(77 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The Flexi-Stat SpO2 Sensor is indicated for use in patients weighing >30 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 finger clip housing. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
Here's a breakdown of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome Demonstrated | Reported Device Performance |
|---|---|---|
| Accuracy (SpO2) | Equivalent to predicate device accuracy claims. | "found to be equivalent to predicate device accuracy claims." |
| Biocompatibility | Conformance with established industry standards. | Performed; conformance demonstrated. |
| Electrical Safety | Conformance with established industry standards. | Performed; conformance demonstrated. |
| EMC (Electromagnetic Compatibility) | Conformance with established industry standards. | Performed; conformance demonstrated. |
| Intended Use | Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. For patients weighing >30 kg. | Device is indicated for this use. |
| Principle of Operation | Uses the same theory and principle of operation as predicate device. | Confirmed. |
| Design Characteristics | Equivalent to predicate devices in terms of safety and effectiveness. | Confirmed by testing and accuracy claims. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "clinical hypoxia studies" without specifying the number of subjects.
- Data Provenance: Clinical hypoxia studies conducted in an independent research lab. The country of origin is not specified, but the submission is from Elekon Industries, USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the ground truth was "arterial blood samples analyzed on a laboratory co-oximeter," implying that experts in laboratory co-oximetry would have been involved in analyzing these samples.
4. Adjudication method for the test set:
- Not applicable. The ground truth was established through direct comparison with arterial blood samples analyzed on a co-oximeter, not through expert consensus requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic tool for which MRMC studies are typically performed. The study focused on the sensor's accuracy compared to a reference standard.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance testing described is standalone for the device. The Flexi-Stat SpO2 sensor's readings were compared directly to the ground truth from arterial blood samples without human interpretation being part of the device's measurement process, though human operators would connect and read the oximeter display. The focus was on the sensor's accuracy.
7. The type of ground truth used:
- Reference Standard: Arterial blood samples analyzed on a laboratory co-oximeter. This is considered a gold standard for blood oxygen saturation measurement.
8. The sample size for the training set:
- Not applicable / Not specified. This device is a physiological sensor, not a machine learning algorithm that typically requires a distinct training set. The performance testing validates its function.
9. How the ground truth for the training set was established:
- Not applicable. As a non-AI physiological sensor, there isn't a "training set" in the machine learning sense. The ground truth for performance evaluation was established by comparing sensor readings to concurrently drawn and analyzed arterial blood samples using a laboratory co-oximeter.
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Appendix C Page 1 of 2
SEP - 2 2004
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:
June 11, 2004
Product Name:
Common Name: SpO2 Sensor (accessory to pulse oximeter) Trade Name(s): Flexi-Stat SpO2 Sensors
Predicate Device:
Elekon Flexi-Stat™ sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 510(k) # K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 510(k) # K992215.
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 finger clip housing. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
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Intended Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
Comparison to Predicate Device:
The Flexi-Stat SpO2 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.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2004
Elekon Industries U.S.A, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions, Incorporated 2300 McDermott Road, Suite 200-207 Plano, Texas 75025
Re: K041647
Trade/Device Name: Flexi-Stat SpO2 Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 11, 2004 Received: June 17, 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 mendments, 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 (1111), it nay of basyon 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 moan that I DA nas made statutes and regulations administered by other Federal agencies. of the For of ally I outral the Act's requirements, including, but not limited to: registration r ou intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu fisting (21 CF RT rar 801), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as bet forms in the quadistion 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) Prins feter intification. The FDA finding of substantial equivalence of your device to a premainer nownedled 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. 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 may obtain 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,
QWL
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): K041647
Device Name: Flexi-Stat SpO2 Sensor
Indications for Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial
s and indication is indicated for continues woighing >30 kg The Flext-Stat SpOZ School 13 marcated 15. in patients weighing >30 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)
Auybulion
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number:
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).