(29 days)
TS-AAW-10 and TS-AAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds)
TS-PAW-10 and TS-PAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight ronge: 3-20 kg (6.6-44 pounds)
The TruSignal SpO2 Adult and Pediatric Disposable Sensors are used together with standalone oximeters or modular patient monitors to measure continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
The sensors are to be connected to a device using an interconnect cable TS-G3, TS-M3, TS-H3 or TS-N3 (cleared in K093881). The interconnect cable type depends on the monitor end connector of the device.
The sensors contain light emitting diodes (LEDs) that emit light of different wavelengths. The sensors also contain a photodetector for detecting the emitted light after it has been attenuated by tissue. The sensors further contain a resistor, which is used to encode the wavelength of the LEDs used in the sensor. The resistor value is read by the monitor to determine the calibration curve used for that specific sensor.
This document describes the acceptance criteria and the study performance for the TruSignal® SpO2 Adult and Pediatric Disposable Sensors.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device K093881) | Reported Device Performance (TruSignal® SpO2 Adult and Pediatric Disposable Sensors) |
|---|---|---|
| SpO2 Accuracy | TruTrak®/TruTrak+®: A_rms ± 2 digits in the range of 70% to 100% SpO2 | TruTrak®/TruTrak+®: A_rms ± 2.5 digits in the range of 70% to 100% SpO2 |
| Datex Ohmeda: A_rms ± 3 digits in the range of 70% to 100% SpO2 | Datex Ohmeda: A_rms ± 2.5 digits in the range of 70% to 100% SpO2 | |
| SpO2 Accuracy | (Specific for S5 Compact Monitors with E-PRESTN module) A_rms < 2.5% for 70-100% SpO2 (no predicate specified) | S5 Compact Monitors with an E-PRESTN module meets an A_RMS of less than 2.5% for the same range (70-100%) under steady state/non-motion. |
| Patient Weight | All patients | TS-PAW: 3-20 kg (6.6-44 pounds) TS-AAW: > 20 kg (>44 pounds) |
| Anatomical Sites | Not explicitly stated, but palm of hand and side of foot included. | Palm of the hand and side of the foot excluded. |
| Environment of Use | Not explicitly stated, but ESU included. | Step down units added. ESU removed. |
| Sensor Head Geometry | Identical (for predicate) | TS-AAW: Identical to predicate device. TS-PAW: Geometry identical, but distance of optical components slightly less to fit smaller pediatric patients. |
| Materials (Body Contact) | Identical | No change in Body Contact materials. |
| Electro-optical components | Identical LEDs, detector, leadframes (light pink sensor head color) | Identical LEDs, detector, leadframes (white sensor head color). |
| Connector Geometry & Dimensions | Mating part identical | Mating part identical. Connector body size smaller to reduce material. |
| Materials (Non-body contact) | Specific materials for connector body, conductor insulation, outer jacket, raw cable tissue paper. | Connector body materials changed. Conductor insulation and outer jacket materials changed. Raw cable tissue paper removed. |
| Cable lengths | Not explicitly stated. | Not explicitly stated, but considered "Equivalent to the predicate device". |
| Compatibility with other devices | Specific compatibility list, including discontinued platforms. | Removed discontinued platforms, added platforms released after predicate clearance. |
| Electrical Safety | Identical to predicate K093881. | Identical to predicate K093881. |
| Thermal Safety | Identical to predicate K093881. | Identical to predicate K093881. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Adult Disposable Sensor): Not explicitly stated, but the study refers to "healthy adult volunteers (ages 19-31 yr.)".
- Data Provenance: The adult study was "conducted in an independent research laboratory." No country of origin is specified. The study appears to be prospective as it involved induced hypoxia in volunteers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. It states that "the measured arterial hemoglobin saturation values of the proposed devices were compared to CO-oximeter based arterial hemoglobin saturation values." The CO-oximeter measurement is considered the gold standard (ground truth) for arterial hemoglobin saturation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct physical measurement (CO-oximeter) rather than expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the standalone performance of the device against a gold standard.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done for the TruSignal® SpO2 Adult Disposable Sensor. The device's accuracy (A_rms) was measured against CO-oximeter readings during induced hypoxia in healthy volunteers.
- The proposed sensor demonstrated an A_rms of less than 2 during steady-state conditions over the range of 70-100%.
- When used with S5 Compact Monitors with an E-PRESTN module, the device achieved an A_rms of less than 2.5% for the same range (70-100%).
