(428 days)
Caremed Reusable & Disposable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities
Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.
This document is a 510(k) premarket notification for the Caremed Reusable & Disposable SpO2 Sensors. It states that the device is substantially equivalent to a legally marketed predicate device. The information provided is primarily focused on demonstrating this substantial equivalence through comparisons of technical properties and adherence to standards, rather than providing a detailed clinical study report with specific acceptance criteria and detailed performance of the new device.
Here's an attempt to answer your questions based on the provided text, recognizing that some information is implicit or not fully detailed:
1. A table of acceptance criteria and the reported device performance
The document mentions that the subject device's SpO2 and Pulse Rate accuracy meet the requirements of ISO80601-2-61. However, it only provides the SpO2 Accuracy and Pulse Rate Accuracy of the predicate device (K100077 and K111888) as a comparison point in Table 1. It also states the subject device's accuracy has a "slight difference" from the predicate. Without the explicit values for the subject device's SpO2 and Pulse Rate accuracy and the specific ISO80601-2-61 requirements, a direct "acceptance criteria vs. reported performance" table cannot be fully constructed for the subject device.
However, based on the predicate device's performance as a proxy for expected accuracy and the statement that the subject device meets ISO80601-2-61 standards, we can infer some criteria.
| Acceptance Criteria (Inferred from Predicate & Standard) | Reported Device Performance (Implicit from "meets ISO80601-2-61") |
|---|---|
| SpO2 Accuracy (70-100%): | Meets ISO80601-2-61 requirements |
| - For systems with predicate K100077: $\pm$ 2% | |
| - For systems with predicate K111888: $\pm$ 3% | |
| Pulse Rate Accuracy (30-250bpm): | Meets ISO80601-2-61 requirements |
| - For systems with predicate K100077: $\pm$ 2 | |
| - For systems with predicate K111888: $\pm$ 3 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "human adult volunteers" but does not specify the number.
- Data Provenance: Not explicitly stated for the clinical trial. The company is based in Shenzhen, China.
- Retrospective or Prospective: "Clinical hypoxia test results were obtained in human adult volunteers" typically implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable or not mentioned. For SpO2 sensor accuracy testing, the ground truth (arterial oxygen saturation, SaO2) is typically established by laboratory methods such as co-oximetry of arterial blood samples, not by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not mentioned. As the ground truth is established by co-oximetry, there's no need for an adjudication method involving human experts for the primary endpoints.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance test was done. The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Reusable & Disposable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry." This is a direct measurement of the device's accuracy against a gold standard, which is a standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry from arterial blood samples. This is considered a gold standard laboratory method.
8. The sample size for the training set
Not explicitly stated. For SpO2 sensors, "training data" often refers to data used to derive or refine the oximetry algorithm. If this refers to the data used for the algorithm, its size is not mentioned. If it refers to clinical data, the document mainly references the clinical performance study (test set).
9. How the ground truth for the training set was established
Not explicitly stated. Assuming a similar methodology to the test set, the ground truth for any algorithm development or training would likely have been established using co-oximetry from arterial blood samples.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 04, 2017
Shenzhen Caremed Medical Technology Co., Ltd. Xinlin Xiao OA Manager Zone B, 3/F, 11 Building, Hebei Industrial Area Longhua Office, Longhua New District Shenzhen, Guangdong 518021 China
Re: K153184
Trade/Device Name: Caremed Reusable & Disposable SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 13, 2016 Received: December 5, 2016
Dear Xinlin Xiao:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K153184
Device Name
Caremed Reusable & Disposable SPO2 Sensors
Indications for Use (Describe)
Caremed Reusable & Disposable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in red and black, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray.
