(68 days)
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.
This document describes the Flexi-Stat SpO2 Ear Sensor, an accessory to a pulse oximeter, and its clearance for market based on substantial equivalence to a predicate device. This is primarily a descriptive summary of the device and its testing rather than a detailed study report. Therefore, specific details typically found in a robust study publication are limited.
Here's an attempt to extract the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" table with numerical metrics beyond the general statement of equivalence. It states that the device was found to be "equivalent to predicate device accuracy claims." The predicate device is the Nellcor Dura-Y ear sensor (K944760). Without the predicate device's specific accuracy claims, it's impossible to quantify the acceptance criteria or performance from this document alone.
| Feature / Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Equivalent to predicate device accuracy claims (Nellcor Dura-Y ear sensor K944760) | "found to be equivalent to predicate device accuracy claims" based on comparison to arterial blood samples analyzed on a laboratory co-oximeter during clinical hypoxia studies. |
| Pulse Rate Accuracy | Not specified (implied to be within acceptable limits for a pulse oximeter accessory) | "validated using bench testing with a pulse rate simulator." |
| Biocompatibility | Conformance with established industry standards | "performed to demonstrate conformance with established industry standards." |
| Electrical Safety | Conformance with established industry standards | "performed to demonstrate conformance with established industry standards." |
| EMC (Electromagnetic Compatibility) | Conformance with established industry standards | "performed to demonstrate conformance with established industry standards." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document mentions "clinical hypoxia studies" but does not provide the number of subjects or data points.
- Data Provenance:
- Country of Origin: Not explicitly stated, though Elekon Industries, USA, Inc. is located in Torrance, CA, USA. The clinical studies were conducted in an "independent research lab," the location of which is not specified.
- Retrospective or Prospective: "Clinical hypoxia studies" implies a prospective study design, as subjects would be intentionally exposed to hypoxic conditions for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. The ground truth for SpO2 accuracy was established by comparing the device readings to "arterial blood samples analyzed on a laboratory co-oximeter." This is a direct physiological measurement, not an expert consensus on interpreting images or clinical signs.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was based on objective laboratory co-oximetry measurements of arterial blood samples. There was no need for expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the performance testing of a medical device (SpO2 ear sensor), not an AI algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The SpO2 Ear Sensor itself is the "algorithm" (or the sensing and output component). Its performance in determining SpO2 and pulse rate was evaluated directly against a gold standard (co-oximetry for SpO2, pulse rate simulator for pulse rate) in a standalone manner, without requiring human interpretation of its raw output. The pulse oximeter to which it connects would then display these values, but the sensor's accuracy is evaluated independently.
7. The Type of Ground Truth Used
- For SpO2 Accuracy: "Arterial blood samples analyzed on a laboratory co-oximeter." This is considered a physiological measurement/outcome data, which is a gold standard for blood oxygen saturation.
- For Pulse Rate Accuracy: "Bench testing with a pulse rate simulator." This is a simulated/bench-test ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware sensor, not a machine learning algorithm that requires a training set. Its "training" is in its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a hardware sensor.
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DEC - 6 2004
Appendix C Page 1 of 2
510(k) Summary
Submitter Information:
Elekon Industries, USA, Inc. 3848 Del Amo Blvd. Torrance CA 90503 USA
Contact:
Tom Dietiker, President Tel: 310-370-8022 Fax:310-861-5619
Date Prepared:
September 13, 2004
Product Name:
Common Name: SpO2 Ear Sensor (accessory to pulse oximeter - ear oximeter) Trade Name(s): Flexi-Stat SpO2 Ear Sensor
Predicate Device:
Elekon Flexi-Stat™ ear sensor is substantially equivalent to the Nellcor Dura-Y ear sensor marketed under K944760.
Description:
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.
Intended Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
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Comparison to Predicate Device:
The Flexi-Stat SpO2 Ear Sensor uses the same theory and principle of operation as the predicate device. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims.
Performance Data & Conclusions:
Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims.
Pulse rate accuracy was validated using bench testing with a pulse rate simulator.
Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 2004
Elekon Industries U.S.A., Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road, #200-207 Plano, Texas 75025
Re: K042675
Trade/Device Name: Flexi-Stat SpO2 Ear Sensor Regulation Number: 21 CFR 870.2710 Regulation Name: Ear Oximeter Regulatory Class: II Product Code: DPZ Dated: September 14, 2004 Received: October 4, 2004
Dear Ms. Oakes:
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 vour 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 - Ms. Oakes
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Rumme
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. 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) # (if known):
Device Name: Flexi-Stat SpO2 Ear Sensor
Indications for Use:
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg
Prescription Use __ x (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aun Syleon
(Division Sig Division of Anesthesiology, General Hospital, Infection Control. Denta
510(k) Number: K042615
§ 870.2710 Ear oximeter.
(a)
Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.(b)
Classification. Class II (performance standards).