(266 days)
Not Found
No
The description focuses on traditional pulse oximetry technology using LEDs and photodiodes to measure light absorption and determine SpO2 and pulse rate. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is a sensor used for monitoring SpO2 and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device measures physiological parameters (arterial hemoglobin and pulse rate) which are used by clinicians to assess a patient's health status. The "Intended Use" explicitly states it's for "facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate," which are diagnostic inputs.
No
The device description explicitly states that the device consists of a "sensor assembly and cable assembly" which are hardware components. It also describes the use of LEDs and a photodiode, further indicating a hardware-based device.
Based on the provided information, the Nellcor™ OxySoftN single patient use sensor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing substances like blood, urine, or tissue samples outside of the body.
- Device Function: The Nellcor™ OxySoftN sensor measures oxygen saturation and pulse rate by applying the sensor topically to the patient's skin (finger, foot, or hand). It uses light to analyze the blood within the body.
- Lack of Specimen Analysis: The device does not collect or analyze specimens derived from the human body in a laboratory setting.
Therefore, the Nellcor™ OxySoftN sensor is a non-invasive medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, pediatric and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospit, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Nellcor™ OxySoft™ Neonatal/Adult SpO2 Sensor, OxySoftNHC monitors the amount of oxygen in the patient's blood (oxygen saturation) or SpO2 and pulse rate after applying the sensor on the finger, foot, or hand. The sensor utilizes a pair of light emitting diodes (LEDs) employing light at two wavelengths, and the time varying absorbance of the tissue due to the pulsatile blood signal is obtained, amplified from a photodiode to determine functional arterial oxygen saturation.
A clinician will prescribe the sensor for use as spot check or continuous use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. The OxySoftNHC sensor can be used with all Nellcor™ compatible systems.
The sensor consists of a sensor assembly and cable assembly and is provided sterile (EtO) and is meant for single use.
NOTE: The two model numbers represent only one sensor type, OxySoftN. The 'HC' suffix denotes the model number that includes an additional Home Use Guide for the lay user for home use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, foot or hand
Indicated Patient Age Range
neonatal, infant, pediatric and adult patients
Intended User / Care Setting
Professionally trained health care providers, patients or a lay operator assisting a patient in a home-care environment / hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters.
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)
- MDT20002VALNIC: Performance evaluation of the OxySoftN neonatal sensor in the NICU compared to SaO2
- Study type: Clinical validation study
- Sample size: 27 patients, 64 observations made
- Key results: The observed SpO2 accuracy was 2.68% in a study of 27 patients with ages of 1 to 9 days, weight from 640 to 4710 grams, and 64 observations made spanning a range of 82.1% to 99.3% SaO2. There was acceptable evidence to demonstrate safe form and fit of the OxySoftN sensor when applied to 31 patients in the intended neonate population.
- MDT20037CYBOXY: Validation of the OxySoftN to Determine the Gentleness on Fragile Skin
- Study type: Clinical study
- Key results: The clinical study data demonstrated the adhesive removed significantly less cells than MAXN sensor (predicate device) and caused a minimal increase in TEWL on subjects likely to have fragile skin.
- MDT20047OXSNOF: Sensor-Off Validation of the OxySoftN sensor in Healthy Adults
- Study type: Clinical study
- Key results: The study demonstrated the sensor off feature performance with a sample proportion of 0.996 and 95% lower bound for the proportion of success of 0.983. The results demonstrate the device posts a "Sensor Off" message within 1 minute after the sensor is removed at least 90% of the time.
- MDT20038CYBADH: Multiple Reposition Peel Adhesion on Human Skin Validation, OxySoftN
- Study type: Clinical study
- Key results: The study concluded that the OxySoftN Sensor can be repositioned and remains adhered to the skin after the 18th repositioning using the above mentioned standardized in-vivo testing procedures.
- MDT20028OXYLOV: SpO2 Accuracy Validation of the OxySoftN sensor via Reference CO-Oximetry in Healthy, Well-Perfused Subject
- Study type: Clinical study
- Key results: when using the N-600x, PM1000N and Oxicable devices, paired with the OxySoftN sensor, during a saturation range of 60-80%, the svstem demonstrates expected SpO2 accuracy of ±3% Arms. When using the N-600x. PM1000N and Oxicable devices, paired with the OxySoftN sensor during a saturation range of 70% - 100%, the system demonstrates expected SpO2 accuracy of ±2% Arms. During a saturation range of 60% - 100%, the system demonstrates expected PR accuracy of ≤3 BPM.
