(394 days)
Because no K/DEN number is provided in the "Predicate Device(s)" section, the answer is "Not Found".
Not Found
No
The device description and performance studies focus on the chemical composition and biological compatibility of culture media, with no mention of AI or ML technologies.
No
The device is a culture media used for in vitro assisted reproductive procedures, which facilitates the process but does not directly treat a disease or condition.
No
The device is a culture medium used in assisted reproductive procedures (fertilization, embryo culture, embryo transfer), not for diagnosing a condition or disease.
No
The device description clearly states it is a bicarbonate-buffered culture media composed of balanced salts, Human Serum Albumin, and other nutrient substances, which are physical components, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer." This clearly indicates the device is used outside of the body ("in vitro") for diagnostic or therapeutic purposes related to human reproduction.
- Device Description: The description confirms it's a "bicarbonate-buffered culture media" used "during assisted reproduction procedures." Culture media used to support and manipulate human cells (gametes and embryos in this case) in a lab setting fall under the scope of IVDs.
- Predicate Device: The mention of the "category of Reproductive Media (21 C.F.R. § 884.6180)" as a predicate device further solidifies its classification as an IVD. This regulation specifically covers devices used in assisted reproduction, which are considered IVDs by the FDA.
While the document doesn't mention image processing, AI, or specific performance metrics like sensitivity or specificity (which are common for some types of IVDs), the core function and intended use of this culture media for in vitro manipulation of human reproductive cells firmly place it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are intended for in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.
For in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.
Product codes (comma separated list FDA assigned to the subject device)
85MQL
Device Description
IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are bicarbonatebuffered culture media composed of a mixture of balanced salts, Human Serum Albumin and other nutrient substances. IVF™-50 includes Penicillin-G. IVF™-500 is manufactured and sold antibiotic-free or with Pc-G. The media is designed for use during assisted reproduction procedures, including fertilization, embryo culture and embryo transfer.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Because IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free are intended to come into contact with gametes, embryos and the patient during assisted reproduction procedures, Scandinavian IVF Sciences has conducted biocompatability testing on the media. This testing included cytotoxicity and rabbit vaginal irritation assays.
Prior to and as a condition for market release, each lot of IVF media is assayed by two-cell Mouse Embryo Assay, Human Sperm Survival Assay, Limulus Amebocyte Lysate (LAL) Assay. These assays are interval insu assure that the media is suitable for its intended use and does not contain unacceptable levels of toxins. Information on these assays is provided in the labeling of the products, and lot specific certificates of analysis are arailable upon request.
IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free has been used for fertilization, embryo culture and embryo transfer for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Substantial equivalence established by comparison to category of Reproductive Media (21 C.F.R. § 884.6180) as provided in the FDA's Notice of Final Rule, 63 Fed. Reg. 48428, 48430 (Sept. 10, 1998)).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K991348/52
Page 1 of 2
PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Scandinavian IVF Sciences AB
Mölndalsvägen 30
SE-412 63 Gothenberg
SWEDEN |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson
Vitrolife AB
Mölndalsvägen 30
SE-412 63 Gothenberg
SWEDEN
Tele: +46 31 721 80 00
Fax: +46 31 721 80 99 |
| Date Prepared: | April 16, 1999 |
| Trade Name: | IVFTM-50, IVFTM-500 and IVFTM-500 Antibiotic-Free |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | Substantial equivalence established by comparison
to category of Reproductive Media (21 C.F.R. §
884.6180) as provided in the FDA's Notice of Final
Rule, 63 Fed. Reg. 48428, 48430 (Sept. 10, 1998)). |
Description of the Device:
IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are bicarbonatebuffered culture media composed of a mixture of balanced salts, Human Serum Albumin and other nutrient substances. IVF™-50 includes Penicillin-G. IVF™-500 is manufactured and sold antibiotic-free or with Pc-G. The media is designed for use during assisted reproduction procedures, including fertilization, embryo culture and embryo transfer.
Intended Use:
IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are intended for in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.
1
K991348/52
Page 2 of 2
Technological Characteristics:
The technological characteristics of IVF™-50, IVF™-500 and IVF™ 500 Antibiotic Free are identical to other legally marketed culture media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.
Testing Performed:
Because IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free are intended to come into contact with gametes, embryos and the patient during assisted reproduction procedures, Scandinavian IVF Sciences has conducted biocompatability testing on the media. This testing included cytotoxicity and rabbit vaginal irritation assays.
Prior to and as a condition for market release, each lot of IVF media is assayed by two-cell Mouse Embryo Assay, Human Sperm Survival Assay, Limulus Amebocyte Lysate (LAL) Assay. These assays are interval insu assure that the media is suitable for its intended use and does not contain unacceptable levels of toxins. Information on these assays is provided in the labeling of the products, and lot specific certificates of analysis are arailable upon request.
IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free has been used for fertilization, embryo culture and embryo transfer for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.
Additional Information:
Donors of the source material for the human serum albumin are screened for CJD. The source material is also tested for HIV and hepatitis.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2000
Scandinavian IVF Sciences AB c/o Mr. Gary L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, DC 20006-1108
Re: K991348 IVF™ -50, IVF™ -500, and IVF™ -500 Antibiotic Free (assisted reproduction media) Dated: May 2, 2000 Received: May 17, 2000 Regulatory Class: II 21 CFR §884.6180/Procode: 85MQL
Dear Mr. Yingling:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate every a 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). You may, theefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act included requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, fille 201 Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning wour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compling at (201) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation antitled, "Misbranding by reference to premarket notification" (21CFR 807. "Also, prose note the tile the timely.
Ant may be able in Division the Discussion" (21CFR 807.97). Other ge Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel S. Schaffer, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
K9913481
Page 1 of
INDICATIONS FOR USE STATEMENT
510(k) Number:
| Device Name: | IVFTM-50, IVFTM-500 and IVFTM-500 Antibiotic- Free Assisted Reproduction Media |
|---|---|
| -------------- | -------------------------------------------------------------------------------- |
Indications For Use:
For in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.
A Sign-Off)
Evision of Reproductive, Abdominal, ENT,
and Radiological Devices
121189
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR
510(k) Number
Over-the-Counter Use
(Per 21 C.F.R. § 801.109)