(298 days)
Indications for Use: Media for freezing of blastocyst stage embryos
MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
The provided text describes a premarket notification for the G-FreezeKit Blast™ device, an Assisted Reproduction Media. However, it does not contain the specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, predicate device.
- Description and Intended Use: MOPS buffered media for freezing blastocyst stage embryos.
- Technological Characteristics: Comparison to a predicate device, noting similar cryopreservation ingredients (Glycerol and Sucrose) and a difference in antibiotic (Penicillin G vs. Gentamicin).
- Regulatory Information: FDA 510(k) clearance, substantial equivalence determination, and general controls.
Therefore, I cannot populate the requested table or answer most of the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness.
The document states that the device is "substantially equivalent" to a legally marketed predicate device (Blastocyst Freeze Media Kit, K000309). This typically means that the device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. The basis for substantial equivalence is often a comparison of technical specifications, safety data, and potentially performance data, but the specific details of such a study are not included in this summary.
Based on the provided text, the following information can be extracted or inferred:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., survival rates, developmental rates). The implicit acceptance criterion is "substantial equivalence" to the predicate device.
- Reported Device Performance: Not reported in terms of specific performance metrics within this document. The document only states its technological characteristics are "similar" to the predicate, and it contains cryopreservation ingredients and an antibiotic.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the provided text.
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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 specified in the provided text. This type of detail is generally not included in a 510(k) summary for a media device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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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:
- Not applicable. This device is an Assisted Reproduction Media, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a media product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for a device like this would typically involve laboratory studies demonstrating embryo viability, survival, and developmental potential after cryopreservation and thawing using the media, compared to the predicate device. However, the specific type and details of such data are not provided in this summary.
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The sample size for the training set:
- Not applicable/Not specified. For a media product, there isn't typically a "training set" in the machine learning sense. Performance data would be generated through laboratory experiments.
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How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons above.
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PREMARKET NOTIFICATION SUMMARY X.
MAY - 7 2004
| Submitted by: | Vitrolife Sweden ABFaktorvägen 13SE-434 37 KungsbackaSWEDEN |
|---|---|
| Contact Person: | Ms. Nina ArvidssonVitrolife Sweden ABFaktorvägen 13SE-434 37 KungsbackaSWEDEN |
| Mr. Gary L. YinglingMr. Michael H. HinckleKirkpatrick & Lockhart, LLP1800 Massachusetts Avenue, NWWashington, DC 20036-1800 | |
| Date Prepared: | July 10, 2003 |
| Trade Name: | G-FreezeKit Blast™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements(21 CF.R. § 884.6180) |
| Predicate Device: | Blastocyst Freeze Media Kit (K000309) |
| Description of the Device: | MOPS buffered media. For use in sequence afterthe addition of G-MM™ or HSA-solution™ andpre-equilibration at +20 ± 5°C and ambientatmosphere. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | Media for freezing of blastocyst stage embryos |
Technological Characteristics:
The technological characteristics of G-FreezeKit Blast™ are similar to those of the predicate device. Both the G-FreezeKit Blast™ and the prodicate device contain the cryopreservation ingredients Glycerol and Sucrose, which are added in a stepwise manner. In combination with G-ThawKit Blast™ , the freezing solutions provide an equal concentration gradient of Glycerol and Sucrose in a step up - step down protocol for freezing and thawing of human blastocysts. The G-FreezeKit Blast™ contains Penicillin G as antibiotic instead of Gentamicin.
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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. To the left of the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 7 2004
Vitrolife Sweden AB % Gary L. Yingling, Esq. Consultant Kirkpatrick & Lockhart, L.L.P. 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K032154
Trade/Device Name: G-FreezeKit Blast™ - Assisted Reproductive Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: February 19, 2004
Received: February 23, 2004
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 such 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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This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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.
Nancy 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
510(k) Number (if known): K032154
Device Name: G-FreezeKit Blast™ Assisted Reproduction Media
Indications For Use: Media for freezing of blastocyst stage embryos
Prescription Use _x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
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§ 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.