The TruSignal® SpO2 Pediatric Disposable Sensor did not undergo separate clinical studies but was deemed substantially equivalent because it has "identical materials and electro-optical components and equivalent sensor characteristics to TruSignal SpO2 Adult Disposable Sensor." Hence, the clinical data from the adult sensor applies.
7. Type of Ground Truth Used
The ground truth used was CO-oximeter based arterial hemoglobin saturation values. This is a direct, objective physiological measurement often considered the gold standard for SpO2 accuracy studies.
8. Sample Size for the Training Set
This document describes a medical device (pulse oximeter sensor) which does not use an algorithm that requires a "training set" in the context of machine learning. The device's performance is based on its physical design, electro-optical components, and signal processing, which are validated through engineering verification and clinical testing against established standards and gold-standard measurement devices (CO-oximeter).
9. How the Ground Truth for the Training Set Was Established
As noted in section 8, this device does not utilize a machine learning algorithm with a training set. The clinical performance is verified directly against CO-oximeter measurements, which serve as the reference standard.
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "g" and "e" intertwined within a circular border. The logo is in black and white.
GE Healthcare Finland Oy
Kuortaneenkatu 2, P.O. Box 900 ビ
Finland
T: +358 10 39411
T: +358 10 39411
F: +358 10 39411
F: +358 9 1463310
510(k) Summary
In accordonce with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 27, 2013 | |
|---|---|---|
| Owner/Submitter: | GE Healthcare Finland OyKuortaneenkatu 2FIN-00510 Helsinki, Finland | |
| Primary Contact Person: | Joel KentManager, Quality and Regulatory AffairsGE HealthcarePhone: 781-449-8685Fax: 781-433-1344E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | Rauno RuohoRegulatory Affairs ManagerGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 10 394 3624Fax: +358-92726532E-mail: Rauno.ruoho@ge.com | |
| Device names (807.92(a)(2)): | Device Trade Name:TruSignal® SpO2 Adult and Pediatric Adhesive Wrap DisposableSensors | |
| Common/Usual Name:Pulse Oximeter Sensors | ||
| Classification Names:21 CFR 870.2700 Oximeter | ||
| Product Code: | DOA | |
| Predicate Device(s)(807.92(a)(3)): | TruSignal SpO2 Allfit Sensor cleared in K093881 TruSignal® Sensorsand Interconnect Cables | |
| Device Description(807.92(a)(4)): | The TruSignal SpO2 Adult and Pediatric Disposable Sensors are usedtogether with standalone oximeters or modular patient monitors tomeasure continuous non-invasive arterial oxygen saturation (SpO2)and pulse rate monitoring. | |
| The sensors are to be connected to a device using an interconnectcable TS-G3, TS-M3, TS-H3 or TS-N3 (cleared in K093881). Theinterconnect cable type depends on the monitor end connector ofthe device. | ||
| The sensors contain light emitting diodes (LEDs) that emit light ofdifferent wavelengths. The sensors also contain a photodetector fordetecting the emitted light after it has been attenuated by tissue. Thesensors further contain a resistor, which is used to encode thewavelength of the LEDs used in the sensor. The resistor value is readby the monitor to determine the calibration curve used for thatspecific sensor. | ||
| Intended Use (807.92(a)(5): | TS-AAW-10 and TS-AAW-25The Disposable Sensor is a single-patient use sensor intended forcontinuous non-invasive arterial oxygen saturation (SpO2) and pulserate monitoring. Patient weight range: > 20 kg (>44 pounds)TS-PAW-10 and TS-PAW-25 | |
| The Disposable Sensor is a single-patient use sensor intended forcontinuous non-invasive arterial oxygen saturation (SpO2) and pulserate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds) | ||
| Technology(807.92(a)(6)): | The TruSignal SpO2 Adult and Pediatric Disposable Sensors employthe same fundamental scientific technology as their predicate deviceTruSignal SpO2 Allfit Sensor K093881. | |
| The following is an overview of the differences between the proposedTruSignal SpO2 Adult and Pediatric Disposable Sensors and thepredicate device: | ||
| Patient Population Equivalent to the predicate device: Patient weight range has been changed from all patients of the predicate device to 3-20 kg (6.6-44 pounds) of the TS-PAW proposed device and > 20 kg (>44 pounds) of the TS-AAW proposed device. Applicable Electromagnetic Compatibility, Electrical safety, Usability, biocompatibility, engineering verification tests (such as cleaning, and material durability) and clinical performance testing test report show that the proposed device is as safe and effective as the predicate K093881. | ||
