OVOIL-150, MODEL 5002 by VITROLIFE SWEDEN AB

This submission is for a Class II medical device, OVOIL™-150, which is an assisted reproduction medium. The premarket notification (510(k)) focuses on demonstrating substantial equivalence to other legally marketed reproductive media, rather than proving novel effectiveness. Therefore, the "acceptance criteria" discussed here relate to lot-release testing to ensure product quality and safety, rather than clinical performance metrics typically associated with AI/software devices. The "study that proves the device meets the acceptance criteria" refers to these routine lot-release assays and general clinical experience.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Purpose/Method	Reported Device Performance (Assurance)
Mouse Embryo Assay (MEA)	Assure suitability for intended use, absence of toxins.	Performed prior to market release for each lot. Test medium droplets under OVOIL are used. Assures the media is suitable and non-toxic.
Limulus Amebocyte Lysate (LAL) Assay	Assure suitability for intended use, absence of toxins.	Performed prior to market release for each lot. Assures the media is suitable and non-toxic.
pH Testing	Ensure chemical stability/suitability.	Tested for each lot prior to release, according to USP and EP guidelines.
Osmolality Testing	Ensure physiological compatibility.	Tested for each lot prior to release, according to USP and EP guidelines.
Clinical Experience	Establish safety and effectiveness over time.	"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. Sample Size Used for the Test Set and Data Provenance

MEA and LAL Assays for each lot: The sample size is not explicitly stated in terms of number of "units" or "batches" tested, but the implication is that each manufactured lot undergoes these tests. The provenance is internal quality control data from the manufacturer.
pH and Osmolality Testing: Similar to MEA and LAL, these are performed for each lot. The provenance is internal quality control data from the manufacturer.
Clinical Experience: This refers to an accumulation of usage over "many years at many different assisted reproduction facilities." This is a retrospective summary of real-world usage, rather than a specific prospective study with a defined sample size. The geographical provenance (countries) is not specified beyond "many different facilities."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For MEA, LAL, pH, and Osmolality: These are analytical laboratory tests with defined protocols (e.g., USP, EP guidelines). The interpretation is typically objective based on quantitative results meeting predefined specifications. There is no mention of "experts" establish ground truth in the sense of consensus interpretation for these tests. Quality control personnel with appropriate laboratory qualifications would perform and interpret these tests.
For Clinical Experience: "Clinical experience" implies interpretation by a broad range of clinicians (e.g., embryologists, reproductive endocrinologists) in their routine practice. There is no formally established number of experts or adjudication process described; it's a general statement about observed safety and effectiveness through widespread use.

4. Adjudication Method for the Test Set

For MEA, LAL, pH, and Osmolality: No adjudication method is described. These are standardized quantitative tests where results are compared against predetermined specifications.
For Clinical Experience: No formal adjudication method is mentioned. The statement relies on the cumulative, informal observation of satisfactory performance in clinical practice over time.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a culture medium, not an imaging or diagnostic AI device that would typically involve human readers. The evaluation here is based on chemical/biological properties and general clinical use, not comparative reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. OVOIL™-150 is a physical product (culture medium), not an algorithm or software device. Therefore, a "standalone algorithm performance" assessment is irrelevant.

7. The Type of Ground Truth Used

For MEA and LAL: The "ground truth" is defined by the objective pass/fail criteria of the standardized assays for toxicity and suitability for supporting embryo development.
For pH and Osmolality: The "ground truth" is adherence to specified numerical ranges as defined by pharmacopoeial guidelines (USP, EP).
For Clinical Experience: The "ground truth" is derived from real-world outcomes and observations in IVF and micromanipulation procedures, indicating safety and effectiveness through consistent, long-term use. This is a form of outcomes data and expert consensus (informal, through broad clinical acceptance).

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/ML device that requires a training set. The device is a physical product.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as this is not an AI/ML device that requires a training set.

Summary

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K991351
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PREMARKET NOTIFICATION SUMMARY

Submitted by:	Scandinavian IVF Sciences ABMölndalsvägen 30SE-412 63 GothenbergSWEDEN
Contact Person:	Mr. Eiler AndersonVitrolife ABMölndalsvägen 30SE-412 63 GothenbergSWEDEN
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 bycomparison to category of Reproductive Media asclassified under 21 C.F.R. § 884.6180.
Description of the Device:	Double-washed, medium-equilibrated light paraffin oilpackaged with a visual pH indicator. Ready to use afterequilibration at +37°C and 5% CO2.
Intended Use:	Covering of medium during IVF and micro-manipulationprocedures.

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

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K991351
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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.

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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

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INDICATIONS FOR USE STATEMENT

510(k) Number:	K991351
Device Name:	OVOIL TM -150Assisted 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

Regulation Number and Section

§ 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.