Section 5
510(K) Summary
1. Prepared Date: 2017/1/3
2. Submitter Information
| Name | Shenzhen Caremed Medical Technology Co., Ltd. |
|---|---|
| Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen,China |
| Tel | 0086-755-27184369 |
| Fax | 0086-755-27186486 |
3. Contact Person
| Contact person | Xinling Xiao |
|---|---|
| Title | QA manager |
| Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen, China |
| Tel | 0086-755-27184369 |
| Fax | 0086-755-27186486 |
| xinling.xiao@gmail.com |
4. Proposed Device Information
| Trade Name | Caremed Reusable & Disposable SPO2 Sensors |
|---|---|
| Model | C403-01,C403S-15&N543-01 |
| Common name | Oximeter |
| Regulatory class | II |
| Production regulation | 21 CFR §870.2700 |
| Product code | DQA |
| Panel | Cardiovascular |
5. Predicate Device Information
| 510(K)No. | Trade Name/model | Submitter |
|---|---|---|
| K100077 | Solaris Medical Technology, Inc.Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. |
| K111888 | Masimo LNOP/M-LNCS/LNCSMultisite-L Oximetry Sensors | Masimo Corporation |
6. Device description
Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission Page 1 of 6
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in a stylized font, with the "C" in red and the "M" in black. To the right of the letters is the word "caremed" in red, with the first letter in lowercase and the rest in uppercase. Below the word "caremed" are two Chinese characters in gray.
patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.
| Model | Description | CompatibleMonitor |
|---|---|---|
| C403-01 | Nellcor Adult Reusable Finger Clip SpO2 Sensor | N395 |
| C403S-15 | Masimo Adult Reusable Soft tip SpO2 Sensor | Masimo RadicalRad-8 |
| N543-01 | Nellcor Adult Disposable Non- Adhesive SpO2 Sensor | N395 |
Three models of sensors are described as follows:
7. Intended use
Caremed Reusable & Disposable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than40kg and pediatric patients weighing 10 -50 kg at hospital facilities.
8. Comparison to predicate device
Caremed Reusable & Disposable SPO2 Sensors use the same technological characteristics as the predicate devices to determine arterial oxygen saturation: arterially perfused tissue is illuminated sequentially by two wavelengths of LEDs, and the time varying absorbance of the tissue is measured by a photodetector.
Based on the following comparison, both device have same intended use,working principle ,measurement part,compatibility ,only in technical parameters and cable length have slightly difference. But the subject devices have passed IEC60601-1,IEC60601-1-2,ISO80601-2-61&performance testing, so these difference does not raise different questions of safety or effectiveness. Please see the following comparison table:
Table 1
| Comparison item | Subject DeviceCaremed Reusable anddisposable SPO2 sensorcompatibility with Nellcor(Model:C403-01,C403S-15&N543-01) | Predicate DeviceReusable and disposableSPO2 sensor compatibilitywith Nellcor(model:T100A-090103 andDP100A-090103)K100077 | Predicate DeviceAdult and pediatric/slenderdigit spo2 sensor (model:LNOP DCI series)K111888 |
|---|---|---|---|
| Intendeduse&Indications for Use | Caremed Disposable andReusable SPO2 Sensors areindicated for continuousnon-invasive monitoring offunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate(PR) for adultpatients weighing greaterthan40kg and pediatricpatients weighing 10 -50 kg | When used with acompatible patient monitoror a pulse oximeter device,Solaris Medical Technology,Inc. reusable & disposableSpO2 sensors are intendedto be used for continuous,non-invasive functionalarterial oxygen saturation(SpO2)and pulse rate monitoring.Solaris Medical Technology,Inc. reusable multi-patientuse SpO2 Soft Sensors,reusable multi-patient useSpO2 Finger Sensors, anddisposable single patientuse SpO2 Soft-fingerSensors are for use withadult/pediatric patientsweighing greater than 40kg.Solaris Medical Technology,Inc. disposable singlepatient use SpO2 AdhesiveSensors are for use withadult patients weighinggreater than 40kg, pediatricpatients weighing 10 - 40kg, and infant(non-neonatal) patientsweighing 3 - 15kg.Prescription device. | The MasimoLNOP/M-LNCS/LNCSMultisite-L OximetrySensors are indicated forthe continuous noninvasivemonitoring of functionaloxygen saturation ofarterialhemoglobin (SPO2) andpulse rate (measured by anSPO2 sensor) for use withadult, pediatric, infant, andneonatal patients duringboth no motion and motionconditions, and for patientswho are well or poorlyperfused in hospitals,hospital-type facilities,mobile, and homeenvironments. |