- MDT20006OXYVMT: SpO2 Accuracy Validation of the OxySoft sensor via Reference CO-Oximetry Motion Study
- Study type: Clinical study
- Key results: When using the N-600x device, in conjunction with the OxySoftN sensor, during a saturation range of 70% - 100% and motion conditions, the system demonstrates expected SpO2 accuracy of ±3% Arms. When using the N-600x device, in conjunction with the OxySoftN sensor, during a saturation range of 70% - 100% and motion conditions, the system demonstrates expected PR accuracy of ≤5 BPM. When using the N-395 device, in conjunction with the OxySoftN sensor, during a saturation range of 70% - 100% and non-motion conditions, the system demonstrates expected SpO2 accuracy of ±3% Arms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- MDT20002VALNIC: SpO2 accuracy: 2.68%
- MDT20047OXSNOF: Sensor Off message within 1 minute, sample proportion of 0.996 and 95% lower bound for the proportion of success of 0.983.
- MDT20028OXYLOV:
- SpO2 accuracy (60-80% saturation): +/-3% Arms
- SpO2 accuracy (70-100% saturation): +/-2% Arms
- PR accuracy (60-100% saturation): ≤3 BPM
- MDT20006OXYVMT:
- SpO2 accuracy (70-100% saturation, motion): +/-3% Arms
- PR accuracy (70-100% saturation, motion): ≤5 BPM
- SpO2 accuracy (70-100% saturation, non-motion with N-395 device): +/-3% Arms
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.
No reference devices were used in this submission.
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it.
Covidien llc Greeshma Kayala Regulatory Affairs Manager 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K212555
Trade/Device Name: Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: April 1, 2022 Received: April 4, 2022
Dear Greeshma Kayala:
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 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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
Todd Courtnev Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212555
Device Name
Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN/OxySoftNHC
Indications for Use (Describe)
The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, pediatric and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospit, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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
SUBMITTER INFORMATION
Submitted By:
Covidien, Ilc 6135 Gunbarrel Avenue Boulder, CO 80301
Date Prepared: May 2, 2022
Contact Person:
Official Correspondent: Elli Marrs, Regulatory Affairs Specialist
Secondary Correspondent: Greeshma Kayala, Sr. Regulatory Affairs Manager
Phone: (303) 579-1718 Email: Greeshma.kayala@medtronic.com
DEVICE NAME
| Trade Name: | Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor OxySoftN
Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor OxySoftNHC |
|----------------------------|------------------------------------------------------------------------------------------------------------------|
| Common Name: | Oximeter |
| Classification Regulation: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Regulatory Class: | Class II |
| Product Code: | DQA |
| Review Panel: | Anesthesiology |
PREDICATE DEVICE
| Predicate Manufacturer: | Covidien |
|---|---|
| Predicate Trade Name: | NellcorTM Neonatal-Adult SpO2 Sensor, MAXN |
| Predicate 510(k): | K012891 |
| Clearance Date: | March 7, 2002 |
No reference devices were used in this submission.
DEVICE DESCRIPTION
The Nellcor™ OxySoft™ Neonatal/Adult SpO2 Sensor, OxySoftNHC monitors the amount of oxygen in the patient's blood (oxygen saturation) or SpO2 and pulse rate after applying the sensor on the finger, foot, or hand. The sensor utilizes a pair of light emitting diodes (LEDs) employing light at two wavelengths, and the time varying absorbance of the
Covidien IIc
4
tissue due to the pulsatile blood signal is obtained, amplified from a photodiode to determine functional arterial oxygen saturation.
A clinician will prescribe the sensor for use as spot check or continuous use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. The OxySoftNHC sensor can be used with all Nellcor™ compatible systems.
The sensor consists of a sensor assembly and cable assembly and is provided sterile (EtO) and is meant for single use.
NOTE: The two model numbers represent only one sensor type, OxySoftN. The 'HC' suffix denotes the model number that includes an additional Home Use Guide for the lay user for home use.
INTENDED USE AND INDICATIONS FOR USE
Intended Use:
The Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, model OxySoftN, is intended for use in non-invasive continuous or spot-check monitoring of functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate for neonates and infants weighing less than 3 kg or adults and pediatrics weighing more than 40 kg.
