature]
Image /page/6/Picture/14 description: The image shows the name "Benjamin R. Fisher" and the date "2014.04.16" followed by the time "08:03:02" and some illegible text. The text is in a simple, sans-serif font and is printed in black ink. The image appears to be a scan or photocopy of a document.
FORM FDA 3881 (9/13)
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