(60 days)
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fingertip Pulse Oximeter, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily refers to the tolerance as the key performance metric.
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Tolerance smaller than ±2% | Tolerance smaller than ±2% |
| Range: 70% to 99% SpO2 | Range: 70% to 99% SpO2 |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%." However, it does not provide specific details on the sample size used for this clinical practice data nor explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature).
It does mention that the subject device (CMS-50D, CMS-50L, and CMS-50DL) is a modification to a previously cleared device (CMS-50C) and that "we believe the clinical test per ISO 9919 Annex EE.4 is not required to be conducted on the modified device." This implies that the performance data might be largely based on the predicate device or general clinical understanding rather than a dedicated new clinical trial for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The text refers to "clinical practice" for the tolerance, but it doesn't detail how ground truth for SpO2 was established in that context (e.g., comparison to arterial blood gas analysis performed by qualified personnel).
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in the provided document. The focus is on the device's standalone performance rather than comparing human readers with and without AI assistance. The device is a pulse oximeter, not an AI-assisted diagnostic tool for image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance evaluation was done for the device. The document states: "In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%." This refers to the device's ability to measure SpO2 independently. The specific details of the study (e.g., methods, number of subjects) are not explicitly outlined, but the statement indicates a standalone performance assessment.
7. Type of Ground Truth Used
The document implicitly refers to clinical practice measurements as the ground truth. For SpO2 measurements, the gold standard typically involves arterial blood gas analysis. While the document states "In the clinical practice, the tolerance is smaller than ±2%", it does not explicitly state that arterial blood gas analysis was used as the ground truth; however, this is a standard method for validating pulse oximeter accuracy in clinical settings.
8. Sample Size for the Training Set
This information is not applicable as the device described is a pulse oximeter, which is a sensor-based medical device, not an AI/algorithm that requires a training set in the typical machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for this type of device).
{0}------------------------------------------------
page 1 out of 4
Section 3 510(k) Summary
As required by 807.97
NOV 1 0 2008
The assigned 510(k) Number is _K082641
1 Basic Information
| Sponsor | Contec Medical Systems Co., Ltd |
|---|---|
| No. 24, West Huanghe Road | |
| Qinhuangdao, Hebei, 066000, China | |
| Mr. Li Xueyong, Quality Manager | |
| Tel:+86-335-8015490 | |
| Fax: +86-335-8015505 | |
| Email: lxyong1011@163.com | |
| SubmissionCorrespondent | Ms. Diana Hong / Mr. Lee Fu |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Sute 8D, No.19, Lane 999, Zhongshan No.2 Road(S) | |
| Shanghai, 200030, China | |
| Tel: +86-21-64264467 | |
| Fax: 760-466-5084 | |
| Email: diana.hong@mid-link.net | |
| Proposed Product | |
| Trade Name | Fingertip Pulse Oximeter |
| Model | CMS-50D, CMS-50L and CMS-50DL |
| Product Code: | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Device Class: | Class II |
| Submission Purpose: | Modification to Fingertip Pulse Oximeter CMS-50C cleared |
| in K073454. | |
| Predicate Device: | Fingertip Pulse Oximeter CMS-50C |
| K073454 | |
| Device Description | The Fingertip Pulse Oximeter is tiny, and with low power |
| consumption, convenient to use and carry. You just need to | |
| put the fingertip into the sensor of the device, the SpO2 value | |
| will appear on the screen immediately. In the clinical | |
| Test Conclusion | practice, the tolerance is smaller than ±2% in the range from70% to 99%.Laboratory testing was conducted to validate and verify that theproposed devices met all design specifications, including electricalsafety, EMC, specifications. |
| SE Determination | The proposed device, Fingertip Pulse Oximeter, issubstantially equivalent (SE) to the predicate device FingertipPulse Oximeter (K073454). |
{1}------------------------------------------------
2 Device Description
General Description
The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration. Many of the respiration disease will cause hypoxemia, even damage the patient' s life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional method to measure SpO2 is to analyze the sample of the patient's blood to get the partial pressure of oxygen and calculate the SpO2 by use the blood-gas analyzer. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Pulse Oximeter. The device can measure the pulse rate simultaneously.
The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%.
{2}------------------------------------------------
The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain druq or biological products
The proposed devices, Fingertip Pulse Oximeter, CMS-50D, CMS-50L and CMS-50DL are modification device to Fingertip Pulse Oximeter, CMS-50C which was cleared in K073454. The proposed devices have same intended use, same design and working principle, same key components (including led, photo detector and medical silicon cushion), same data process module and same specifications with the predicate device. The modifications mainly concern on the display function of the device.
3 Indication for Use
The indications for use of the proposed device Fingertip Pulse Oximeter, CMS-50D, CMS-50L and CMS -50DL are same and identical to the original device CMS-50C.
The indication for use is listed below and an Indication for Use Form is presented in Exhibit A Indication for Use Form per FDA required format.
Indication for Use:
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
4 Testing Summary
Validation tests were conducted to validate the design control activity.
{3}------------------------------------------------
The proposed device, Fingertip Pulse Oximeter CMS-50D, CMS-50L and CMS-50DL were tested in accordance with IEC 60601-1 and IEC 60601-1-2 to evaluate the electrical safety and EMC. A declaration of conformity to IEC 60601-1 and IEC 60601-1-2 is presented in Exhibit E Declaration of Conformity.
The proposed device, Fingertip Pulse Oximeter CMS-50D, CMS-50L and CMS-50DL, were tested in accordance with ISO 9919:2005:, Medical electrical equipment -Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. A declaration of conformity to ISO is presented in Exhibit E Declaration of Conformity.
In addition, the modification to the original device doesn't cover the intended use, key components and data process unit. Therefore, we believe the clinical test per ISO 9919 Annex EE.4 is not required to be conducted on the modified device.
5 SE comparison conclusion
The subject device has same classification information, same indications and intended use, same design principle, same product design and similar specifications, same effectiveness performance, same safety performance as the predicate device.
The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Public Health Service
NOV 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Contec Medical Systems Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030 CHINA
Re: K082641
Trade/Device Name: Fingertip Pulse Oximeter (CMS-50D, CMS-50L and CMS-50DL) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 3, 2008 Received: November 3, 2008
Dear Ms. Hong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting 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.
{5}------------------------------------------------
Page 2 - Ms. Hong
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suite y. Michin Oms.
FOR BR CHILL UN Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Exhibit A Indication for Use Form
510(k) Number:
Device Name: Fingertip Pulse Oximeter (CMS-50D, CMS-50L and CMS-50DL)
Indications for Use:
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saute Y. Mcheu Ons
Page 1 of 1
(Division Sign-Of Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082641
§ 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).