Indications for Use:
The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, pediatric and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft™ SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.
CONTRAINDICATIONS
The OxySoftN sensor is contraindicated for use on patients who exhibit allergic reactions to synthetic fabrics or silicone.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, models OxySoftN and OxysoftNHC are designed for the same functionality as the predicate device sensors, Nellcor™ Neonatal-Adult SpO2 Sensor, MAXN, measuring functional oxygen saturation.
The following technological characteristics were compared between the subject device and predicate device to demonstrate substantial equivalence in Table 1 below.
5
Table 1. Comparison of Technological Characteristics
| Characteristic | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| Nellcor™ OxySoft™ | |||
| Neonatal-Adult SpO2 | |||
| Sensor, OxySoftN and | |||
| OxySoftNHC | Nellcor™ Neonatal-Adult | ||
| SpO2 Sensor, MAXN | |||
| (K012891) | |||
| Device | Oximeter | Oximeter | Same |
| Product Code | DQA | DQA | Same |
| Device Class | II | II | Same |
| Indications for | |||
| Use | The Nellcor™ OxySoftN | ||
| single patient use sensor is | |||
| indicated for use with | |||
| neonatal, infant, pediatric | |||
| and adult patients during | |||
| both no motion and motion | |||
| conditions and for patients | |||
| who are either well or poorly | |||
| perfused, in hospitals, | |||
| hospital-type facilities, intra- | |||
| hospital transport, mobile | |||
| emergency medical | |||
| applications including both | |||
| ground and air transport | |||
| and home environments. | |||
| Transport environments | |||
| include intra-hospital | |||
| transport and both ground | |||
| and air emergency | |||
| transport: road ambulances | |||
| and fixed-wing aircraft and | |||
| helicopters. The Nellcor™ | |||
| OxySoft SpO2 Sensor | |||
| works in conjunction with | |||
| monitoring systems that use | |||
| OxiMax™ and Nellcor | |||
| compatible pulse oximetry | |||
| systems to facilitate spot | |||
| checking or continuous | |||
| monitoring of a patient's | |||
| arterial hemoglobin (SpO2) | |||
| and pulse rate via topical | |||
| application of the sensor | |||
| over a pulsating arteriolar | |||
| vascular bed, such as a | |||
| finger, foot or hand. This | |||
| device is for prescription | |||
| use only. | The OxiMax™ single | ||
| patient use sensors (which | |||
| includes the MaxN) is | |||
| indicated for use with | |||
| neonatal, infant, pediatric, | |||
| and adult patients during | |||
| both no motion and motion | |||
| conditions and for patients | |||
| who are either well or poorly | |||
| perfused, in hospitals, | |||
| hospital-type facilities, intra- | |||
| hospital transport, and | |||
| home environments. These | |||
| devices are for prescription | |||
| use only. | Different: | ||
| Indications for Use | |||
| were updated to | |||
| include clarity of | |||
| systems OxySoftN | |||
| is compatible with. | |||
| Additionally | |||
| environments for | |||
| use were expanded | |||
| to include home | |||
| use environments | |||
| and mobile | |||
| emergency medical | |||
| applications, | |||
| including both | |||
| ground and air | |||
| transport, | |||
| environments | |||
| which is supported | |||
| by compliance to | |||
| IEC 60601-1- | |||
| 11:2015 and IEC | |||
| 60601-1-12:2014. | |||
| Characteristic | Subject Device | Predicate Device | Comments |
| Nellcor™ OxySoft™ | |||
| Neonatal-Adult SpO2 | |||
| Sensor, OxySoftN and | |||
| OxySoftNHC | Nellcor™ Neonatal-Adult | ||
| SpO2 Sensor, MAXN | |||
| (K012891) | |||
| Purpose and | |||
| Function | Non-invasive continuous or | ||
| spot-check monitoring of | |||
| functional oxygen saturation | |||
| of arterial oxygen saturation | |||
| (SpO2) and pulse rate | Non-invasive continuous | ||
| monitoring of functional | |||
| oxygen saturation of arterial | |||
