(42 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
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 foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
This submission describes the Flexi-Stat SpO2 Sensor, an accessory to a pulse oximeter for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The summary provided primarily focuses on the substantial equivalence of the Flexi-Stat SpO2 Sensor to existing predicate devices, rather than detailed acceptance criteria and supporting studies for a novel or significantly modified device. Therefore, some information requested, particularly regarding specific numerical acceptance criteria and a detailed study design as might be seen for a new algorithmic device, is not explicitly present in the provided text.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Specific numerical acceptance criteria (e.g., accuracy ranges for SpO2 measurements) are not explicitly stated in the provided text for the Flexi-Stat SpO2 Sensor itself. Instead, the document states: "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." This implies that the acceptance criteria for the Flexi-Stat SpO2 Sensor were to meet or be equivalent to the accuracy claims of its predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy (SpO2) | Equivalent to predicate device accuracy claims | "found to be equivalent to predicate device accuracy claims" based on comparison to arterial blood samples analyzed on a laboratory co-oximeter. |
| Biocompatibility | Conformance with established industry standards | "Biocompatibility... was also performed to demonstrate conformance with established industry standards." |
| Electrical Safety | Conformance with established industry standards | "electrical safety... was also performed to demonstrate conformance with established industry standards." |
| EMC (Electromagnetic Compatibility) | Conformance with established industry standards | "EMC testing was also performed to demonstrate conformance with established industry standards." |
| Principle of Operation | Same as predicate device | "The Flexi-Stat SpO2 Sensor uses the same theory and principle of operation as the predicate device." |
| Design Characteristics | Equivalent to predicate device in terms of safety and effectiveness | "Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not explicitly stated in the provided text. The document mentions "clinical hypoxia studies" but does not give the number of subjects.
- Data Provenance: The studies were described as "clinical hypoxia studies conducted in an independent research lab." No specific country of origin is mentioned, but the company is US-based. It is a prospective study as clinical hypoxia studies involve actively inducing hypoxia in subjects under controlled conditions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The ground truth was established using an objective measurement from a laboratory co-oximeter and arterial blood samples, not through expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. The ground truth was based on objective laboratory measurements (co-oximetry of arterial blood samples), not on expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI), not for objective physiological measurement devices like an SpO2 sensor where the output is a direct numerical reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, the accuracy assessment described ("The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter") represents a standalone performance evaluation of the device's measurement capabilities. There is no human intervention mentioned in the process of generating the SpO2 values from the Flexi-Stat sensor and comparing them to the ground truth.
7. The Type of Ground Truth Used
The ground truth used was objective physiological measurement:
- "arterial blood samples analyzed on a laboratory co-oximeter"
8. The Sample Size for the Training Set
This information is not applicable as the Flexi-Stat SpO2 Sensor is not a machine learning or AI-based device that typically requires a "training set" in the conventional sense. Its function is based on electro-optical principles, not learned patterns from data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons mentioned above.
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Appendix C Page 1 of 2
Koyl 644
JUL 2 9 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, K030930, 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 foam and Velcro wrap. 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 shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
JUL 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elekon Industries, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions, Incorporated 2300 McDermott Road, Suite 200-207 Plano, Texas 75025
Re: K041644
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 Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the referenced doove and have to 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 Amendinents, of to arrivand Cosmetic Act (Act) that do not require approval of a premarket the Federal 2 000, Drag) . You may, therefore, market the device, subject to the general approvin application (she 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 (1 mr), it ney of 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 I Teast be advisod that 1 Dr. o termination that your device complies with other requirements modifine in 1 DT may made statutes and regulations administered by other Federal agencies. or the Act of any I each and the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF read 007), mailing systems (QS) regulation (21 CFR Part 820); and if requirements as bet form mode of 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) Fins feter will and in your began 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), n you acontact the Office of Compliance at (301) 594-4613. 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 yours,
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): K041644
Device Name: Flexi-Stat SpO2 Sensor
Indications for Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
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)
Ques Sfr
(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).