MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
Applicant
Masimo Corp.
Product Code
DQA · Cardiovascular
Decision Date
Nov 19, 1999
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.2700
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Masimo SET® (Quartz 2500 Pulse Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation or arterial hernoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET "Quartz 2500 Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and home environments. The Masimo LNOP® Series of Sensors are indicated for the Masimo SETYQuartz 2500 Pulse Oximeter and the following: A single use oximetry sensor intended for adults and pediatrics greater than 30kg. A single use oximetry sensor intended for pediati.cs and small adults greater than 10 kg and less than 50 kg; A single use oximetry sensor intended for neonates with good skin integrity less than 10kg; A single use oximetry sensor intended for neonates with integrity less than 1kg; and A reusable oximetry sensor intended for adults and pediatrics greater than 30kg. The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET /Quartz 2500 Pulse Oximeter.
Device Story
Portable stand-alone pulse oximeter; calculates functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Inputs: optical signals from LNOP series sensors (two LEDs); monitor processes light absorption ratios of oxygenated vs. unsaturated hemoglobin. Outputs: plethysmographic waveform, SpO2 value, pulse rate, alarm limits, trends, status messages. Used in hospitals and home environments; operated by clinicians or patients. Device provides real-time physiological data to assist in patient monitoring and clinical decision-making; benefits include noninvasive assessment of oxygenation status.
Clinical Evidence
Bench testing only. Compliance with safety and performance standards (CSA C22.2 #601, IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, ISO 9919:1992, EN 865:1997, UL 2601-1) and validation of software development processes.
Technological Characteristics
Portable monitor (10cm x 27.5cm x 25cm, 4kg); powered by 100-240 Vac or sealed lead-acid battery. Uses LNOP series sensors with two LEDs for light absorption measurement. Connectivity via PC series cables. Complies with IEC 601-1, ISO 9919, and UL 2601-1 standards.
Indications for Use
Indicated for continuous noninvasive monitoring of functional SpO2 and pulse rate in adult, pediatric, and neonatal patients. Applicable for patients who are well or poorly perfused, in no-motion conditions, within hospitals, hospital-type facilities, and home 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
Masimo SET® 2000 Pulse Oximeter and Accessories
Submission Summary (Full Text)
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K99355-5
NOV 1 9 1999
Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo. The logo is a stylized, bold typeface with a small circle above the 'i'. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686.
18 October 1999
510(k) Summary of Safety and Effectiveness Information for the Masimo Subject:s SET®/Ouartz 2500 Pulse Oximeter Accessories Proprietary: Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories Common: Oximeter Classification: Oximeter Class II - 21CFR870.2700 - 74 DQA
The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.
The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):
- Masimo SET® 2000 Pulse Oximeter and Accessories .
The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is a portable stand alone device, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LED's to determine the functional oxygen saturation of arterial hemoglobin (SpO>) and pulse rate and provide for the connection to the connecting cable.
The Masimo SET®/Quartz 2500 Pulse Oximeter is available in one configuration as a portable stand alone pulse oximeter that is 10cm high, 27.5cm wide, 25cm deep and weighs 4 kg. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of 5.5 hours and a charge time of 4.5 hours to 80% capacity.
The PC series of connecting cables connects the monitor to the oximetry sensors and transfers LED drive power and the calibration drive to the oximetry sensors from the monitor and the monitor receives the detector signal from the oximetry sensor.
The PC series of connecting cables is available in one configuration and three lengths, 4 feet, 8 feet and 12 feet.
Page 1 of 2
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The LNOP® series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
The LNOP® series of oximetry sensors is available in five configurations:
- a single use oximetry sensor intended for adults and pediatrics greater than 30 kg; ●
- a single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and . less than 50 kg:
- . a single use oximetry sensor intended for neonates with good skin integrity less than 10kg;
- a single use oximetry sensor intended for neonates with integrity less than 1kg; and .
- . a reusable oximetry sensor intended for adults and pediatrics greater than 30kg.
The Masimo SET®/Quartz 2500 Pulse Oximeter is designed to comply with the following standards:
- 1. CSA C22.2 #601
- 2. IEC 601-1, Part 1 and Amendments 1 and 2
- 3. IEC 601-1-1, Part 1
- 4. IEC 601-1-2, Part 1
- 5. IEC 601-1-4, Part 1
- 6. ISO 9919: 1992
- 7. EN 865: 1997
- 8. UL 2601-1
The Masimo SET® 2000 Pulse Oximeter and the Masimo SET®/Quartz 2500 Pulse Oximeter are substantially equivalent in design concepts, technologies and materials. The Masimo SET®/Quartz 2500 Pulse Oximeter was validated through rigorous testing that, in part, support the compliance of the Masimo SET®/Quartz 2500 Pulse Oximeter to the above mentioned standards. Additionally, the software for the Masimo SET®/Quartz 2500 Pulse Oximeter was developed following a robust software development process and was fully specified and validated by Masimo and Quartz.
The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is the next generation in the Masimo Pulse Oximeter family of products.
13
Page 2 of 2
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Image /page/2/Picture/1 description: The image is a black and white 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 a stylized caduceus, with three curved lines representing snakes or streams.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614
K993555 Re: Masimo SET®/Quartz 2500 Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: October 18, 1999 Received: October 20, 1999
Dear Mr. Cronin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James J. Cronin
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Chale ( Ho
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## 7142509686
## Indications for Use
510(k) Number (if known): K993555
Device Name:
Masimo SET®/Quartz 2500 Pulse Oximeter
Indications for Use:
The Masimo SET® (Quartz 2500 Pulse Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation or arterial hernoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET "Quartz 2500 Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and home environments.
The Masimo LNOP® Series of Sensors are indicated for the Masimo SETYQuartz 2500 Pulse Oximeter and the following:
A single use oximetry sensor intended for adults and pediatrics greater than 30kg.
A single use oximetry sensor intended for pediati.cs and small adults greater than 10 kg and less than 50 kg;
A single use oximetry sensor intended for neonates with good skin integrity less than 10kg;
A single use oximetry sensor intended for neonates with integrity less than 1kg; and
A reusable oximetry sensor intended for adults and pediatrics greater than 30kg.
The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET /Quartz 2500 Pulse Oximeter.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chas Ads for JXH
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number:
Prescription Use (Per 21CFR801.109)
X
Over-The-Counter Use OR
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.