| oxygen saturation (SpO2) | |||
| and pulse rate | Same | ||
| Target | |||
| Population | Neonatal, infant, pediatric, | ||
| and adult patients | Neonatal, infant, pediatric, | ||
| and adult patients | Same | ||
| Intended User | Professionally trained | ||
| health care providers, | |||
| patients or a lay operator | |||
| assisting a patient in a | |||
| home-care environment | Professionally trained | ||
| health care providers, | |||
| patients or a lay operator | |||
| assisting a patient in a | |||
| home-care environment | Same | ||
| Where Used | In hospitals, hospital-type | ||
| facilities, intra-hospital | |||
| transport, mobile | |||
| emergency medical | |||
| applications including both | |||
| ground and air transport | |||
| and home environments. | |||
| Transport environments | |||
| include intra-hospital | |||
| transport and both ground | |||
| and air emergency | |||
| transport: road ambulances | |||
| and fixed-wing aircraft and | |||
| helicopters. | In hospitals, hospital-type | ||
| facilities, intra-hospital | |||
| transport, and home | |||
| environments. | Different: | ||
| Environments for | |||
| use were expanded | |||
| to include home | |||
| use environments | |||
| and mobile | |||
| emergency medical | |||
| applications, | |||
| including both | |||
| ground and air | |||
| transport, | |||
| environments | |||
| which is supported | |||
| by compliance to | |||
| IEC 60601-1- | |||
| 11:2015 and IEC | |||
| 60601-1-12:2014. | |||
| Energy source | Sensor itself has no energy | ||
| source. When used with a | |||
| compatible monitor | |||
| (powered by battery or AC | |||
| power source), the monitor | |||
| powers the sensor. | Sensor itself has no energy | ||
| source. When used with a | |||
| compatible monitor | |||
| (powered by battery or AC | |||
| power source), the monitor | |||
| powers the sensor. | Same | ||
| Fundamental | |||
| Technology | Transmittance sensor that | ||
| measures functional oxygen | |||
| saturation and pulse rate | |||
| non-invasively: utilizing | |||
| spectrophotometry, a pair of | |||
| light emitting diodes (LEDs) | Transmittance sensor that | ||
| measures functional oxygen | |||
| saturation and pulse rate | |||
| non-invasively: utilizing | |||
| spectrophotometry, a pair of | |||
| light emitting diodes (LEDs) | Same | ||
| Characteristic | Subject Device | Predicate Device | Comments |
| Nellcor™ OxySoft™ | |||
| Neonatal-Adult SpO2 | |||
| Sensor, OxySoftN and | |||
| OxySoftNHC |
wavelengths, and using
plethysmography, the time
varying absorbance of the
tissue due to the pulsatile
blood signal is obtained,
amplified and digitized from
a photodiode to determine
functional arterial oxygen
saturation. | Nellcor™ Neonatal-Adult
SpO2 Sensor, MAXN
(K012891)
wavelengths, and using
plethysmography, the time
varying absorbance of the
tissue due to the pulsatile
blood signal is obtained,
amplified and digitized from
a photodiode to determine
functional arterial oxygen
saturation. | |
| Performance
Standards | EN ISO 80601-2-61
ISO 80601-2-61 | EN ISO 80601-2-61 | Same |
| Key
Performance
Specifications | Pulse rate accuracy: +/- 3
BPM RMS
SpO2 Accuracy (Adult and
Neonate with Motion):
70% to 100% (+/- 3% RMS)
SpO2 Accuracy (Adult and
Neonate): 70% to 100%
(+/- 2% RMS)
SpO2 Accuracy (Low
Saturation): 60% to 80%
(+/- 3% RMS)
SpO2 Accuracy (Low
Perfusion): 70% to 100%
(+/- 2% RMS) | Pulse rate accuracy: +/- 3
BPM RMS
SpO2 Accuracy (Adult and
Neonate with Motion):
70% to 100% (+/- 3% RMS)
SpO2 Accuracy (Adult and
Neonate): 70% to 100%
(+/- 2% RMS)
SpO2 Accuracy (Low
Saturation): 60% to 80%
(+/- 3% RMS)
SpO2 Accuracy (Low
Perfusion): 70% to 100%
(+/- 2% RMS) | Same |
| External
Materials | Polyurethane
Silicone
Synthetic fabric
Aluminum polypropylene
Synthetic rubber
PVC | Polyethylene
Acrylic
Woven cotton
Polypropylene
Rayon elastic
PVC | Different: The
subject and
predicate device
have equivalent
materials, with the
exception of the
bandage and
adhesive.
