(53 days)
Not Found
No
The device description focuses solely on the physical characteristics and configurations of tissue culture plates, with no mention of software, algorithms, or data processing capabilities.
No.
The device is described as "single-use labware intended for use in cell culturing and diagnostic laboratory procedures," not for directly treating a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in cell culturing and diagnostic laboratory procedures."
No
The device description clearly details physical components (polystyrene plates, lids, wells, grid) and manufacturing processes (molding, gamma irradiation), indicating it is a hardware device, not software.
Based on the provided information, the ESP Tissue Culture Plates are likely considered IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states "intended for use in cell culturing and diagnostic laboratory procedures." This directly aligns with the definition of an IVD, which are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: While the description focuses on the physical characteristics of the plates, the fact that they are designed for cell culturing, a common practice in diagnostic procedures (e.g., growing patient cells for testing), supports their use in an IVD context.
- Predicate Device: The mention of a predicate device, "K991249; Falcon IVF Four Well Plate," is a strong indicator that this device is being submitted for regulatory review as a medical device, and given its intended use, likely as an IVD. IVF procedures often involve diagnostic steps.
In summary, the explicit mention of "diagnostic laboratory procedures" in the intended use is the primary reason to classify this device as an IVD. The other details support this classification.
N/A
Intended Use / Indications for Use
The ESP Tissue Culture Plates are single-use labware intended for use in cell culturing and diagnostic laboratory procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 MQK
Device Description
The polystyrene ESP tissue culture plates consist of a square base plate with a square lid key wayed to interlock with the base plate. The key way system keeps the lid securely on the base plate. The bottom of the base plate is recessed to allow stacking of multiple plates without the plates sliding apart. The ability to stack plates reduces space requirements during storage and incubation. The 7 cm x 7 cm square shape allows for handling ease regardless of hand size. ESP plates are sterilized using gamma irradiation.
Five configurations of ESP tissue culture plates are available. All five types of plates are identical except for the different physical configurations described below.
ESP Four Well Tissue Culture Plate
Four equally spaced wells with rounded bottoms. Each well is 3 cm in diameter and has a 5 milliliter capacity. The wells are numbered clockwise, with the numbers molded into each plate.
ESP Six Well Tissue Culture Plate
Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 2.5 milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate.
ESP Micro Six Well Tissue Culture Plate
Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 1milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate.
ESP Well in Well Tissue Culture Plate
A small well (2 cm diameter) within a large well (5.5 cm diameter). The two wells are separated by a vertical wall and a flat ledge.
ESP Square Tissue Culture Plate with Grid
A flat surface marked with a square grid consisting of 25 one-half inch squares. The squares are numbered 1 - 5 across the top, and A - E down the left side. The markings are molded into the bottom side of the base, leaving a smooth working surface on the top side of the base.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
K 994361
Page 1 of 4
| Company
| Name: | Genesis Industries |
|---|---|
| Address: | 601 Pro-ject Drive |
| Elmwood, WI 54740 | |
| Contact Person(s): Mark L. Anderson, President | |
| Angela M. Richardson, Regulatory Affairs Manager | |
| Telephone Number: | (715) 778-5821 |
| Fax Number: | (715) 778-4808 |
| Date of Summary: | 22-Dec-1999 |
| Device | |
| Proprietary Names: | ESP Four Well Tissue Culture Plate |
| ESP Six Well Tissue Culture Plate | |
| ESP Micro Six Well Tissue Culture Plate | |
| ESP Well in Well Tissue Culture Plate | |
| ESP Square Tissue Culture Plate with Grid | |
| Common Name: | Culture Dish |
| Class: | II |
| CFR Reference: | 884.6160 |
| Procode: | 85 MQK |
| Predicate Device | |
| Proprietary Name: | Falcon IVF Four Well Plate |
| Common Name: | Culture Dish |
| Manufacturer: | Becton Dickinson Labware |
| Model Number: | 353654 |
| 510(k) Number: | K991249 |
Device Description
The polystyrene ESP tissue culture plates consist of a square base plate with a square lid key wayed to interlock with the base plate. The key way system keeps the lid securely on the base plate. The bottom of the base plate is recessed to allow stacking of multiple plates without the plates sliding apart. The ability to stack plates reduces space requirements during storage and incubation. The 7 cm x 7 cm square shape allows for handling ease regardless of hand size. ESP plates are sterilized using gamma irradiation.
Five configurations of ESP tissue culture plates are available. All five types of plates are identical except for the different physical configurations described below.
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K994361
Page 2 of 4
ESP Four Well Tissue Culture Plate
Four equally spaced wells with rounded bottoms. Each well is 3 cm in diameter and has a 5 milliliter capacity. The wells are numbered clockwise, with the numbers molded into each plate.
ESP Six Well Tissue Culture Plate
Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 2.5 milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate.
ESP Micro Six Well Tissue Culture Plate
Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 1milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate.
ESP Well in Well Tissue Culture Plate
A small well (2 cm diameter) within a large well (5.5 cm diameter). The two wells are separated by a vertical wall and a flat ledge.
