K102715 · Nonin Medical, Inc. · MUD · Dec 17, 2010 · Cardiovascular
Device Facts
Record ID
K102715
Device Name
REGIONAL OXIMETER
Applicant
Nonin Medical, Inc.
Product Code
MUD · Cardiovascular
Decision Date
Dec 17, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.2700
Device Class
Class 2
Attributes
Pediatric
Indications for Use
Model 7600 Regional Oximeter System: Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments. Model 8004CA Regional Sensor: The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments. Model 8000CA Regional Oximeter Sensor: The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments.
Device Story
System monitors mixed arterial/venous blood oxygen levels via non-invasive near-infrared spectroscopy (NIRS). Comprised of disposable sensors (8004CA/8000CA), patient oximetry device (pod), and 4-channel display unit. Sensors emit light (700-900 nm) and measure returning light via photodiodes; pod calculates absorption values and rSO2 saturation. Display unit provides real-time numeric data and trend lines with audio/visual alarms. Bluetooth module enables data output. Used by clinicians in hospital/mobile environments to monitor regional oxygenation; output aids clinical decision-making regarding patient perfusion and oxygen status.
Clinical Evidence
The device underwent extensive performance, electromagnetic, safety, and clinical testing. No specific clinical trial metrics (e.g., sensitivity, specificity) are detailed in the provided summary, but testing confirmed substantial equivalence to predicate devices.
Technological Characteristics
NIRS-based regional oximeter; sensors measure light absorption at 700-900 nm. System includes disposable sensors, patient oximetry pod, and 4-channel display unit. Battery-backed, mains-powered. Connectivity via Bluetooth. Software-controlled signal processing.
Indications for Use
Indicated for adult and pediatric patients >40 kg requiring spot-check or continuous monitoring of regional hemoglobin oxygen saturation (rSO2) in clinical settings including OR, recovery, critical care, ER, long-term care, and mobile environments.
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Predicate Devices
Nonin Medical, Model 7600 Regional Oximeter System (K090807)
CAS Medical, Fore-Sight® Cerebral Oximeter MC-2000 (K091452)
Somanetics Corporation, INVOS® Model 5100B Adult/Pediatric Cerebral Oximeter (K051274)
Submission Summary (Full Text)
{0}------------------------------------------------
K102715
## SECTION 2. SUMMARY AND CERTIFICATION
.
| DEC | | 2010 |
|-----|--|------|
|-----|--|------|
| A. 510(k) Summary | DEC 17 2010 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nonin Medical, Inc. |
| Contact Person: | Lori M. Mitchell RN, BSN<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
| Date Prepared: | September 17, 2010 |
| Trade Name: | Model 7600 Regional Oximeter with Equanox™<br>Technology and Bluetooth® Wireless Technology and<br>compatible Regional Sensors (Models 8004CA and<br>8000CA) |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | MUD |
| Predicate Device(s): | Nonin's Model 7600 4-Channel Regional Oximeter with<br>Equanox™ Technology and Bluetooth® Wireless<br>Technology and compatible Regional Sensors (Models<br>8004CA and 8000CA) are substantially equivalent to the<br>Nonin Medical, Model 7600 Regional Oximeter System<br>(K090807), CAS Medical, Fore-Sight® Cerebral Oximeter<br>MC-2000 (K091452), Somanetics Corporation, INVOS®<br>Model 5100B Adult/Pediatric Cerebral Oximeter<br>(K051274). |
| Device Description: | Nonin's® Model 7600 4-Channel Regional Oximeter<br>System with Equanox™ Technology and Bluetooth®<br>Wireless Technology and compatible sensors (8004CA,<br>8000CA) continuously monitor and record the mixed<br>arterial/venous blood oxygen levels through non-invasive<br>near-infrared spectroscopy sensors.<br>The system is comprised of three subsystems; sensor,<br>patient oximetry device (pod) and 4-channel display unit. |
Nonin Medical Inc.
Model 7600 4-Channel Regional Oximeter System Traditional 510(K): Premarket Notification
{1}------------------------------------------------
The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches.
The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The pods then communicate the regional oxygen saturation readings and other data to the display unit.
The 4-channel display unit displays absolute real-time regional hemoglobin oxygen saturation (rSO2) numeric data and trend lines. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.
Model 7600 4-Channel Regional Oximeter System:
Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (>40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
## Model 8004CA Regional Sensor:
The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating
# Intended Use:
{2}------------------------------------------------
room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
Model 8000CA Regional Sensor:
The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
## Functional and Safety Testing:
Nonin's Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA) have successfully undergone extensive performance, electromagnetic, safety, clinical, environmental, and software testing to ensure that it has appropriate functional features and is substantially equivalent to the predicate devices.
Conclusion: Nonin's Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA) are substantially equivalent to the Nonin Medical, Model 7600 Regional Oximeter System (K090807), CAS Medical, Fore-Sight® Cerebral Oximeter MC-2000 (K091452), Somanetics Corporation, INVOS® Model 5100B Adult/Pediatric Cerebral Oximeter (K051274).
Nonin Medical Inc.
{3}------------------------------------------------
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lori M. Mitchell Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 15t Avenue North Plymouth, Minneapolis 55441-5443
DEC 1 7 2010
Re: K102715
Trade/Device Name: Nonin Medical, Inc. Model 7600 4-Channel Regional Oximeter. With Equanox " Technology and Bluetooth Wireless Technology and Compatible Regional Sensors (Models 8004CA and 80000CA) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: September 17, 2010 Received: September 20, 2010
Dear Ms. Mitchell:
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.
{4}------------------------------------------------
## Page 2- Ms. Mitchell
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 reporting (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/CentersOffices/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.htm 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
um d. Rosas
for
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
{5}------------------------------------------------
### Indications for Use Statement
102715
510(K) Number:
Device Name:
Nonin Medical, Inc. Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA)
Indications for Use:
### Model 7600 Regional Oximeter System:
Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
### Model 8004CA Regional Sensor:
The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments.
### Model 8000CA Regional Oximeter Sensor:
The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments.
| 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 Evanianos (RBB) ov. General Hospital |
|--------------------|------------------------------------------------------------------------------------------------------------------|
| Nonin Medical Inc. | Infection Control, Dental Devices<br>Model 7600 4-Channel Regional Oximeter System Traditional 510(K): Premarket |
| | Notification<br>510/k) Number: .<br>3 |
| | |
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.
