CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
K083185 · Cadi Scientific Pte.Ltd · FLL · Mar 11, 2009 · General Hospital
Device Facts
Record ID
K083185
Device Name
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
Applicant
Cadi Scientific Pte.Ltd
Product Code
FLL · General Hospital
Decision Date
Mar 11, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.2910
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes. The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information. Warning: This equipment measures and reports abdominal surface temperature – where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose. Prescription device.
Device Story
System provides wireless, automated abdominal surface temperature monitoring; intended for healthcare facility use. Components: ThermoSENSOR (reusable, patient-applied via single-use tape), SmartNODE (wireless receiver), SmartSWITCH (activator), and SmartSense PC Application. Thermistor sensor detects temperature; converts to electrical signal; digitizes; transmits wirelessly to SmartNODE. PC application records, stores, and displays temperature data; provides dashboard for manual entry of other vital signs. Enables continuous tracking without limiting patient mobility. Healthcare providers use dashboard to monitor patient trends; aids clinical decision-making regarding temperature status. Not for core temperature measurement.
Clinical Evidence
Bench testing only. System evaluated against FDA guidance for clinical electronic thermometers and standards for electrical safety, electromagnetic compatibility, environmental operation, and shock/vibration. Software verified and validated via system-level performance testing. Biocompatibility of patient-contact materials confirmed.
Technological Characteristics
Thermistor-based temperature sensing; wireless data transmission; four-layer architecture (ThermoSENSOR, SmartNODE, SmartSWITCH, PC application). PC-based monitoring; local area Ethernet network connectivity. Biocompatible patient-contact materials. Software-controlled data acquisition and display.
Indications for Use
Indicated for abdominal surface temperature measurement in patients ranging from neonates to adults. Prescription use only. Not for core body temperature measurement.
Regulatory Classification
Identification
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
Special Controls
(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
Funai Amy Mama Wireless Thermometer Monitor (Baby Minder) (K003326)
Submission Summary (Full Text)
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K083 N5
# MAR 1 1 2009
Page 1 of 3
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
- (1) Submitted by: (a) CADI Scientific Pte. Ltd 31 Ubi Road 1, #03-00 Aztech Building Singapore 408694 Tel.: +49-38 41 360 221 Fax: +49-38 41 360 222 E-mail: zenton.goh@cadi.com.sg Contact Person: Mr. GOH Zenton, Ph.D. Position/Title: CEO Date of Preparation: February 23, 2008 (2) Trade Name: Cadi SmartSense Wireless Temperature Monitoring System Common/Classification Name: Thermometer, electronic, clinical FLL; 21 CFR § 880.2910 Product Code(s): Class: Class II (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K033534 VitalSense Integrated Mini Mitter Co., Inc. (now Physiological Monitoring Respironics) System K003326 Funai Amy Mama Wireless Funai Radio & Thermometer Monitor (Baby Communications Corp. Minder)
Reason for Submission: New device
(4) Description of Device:
> The Cadi SmartSense Wireless Temperature Monitoring System is intended for wireless automated measurement of abdominal surface temperature in adults through neonates used in any instance where quantifiable measurement of temperature data is desirable.
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## Page 2 of 3
The system further provides the SmartSense PC Application with a dataentry interface that allows users to manually enter other vital signs parameters.
The SmartSense PC Application additionally provides a Vital Signs Dashboard view for convenient viewing and monitoring of patients' monitored temperature and manually entered vital signs.
The Cadi SmartSense Wireless Temperature Monitoring System consists of the following proprietary components:
- ThermoSENSOR patient applied wireless temperature sensor .
- SmartNODE wireless telemetry receiver receives ThermoSENSOR . data
- SmartSWITCH sensor activator accessory .
- SmartSense PC Application PC application software .
Additional system elements include information technology (IT) equipment used in a local area Ethernet network such as routers and switches.
#### (5) Intended use:
Abominal surface temperature monitoring provides a convenient means to track patient temperature and trends without limiting patient mobility. The system is intended to be deployed within a health care facility to allow the monitoring of temperature wherever the patient applied sensor is within range of a receiver or receivers.
## Indications for Use:
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.
ThermoSENSOR provides periodic wireless transmission of The temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.
WARNING This equipment measures and reports abdominal surface temperature - where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
Prescription device.
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#### (6) Technological Characteristics:
The CADI SmartSense Wireless Temperature Monitoring System employ the same technological characteristics as the predicate device to measure temperature - a thermistor temperature sensor changes electrical characteristics in response to temperature. The resultant electrical signal is digitized and transmitted to the host to determine the measured Temperature information is displayed on a PC monitor temperature. display.
The SmartSense system utilizes a four-layer architecture in which the temperature measurement and wireless transmit functions are managed by the ThermoSENSOR. Wireless receiver, SmartSWITCH accessory, and SmartSense PC application functions are managed by separate control programs.
#### (b) (1) Non-Clinical Tests Submitted:
The SmartSense System was evaluated to the requirements of the FDA guidance document on clinical electronic thermometers and referenced standards.
The system elements were tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, environmental operation and storage conditions, resistance to moisture ingress, and shock and vibration. The device passed all of the tests.
SmartSense PC/host software and embedded software in the subsystems was verified to requirements and validated to meet intended use by software and system level performance testing.
Sensor patient contact materials meet applicable standards for biocompatibility.
#### (2) Clinical Tests Submitted:
(none / none required).
#### (3) Conclusions from Tests:
As described above, the Cadi SmartSense Wireless. Temperature Monitoring System including accessory ThermoSENSOR's function and perform in a manner equivalent to the predicate device(s) as validated by parameter and bench testing. Device safety is substantiated by compliance testing to applicable standards and by biocompatibility of patient contact materials.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CADI Scientific Pte. Limited C/o Mr. Stephen H. Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K083185
> Trade/Device Name: CADI Scientific Pte.Ltd. Cadi SmartSense Wireless Temperature Monitoring System
Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 23, 2009 Received: February 25, 2009
Dear Mr. Gorski:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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## Page 2 - Mr. Gorski
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sayette Y. Michael ms.
Ginette Y. Michaud, M.D. Acting 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:
CADI Scientific Pte. Ltd. Cadi SmartSense Wireless Temperature Monitoring System
### Indications for use:
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.
The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.
Warning: This equipment measures and reports abdominal surface temperature – where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hall
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of __
510(k) Number: K083185
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.
