(240 days)
Not Found
No
The device description and performance studies focus on the physical construction, materials, and basic temperature measurement functionality of a reusable temperature probe. There is no mention of AI, ML, or any computational analysis of the temperature data beyond simple measurement.
Yes.
The device is intended for monitoring temperature, which provides information on a patient's physiological state. This information can be used for diagnosis, treatment, or prevention of disease, thus qualifying it as a therapeutic device.
No
Explanation: The device is described as "reusable temperature probes" intended for "monitoring temperature." Monitoring temperature is a measurement function, not a diagnostic one. While temperature can be a symptom related to diagnostics, the device itself only measures and does not interpret or diagnose conditions.
No
The device description clearly outlines physical components like sealed phone plugs, internal conductors, Kevlar fibers, and a biocompatible outer jacket. It also details different sizes and types of probes for various applications (esophageal/rectal, skin). This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring temperature." This is a physiological measurement taken directly from the patient's body (rectal, esophageal, or skin).
- Device Description: The device is a temperature probe designed to connect to monitoring systems. It measures temperature directly.
- Lack of In Vitro Activity: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not perform any analysis on bodily specimens.
The device is a medical device used for patient monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.
The probes are indicated for use by qualified medical personnel only.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification.
Sensatronic Reusable Temperature Probes are constructed with the following features:
- . Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization
- . Two internal conductors for connection to the thermistor
- . Internal Kevlar fibers for strength and pull resistance
- Biocompatible outer jacket of thermoplastic rubber (TPR)
- . The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below)
- The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm
- 트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems. The following configurations are offered:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal/esophageal; Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Submitted:
Sensatronic Reusable Temperature Probes were laboratory tested to current applicable standards for medical device electrical safety and electromagnetic compatibility as well as particular standards for clinical thermometers. The following standards were utilized in compliance testing:
- Electrical safety testing per IEC 60601-1 ●
- Electromagnetic compatibility testing per IEC 60601-1-2
- Usability evaluation per IEC 60601-1-6 and IEC 62366 for professional use ●
- Particular requirements for clinical thermometers per ISO 80601-2-56 ● including accuracy.
- Environmental storage testing per IEC 60068-2-78 and IEC 60068-2-1 ●
- . Cable pull testing per ANSI/AAMI/ EC53 (used as reference standard only)
The probes met acceptance criteria for compliance to the standards.
The probes were evaluated to the requirements of the following guidance:
- Guidance on the Content of Premarket Notification [510(k)] Submissions for . Clinical Electronic Thermometers, March 1993
The probes met the requirements of quidance.
Risk management, risk and hazard analysis of the probes was performed to the following standard:
- . Application of risk management to medical devices per ISO 14971
The probes met risk management criteria for acceptability of residual risks.
Probe patient contact materials were evaluated for biocompatibility. The tests were performed to the following standards and included the listed tests:
- Biocompatibility testing per ISO-10993-1. ISO-10993-5 and ISO-10993-10 .
- . Cytotoxicity test
- . Irritation testing
- Sensitization testing
The probe materials met the acceptance criteria for biocompatibility.
The probes were evaluated for the efficacy of the specified manual and machine reprocessing methods and cleaning and disinfection agents for:
- Efficacy of cleaning/bioburden removal per methods of ISO 15583-5, AAMI . TIR30, FDA Guidance for Reprocessing Medical Devices in Health Care Settings
- Efficacy of disinfection methods (bioburden) ●
The probes met acceptance criteria for cleaning and disinfection.
The probes were evaluated for the efficacy of steam sterilization:
- . Efficacy of steam sterilization (gravity, forced vacuum) per methods of ISO 17665-1 and ISO 11737-2.
The probes met the acceptance criteria for steam sterilization.
The probes were evaluated for reuse life durability for per the reprocessing methods specified in device labeling:
- . Manual cleaning/disinfection: up to 300 cycles
- Machine washing/disinfection: ● up to 300 cycles
- . Steam sterilization: up to 100 cycles
The probes met acceptance criteria for durability and performance after testing.
In summary, the probes met acceptance criteria for conformance to the applicable standards, performance accuracy, biocompatibility, cleaning and disinfection, steam sterilization, and durability. Residual risks met criteria for acceptability for the intended use.
Clinical Tests Submitted:
(none)
Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the Sensatronic Reusable Temperature Probes are equivalent to the predicate temperature probes as supported by compliance, laboratory, and biocompatibility testing.
