(218 days)
K/DEN: Not Found
No
The description focuses on standard oximetry technology and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is for measuring and monitoring physiological parameters (pulse rate and SpO2), not for treating any condition or disease.
Yes
The device is described as "intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger" and for "spot-checking of SpO2 and pulse rate in home and clinic." These are measurements used to assess physiological status, which falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "Fingertip Oximeter" and is "powered by 2 AAA batteries," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The PC-60 Fingertip Oximeter measures pulse rate and oxygen saturation (SpO2) through the patient's finger. This is a non-invasive measurement taken directly from the body, not from a specimen taken from the body.
- Intended Use: The intended use describes measuring physiological parameters directly from the patient.
- Device Description: The description reinforces that it monitors pulse rate and SpO2 directly from the patient.
Therefore, since the device does not analyze specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The PC-60 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.
Product codes
DOA
Device Description
The Shenzhen Creative Industry Co., LTD, Model PC-60 Fingertip oximeter is to monitor pulse rate and SPO2, for adult and pediatric patients in home use and clinical applications. This monitor is available for sale by the order of a physician or licensed health care professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's finger, index finger
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Home use and clinical applications, by the order of a physician or licensed health care professional.
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)
The PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market. A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of design control procedure. Shenzhen Creative Industry, LTD quality system confirms to 21CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 1 8 2007
510(k) Summary of Safety and Effectiveness
Submitter
Shenzhen Creative Industry Co., LTD. 2/F. Block 3, Nanyou Tian'an Industry Town, Shenzhen, GD P. R. China-518054 Telephone: +86 755 2643 3514 Fax: +86 755 2643 2832 E-mail: market@creative-sz.com Company Contact: Nang Jin Date Summary Prepared: 8-20-2006
Device Name
Trade Name: PC-60, Fingertip Oximeter Common Name: Pulse oximeter Classification Name: Pulse Oximeter (21CFR870.2700) Classification: Class II
Predicate Devices (Legally Marketed Devices)
The predicate device for Non-invasive pulse oximeter, Model PC-60 Fingertip Oximeter is: Nonin Onyx®II Fingertip Oximeter, pulse oximeter, Model 9550, cleared by FDA through 510(k) No. K051107.
Device Description
The Shenzhen Creative Industry Co., LTD, Model PC-60 Fingertip oximeter is to monitor pulse rate and SPO2, for adult and pediatric patients in home use and clinical applications. This monitor is available for sale by the order of a physician or licensed health care professional.
Intended Use
The PC-60 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.
Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)
The Non-invasive pulse oximeter, Model PC-60 is substantially equivalent to the
Nonin Onyx® II Fingertip Oximeter, Model 9550.
The Non-Invasive Pulse oximeter measurement specifications and performance are equivalent to the Nonin Onyx® II Fingertip Oximeter, Model 9550.
1
Summary of Performance Testing
The PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market.
A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of design control procedure. Shenzhen Creative Industry, LTD quality system confirms to 21CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485.
Conclusions
As stated above, the PC-60 Fingertip Oximeter is safe and effective and complies with the appropriate medical device standards and is substantially equivalent to the earlier identified predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
JUL 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shenzhen Creative Industry Company, Ltd. C/O Mr. Charles Mack Principal Engineer International Regulatory Consultants, LLC 340 Shady Grove Road Flintville, Tennessee 37335
Re: K063641
Trade/Device Name: PC-60, Fingertip Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: July 4, 2007 Received: July 9, 2007
Dear Mr. Mack:
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.
3
Page 2 - Mr. Mack
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Senyte Y. Michaud MD.
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
4
Indications for Use
510(k) Number (if known):
Device Name: PC-60 Fingertip Oximeter
Indications for Use:
Indications
For Use
The PC-60 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO ) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.
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Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Number: