(90 days)
The Culture Dish is intended to be used when culturing tissues and cells. It may be used for the use with sperm and for the culturing of embryos.
"To culture tissues and cells"
May be used to hold sperm and culture embryos
The Culture Dish is intended to be used when culturing tissues and cells. It may be used for the use with sperm and for the culturing of embryos. The catalog number is GDEC-100. The basic design is that of a traditional culture dish. Approx 60mm round with 1½ inch sidewalls. This dish does have defined areas for the cell to be confined within. These areas are squares of picket-fenced walls, which will allow fluids, nutrients and byproducts to freely flow among the culturing cell, embryos.
This document is a 510(k) Premarket Notification for the genX Culture Dish. It mainly focuses on demonstrating substantial equivalence to existing devices rather than providing detailed performance studies with hard acceptance criteria or specific metrics of accuracy, sensitivity, or specificity commonly found for diagnostic devices.
Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered with the provided information as the document does not contain data from such studies.
Here's an analysis of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "To culture tissues and cells". "May be used to hold sperm and culture embryos." (Matches predicate devices) |
| Design | Traditional culture dish, approx. 60mm round with 1.5 inch sidewalls, defined square areas ("picket-fenced walls") for cell confinement. (Stated as "Same design" as predicate, implying it meets their design criteria). |
| Materials | Configured the same for use as predicate devices. (Stated as "Same materials configured the same for use"). |
| Procedures/Method | Performs similar procedures by method as predicate devices. (Stated as "Perform similar procedures, by method"). |
| Performance Criteria | Same performance criteria as predicate devices. (Stated as "Same performance criteria"). |
| Sterility Methods | Gamma Irradiated by contractor; Dosage: 2.5 Mrad; Sterility Assurance Level (SAL): 10^-6. Validation in accordance with ANSI / AAMI / ISO 11137-1994 Standards. |
| Sterility Release | Contractor issues a "Certificate of Sterilization". |
| Intended Population | Same as predicate devices. (Stated as "Same intended population"). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a performance study with a test set. The submission focuses on demonstrating substantial equivalence based on design, materials, and intended use, rather than presenting clinical or laboratory performance data from a specific test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No adjudicated test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is not mentioned as the device is not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a culture dish, not a digital algorithm or AI.
7. Type of Ground Truth Used
Not applicable. The submission for this type of device (culture dish) relies on demonstrating equivalency to already marketed devices, not on proving diagnostic accuracy against a specific ground truth. The "ground truth" in this context would be the successful and safe use of existing, predicate culture dishes.
8. Sample Size for the Training Set
Not applicable. As a physical medical device (culture dish), there is no 'training set' in the context of machine learning or algorithms. The design and manufacturing process would involve validation and verification, but not in the same way as an AI system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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FEB 1 4 2000
Page 1 of 2
international, Inc. 510(K) Premarket Notification
510(K) Summary
- DEVICE NAME a) Proprietary Name: Culture dish
Classification Name: Assisted Reproduction Labware
b)Submitted bv:
international, inc. 170 Fort Path Rd. Madison, CT 06443
ESTABLISHMENT REGISTRATION No.: 9003605
Telephone number: 203-245-4901 Fax number: 203-245-4994 E-mail: genXintl@aol.com
Contact individual: Michael D. Cecchi President
- CLASSIFICATION: Class II c) Assisted Reproductive Labware Product: Culture dish Procode: 85 MQK CFR#: 884.6160
- d) PERFORMANCE STANDARDS Performance Standards under Section 514 of the ACT have not been developed for this device. However, Special controls have been identified by the FDA to provide reasonable assurance of safety and effectiveness of the device in assisted reproductive procedures.
- e) PROPOSED LABELS, LABELING, AND ADVERTISING The proposed labeling and instruction material is included in this package in the appropriate section.
- f) DESCRIPTION AND INTENDED USE The Culture Dish is intended to be used when culturing tissues and cells. It may be used for the use with sperm and for the culturing of embryos.
The catalog number is GDEC-100
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K993881
Page 2 of 2
The basic design is that of a traditional culture dish. Approx 60mm round with 1½ inch sidewalls. This dish does have defined areas for the cell to be confined within. These areas are squares of picket-fenced walls, which will allow fluids, nutrients and byproducts to freely flow among the culturing cell, embryos.
SUBSTANTIALLY EQUIVALENT ದಿ)
The Culture Dish is substantially equivalent to several products currently marketed in the US. See the appropriate section for the comparisons. (Section 2)
-
- Same intended use
-
- Same design
-
- Same materials configured the same for use.
-
- Perform similar procedures, by method.
-
- Same performance criteria
-
- Same sterility methods and testing
-
- Same intended population
h) STERILIZATION PROCEDURES AND FACILITIES
All dishes manufactured, will be Gamma Irradiated by and according to the guidelines in place.
Dosage: 2.5 Mrad Sterility Assurance Level (SAL): of (10 to the -6 ) After sterilization the contractor will issue a "Certificate of Sterilization".
Validation assurance is in accordance with ANSI / AAMI / ISO 11137-1994 Standards.
See Section 11.0
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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
FEB 1 4 2000
Mr. Michael D. Cecchi President international, Inc. 170 Fort Path Road Madison, CT 06443
Re: K993881 Tissue Culture Dish Dated: November 15, 1999 Received: November 16, 1999 Regulatory Class: II 21 CFR §884.6110/Procode: 85 MQK
Dear Mr. Cecchi:
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 II (Special Controls) or class III (Premarket Approval), 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 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.
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 Compliance 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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international, Inc. 510(K) Premarket Notification
INDICATIONS FOR USE
49 2881 510 (k) Number (if known)
Device Names: Tissue Culture Dish
Indication for Use:
"To culture tissues and cells"
May be used to hold sperm and culture embryos
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Prescription Use X
Over the Counter Use __
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.
or
§ 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.