(56 days)
Medium for In Vitro Fertilization Procedures
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +37°C and 6 % CO2
The provided text is a Premarket Notification Summary (510(k)) for the G-FERT™ Assisted Reproduction Media. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study with acceptance criteria in the manner typically seen for new diagnostic algorithms or devices requiring robust performance validation against specific metrics.
Therefore, the information requested regarding acceptance criteria, study design elements (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies), and training set details are not present in this type of regulatory submission. The 510(k) process primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device.
However, based on the provided text, I can infer the "acceptance criteria" were related to establishing substantial equivalence, and the "study" was a comparison to a predicate device.
Here's a breakdown of what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Inferred from 510(k) process) |
|---|---|
| Substantially equivalent to predicate device (IVF™) in technological characteristics. | "The technological characteristics of G-FERT™ are essentially similar to those of the predicate device." |
| No new questions of safety or effectiveness raised by differences from predicate. | "None of these differences raise new questions of safety or effectiveness." |
| Intended Use is consistent with predicate. | "Medium for In Vitro Fertilization Procedures" (Consistent with general use of reproductive media). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The 510(k) summary does not describe a formal "test set" or clinical study with sample sizes. Substantial equivalence is often demonstrated through comparisons of materials, manufacturing, and existing scientific literature/data for the predicate, not necessarily new clinical trials for a Class II device like this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available. There is no mention of experts establishing ground truth for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. No test set or adjudication method is mentioned.
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-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. The concept of "ground truth" as used in diagnostic performance studies doesn't directly apply to the establishment of substantial equivalence for an IVF medium. The "truth" in this context is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set
- Not Applicable/Not Available. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set for ground truth establishment.
Summary of the "Study" (as presented in the 510(k)):
The "study" to prove the device meets acceptance criteria (i.e., substantial equivalence) was a comparison of the G-FERT™ with its predicate device, IVF™. The submission states: "The technological characteristics of G-FERT™ are essentially similar to those of the predicate device. The G-FERT is a modification of the predicate device and is intended to be supplemented with albumin prior to use. Other formulation changes were made to improve the performance of the G-FERT device. None of these differences raise new questions of safety or effectiveness."
This means the "study" involved a detailed technical comparison of the formulation and intended use, asserting that any changes from the predicate device do not introduce new safety concerns or alter its fundamental effectiveness, thus demonstrating substantial equivalence. The FDA concurred with this assessment in their letter.
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SEP 6 2002
IX. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
|---|---|
| Contact Person: | Mr. Eiler AndersonVitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
| Date Prepared: | July 10, 2002 |
| Trade Name: | G-FERT™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. § 884.6180) |
| Predicate Device: | IVF™ |
| Description of the Device: | Bicarbonate buffered medium containingHyaluronan. For use after the addition of G-MM™or HSA-solution™ and pre-equilibration at +37°Cand 6 % CO2 |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Technological Characteristics: | The technological characteristics of G-FERT™are essentially similar to those of the predicatedevice. The G-FERT is a modification of thepredicate device and is intended to besupplemented with albumin prior to use. Otherformulation changes were made to improve theperformance of the G-FERT device. None ofthese differences raise new questions of safety oreffectiveness. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 6 200
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022245 Trade/Device Name: G-FERT™ Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: July 10, 2002 Received: July 12, 2002
Dear Mr. Yingling:
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.
If your device is classified (see above) 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Henry C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT X. . :
510(k) Number:
and the same of the same of the same
.
.
KD2245
Device Name:
G-FERTTM Assisted Reproduction Media
Indications For Use:
Medium for preparation and handling of gametes and for in vitro fertilization.
Rate Phillips f NCB
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 5 D(k) Number ________________________________________________________________________________________________________________________________________________________________
(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)
( ) IR
()ver-the Counter Use______________________________
§ 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.