| Anatomical SitesEquivalent to the predicate device:Palm of the hand and side of the foot excluded from0the application sites.Applicable Electromagnetic Compatibility, Electrical0safety, Usability, biocompatibility, engineeringverification tests (such as cleaning, and materialdurability) and clinical performance testing test reportshow that the proposed device is as safe andeffective as the predicate K093881Environment of UseStep down units added to the list of environments ofouse of the proposed device. ESU removed from the listof environments of use of the proposed device.Applicable Electromagnetic Compatibility, ElectricalOsafety, Usability, biocompatibility, engineeringverification tests (such as cleaning, and materialdurability) and clinical performance testing test reportshow that the proposed device is as safe andeffective as the predicate K093881.Sensor headGeometry and dimensions0TS-AAW-10 and TS-AAW-25: Identical to the predicate0device.TS-PAW-10, TS-PAW-25: Equivalent to the predicateOdevice: Geometry is identical to the predicate device.The distance of the optical components have beenchanged to be slightly less compared to the predicatedevice to better fit the finger of the smaller pediatricpatients.Applicable Electromagnetic Compatibility, ElectricalOsafety, Usability, biocompatibility, engineeringverification tests (such as cleaning, and materialdurability) and clinical performance testing test report | ||
| show that the proposed device is as safe andeffective as the predicate K093881.Equivalent to the predicate device in terms ofMaterialsintended use.Applicable Electromagnetic Compatibility, Electricalosafety, Usability, biocompatibility, engineeringverification tests (such as cleaning, and materialdurability) and clinical performance testing test report | ||
| show that the proposed device is as safe andeffective as the predicate K093881. | ||
| Electro-optical components Equivalent to the predicatedevice:• | ||
| • Identical LEDs, detector and leadframes. The color ofthe sensor head have been changed from light pinkof the predicate device to white of the proposeddevice. | ||
| • Applicable Electromagnetic Compatibility, Electricalsafety, Usability, biocompatibility, engineeringverification tests (such as cleaning, and materialdurability) and clinical performance testing test reportshow that the proposed device is as safe andeffective as the predicate K093881. | ||
| Performance Equivalent to the predicate device: | ||
| • Accuracy of the TruTrak®, TruTrak+® technologieschanged to A_rms ± 2.5 digits in the range of 70% to100% SpO2 compared to ± 2 digits in the range of70% to 100% SpO2 of the predicate device. | ||
| • Accuracy of the Datex Ohmeda technology changedto A_rms ± 2.5 digits in the range of 70% to 100%SpO2 compared to ± 3 digits in the range of 70% to100% SpO2 of the predicate device. | ||
| • Applicable Electromagnetic Compatibility, Electricalsafety, Usability, biocompatibility, engineeringverification tests (such as cleaning, and materialdurability) and clinical performance testing test reportshow that the proposed device is as safe andeffective as the predicate K093881 | ||
| Biocompatibility: Identical to the predicate device.• | ||
| • No change in the Body Contact materials | ||
| Connector Geometry and dimensions Equivalent to thepredicate device: | ||
| • The mating part of the connector is identical to thepredicate device. The size of the connector body ofthe proposed devices is made smaller to reduce theamount of material needed. | ||
| • Applicable Electromagnetic Compatibility, Electricalsafety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and materialdurability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Materials (non body contact) Equivalent to the predicate | ||
| device: | ||
| Connector body materials have been changedO | ||
| compared to the predicate device. Conductor | ||
| insulation and outer jacket materials have been | ||
| changed compared to the predicate device. Raw | ||
| cable tissue paper was removed from the raw cable | ||
| of the proposed device. | ||
| Applicable Electromagnetic Compatibility, Electricalo | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Cable lengths Equivalent to the predicate device: | ||
| Applicable Electromagnetic Compatibility, Electricalo | ||
| safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Compatibility with other devices Equivalent to the predicate | ||
| device: | ||
| Removed discontinued platforms from the0 | ||
| compatibility list of the proposed devices and added | ||
| platforms released after the clearance of thepredicate device. | ||
| Applicable Electromoqnetic Compatibility, Electrical | ||
| 0safety, Usability, biocompatibility, engineering | ||
| verification tests (such as cleaning, and material - | ||
| durability) and clinical performance testing test report | ||
| show that the proposed device is as safe and | ||
| effective as the predicate K093881. | ||
| Electrical Safety Identical to the predicate device K093881. | ||
| Thermal Safety Identical to the predicate device K093881. | ||
| This comparison of the specifications demonstrates the functional | ||
| equivalence of the products. The differences discussed do not raise | ||
| new issues of safety and effectiveness. Verification and Validation | ||
| testing demonstrated that no adverse effects have been introducedby these differences. | ||
