THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749 · Philips Medical Systems · DRG · Nov 19, 2002 · Cardiovascular
Device Facts
Record ID
K023749
Device Name
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
Applicant
Philips Medical Systems
Product Code
DRG · Cardiovascular
Decision Date
Nov 19, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.2910
Device Class
Class 2
Indications for Use
The M3810A Philips TeleMonitoring System with M3812B TeleStation is intended to be used upon prescription by a licensed physcian or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a healthcare professional at the authorized provider. Apart from the convenience features added for enhanced interaction, and blood glucose meter data transmission, that is the same intended use as previously cleared for the M3810A Interactive Health System
Device Story
System collects patient physiological data (weight, blood pressure, pulse, non-diagnostic ECG) and subjective responses via automated interactions; includes glucose meter download capability. Data transmitted automatically over residential telephone lines from home to healthcare provider. Device used by patients for daily self-measurement; healthcare professionals review transmitted data to support clinical management of cardiac conditions. No real-time alarms; clinical judgment required for interpretation. Benefits include remote monitoring of chronic conditions and post-event recovery.
Clinical Evidence
Bench testing only. Verification and validation activities included laboratory studies for biocompatibility, electrical safety, EMC, and radio telemetry, alongside user evaluations for consumer accuracy. Acceptance criteria were based on specifications cleared for the predicate device.
Technological Characteristics
Physiological signal transmitter and receiver system. Components include M3810A TeleMonitoring System and M3812B TeleStation. Connectivity via residential telephone lines. Features include automated data collection for weight, blood pressure, pulse, non-diagnostic ECG, and glucose meter data. No specific software algorithm architecture or material standards provided.
Indications for Use
Indicated for home patients capable of self-administration, prescribed by healthcare providers, to collect/transmit weight, blood pressure (including pulse), and non-diagnostic ECG rhythm strips. Used for management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post-cardiovascular surgery, post-myocardial infarction, and other post-cardiac events. No real-time alarms.
Regulatory Classification
Identification
A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.
Predicate Devices
Modification of Physiological Signal Transmitter & Receiver (K993169)
Submission Summary (Full Text)
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Confidential
## Special 510(k) Modification
K023749
# NOV 1 9 2002
## 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 C.F.R. §807.92.
| The submitter of this<br>premarket notification<br>is: | J. P. Ouellette<br>Quality Program Manager<br>Cardiac and Monitoring Solutions<br>New Clinical Ventures Division/eCare MS 0024<br>Philips Medical Systems<br>3000 Minuteman Road<br>Andover MA 01810-1099<br>Tel: (978) 659-4308<br>Fax: (978) 659-3456<br>e-mail: joe.ouellette@philips.com | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------|
| Date of summary | October 25, 2002 | | |
| Device name | The M3810A Philips TeleMonitoring System with M3812B TeleStation | | |
| Common name | Physiological Transmitter and Receiver | | |
| Classification names | Regulation Number | ProCode | Classification Name |
| | 870.2910 | DRG | Physiological Signal<br>Transmitters And<br>Receivers |
| | 870.1130 | DXN | Non-invasive Blood<br>Pressure<br>Measurement System |
| | 870.2340 | DPS | Electrograph |
| | 870.2720 | FRW | Patient Scale |
| Predicate Devices | The modified device is substantially equivalent to the previously cleared<br>Modification of Physiological Signal Transmitter & Receiver pursuant to<br>K993169 (September 22, 1999). | | |
| Modifications | The primary modification is a change to add the functionality of glucose<br>meter downloads and subjective questions (automated interactions). | | |
| Intended Use | The modified device has the same intended use as the legally marketed<br>predicate devices. The M3810A Philips TeleMonitoring System with<br>M312B TeleStation is intended to be used upon prescription by a licensed<br>physcian or authorized healthcare provider by patients as a means to<br>automatically collect and transmit medical information, such as weight,<br>blood pressure, and non-diagnostic ECG, over normal residential telephone<br>lines, between a patient, typically at home, and a healthcare professional at | | |
Philips Medical Systems
Page 54 of 87
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| Confidential | Special 510(k) Modification |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the authorized provider. Apart from the convenience features added for<br>enhanced interaction, and blood glucose meter data transmission, that is the<br>same intended use as previously cleared for the M3810A Interactive Health<br>System |
| Technological<br>characteristics | The modified device has the same technological characteristics as the<br>legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted to establish the<br>performance and reliability characteristics of the modified device.<br>Testing involved safety testing from the risk analysis, including laboratory<br>studies for biocompatibility electrical safety testing, EMC testing and radio<br>telemetry testing and user evaluations for consumer accuracy. Acceptance<br>criteria were based on the specifications cleared for the predicate device and<br>test results showed substantial equivalence. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems c/o Mr. J.P. Ouellette, M.S. Quality Program Manager 3000 Minuteman Road Andover, MA 01810
#### Re: K023749
Trade Name: The M3810A Philips TeleMonitoring System with M3812B TeleStation Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: November 6, 2002 Received: November 8, 2002
#### Dear Mr. Ouellette:
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. J.P. Ouellette, M.S.
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 (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. 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 Office of Compliance at (301) 594-4646: 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely vours.
Ana Alumku fo
Brant D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Special 510(k): Device Modification
#### 3.1 ODE Indications Statement
#### Indications for Use Statement
510(k) Number (if known)
Device Name: The M3810A Philips TeleMonitoring System with M3812B TeleStation
## Indications for Use:
The M3810A Philips TeleMonitoring System with M3812B TeleStation is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K023749
DOF 11/18
Philips Medical Systems
Page 13 of 87
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.
