(312 days)
Not Applicable
Not Found
No
The device description and performance studies focus on the chemical and biological properties of the oil, with no mention of AI/ML or image processing.
No.
The device is described as paraffin oil used to cover medium during IVF and micro-manipulation procedures, which is a supportive role in a procedure rather than directly treating a disease or condition. The "Intended Use / Indications for Use" specifies "Covering of medium," which aligns with an accessory or component for a procedure, not a direct therapeutic intervention.
No.
The device is a medium for IVF and micro-manipulation procedures and its intended use is to cover media during these procedures. It does not diagnose any disease or condition. The performance studies mentioned are quality control assays for the product itself, not diagnostic performance metrics.
No
The device description clearly states it is a physical product (paraffin oil) and does not mention any software components.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Covering of medium during IVF and micro-manipulation procedures." IVF (In Vitro Fertilization) is a process that involves handling human gametes and embryos outside of the body.
- Device Description: The device is a "medium-equilibrated light paraffin oil packaged with a visual pH indicator." This oil is used in conjunction with culture media for these in vitro procedures.
- Performance Studies: The performance studies described (Mouse Embryo Assay and Limulus Amebocyte Lysate Assay) are tests performed on the product itself to ensure its suitability for use in these in vitro procedures. This is characteristic of IVD testing.
- Predicate Device Classification: The device is compared to the category of "Reproductive Media as classified under 21 C.F.R. § 884.6180." This specific regulation (21 CFR 884.6180) is for Reproductive media and supplements. Devices classified under this regulation are generally considered IVDs because they are used in vitro for procedures related to human reproduction.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device type, and regulatory classification strongly indicate that this product falls under the definition of an IVD. It is a reagent or system intended for use in the collection, preparation, and handling of human specimens (gametes and embryos) outside the body for the purpose of assisting in reproduction.
N/A
Intended Use / Indications for Use
Covering of medium during IVF and micro-manipulation procedures.
Product codes
85 MQL
Device Description
Double-washed, medium-equilibrated light paraffin oil packaged with a visual pH indicator. Ready to use after equilibration at +37°C and 5% CO2.
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)
Prior to and as a condition for market release, each lot of OVOIL™-150 is assayed by two-cell Mouse Embryo Assay (MEA) and Limulus Amebocyte Lysate (LAL) Assay. These assays are intended to assure that the media is suitable for its intended use and does not contain unacceptable levels of toxins. The MEA is performed using test medium droplets under OVOIL. Information on these assays is provided on the label and in labeling of the products, and on a LOT-specific Certificate of Analysis provided with each delivery.
The pH and osmolality of each LOT of OVOIL is also tested prior to release. These tests are conducted according to guidelines issued by the United States Pharmacopoeia and the European Pharmacopoeia. Information on these tests is provided on the LOT-specific Certificate of Analysis provided with each delivery.
OVOIL™-150 has been used for IVF and micromanipulation procedures 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)
Not Applicable -- Substantial equivalence established by comparison to category of Reproductive Media as classified under 21 C.F.R. § 884.6180.
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
FEB 2 5 2000
K991351
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 |
| Date Prepared: | April 16, 1999 |
| Trade Name: | OVOILTM-150 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | Not Applicable -- Substantial equivalence established by
comparison to category of Reproductive Media as
classified under 21 C.F.R. § 884.6180. |
| Description of the Device: | Double-washed, medium-equilibrated light paraffin oil
packaged with a visual pH indicator. Ready to use after
equilibration at +37°C and 5% CO2. |
| Intended Use: | Covering of medium during IVF and micro-manipulation
procedures. |
Technological Characteristics:
The technological characteristics of OVOIL™-150 are identical to other legally marketed culture media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.
Testing Performed:
Prior to and as a condition for market release, each lot of OVOIL™-150 is assayed by two-cell Mouse Embryo Assay (MEA) and Limulus Amebocyte Lysate (LAL) Assay. These assays are intended to assure that the media is suitable for its intended use and does not contain unacceptable levels of toxins. The MEA is performed
1
K991351
Page 2 of 2
using test medium droplets under OVOIL. Information on these assays is provided on the label and in labeling of the products, and on a LOT-specific Certificate of Analysis provided with each delivery.
The pH and osmolality of each LOT of OVOIL is also tested prior to release. These tests are conducted according to guidelines issued by the United States Pharmacopoeia and the European Pharmacopoeia. Information on these tests is provided on the LOT-specific Certificate of Analysis provided with each delivery.
OVOIL™-150 has been used for IVF and micromanipulation procedures for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2000
Scandinavian IVF Sciences AB c/o Mr. Garv L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington D.C. 20006
Re: K991351
OVOIL™-150 Dated: November 30, 1999 Received: November 30, 1999 Regulatory Class: Il 21 CFR §884.6180/Procode: 85 MQL
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 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). 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either dass III (Special Controls) or class III (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, Title 21, 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 your 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 requlations.
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 predicate device results in a classification 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 Compliance at (301) 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 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
Department
Health
3
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K991351 |
|---|---|
| Device Name: | OVOIL TM -150 |
| Assisted Reproduction Media | |
| Indications For Use: | Covering of medium during IVF and micro-manipulation procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use the image is of a form, here is the data in the form:
| Labels | Values |
|---|---|
| Prescription Use (Per 21 C.F.R. § 801.109) | ✓ |
| OR | |
| Over-the-Counter Use | |
| (Division Sign-Off) Division of Reproductive, Abdominal, BNT, and Radiological Devices | |
| 510(k) Number | K991351 / S⁰⁰¹ |