(48 days)
The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or incended for proparing, (IVF), or other in vitro fertilization techniques or cell culture.
Biogenics BioQuad™ 4-Well IVF Culture Dish
This document is a 510(k) clearance letter from the FDA for the Biogenics BioQuad™ 4-Well IVF Culture Dish. It states that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria as typically found in a clinical or performance study report for AI/CADe systems.
The information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) pertains to the evaluation of AI/CADe systems or diagnostic devices where performance metrics like sensitivity, specificity, or AUC are typically assessed against a ground truth.
For a physical device like an IVF culture dish, the "acceptance criteria" and "study" are different. They would typically involve:
-
Acceptance Criteria for an IVF Culture Dish:
- Sterility (e.g., meeting USP standards or equivalent)
- Non-pyrogenicity (e.g., Limulus Amebocyte Lysate (LAL) test results)
- Embryotoxicity (e.g., mouse embryo assay (MEA) or human embryo assay (HEA) results demonstrating no adverse effect on embryo development)
- Biocompatibility (e.g., ISO 10993 standards)
- Material safety (e.g., leachables/extractables testing)
- Physical dimensions and integrity
- Functionality (e.g., ability to sustain culture, gas exchange properties, no visible defects)
- Labeling accuracy and legibility
-
The "Study" for an IVF Culture Dish: This would be a series of laboratory tests and assays designed to demonstrate compliance with the above acceptance criteria. These are often described in the 510(k) submission itself but are not detailed in this particular summary letter from the FDA.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The document only confirms the device's clearance and indications for use.
However, I can extract the following limited information which is relevant to the type of device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (as implied by FDA clearance and indications) |
|---|---|
| Sterility | Sterile (stated in Indications for Use) |
| Non-pyrogenicity | Non-pyrogenic (stated in Indications for Use) |
| Embryotoxicity | Embryotoxicity tested (stated in Indications for Use) |
| Intended Use | Intended for preparing, storing, manipulating, or transferring human gametes/embryos in IVF or other in vitro fertilization techniques or cell culture. (stated in Indications for Use) |
Regarding the remaining questions, the provided text does not contain the information requested for an AI/CADe system study. Here's why and what kind of information would be needed for a physical device like this:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable in this context. For an IVF dish, this would refer to the number of dishes tested for sterility, pyrogenicity, or the number of embryo assays performed. The document doesn't provide this.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an IVF dish, "ground truth" is established by laboratory assay results (e.g., bacterial growth, LAL test results, embryo development scores).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Lab tests have objective pass/fail criteria.
- 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 is for AI/diagnostic image interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth would be based on validated laboratory assay results (e.g., absence of microbial growth for sterility, specific LAL units for pyrogenicity, embryo viability/development rates for embryotoxicity).
- The sample size for the training set: Not applicable in this context. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable. There is no AI model being trained.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biogenics, Inc. c/o Mr. Daniel W. Lehtonen Senior Staff Engineer, Medical Devices Intertek Testing Services 2307 East Aurora Road Unit B7 TWINSBURG OH 44087
AUG 2 0 2008
Re: K081896
Trade/Device Name: Biogenics BioQuad™ 4-Well IVF Culture Dish Regulation Number: 21 CFR §884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQL Dated: August 4, 2008 Received: August 5, 2008
Dear Mr. Lehtonen:
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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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 or any I out 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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 vours.
Nancy C Brogdon
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
K081896 510K Number:
Device Name: Blogenics BioQuad im 4 Well Vented IVF Culture Dish
Indications for Use:
The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or incended for proparing, (IVF), or other in vitro fertilization techniques or cell culture.
Prescription use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
4.1
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.