The results of all tests demonstrate that the Sensatronic Reusable Temperature Probes meet specified requirements for device compatibility and substantial equivalence to the referenced predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ± 0.1 °C (25 °C – 45 °C)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 11, 2021
Sensatronic GmbH % Stephen Gorski President Imagenix, Inc. S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K203643
Trade/Device Name: Sensatronic Reusable Temperature Probes Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 9, 2021 Received: July 12, 2021
Dear Stephen Gorski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Sensatronic Reusable Temperature Probes
Indications for Use (Describe)
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.
The probes are indicated for use by qualified medical personnel only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | Sensatronic GmbH
Am Ring 9
D-23970 Wismar
Germany
Tel.: +49 3841 2252 440
Fax: +49 3841 2252 442
j.schwarz(at)sensatronic.com | |
|-----|-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| | | Contact Person: | Mr. Jens Schwarz | |
| | | Position/Title: | General Manager | |
| | | Date of Preparation: | July 9, 2021 | |
| | (2) | Trade Name: | Sensatronic Reusable Temperature Probes | |
| | | Common/Classification Name: | Thermometer, Electronic, Clinical | |
| | | Product Code(s): | 21 CFR §880.2910; FLL | |
| | | Class: | Class II | |
| | (3) | Predicate Device(s): | Substantial Equivalence to: | |
| | | K Number | Model | Manufacturer |
| | | K050837 | Reusable Temperature Probes (M1024254 Skin
Temperature probe, reusable; M1024247, GP
Temperature Probe, Adult, reusable; M1024251
GP Temperature Probe, Pediatric, reusable) | GE Healthcare |
Reason for Submission: New Device(s)
(4) Description of Device:
Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification.
Sensatronic Reusable Temperature Probes are constructed with the following features:
- . Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization
- . Two internal conductors for connection to the thermistor
- . Internal Kevlar fibers for strength and pull resistance
4
- Biocompatible outer jacket of thermoplastic rubber (TPR)
- . The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below)
- The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm
- 트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems. The following configurations are offered:
| Temperature
Probe Types | Model | Suffix
(Connector) | Compatibility Series | Cable length | Diameter of
Cable/(Tip) |
|-----------------------------------------------------------|-----------------------------------------------------|----------------------------------|-----------------------------------------------------|--------------------------------------|----------------------------|
| General
Purpose | AR-275 | -PA | GE Healthcare (YSI
¼ in. phono plug) | 275 cm | 4.0 mm
(4.5 mm tip) |
| Rectal/
Esophageal
Probe, Large | AR-275
AR-200
AR-300
AR-500 | -PRA
-S2
-S1
-S1 | Schiller | 200 cm
300 cm
500 cm | |
| General
Purpose | PR-275 | -PA | GE Healthcare (YSI
¼ in. phono plug) | 275 cm | 3.2 mm
(3.7mm tip) |
| Rectal/
Esophageal
Probe, Medium | PR-275
PR-200
PR-300
PR-500 | -PRA
-S2
-S1
-S1 | Schiller | 200 cm
300 cm
500 cm | |
| General
Purpose
Rectal/Esophageal Probe,
Small * | NR-275
NR-275 | -PA
-PRA | GE Healthcare (YSI
¼ in. phono plug) | 275 cm | 3.2/2.3 mm
(2.7mm tip) |
| Skin
Temperature
Probe, Large | SAR-275
SAR-275
SAR-200
SAR-300
SAR-500 | -PA
-PRA
-S2
-S1
-S1 | GE Healthcare (YSI
¼ in. phono plug) | 275 cm
200 cm
300 cm
500 cm | 4.0 mm
(16mm disk) |
| Skin
Temperature
Probe, Medium | SPR-275
SPR-275
SPR-300
SPR-500 | -PA
-PRA
-S1
-S1 | GE Healthcare (YSI
¼ in. phono plug)
Schiller | 275 cm
300 cm
500 cm | 3.0 mm
(10mm disk) |
| Skin
Temperature
Probe, Small * | SNR-275
SNR-275
SNR-300 | -PA
-PRA
-S1 | GE Healthcare (YSI
¼ in. phono plug)
Schiller | 275 cm
300 cm | 3.2/2.3 mm
(6mm disk) |
- NOTE: The distal 50cm of the probe cable is stepped to the smaller diameter 2.3mm cable
Probe Connector Suffix Guide:
| Connector Suffix | Connector/Contact Description |
|---|---|
| -PA | 6.35 mm phono plug, 2 conductor, straight |
| -PRA | 6.35 mm phono plug, 2 conductor, right angle |
| -S1 | Siemens monitor, 5 pin, straight |
| -S2 | Siemens monitor, 8 pin, straight |
Table 1: Probe Configurations offered
(5) Intended use:
The intended use for the Sensatronic Reusable Temperature Probes is the same as the predicate Temperature Probes: monitoring of temperature.
