KONICA MINOLTA PULSOX-300, 300I

K053419 · Konica Minolta Sensing, Inc. · DQA · May 11, 2006 · Cardiovascular

Device Facts

• Record ID: K053419
• Device Name: KONICA MINOLTA PULSOX-300, 300I
• Applicant: Konica Minolta Sensing, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.

Device Story

Pulse oximeter measuring SpO2 and pulse rate; utilizes two-wavelength light transmission through tissue; detects pulsatile blood flow signals; intended for adult patients with pulmonary conditions or sleep study needs; provides non-invasive monitoring; used by clinicians to assess oxygenation status; aids in clinical decision-making for respiratory management.

Clinical Evidence

Bench testing only. Performance demonstrated through compliance with ISO 9919:2005 and comparison to published literature for pulse oximeters.

Technological Characteristics

Non-invasive pulse oximeter; two-wavelength light transmission; measures SpO2 and pulse rate; intended for adult use; Class II device (21 CFR 870.2700).

Indications for Use

Indicated for non-invasive measurement of arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult patients with pulmonary disease, pulmonary dysfunction, or requiring sleep studies.

Regulatory Classification

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.

Predicate Devices

• Minolta Oxygen Saturation Monitor PULSOX-3 (K984570)
• Minolta Oxygen Saturation Monitor PULSOX-3Si (K010413)

Submission Summary (Full Text)

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K053419

Image /page/0/Picture/1 description: The image shows a logo for Compliance Systems, LLC. The logo has a dark rectangle with the text "Compliance Systems +, LLC" on the right side. The left side of the rectangle has a seal or emblem. The top of the rectangle has a dotted line.

2703 Josephine Street Denver, CO 80205 Phone: [phone]

## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS Konica Minolta PULSOX-300 and PULSOX-300i™ MAY 11 2006

December 2, 2005

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The Konica Minolta PULSOX-300 and PULSOX-300i are similar in function, design and construction to other products which were in the market place prior to May 28, 1976. The Konica Minolta PULSOX-300 and PULSOX-300i are also similar to several other products currently being marketed in the United States including the legally marketed predicate devices and a substantial equivalence claim is made, The predicate devices are the Minolta Oxygen Saturation Monitor PULSOX-3 and PULSOX-3Si. The predicate devices are legally marketed Class II post-amendment devices, K984570 and K010413 currently manufactured by Konica Minolta Sension. Inc., Aichi, Japan,

The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemogliobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study. SpO2 is, as defined in ISO 9919:2005, percent of hemoglobin saturation with oxygen measured by a pulse oximer and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.

Performance indicates that the Konica Minolta Models PULSOX-300 and PULSOX-300i, are equivalent to the Minolta PULSOX-3 and PULSOX 3Si. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Konica Minolta Models PULSOX-300 and PULSOX-300i are safe and effective.

Nance Dett

Nanci Dexter Owner, Compliance Systems +, LLC

12/02/05

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2006

Konica Minolta Sensing, Incorporated C/O Ms. Nanci Dexter Compliance Systems, LLC 2703 Josephine Street Denver, Colorado 80205

Re: K053419

Trade/Device Name: PULSOX-300/300i Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 28, 2006 Received: May 3, 2006

Dear Ms. Dexter:

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 - Ms. Dexter

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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 Statement

510(k) Number: K053419

Device Name: PULSOX-300/300i

Indications for Use:

The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.

Prescription Use __ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Sulhorn

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sinlogy, General Hospital In of Anesth Control, Dent

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