| MeasurementMethod | 2-wavelength RelativeOptical Absorption | 2-wavelength RelativeOptical Absorption | |
| LightEmitting | Red:660-666nm,Ired:880-950nm | Red:660-666nm,Ired:880-950nm | |
| SignalDetectionMethod | Photodetector | Photodetector | |
| SPO2Accuracy | $\pm$ 3%(70-100%) | $\pm$ 2%(70-100%) | |
| PulseRateAccuracy | ±3(30-250bpm) | ±2(30-250bpm) | ±3(30-250bpm) |
| Appliedpopulation | C403-01 & C403S-15:Adult(≥40Kg)N543-01: Adult(≥40Kg) &Pediatric(10-50Kg) | Adult(≥40Kg) | Adult(≥30Kg) |
| Measurement part | Fingers or toes | Fingers or toes | Fingers or toes |
| compatible monitor | Nellcor Non oximax(N395)& Masimo set | Nellcor Non oximax (N395) | Masimo set |
| Sterility | No | No | No |
| Usage | Reusable&disposable | Reusable&disposable | Reusable |
| Material | ABS,PVC,TPU,Silicone,sponge | ABS,PVC,Silicone and 3M | ABS,PVC,TPU,Silicone |
| CableLength | 1.1 | 0.9 | 0.9 |
| ProximalconnectorDesign | DB9 9pin&1269 LNOP DC | DB9 7pin | 1269 LNOP DC |
| DistalconnectorDesign | finger clip and spongeadhesive | soft tip and textile adhesive | finger clip |
| Conformancestandard | IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10 | IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10 | IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10 |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in red and black, followed by the word "caremed" in black. Below the word "caremed" are two Chinese characters in black.
Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and black, followed by the word "caremed" in gray. Below the word "caremed" are two Chinese characters in gray.
From the comparison form above, both devices have the same Measurement Method, Light Emitting, Signal Detection Method, Measurement part, compatible monitor, Sterility, Usage & Conformance standard.
In Intended use& Indications for Use, SPO2 & Pulse Rate Accuracy, Applied population, Material item, both devices have some differences; please see the following analyses.
Note1 Intended use, Indications for Use& Applied population
The C403-01 is intended use for adult keeping still in in hospital environment which is same as predicate device T100A-090103. And the applied population of C403S-15 is adult with no motion which is slightly difference from the predicate device LNOP DCI series sensor. The N543-01 will be intended use for adult and Pediatric patients weighting 10-50Kg, which are same as the Nellcor(OEM) spo2 sensor. The subject Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission Page 4 of 6
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and black, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in black.
device has passed the IEC60601-1, IEC60601-1-2and ISO80601-2-61, so this difference does not raise different questions of safety and effectiveness.
Note2 SPO2 Accuracy & Pulse Rate Accuracy
The SPO2&Pulse rate Accuracy of subject device has slightly difference from the predicate device. But, the subject device's SPO2&Pulse rate Accuracy meets the requirement of ISO80601-2-61,so this difference also does not raise different questions of safety and effectiveness.
Note3 Material
The reusable spo2 sensor of both device have the same material of patient end, only the cable connecting with skin material is different, the subject device's is TPU, and the predicate device's is PVC. The patient end of Caremed disposable sensors is sponge adhesive, but the subject device meets the requirements of ISO10993-5/10, so this difference also does not raise different questions of safety and effectiveness.
According to contrast and analysis, the differences between subject device and predicate device does not raise different questions of safety and effectiveness.
9. Non-clinical test data
The subject device meets the following the recognized standards:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 2005
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
10. Clinical test data
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Reusable & Disposable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below "caremed" is some text in a different language, possibly Chinese.
11. Conclusions
Based on the comparison, analysis, and the submitted performance data, Caremed Reusable & Disposable SPO2 Sensors are substantially equivalent to the predicate devices.
§ 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).