5
Indications for Use:
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.
The probes are indicated for use by qualified medical personnel only.
Prescription use only.
(6) Technological Characteristics:
The Sensatronic Reusable Temperature Probes utilize the same technological principles as the predicate devices to measure temperature: both incorporate thermistor temperature sensors in the probes which utilize the YSI 400 resistance specification, and are offered in both rectal/esophageal and skin-applied models. Refer to the following comparison table:
Comparison of Technological Features to Predicate Devices:
| Product/Feature | Sensatronic
Reusable Temperature
Probes | GE Healthcare Reusable
Temperature Probes | Remark | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer | Sensatronic GmbH | GE Healthcare | | |
| Model Number(s) | AR-275-PA; AR-275-PRA; AR-200-S2; AR-300-S1; AR-500-S1;
PR-275-PA; PR-275-PRA; PR-200-S2; PR-300-S1; PR-500-S1;
NR-275-PA; NR-275-PRA;
SAR-275-PA; SAR-275-PRA; SAR-200-S2; SAR-300-S1; SAR-500-S1;
SPR-275-PA; SPR-275-PRA; SPR-300-S1; SPR-500-S1;
SNR-275-PA; SNR-275-PRA; SNR-300-S1 | M1024254 (Skin probe)
M1024247 (GP Probe)
M1024251 (GP Probe)
GP is general purpose
esophageal/rectal | Product range for both
devices includes both
general purpose and Skin
probes | |
| 510(k) Number | K203643 | K050837 | | |
| Application/Intended use: | Measurement and
monitoring of patient
temperature | Measurement and
monitoring of patient
temperature | Same | |
| Product/Feature | Sensatronic
Reusable Temperature
Probes | GE Healthcare Reusable
Temperature Probes | Remark | |
| Application Site(s) | Rectal/esophageal; Skin | Rectal/esophageal; Skin | Same application sites | |
| Reusable | ✓ YES | ✓ YES | Same | |
| Steam Sterilization | ✓ YES | ✓ YES | Same | |
| Operating principle(s) | Single thermistor sensor,
with NTC (negative
temperature coefficient)
specification meeting YSI
400 series compatibility | Single thermistor sensor,
with NTC (negative
temperature coefficient)
specification meeting YSI
400 series compatibility | Same thermistor
characteristics, both meet
YSI 400 series
compatibility | |
| Accuracy | ± 0.1 °C (25 °C – 45 °C) | ± 0.1°C (0°C to 50°C) | Equivalent in the
physiological range | |
| Measurement Range | 0°C to 50°C | 0°C to 50°C | Same | |
| | | Probe Construction – Rectal/Esophageal | | |
| Cable and Tip Material | Biocompatible
Thermoplastic Elastomer | Biocompatible Plastic
(type not specified) | Equivalent Function | |
| Tip Profile | Cylindrical, with formed
rounded tip | Cylindrical, with formed
rounded tip | Same | |
| Esophageal/Rectal Probe
Tip dimensions | Type A: 4.5 mm;
Type P: 3.7 mm;
Type N: 2.7 mm | 4mm;
3mm; | Sensatronic tip has 3
available diameters, GE
has 2; minor differences
in dimensions | |
| | | Probe Construction – Skin | | |
| Tip (Disk) Material | Stainless steel,
Biocompatible Plastic | Stainless steel, Plastic
(type not specified) | Equivalent function | |
| Tip (Disk) dimensions | Type A: 16 mm;
Type P: 10 mm;
Type N: 6 mm | 10 mm; | Sensatronic disk offers 3
available diameters, GE
offers 1 | |
| Cable and Connector | | | | |
| Cable overall length | 2.75 meters standard
length; 2, 3, and 5 meters
in specific models | 3 meters (all models) | Equivalent functionality,
some difference in length | |
| Connector(s) | Straight Phone Plug;
Right Angle Phono Plug;
Manufacture specified
types (incl. Schiller); YSI
400 series function | Straight Phone Plug); YSI
400 series function | Equivalent electrical
function; GE Healthcare
offers straight Phono plug
style; Sensatronic Probes
are offered in additional
connector styles; all have
YSI 400 series function | |
| Cleaning, Disinfection, and Sterilization Methods | | | | |
| Product/Feature | Sensatronic
Reusable Temperature
Probes | GE Healthcare Reusable
Temperature Probes | Remark | |
| Cleaning & Disinfection
Method(s) | Manual wipe with
cleaning agents or
machine washing;
immersion in disinfectant | Manual wipe with
cleaning agents or
machine wash;
immersion in disinfectant | Equivalent function: both
support manual cleaning,
machine wash and
disinfectant immersion | |