The subject device
was assessed for
form, fit and
function through a
clinical study,
MDT20002VALNIC |
| Main Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-2
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-2
IEC 60601-1-2 | Different:
Expanded to
include IEC 60601-
1-11 and IEC |
| Characteristic | Subject Device | Predicate Device | Comments |
| | Nellcor™ OxySoft™
Neonatal-Adult SpO2
Sensor, OxySoftN and
OxySoftNHC
IEC 60601-1-11
IEC 60601-1-12 | Nellcor™ Neonatal-Adult
SpO2 Sensor, MAXN
(K012891) | 60601-1-12 to
address emergency
and home use
environments. |
6
7
8
The subject device, the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, models OxySoftN and OxysoftNHC. has the same principle of operation. intended use, patient population and fundamental technology as the predicate device, Nellcor™ Neonatal-Adult SpO2 Sensor, MAXN.
The differences in technological characteristics do not alter the fundamental performance or the clinical use of the device, these differences do not raise different questions of safety and effectiveness based on the performance data and clinical studies, summarized below.
PERFORMANCE DATA SUMMARY
The following performance data were provided to support the substantial equivalence determination for the modification being made as part of this submission.
Biocompatibility Testing
The Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, models OxySoftNand OxysoftNHC are classified as surface devices with permanent (>30 days) skin contact. The biocompatibility evaluation was conducted in accordance with International Standard (ISO) 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" and FDA Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
The biocompatibility assessment included the following:
- Cytotoxicity (MEM elution method) ●
- Sensitization (Guinea pig maximization) ●
- Intracutaneous reactivity
- . Chemical characterization and toxicological risk assessment
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, models OxySoftN and OxysoftNHC. The sensor complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Non-clinical Performance Testing
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Non-clinical testing for the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, models OxySoftN and OxysoftNHC included the following:
- Mechanical
- Use Life
- Type 1 Light Shunting ●
- Storage Altitude .
- Storage Temperature and Humidity ●
- Ambient Light
- Ingress Protection
- Shock and Vibration ●
- Time to Post
- . Adhesive Liner Card and Initial Peel Force
- Nellcor Functional Compatibility ●
- Surface Temperature Rise Measurement System
- . Operational Altitude
- Operational Humidity and Temperature
- Transient Temperature and Humidity ●
- Pulse Rate Motion
- Low Perfusion ●
- Human Factors
Non-clinical testing was performed to demonstrate that the User Requirements and Product Requirements have been fulfilled. Specifically, testing was completed to demonstrate that the subject device is substantially equivalent to the predicate device and as safe and effective with respect to design characteristics and performance. A Human Factors Validation study was used to evaluate shortening of the subject device cable and confirmed that this design attribute did not contribute to any or existing usability issues. Ingress Protection testing was performed to ensure subject device functions, including the new bandage material, after being subjected to particle IP3X and liquid ingress IPX3 conditioning per IEC 60529. To demonstrate that the new adhesive material of the subject device adds benefit but does not impact clinical use or performance, biocompatibility testing was performed.
Animal Performance Testing
Not applicable. No animal performance testing was required to demonstrate device safety and effectiveness.
Clinical Studies
To support the substantial equivalence of the subject device with the expanded indications for use Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftNHC, clinical studies were conducted.
MDT20002VALNIC: Performance evaluation of the OxySoftN neonatal sensor in the NICU compared to SaO2
A clinical validation study, Performance Evaluation of the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN (subject device) in the NICU Compared to SaO2 was performed. Arterial samples were collected on neonates to demonstrate form, fit, and function (clinical performance) of the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN(subject
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device). The standard reference for the SpO2 accuracy as read by pulse oximetry equipment was compared to SaO2 values obtained from CO-oximeter analysis of simultaneously drawn arterial blood. The observed SpO2 accuracy was 2.68% in a study of 27 patients with ages of 1 to 9 days, weight from 640 to 4710 grams, and 64 observations made spanning a range of 82.1% to 99.3% SaO2. There was acceptable evidence to demonstrate safe form and fit of the OxySoftN sensor when applied to 31 patients in the intended neonate population.
