(151 days)
G-1TM v5/G-1TM v5 PLUS is intended for culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved medias are called IVF Media G5 Series. G-1TM v5/G-1TM v5 PLUS is used for culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5/G-1™ PLUS is a device used for the culture of embryos from the pronucleate stage to day 2 or day 3.
This submission for medical device K081114, G-1™ v5 and G-1™ v5 PLUS IVF Media, is a 510(k) premarket notification. As such, the FDA determines substantial equivalence to a predicate device rather than requiring specific acceptance criteria and a detailed study proving the device meets those criteria, as would typically be seen in a de novo or PMA submission.
Therefore, the provided document does not report specific acceptance criteria or a dedicated study demonstrating the device meets those criteria in the way a clinical trial or performance study report would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (G-1™ version 3, K02244).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this 510(k) submission. The document does not specify quantitative acceptance criteria or a study designed to measure and report against those criteria for the new devices (G-1™ v5 and G-1™ v5 PLUS). The regulatory pathway for this device, being a 510(k), relies on demonstrating that the new device has "technological characteristics essentially similar" to a predicate device and "none of the differences...do raise any new questions of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document does not describe a "test set" in the context of a performance study with a defined sample size for the evaluation of the new device. The evaluation of "differences" mentioned is conceptual and regulatory, not data-driven from a specific study outlined here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. There is no mention of experts establishing ground truth for a test set in this 510(k) summary.
4. Adjudication Method
Not applicable/Not provided. No adjudication method is mentioned as there is no described test set or ground truth establishment process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of the AI. As the device is an IVF culture medium, an MRMC study is not relevant to its intended use.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is an IVF culture medium, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Not applicable/Not provided. There is no mention of ground truth as no specific performance study is detailed.
8. Sample Size for the Training Set
Not applicable. The device is an IVF culture medium, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set mentioned, there is no ground truth established for it.
Summary of the 510(k) Submission Approach:
The provided document details a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a new clinical study with acceptance criteria. The key arguments for substantial equivalence are:
- Identical Intended Use: The G-1™ v5/G-1™ v5 PLUS products have the same intended use as the predicate device (G-1™ version 3) – "culture of embryos from the pronucleate stage to day 2 or day 3."
- "Essentially Similar" Technological Characteristics: The submission asserts that the "technological characteristics of G-1™ v5/G-1™ v5 PLUS are essentially similar to those of the predicate device."
- No New Questions of Safety or Effectiveness: Crucially, the document states, "None of the differences between the predicate device and G-1™ v5/G-1™ v5 PLUS do raise any new questions of safety or effectiveness."
This approach means that the "study" proving the device meets acceptance criteria is essentially the regulatory comparison to the predicate device and the assertion that any modifications do not introduce new risks or alter effectiveness. The FDA's letter of substantial equivalence confirms that this demonstration was satisfactory for market clearance under the 510(k) pathway.
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K081114
.
PREMARKET NOTIFICATION SUMMARY X.
:
SEP 1 6 2008
| Submitted by: | Vitrolife Sweden ABFaktorv\u00e4gen 13SE-434 37 KungsbackaSWEDEN |
|---|---|
| Contact Person: | Mr Kjell Kj\u00f6rkVitrolife Sweden ABFaktorv\u00e4gen 13SE-434 37 KungsbackaSWEDENPhone +46 31 721 80 77Fax +46 31 721 80 90Mail kkjork@vitrolife.com |
| Date Prepared: | 7 July 2008 |
| Trade Name: | G-1TM v5/G-1TM v5 PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. \u00a7 884.6180) |
| Predicate Device: | G-1TM version 3 (K022244) |
| Description of the Device: | The IVF Media GIII Series have been on the marketfor a number of years and Vitrolife Sweden AB hasnow made some product changes in order to furtherimprove the robustness of these media. Theseimproved medias are called IVF Media G5 Series.G-1TM v5/G-1TM v5 PLUS is used for culture ofembryos from the pronucleate stage to day 2 or day 3 |
| Intended Use: | G-1TM v5/G-1TM v5 PLUS is intended for culture ofembryos from the pronucleate stage to day 2 or day 3 |
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Technological Characteristics:
G-1™ v5/G-1™ PLUS is a device used for the culture of embryos from the pronucleate stage to day 2 or day 3.
The product G-1™ v5/G-1™ v5 PLUS is a modification of the device G-1™ version 3 (K022244). The technological characteristics of G-1™ v5/G-1™ v5 PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-1™ v5/G-1™ v5 PLUS do raise any new questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes emanating from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2008
Vitrolife Sweden AB c/o Mr. Kjell Kjörk Pharmacist; Regulatory Affairs Manager Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
K081114 Re:
Trade Name: G-1" v5 and G-1" v5 PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 13, 2008 Received: August 15, 2008
Dear Mr. Kjörk:
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.
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Page 2
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jozpu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081114
Device Name: G-1™ v5
:
:
Indications for Use:
G-1™ v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
:
(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) | X |
|---|---|
| OR Over-the Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | KD81114 |
|---|---|
| --------------- | --------- |
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XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081114
Device Name:
G-1™ v5 PLUS
Indications for Use:
G-1™ v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
(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) | X |
|---|---|
| OROver-the Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
| 510(k) Number | K081114 |
|---|---|
| --------------- | --------- |
§ 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.