THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.
Device Story
THERMOPLATE is a microscope stage warmer consisting of a plate section and a controller unit. The plate section, placed on a microscope stage, features a clear heating material coated inside to maintain specimen temperature. It is designed to match specific microscope configurations (upright, inverted, stereo). The device provides uniform heating from beneath the specimen, allowing for simultaneous observation of multiple specimens without replacement. It is intended for use by laboratory personnel in clinical or research settings to maintain optimal conditions for gametes and embryos during microscopic examination. The clear construction ensures visibility, while the dual-glass structure with silicone bonding prevents glass fragmentation in case of breakage. The device is designed for electrical safety and accurate temperature regulation.
Clinical Evidence
No clinical data. Bench testing only; electrical safety and accuracy confirmed via UL/CE standards compliance.
Technological Characteristics
Plate section composed of rigid glass and clear heating material; resin frame. Dual-glass structure bonded with silicone. External surface covered with non-conductive heat-resisting glass and resin. Heating control unit provides temperature regulation. Designed for specific microscope stage configurations. Electrical safety per UL/CE standards.
Indications for Use
Indicated for temperature control of gametes and embryos during microscopic observation.
Regulatory Classification
Identification
Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
Special Controls
*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Submission Summary (Full Text)
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JUL -8 1900
K99/263
p. 1 of 2
Microscopc-stage Automatic Thermocontrol System
TOKAI HI 306-1 Gendoji-cho. Fujinomiy TELEFHONE: 1811544 24 6699 E-mail: tokaihit@tokai.c
510(k) Summary of THERMOPLATE Stage Warmer
(As required by 21 CFR 807.92(c))
July 5, 1999
Submitter: Tokai Hit Co., Ltd.
Address: 306-1, Gendoji-cho,
Fujinomiya City, Shizuoka Pref.,
Japan 418-0074
Phone: +81 544 24 6699
Fax: +81 544 24 6641
E-mail: tokaihit@tokai.or.jp
Contact Person: Hideharu Tsuchiya, Director of Tokai Hit Co., Ltd.
Trade Name of the Device: THERMOPLATE
Common Name: Stage Warmer
Classification Name: Assisted Reproduction Accessories (CFR#:884.6120)
Legally Marketed Device: 63 FR 48428 97N-0335 September 10,1998, Effective Date October 13,1998
# 1. Description of Device
The THERMOPLATE is a device automatically controls the temperature of specimens under the microscopes. The THERMOPLATE is made up of two sections: the plate section and the controller section. The plate section is to be set on the stage of a microscope. The specimen placed on the plate section can be maintained at an optimum temperature by the function of the heating element and the heating control unit. As a clear heating material is being coated inside the plate section, sufficient insulation is provided for the heating mechanism.
This product's electrical safety and accuracy had been proven by conforming to UL/CE standards.
# 2. Indication for Use
THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.
# 3. Technological Characteristics
# 1) Design features
with individual The plate section is designed specifically to match type, upright/inverted/stereo, and configuration of the microscopes.
07/05/99 510(k) Summary 1 of 2
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## 2) Safety features
The external surface of the plate section is covered by non-electric conductible material, such as heat resisting rigid glass and resin. Accordingly hazardous events i.e. leakage of electricity and/or electric shock will not take place.
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The plate is made of two pieces of rigid glass paste together with clear sillicone. Accordingly, the plate has dual structure which prevents breakage of glass and by any possibility the event takes place fragment of the broken glass will not fly apart for the glasses are paste together with silicone.
### 3) Other features
The prime characteristic of TEHRMOPLATE is that the plate section is composed of clear materials excluding the resin frame.
As a consequence of adopting clear heating plate, the device had acquired two significant features, accurate temperature control of the specimens and wide efficient area.
THERMOPATE has very strict accuracy in temperature control of the specimens for the optimum heat is supplied from right beneath the specimens regardless of the area one is placed on the plate. (Refer the drawings below) The wide efficient area allows multiple specimens to be heated at the same time and observed without replacing them as the heating plate is made of clear materials.
Along with quick start up and the most reliable accurate temperature control, THERMOPLATE provides the user easy operation and the accurate temperature control.
Image /page/1/Figure/8 description: The image compares two different types of heating plates: a perforated metal stage warmer and a clear glass heating plate. Each plate has a slide glass and a specimen placed on top of the heated area. The perforated metal stage warmer has a perforated area with a diameter of 20mm, while the clear glass heating plate does not have any perforations.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1999
Mr. Hideharu Tsuchiya Director Tokai Hit Co., Ltd. 306-1 Gendoji-cho Fuiinomiya-shi Shizuoka-ken JAPAN 418-0074
Re: K991263 Thermoplate Stage Warmer Dated: April 10, 1999 Received: April 13, 1999 Regulatory Class: II 21 CFR §884.6120/Procode: 85 MQG
Dear Mr. Tsuchiya:
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 Requlations, 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 Compiance 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): | K991263 |
|---------------------------|-------------|
| Device Name: | THERMOPLATE |
Indications For Use:
THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.
(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.
(Optional Format 3-10-98)
**Prescription Use**
(Per 21 CFR 801.109)
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