MDT20037CYBOXY: Validation of the OxySoftN to Determine the Gentleness on Fragile Skin
A clinical study was performed on healthy elderly subjects (known for having fragile skin) to evaluate evaporative water loss (TEWL), and amount of skin protein disruption between the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN (subject device) and the Nellcor™ Neonatal-Adult SpO2 Sensor, MAXN (predicate device) to evaluate gentleness of the new adhesive OxySoftN (subject device). The clinical study data demonstrated the adhesive removed significantly less cells than MAXN sensor (predicate device) and caused a minimal increase in TEWL on subjects likely to have fragile skin.
MDT20047OXSNOF: Sensor-Off Validation of the OxySoftN sensor in Healthy Adults
A clinical study, Nellcor™ Sensor-Off Validation of the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN (subject device) in healthy adults was performed to further ensure the clinical use of the sensor, and validated that the investigational OxySoftN oximetry sensor displayed a "Sensor Off" message within 1 minute after the sensor is removed at least 90% of the time. A sequence of steps for different sensor off configurations was performed per subject. This study was completed to determine whether simulated and real-world situations known to represent challenges to pulse oximetry have an effect on the ability of the "Sensor Off" feature to function according to product design specifications. The study demonstrated the sensor off feature performance with a sample proportion of 0.996 and 95% lower bound for the proportion of success of 0.983. The results demonstrate the device posts a "Sensor Off" message within 1 minute after the sensor is removed at least 90% of the time.
MDT20038CYBADH: Multiple Reposition Peel Adhesion on Human Skin Validation, OxySoftN
The objective of this study was to demonstrate that the Nellcor™ OxySoft ™ Neonatal-Adult SpO2 Sensor, OxySoftN (subject device) remains adhered to the skin after the 18th repositioning by measuring peel adhesion as the sensor was serially removed and reapplied to alternating sites on the volar forearm of healthy adults using standardized in-vivo testing procedures. The study concluded that the OxySoftN Sensor can be repositioned and remains adhered to the skin after the 18th repositioning using the above mentioned standardized in-vivo testing procedures.
MDT20028OXYLOV: SpO2 Accuracy Validation of the OxySoftN sensor via Reference CO-Oximetry in Healthy, Well-Perfused Subject
The purpose of this study was to directly compare the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor. OxySoftN (subject device) saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from
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arterial blood samples from healthy adult subjects. Additionally, prototype pulse rate measurements were compared to 3-lead ECG pulse rate measurements made via a multiparameter monitor. Results of this study concluded, when using the N-600x, PM1000N and Oxicable devices, paired with the OxySoftN sensor, during a saturation range of 60-80%, the svstem demonstrates expected SpO2 accuracy of ±3% Arms. When using the N-600x. PM1000N and Oxicable devices, paired with the OxySoftN sensor during a saturation range of 70% - 100%, the system demonstrates expected SpO2 accuracy of ±2% Arms. During a saturation range of 60% - 100%, the system demonstrates expected PR accuracy of ≤3 BPM.
MDT20006OXYVMT: SpO2 Accuracy Validation of the OxySoft sensor via Reference CO-Oximetry Motion Study
The primary objective of the study is to investigate the performance of the Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN (subject device) for pulse rate and saturation accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range. When using the N-600x device, in conjunction with the OxySoftN sensor, during a saturation range of 70% - 100% and motion conditions, the system demonstrates expected SpO2 accuracy of ±3% Arms. When using the N-600x device, in conjunction with the OxySoftN sensor, during a saturation range of 70% - 100% and motion conditions, the system demonstrates expected PR accuracy of ≤5 BPM. When using the N-395 device, in conjunction with the OxySoftN sensor, during a saturation range of 70% - 100% and non-motion conditions, the system demonstrates expected SpO2 accuracy of ±3% Arms. The N-395 device uses a leqacy calibration scheme where the calibration curve is stored in the monitor and the appropriate curve to be used is identified by a resistor value in the sensor connector. The RCAL calibration scheme was replaced by the sensor EPROM digital calibration scheme but to ensure efficacy of the legacy N-395 device the RCAL calibration scheme was included in testing.
CONCLUSIONS
The comprehensive verification and validating testing of non-clinical performance testing and clinical validation studies, demonstrate that the Nellcor™ OxySoft ™ Neonatal-Adult SpO2 Sensor, OxySoftN/ OxySoftNHC is substantially equivalent to the predicate device with respect to clinical use case, characteristics and performance.