(305 days)
ASP™-100 is intended to be used for follicle flushing during assisted reproduction procedures.
Indications For Use:
Follicle flushing.
ASP™-100 is a bicarbonate- and HEPES-buffered flushing medium for use during assisted reproduction procedures. Ready-to-use after equilibrium at +37 °C and 5% CO2.
The provided text describes the premarket notification for the ASP™-100 Assisted Reproduction Media. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a detailed study proving device performance in the manner you've outlined for an AI/CAD-type device.
The document discusses biocompatibility testing and clinical experience but does not provide quantitative acceptance criteria or detailed study results with sample sizes, expert qualifications, or ground truth methodologies as would be expected for a diagnostic or AI-driven device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance/Testing |
|---|---|
| Biocompatibility (general safety) | Cytotoxicity: Tested to ensure the media is not toxic to cells. Rabbit Vaginal Irritation: Tested to ensure it does not cause irritation. Delayed Contact Sensitization: Tested for allergic reactions. Limulus Amebocyte Lysate (LAL) Assay: Performed on each lot to assure unacceptable levels of toxins are not present. |
| Clinical Safety and Effectiveness (general) | "ASP™-100 has been used in assisted reproduction procedures for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use." (This is a qualitative statement of long-term use, not a quantitative study result). |
What is Not Provided: Specific quantitative thresholds for "acceptable levels" for the LAL assay, or specific outcomes/metrics from the biocompatibility tests (e.g., cell viability percentages, irritation scores).
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified for any of the mentioned tests (cytotoxicity, irritation, sensitization, LAL assay).
- Data Provenance: Not specified. The "clinical experience" is retrospective and implied to be multinational ("many different assisted reproduction facilities").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The "ground truth" for the biocompatibility tests would generally be based on lab assay results interpreted by standard laboratory protocols, not expert consensus in the way a diagnostic image is interpreted. For "clinical experience," it's based on practitioners' observations over time.
4. Adjudication method for the test set
- Not specified, and likely not applicable in the requested format given the nature of the tests (biocompatibility assays).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an assisted reproduction medium, not an AI/CAD diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is entirely irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used
- Biocompatibility Testing: The ground truth for these tests would be the results of the specific assays (e.g., cell viability, presence/absence of an inflammatory response, endotoxin levels). These are objective lab measurements rather than expert consensus on a diagnostic outcome.
- Clinical Experience: The "ground truth" here is the observed safety and effectiveness outcomes during routine clinical use, which is a form of real-world outcomes data.
8. The sample size for the training set
- Not applicable as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and Approval:
The ASP™-100 is a medical device (reproductive media), not an AI/CAD or diagnostic imaging device. Its premarket notification (K991345) focuses on demonstrating substantial equivalence to existing legally marketed predicate devices and confirming its biocompatibility and established clinical safety through long-term use rather than detailed performance metrics of a diagnostic tool. The "acceptance criteria" discussed are related to the safety and non-toxicity of the medium itself, as required for a substance that comes into contact with gametes and patients.
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K991345
Page 1 of 2
PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Scandinavian IVF Sciences ABMölndalsvägen 30SE-412 63 GothenbergSWEDEN |
|---|---|
| Contact Person: | Mr. Eiler AndersonVitrolife ABMölndalsvägen 30SE-412 63 GothenbergSWEDENTele: +46 31 721 80 00Fax: +46 31 721 80 99 |
| Date Prepared: | April 16, 1999 |
| Trade Name: | ASP™-100 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. § 884.6180) |
| Predicate Device: | Substantial equivalence established by comparison tocategory of Reproductive Media (21 C.F.R. §884.61800) as provided in the FDA's Notice of FinalRule. 63 Fed. Reg. 48428, 48430 (Sept. 10, 1998)). |
Description of the Device:
ASP™-100 is a bicarbonate- and HEPES-buffered flushing medium for use during assisted reproduction procedures. Ready-to-use after equilibrium at +37 °C and 5% CO2.
Intended Use:
ASP™-100 is intended to be used for follicle flushing during assisted reproduction procedures.
Technological Characteristics:
The technological characteristics of ASP™-100 are identical to other legally marketed media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.
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Testing Performed:
Because ASP™-100 is intended to come into contact with gametes and the patient during assisted reproduction procedures, Scandinavian IVF Sciences has conducted biocompatability testing on the media. This testing included cytotoxicity, rabbit vaginal irritation and delayed contact sensitization assays.
Prior to and as a condition for market release, each lot of ASP™ 100 is assayed by Limulus Amebocyte Lysate (LAL) Assay. This assay is intended to assure that the media does not contain unacceptable levels of toxins. Information on the assay is provided in the labeling of the products and on a LOT-specific Certificate of Analysis provided with each delivery. The Mouse Embryo Assay is not performed on ASP™-100 because the composition of the product is neither intended for nor compatible with embryo development.
ASP™-100 has been used in assisted reproduction 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three lines representing the head, body, and legs. The figure is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2000
Scandinavian IVF Sciences AB c/o Mr. Gary L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108
Re: K991345
ASPTM -100, Assisted Reproduction Media Dated: November 30, 1999 Received: November 30, 1999 Requiatory Class: II 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). 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.
If your device is classified (see above) into either class II (Special Controls) or dass 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 requlation 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 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 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) 594-4613. 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"(21 CFR 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VIII. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
ASP™ -100 Assisted Reproduction Media
Indications For Use:
Follicle flushing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 C.F.R. § 801.109) | ✓ |
|---|---|
| ----------------------------------------------- | ----------------------------------------- |
OR
| Over-the Counter Use | |
|---|---|
| ---------------------- | -- |
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| (Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices | |
|---|---|
| 510(k) Number | K991345 |
§ 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.