| Sterilization Method(s) | Steam autoclave at
132°C/4 minutes
(max 100 cycles) | 1) Plasma (Sterrad);
2) Steam autoclave for 20
minutes at 121°C/250°F
(max 100 cycles), or
3) Steam autoclave 18
minutes at 134°C/273°F
(max 30 cycles) | Equivalent function:
Sensatronic specifies
current industry practices
for autoclave temperature
of 132°C with 100 cycles
durability; predicate lists
30 cycles durability;
Sensatronic does not
specify plasma (Sterrad)
method | |
| Physical and Environmental Specifications | | | | |
| Operating Conditions | 0°C...+50°C
10...100 % r. h | 0°C - +50°C | Equivalent Operating
Range | |
6
7
Page 5 of 6
As summarized above, the Sensatronic Reusable Temperature Probes utilize equivalent technological characteristics and specifications as the listed predicate devices.
(b) (1) Non-Clinical Tests Submitted:
Sensatronic Reusable Temperature Probes were laboratory tested to current applicable standards for medical device electrical safety and electromagnetic compatibility as well as particular standards for clinical thermometers. The following standards were utilized in compliance testing:
- Electrical safety testing per IEC 60601-1 ●
- Electromagnetic compatibility testing per IEC 60601-1-2
- Usability evaluation per IEC 60601-1-6 and IEC 62366 for professional use ●
- Particular requirements for clinical thermometers per ISO 80601-2-56 ● including accuracy.
- Environmental storage testing per IEC 60068-2-78 and IEC 60068-2-1 ●
- . Cable pull testing per ANSI/AAMI/ EC53 (used as reference standard only)
The probes met acceptance criteria for compliance to the standards.
The probes were evaluated to the requirements of the following guidance:
- Guidance on the Content of Premarket Notification [510(k)] Submissions for . Clinical Electronic Thermometers, March 1993
The probes met the requirements of quidance.
Risk management, risk and hazard analysis of the probes was performed to the following standard:
- . Application of risk management to medical devices per ISO 14971
8
The probes met risk management criteria for acceptability of residual risks.
Probe patient contact materials were evaluated for biocompatibility. The tests were performed to the following standards and included the listed tests:
- Biocompatibility testing per ISO-10993-1. ISO-10993-5 and ISO-10993-10 .
- . Cytotoxicity test
- . Irritation testing
- Sensitization testing
The probe materials met the acceptance criteria for biocompatibility.
The probes were evaluated for the efficacy of the specified manual and machine reprocessing methods and cleaning and disinfection agents for:
- Efficacy of cleaning/bioburden removal per methods of ISO 15583-5, AAMI . TIR30, FDA Guidance for Reprocessing Medical Devices in Health Care Settings
- Efficacy of disinfection methods (bioburden) ●
The probes met acceptance criteria for cleaning and disinfection.
The probes were evaluated for the efficacy of steam sterilization:
- . Efficacy of steam sterilization (gravity, forced vacuum) per methods of ISO 17665-1 and ISO 11737-2.
The probes met the acceptance criteria for steam sterilization.
The probes were evaluated for reuse life durability for per the reprocessing methods specified in device labeling:
- . Manual cleaning/disinfection: up to 300 cycles
- Machine washing/disinfection: ● up to 300 cycles
- . Steam sterilization: up to 100 cycles
The probes met acceptance criteria for durability and performance after testing.
In summary, the probes met acceptance criteria for conformance to the applicable standards, performance accuracy, biocompatibility, cleaning and disinfection, steam sterilization, and durability. Residual risks met criteria for acceptability for the intended use.
(2) Clinical Tests Submitted:
(none)
(3) Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the Sensatronic Reusable Temperature Probes are equivalent to the predicate temperature probes as supported by compliance, laboratory, and biocompatibility testing.
The results of all tests demonstrate that the Sensatronic Reusable Temperature Probes meet specified requirements for device compatibility and substantial equivalence to the referenced predicate devices.