NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation.

The dishes are disposable tissue culture labware used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male infertility is impaired.

Device Description

NewLife Dishes are fabricated from polysterene and are 60 mm. diameter. Dishes are made with or without clear lids, etched or unetched. Etched dishes have a center circle with 8 smaller circles inside the larger circle, and a 9th circle inside the 8 circles. There are numbers 1 through 8 outside the large circle, with the number 1 at the top of the dish. Unetched dishes have center circles, but no other circles are etched on the dishes. Dishes are disposable, intended for one time use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NewLife Dish, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mouse Embryo Test (MEA)
% of embryos developing to expanded and/or hatching blastocysts in the treated group must be within 10% of the control group.	"Embryos exposed to the dishes are considered nontoxic if the number of expanded and/or hatching blastocysts in the treated group is within 10% of the control group..." (Implies this was met as there's no mention of failure)
No contamination of the culture.	"...and no contamination of the culture has occurred." (Implies this was met as there's no mention of failure)
Control group must have > 80% hatching/expanded blastocysts to indicate a valid assay.	"Greater than 80% hatching/expanded blastoycysts in the control group indicates a valid assay." (Implies this was met as the test results were used)
Endotoxin Level (Limulus Amebocyte Lysate assay)
Less than 20 Endotoxin Units (EU) per device.	"The level of endotoxin units per device must be less than 20 to be considered acceptable." (Implies this was met as there's no mention of failure)
Sterility
Sterility Assurance Level (SAL) of 10^-6.	"Each lot of dishes is sterilized by gamma radiation with a sterility assurance level of 10^-6." (Implies this was met as they are performing this sterilization)
Packaging (Shelf Life)
Maintain sterility for a shelf life of 2 years.	"This packaging has been tested to ensure a microbial barrier, and has been validated to maintain sterility for a shelf life of 2 years." (Implies this was validated and met)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Mouse Embryo Bioassay: The text states, "25 ul tissue culture medium...For NewLife Dishes, the MEA is performed in the test dish, providing continuous exposure." and "Control droplets of medium were not exposed to product before receiving embryos." It further mentions "embryos were cultured in the media beginning at the two-cell stage." However, it does not specify the number of dishes or the precise number of embryos used per assay for either the test or control groups within each lot. It just describes the procedure.
Data Provenance: The study appears to be prospective testing conducted by the manufacturer, Humagen Fertility Diagnostics, Inc., on each lot of their NewLife dishes. There is no information about the country of origin of the data beyond the manufacturer being in Charlottesville, VA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The ground truth (embryo development, endotoxin levels, sterility) is established by laboratory testing methods (mouse embryo bioassay, Limulus Amebocyte Lysate assay, gamma radiation verification) rather than human expert consensus for the test set.

4. Adjudication Method for the Test Set

This information is not applicable as the "ground truth" for the performance criteria is determined by laboratory assay results and compliance with specified numerical thresholds, not by human expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a piece of labware, and its performance is evaluated through direct biological and chemical testing, not by comparing human reader performance with and without AI assistance.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The performance evaluation for the NewLife Dish (toxicity, endotoxin, sterility, packaging integrity) directly assesses the device itself against established criteria, without involving human users for performance assessment.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is a combination of:
- Biological Assay Outcomes: The development of mouse embryos to expanded and/or hatching blastocysts, compared against control, as an indicator of non-toxicity.
- Chemical Assay Results: Endotoxin levels measured by the Limulus Amebocyte Lysate assay.
- Physical/Biological Validation: Sterility assurance levels achieved through gamma radiation and validation of packaging to maintain sterility over a defined shelf life.
In essence, the ground truth is based on established laboratory and manufacturing control standards relevant to medical devices used in assisted reproduction.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of an AI/machine learning model. The product is a manufactured item, and its performance is assessed through testing of each production lot against predetermined specifications. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/machine learning model, this question is not applicable. The "ground truth" for the device's performance (i.e., the acceptance criteria) was established through industry standards and scientific understanding of what constitutes a safe and effective tissue culture dish for IVF procedures.

Summary

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12990941

510(k) SUMMARY

Submitter's Name: Humagen Fertility Diagnostics, Inc.

Address: 2400 Hunter's Way Charlottesville, VA 22911

Telephone #: (804) 979-4000

FAX #: (804) 295-5912

Contact person: Cindy Showalter

Date summary prepared: May 28, 1999

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Device name:

Classification name: Assisted reproduction labware (per CFR# 884.6160)

Common/Usual name: ICSI Tissue Culture Dish

NewLife™ Dish Proprietary names:

Substantial Equivalence:

Substantial equivalence is being supported by the Federal Register Notice Final Rule entitled "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures. This equivalence is supported by the SUMMARY statement:

Upon the effective date, the Federal Register document may be cited in the absence of an existing predicate device which would be used to support substantial equivalence.

Description of Device:

Testing Procedures:

Each lot of New Life dishes is mouse embryo tested for toxicity. We use a two-cell mouse embryo bioassay. A two-cell mouse embryo test was performed as follows: 25 ul tissue culture medium containing serum albumin and penicillin/streptomycin was overlaid with 1 ml mineral oil and equilibrated overnight in 5.5% CO2. On the morning of the embryo harvest, medium was exposed to product and embryos were cultured in the media beginning at the two-cell stage. For NewLife Dishes, the MEA is performed in the test dish, providing continuous exposure. Control droplets of medium were not exposed to product before receiving embryos. The combined percent of embryos developing to expanded and/or hatching blastocysts were assessed at 72 hours of culture. Embryos exposed to the dishes are considered nontoxic if the number of expanded and/or hatching blastocysts in the treated group is within 10% of the control group, and no contamination of the culture

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has occurred. Greater than 80% hatching/expanded blastoycysts in the control group indicates a valid assay.

Each lot of dishes is also tested for endotoxin levels using the Limulus Amebocyte Lysate assay. The level of endotoxin units per device must be less than 20 to be considered acceptable.

Each lot of dishes is sterilized by gamma radiation with a sterility assurance level of 106. Quarterly dose audits are performed to insure the sterility assurance level is maintained or following each batch sterilization if less often than quarterly.

The packaging to maintain device sterility consists of a pouch made from INTEGRA® Peel K packaging. This is a reinforced, heavy-weight 70 lb. paper coated with a sealant, designed for medical device packaging applications. The package is heat-sealed. This packaging has been tested to ensure a microbial barrier, and has been validated to maintain sterility for a shelf life of 2 years.

Intended use statement:

The NewLife Dish's intended use is to hold zygotes/embryos during micromanipulation or other tissue culture procedures in the IVF laboratory.

New Life Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 1999

Ms. Cindy Showalter Quality Assurance Manager Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911

Re: K990941 Newlife Dish Dated: May 31, 1999 Received: June 2, 1999 Regulatory Class: II 21 CFR §884.6160/Procode: 85 MQK

Dear Ms. Showalter:

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 (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 III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Druq 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 requlations.

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 Compilance 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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510 (k) NUMBER (IF KNOWN) :	KG90941
DEVICE NAME:	NewLife Dish

INDICATIONS FOR USE:

The NewLife Dish s indication for use is to hold zygotes/embryos during micromanipulation or other tissue culture procedures in the IVF laboratory.

NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to re-implantation.

(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 CFR 801.109)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter-Use (Optional Format 1-2-96)

Rati Palys

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological

510(k) Number

Regulation Number and Section

§ 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.