ESP Square Tissue Culture Plate with Grid
A flat surface marked with a square grid consisting of 25 one-half inch squares. The squares are numbered 1 - 5 across the top, and A - E down the left side. The markings are molded into the bottom side of the base, leaving a smooth working surface on the top side of the base.
Intended Device Usage
The ESP tissue culture plates are single-use labware intended for use in cell culturing and diagnostic laboratory procedures.
Comparison to Predicate Device
| | ESP Culture Plate | Falcon IVF Four Well
Plate |
|--------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Cell culturing, diagnostic
lab procedures | Preparing, storing,
manipulating, or
transferring human
gametes or embryos for
in vitro fertilization (IVF),
gamete intrafallopian
transfer (GIFT), or other
reproduction procedures. |
| Indications | Cell culturing, diagnostic
lab procedures | In vitro fertilization
techniques; tissue culture |
Table 1: Comparison of ESP Culture Plate to Falcon IVF Four Well Plate
2
| Contraindications | N/A | N/A |
|---|---|---|
| Patient/Embryo- | ||
| Contacting Materials | Polystyrene | Polystyrene, surface |
| treated | ||
| Design Features | Lid is key wayed to | |
| interlock with the base | ||
| plate. Bottom of base | ||
| plate is recessed to allow | ||
| stacking of multiple | ||
| plates without the plates | ||
| sliding apart. Five | ||
| configurations: Four | ||
| Well, Six Well, Micro Six | ||
| Well, Well in Well, and | ||
| Square Grid. | Plate has perfectly flat, | |
| optically clear surface for | ||
| optimum manipulation | ||
| and observation of ova | ||
| and embryos. Lid | ||
| provides access to two | ||
| wells while other two | ||
| remain covered. Lid | ||
| design allows aseptic | ||
| manipulation and | ||
| consistent venting to | ||
| maintain proper | ||
| humidification. | ||
| Safety Features | N/A | N/A |
| Other Relevant | ||
| Characteristics | Sterile (SAL 10-6) Non-pyrogenic by LAL Passes one-cell MEA | Sterile (SAL 10-6) Non-pyrogenic by LAL Passes two-cell MEA |
The ESP plates and the Falcon IVF Four Well Plate have similar applications, which include cell culturing and IVF. Both devices are sterile (SAL of 100), nonpvrogenic by Limulus Amebocvte Lysate (LAL), and nonembryotoxic as tested by the mouse embryo assay (MEA). The ESP plates and the Falcon plate are made from the same material, polystyrene. The ESP Four Well Plate and the Falcon IVF Four Well plate are very similar in configuration, with each plate having four wells.
The primary difference between the ESP plates and the Falcon plate is the physical configuration of the plates. The ESP plates come in a variety of configurations, including four well, six well, micro six well, well in well, and square grid. All ESP lids are key wayed to interlock with the base plate. The Falcon plate has four wells and a special lid to allow access to two wells while keeping the other two wells covered. These differences affect the ease of use of each device for varying applications. These differences do not alter the safety and effectiveness of the devices.
The Falcon plate is surface treated to improve hydrophilicity of the plate surface. whereas the ESP plates are not surface treated. However, both devices are comprised of polystyrene, which has been shown to be biocompatible (see section on Biocompatibility). The surface treating of the Falcon plate is simply an enhancement to improve the ease of use of the product. The non-treated
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K994361
Page 4 of 4
surface of the ESP plates does not compromise the safety and effectiveness of the ESP plates as compared to the Falcon plate.
Both the Falcon plate and the ESP plates pass the mouse embryo assay (MEA), however, the two-cell MEA was used for the Falcon plate whereas the one-cell MEA was used for the ESP plates. Currently, there is no consensus in the medical community on whether the one-cell MEA is most appropriate. Both assays test the viability of an embryo in the test device. Since both devices passed the MEA test, both devices have been shown to be non-embryotoxic. The type of MEA test used is not relevant to the safety and effectiveness of the devices.
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB 1 8 2000
Mr. Mark L. Anderson President Genesis Industries, Inc. 601 Pro-ject Drive Elmwood, WI 54740
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K994361 ESP Four Well Tissue Culture Plate ESP Six Well Tissue Culture Plate ESP Micro Six Well Tissue Culture Plate ESP Well in Well Tissue Culture Plate ESP Square Tissue Culture Plate with Grid Dated: December 22, 1999 Received: December 27, 1999 Requiatory Class: II 21 CFR §884.6160/Procode: 85 MQK
Dear Mr. Anderson:
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. Isting 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 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 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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Page 1 of 1
510(k) Number (if known): K994361
- Device Name: ESP Four Well Tissue Culture Plate ESP Six Well Tissue Culture Plate ESP Micro Six Well Tissue Culture Plate ESP Well in Well Tissue Culture Plate ESP Square Tissue Culture Plate with Grid
Indications For Use: The ESP Tissue Culture Plates are single-use labware intended for use in cell culturing and diagnostic laboratory procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K994361 |
|---|---|
| --------------- | --------- |