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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Shenzhen Creative Industry Co., LTD. PC-60 Fingertip Oximeter. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (Nonin Onyx® II Fingertip Oximeter, Model 9550). This means the device is considered safe and effective if its performance is comparable to the legally marketed predicate.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Measurement of pulse rate and functional oxygen saturation (SpO2) through patient's finger.	Measures pulse rate and functional oxygen saturation (SpO2) through patient's finger.
Indication of pulse intensity by a bar-graph display.	Indicates pulse intensity by a bar-graph display.
Applicable for spot-checking in home and clinic for adult and pediatric patients.	Applicable for spot-checking in home and clinic for adult and pediatric patients.
Functional equivalence to 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."

Missing specific numerical acceptance criteria (e.g., SpO2 accuracy within +/- X%, heart rate accuracy within +/- Y bpm) and detailed performance data against those criteria.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The submission mentions "performance testing" but no details on patient cohorts or data points.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The common method for pulse oximeter accuracy is comparison against arterial blood gas analysis in a controlled desaturation study, often involving clinical experts to monitor subjects and collect data, but no such study details are present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Since there's no detailed clinical performance study described, an adjudication method is not applicable and not mentioned.

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

No MRMC study was performed or described. This device is a standalone measurement device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, implicitly. The device itself performs the measurement (algorithm only) and displays the results. The "Summary of Performance Testing" refers to testing the "system V & V plan and summary included with the submission using production equivalent units." However, the results of this testing, beyond the claim of equivalence, are not detailed in this public summary. For pulse oximeters, standalone performance is the primary focus, measuring its accuracy against established reference methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated. For pulse oximeters, the ground truth for SpO2 accuracy is typically co-oximetry readings from arterial blood samples (a gold standard for measuring fractional hemoglobin oxygen saturation). While implied for demonstrating equivalence to the predicate, this specific methodology is not described as being used by the applicant in this document.

8. The sample size for the training set

Not applicable/Not mentioned. This device is a hardware sensor and signal processing unit, not a machine learning model that requires a "training set" in the typical sense.

9. How the ground truth for the training set was established

Not applicable/Not mentioned (see point 8).

Conclusion:

The provided 510(k) summary for the PC-60 Fingertip Oximeter establishes substantial equivalence to the Nonin Onyx® II Fingertip Oximeter. It states that the "measurement specifications and performance are equivalent." However, it does not provide detailed clinical study results, specific acceptance criteria with numerical performance data, or detailed methodologies for establishing ground truth or sample sizes for specific tests beyond the general statement of "Summary of Performance Testing" in accordance with a V&V plan. Such specific data would typically be found in the full 510(k) submission, but is not included in this publicly available summary.

Summary

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JUL 1 8 2007

K063641

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

Intended Use

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.

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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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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

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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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number:

K063641

Regulation Number and Section

§ 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).