| GE Healthcare believes that the TruSignal SpO2 Adult and Pediatric | ||
| Disposable Sensors are as safe and effective, and perform in asubstantially equivalent manner to the predicate TruSignal® SpO2Allfit sensor (K093881). | ||
| Determination of SubstantialEquivalence (807.92(b)(1)): | Summary of Non-Clinical Tests: | |
| The TruSignal SpO2 Adult and Pediatric Disposable Sensors and itsapplications comply with voluntary standards. The following qualityassurance measures were applied to the development of the system | ||
| Risk Analysis | ||
| Requirements Reviews | ||
| Design Reviews | ||
| Testing on unit level (Module verification) | ||
| Integration testing (System verification) | ||
| Performance testing (Verification) | ||
| Safety testing (Verification) | ||
| Simulated use testing (Validation) | ||
| The TruSignal SpO2 Adult and Pediatric Disposable was designed andtested for compliance to the following standards: | ||
| 1. IEC 60601-1 2005; Medical Electrical Equipment - Part 1: GeneralRequirements for Safety | ||
| 2. IEC 60601-1-2; Ed3. 2007; Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirementsand tests | ||
| 3. ISO 9919 2009; Medical electrical equipment - Particularrequirements for the basic safety and essential performance of pulseoximeter equipment for medical use | ||
| 4. ISO 10993-1:2009; Biological evaluation of medical devices | ||
| 5. IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance -Collateral standard: Usability - Edition 3.0 | ||
| 6. IEC 62366:2007 Medical devices - Application of usabilityengineering to medical devices – Edition 1.0 | ||
| Clinical(807.92(b)(2)): | Summary of Clinical Tests: | |
| Clinical verification tests were performed on the proposed devices onan extensive selection of GE patient monitors. | ||
| TruSignal SpO2 Adult Disposable Sensor: The test consisted ofinduced hypoxia studies on healthy adult volunteers (ages 19-31 yr.) | ||
| conducted in an independent research laboratory. The measuredarterial hemoglobin saturation values of the proposed devices werecompared to CO-oximeter based arterial hemoglobin saturationvalues.The proposed sensor was shown to have an A_RMS of less than 2during steady state conditions over the range of 70-100%. The S5Compact Monitors with an E-PRESTN module meets an A_RMS of lessthan 2.5% for the same range. The results of the study providesupporting evidence that the SpO2 accuracy performance of the newdesign of the GE Healthcare disposable sensors does not adverselyaffect the SpO2 accuracy performance and the proposed sensorspass the respective A_RMS specifications under steady state / non-motion conditions for the range 70-100% as stated in theInstructions for use.TruSignal SpO2 Pediatric Disposable Sensor did not require clinicalstudies to support substantial equivalence.TruSignal SpO2 Pediatric Disposable Sensor has identical materials | ||
| and electro-optical components and equivalent sensorcharacteristics to TruSignal SpO2 Adult Disposable Sensor, thus theclinical data from Adult Disposable Sensor applies to this sensor aswell. | ||
| Conclusion | (807.92(b)(3)): | GE Healthcare considers the TruSignal SpO2 Adult and PediatricDisposable Sensors to be as safe, as effective, and performance issubstantially equivalent to the predicate device TruSignal SpO2 AllfitSensor (K093881). |
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Image /page/7/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2013
GE Healthcare Mr. Joel Kent Manager, Quality and Regulatory Affairs Kuortaneenkatu 2 FIN-00510 Helsinki, Finland
Re: K132696
Trade/Device Name: TruSignal SpO2 Adult and Pediatric Disposable Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 28, 2013 Received: August 29, 2013
Dear Mr. Kent:
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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Page 2 - Mr. Kent
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2)CFR 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/Resourcesfor You/Industry/default.htm.
Image /page/8/Picture/7 description: The image shows a signature and some text. The text includes the phrase "Sincerely yours," and the name "Tejashri Purohit-Sheth, M.D." The text also includes the title "Clinical Deputy Director" and the acronym "DAGRID." The word "FOR" is at the bottom right.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ki32696
Device Nome: TruSignal® SpO2 Adult and Pediatric Disposable Sensors
Indications for Use:
TS-AAW-10 and TS-AAW-25
510fk) Number (if known):
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds)
TS-PAW-10 and TS-PAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight ronge: 3-20 kg (6.6-44 pounds)
AND/OR Prescription Use_X lPart 21 CFR 801 Sub part DI
Over-The-Counter Use lPort 21 CFR 801 Subport Cl
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) - -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nayan J. Patel - S
2013.09.26 17:47:51 -04'00'
Division Sign-Off) ·vision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number K132696
28
§ 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).