K112820 · Cas Medical Systems, Inc. · MUD · Jan 26, 2012 · Cardiovascular
Device Facts
Record ID
K112820
Device Name
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
Applicant
Cas Medical Systems, Inc.
Product Code
MUD · Cardiovascular
Decision Date
Jan 26, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.2700
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The noninvasive FORE-SIGHT® Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 Kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg. The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
Device Story
Noninvasive tissue oximeter; uses diffuse reflectance spectroscopy to measure absolute regional hemoglobin oxygen saturation. Device generates 4 precise wavelengths via LASER-SIGHT optical technology; analyzes light returned through tissue microvasculature (arterioles, capillaries, venules) to calculate oxygenated/deoxygenated hemoglobin levels. Monitor features rechargeable battery for portability; used in hospital settings by clinicians. Output provides continuous or spot-check absolute oxygenation data; serves as adjunct monitor for patients at risk of ischemia. Benefits include real-time tissue oxygenation assessment to inform clinical decision-making. Data not intended as sole basis for diagnosis or therapy.
Clinical Evidence
Clinical validation performed for expanded indications, specifically neonatal and pediatric subjects. Cites validation report: 'Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects'. Testing included extensive clinical study alongside laboratory, safety, electromagnetic, and software verification/validation.
Technological Characteristics
Uses diffuse reflectance spectroscopy; 4-wavelength LASER-SIGHT optical technology. COOL-LIGHT sensor technology. Available in 3 sensor sizes (Large, Medium, Small). Battery-powered or AC-operated. Software-controlled monitor for continuous/spot-check monitoring.
Indications for Use
Indicated for monitoring absolute regional hemoglobin oxygen saturation in individuals at risk for reduced flow or no-flow ischemic states. Large sensors: brain (adults/children >40kg). Medium sensors: brain (small adults/children 4-80kg), skeletal muscle (infants/children/adolescents 4-50kg). Small sensors: brain (infants/neonates <8kg), abdomen (neonates <4kg). Not for sole diagnostic or therapeutic use.
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.
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CASMED FORE-SIGHT ABSOLUTE TISSUE OXIMETER K112820 ADDITIONAL INFORMATION REQUEST Confidential
4 JAN 2012
Page 9 of 396
JAN 2 6 2012
Image /page/0/Picture/4 description: The image shows the word "CASMED" in a bold, sans-serif font. The letters are filled with a textured pattern, giving them a slightly rough appearance. A registered trademark symbol is present to the right of the letter "D".
# 510(k) SUMMARY
| Submitter: | CAS Medical Systems, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory Affairs<br>Phone - (203) 315-6310<br>Fax - (203) 488-9438<br>Email – rjeffrey@casmed.com |
| Prepared: | January 5, 2011 |
| Trade Name: | FORE-SIGHT® Absolute Tissue Oximeter |
| Common Name: | FORE-SIGHT Oximeter |
| Classification Name: | Oximeter, Tissue Saturation (870.2700) |
## PREDICATE DEVICE
The FORE-SIGHT® Absolute Tissue Oximeter is equivalent to the following devices:
- * CAS Oximeter Monitor (K094030)
- Somanetics INVOS® 5100C Oximeter (K091224) 学
### DESCRIPTION
The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue.
The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.
### INTENDED USE
The noninvasive FORE-SIGHT® Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 Kg.
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4 JAN 2012
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of suall adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg,
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
### FORE-SIGHT Monitor Technology Compared to Predicate Devices
The FORE-SIGHT Absolute Tissue Oximeter compares substantially to one or more of the cited predicate devices in that they use fundamentally the same optical operating principle, called diffuse reflectance spectroscopy. All cited monitors use light to examine a cross-section tissue microvasculature (a mixed bed of arterioles, capillaries and venules). The FORE-SIGHT Monitor and predicate devices analyze the light that is returned after having passed through tissues. The analysis is for hemoglobin in is oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue.
The FORE-SIGHT Absolute Tissue Oximeter is identical to the FORE-SIGHT predicate, except for the software and user interface modifications to support the expanded indications.
#### Non-Clinical Performance Testing to Demonstrate Substantial Equivalence
The FORE-SIGHT® Absolute Tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, clinical, software and environmental testing to ensure it has been found to be substantially equivalent to the FORE-SIGHT predicate device. In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software and systems verification and validation studies of the FORE-SIGHT monitor and sensors.
### Clinical Testing to Show Substantial Equivalence
The FORE-SIGHT Absolute Tissue Oximeter has successfully undergone extensive clinical study for the expanded indications for use especially for neonatal subjects. The premarket notification cites validation report "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects".
#### Conclusions Drawn from Clinical and Non-Clinical Testing
Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT Absolute Tissue Oximeter is substantially equivalent to the predicate devices.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
CAS Medical Systems, Inc. c/o Mr. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Road Branford, CT 06405
Re: K112820
Trade/Device Name: FORE-SIGHT® Absolute Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: January 4, 2012 Received: January 9, 2012
Dear Mr. Jeffrey:
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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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.
Debra Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CASMED FORE-SIGHT ABSOLUTE TISSUE OXIMETER K112820 ADDITIONAL INFORMATION REQUEST Confidential
4 JAN 2012
Page 12 of 396
#### INDICATIONS FOR USE
510(k) Number K112820:
Device Name: FORE-SIGHT® Absolute Tissue Oximeter
Indications for Use:
The noninyasive FORE-SIGHT® Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 Kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg.
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
Prescription Use AND/OR Over-The Counter Use
(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Dan I Kaufman MA
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112820
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.
