K102227 · Atom Medical Corporation · FMT · Jan 21, 2011 · General Hospital
Device Facts
Record ID
K102227
Device Name
INFA WARMER I
Applicant
Atom Medical Corporation
Product Code
FMT · General Hospital
Decision Date
Jan 21, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5130
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Infa Warmer i is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery. temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,
Device Story
Infa Warmer i is an open-type radiant infant warmer; consists of canopy with heater, mattress platform, control panel, and stand. Inputs: skin temperature via sensor attached to infant; optional SpO2/pulse monitoring. Operation: servo-control mode (automatic heater adjustment based on skin temperature setpoint 34°C–38°C) or manual mode (0–100% heater output). Used in neonatal nurseries/surgery; operated by clinicians. Provides thermal regulation to prevent hypothermia; supports resuscitation/oxygen therapy via integrated space for external gas blenders/resuscitators (functionally independent). Output: thermal energy to infant; visual monitoring of temperature/SpO2. Benefits: maintains stable body temperature for neonates.
Clinical Evidence
Bench testing only. Device verified against IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21 standards. Biocompatibility evaluated per ISO 10993-1 using materials identical to the predicate device. Software validation was conducted.
Technological Characteristics
Radiant warming heater; servo-control and manual control modes. Components: canopy, mattress platform, pole, control panel. Connectivity: optional SpO2 module. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-21 (infant radiant warmers), ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for newborns and premature neonates requiring thermal support, including pre/post-operative intensive care, neonatal hypothermia management, observation, examination, and prevention of temperature drop post-delivery.
Regulatory Classification
Identification
The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.
Special Controls
*Classification.* Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
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K102227
### 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR \$807.92.
# Sponsor Information:
Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku 113-0033 Tokyo Japan
JAN 2 1 201
Date Summary Prepared: July 30, 2010
## Contact Person:
Mr. Tsuyoshi Sugino Atom Medical Corporation Regulatory Affairs Department Manager TEL +81-3-3815-3632 FAX +81-3-3812-3199 E-mail t-sugino@atomed.co.jp
#### Device Name:
Trade Name(s): Infa Warmer i (Atom Infant Warmer Model 103) Classification Name: Infant Radiant Warmer Classification Regulation: 880.5130 Panel: General Hospital Product Code: FMT
## Predicate Device Information:
Device Name: V-505 Infa Warmer 510(k) Reference: K060461 Manufacturer: Atom Medical Corporation
#### Device Description:
Infa Warmer i (Atom Infant Warmer Model 103) consists of a canopy, a warming heater (heater), a pole, a control panel, a mattress, a mattress platform, baby guards and a stand with casters. This product has 3 types (Type Name: HE, MS, ST) according to the following specification.
HE: (1)With mattress platform, stand can go up and down
MS: (2)With mattress platform, stand cannot go up and down
ST: (3)Without mattress platform
A warming heater is installed in the canopy.
Skin temperature sensors are connected to front panel of the pole.
This product has 2 types of function modes; one is "servo control model" (called as "skin temperature control mode") and another is manual control mode.
In "servo control mode", skin temperature can be set from 34°C to 38°C
In "bel to control mode", heater output of the warming heater can be set from 0 to 100% (in 5% increments).
When the product is functioned in "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature.
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When the product is functioned in "manual control mode", heater output of the warming heater is controlled manually according to measured baby's skin temperature. The mattress platform can be tilted.
The mattress platform can be tilted.
The skin temperature sensors and X-ray cassette tray
The skin temperature sensors and X-ray cassette tray are accessories.
The X-ray cassette tray is optional accessory, and it can be installed under the mattress platform. These accessories are available separately as replacements.
SpO2 module is component of this product, and it is optional whether they are attached initially or not. If it is not attached initially, it can be attached later, and SpO2/pulse monitoring can be available. The component can be supplied individually.
This product has a space inside the pole, and gas powered resuscitator or oxygen/air gas blender whose sizes are within the space, can be installed in the space, so that resuscitation or oxygen therapy can be done immediately for any new born baby who needs such the treatments. When the resuscitator or the blender is installed in this space, it is completely separated from this product, and it does not have any connections with this product regarding function, operation and power source. Therefore, this product operates normally without the resuscitator or the blender. Also, this product operates normally, even if the resuscitator or the blender is out of order.
### Intended Use:
The Infa Warmer i is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery. temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,
### Comparison to Predicate Device:
Main differences between Infa Warmer i and Atom V-505 are as follows.
The functions of oxygen delivery and suction are installed in Atom V-505 but are not installed in the Infa Warmer i.
The technological characteristics of the Infa Warmer i as compared to the predicate products, the V-505 Infa Warmer. is equivalent in the following areas and do not compromise the safety or efficacy of the device.
-Intended use
- Feature
- Appearance
- Temperature Modes
- Components and those function
## Testing and Conclusions:
Infa Warmer i is electrical medical device. Therefore, tests based on IEC60601-1-2 and IEC60601-2-21 standards were carried out for Infa Warmer i, and it was verified that Infa Warmer i is met to requirements of IEC60601-1, IEC60601-1-2 and IEC60601-2-21.
Biocompatibility was evaluated based on ISO10993-1. Infants-contacting narts of the Infa Warmer i are not unprecedented and are generally used for various type of medical devices. And
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also the materials are identical to those used for the 510(k)-cleared predicate device. Thus the biological safety can be evaluated to have been assured.
Validation has been conducted on the device software.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring. MD 20993-0002
Mr. Tsuyoshi Sugino Regulatory Affairs Manager Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku 113-0033 Tokyo JAPAN
JAN 2 1 201
Re: K102227
Trade/Device Name: Infa Warmer i (Atom Infant Warmer Model 103) Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: January 17, 2011 Received: January 18, 2011
Dear Mr. Sugino:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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Page 2- Mr. Sugino
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reportung (reporting of medical device-related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/Centers.offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jums f. Rofot
fes
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
## Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name: Infa Warmer i (Atom Infant Warmer Model 103)
## Indications for Use:
The Infa Warmer i is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/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)
for RICHARD
CHAPMAN
Juston Sign ്വാന്ട്രിഗ്രം(പ്രുമംഗീ)
Division of Anesthesionogy, General Hospital
Division of Anesthesion Devices Division of Anoothool, Dental Devices
510(k) Number: K102227
.
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.
