AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS

K050252 · Masimo Corporation · DQA · May 11, 2005 · Cardiovascular

Device Facts

• Record ID: K050252
• Device Name: AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AC-1 Adapter Cables, 8 pin and 12 pin Philips used with Masimo LNOP Sensors are intended for an SpO2 sensor for adult, pediatric, infant, and neonatal patients in hospital-type facilities, mobile, and home environments for the monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.

Device Story

AC-1 Adapter Cable (8-pin and 12-pin) serves as interface between Masimo LNOP sensors and Philips pulse oximeter monitors; enables non-invasive optical assessment of tissue oxygenation. Device transmits signals from sensors to monitor; allows clinician to view real-time SpO2 and pulse rate data. Used in hospital, mobile, and home settings to facilitate continuous patient monitoring; assists healthcare providers in clinical decision-making regarding patient oxygenation status. Benefits include reliable, continuous monitoring of arterial hemoglobin saturation across all patient populations.

Clinical Evidence

Clinical studies performed using AC-1 Adapter Cables with Masimo LNOP sensors on human subjects subjected to progressive induced hypoxia. Arterial blood samples measured via CO-Oximeter. Results demonstrated SpO2 accuracy of <2% Arms in 70%-100% range for standard sensors, and <3.5% Arms for LNOP TC-I sensors.

Technological Characteristics

Adapter cable for pulse oximetry; 8-pin and 12-pin configurations for Philips monitors. Operates via non-invasive optical assessment (emitters/detectors). Constructed of materials equivalent to predicate devices. Connectivity: wired interface between sensor and monitor.

Indications for Use

Indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients in hospital, mobile, and home environments.

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

• AC-1 Adapter Cable (K033349)

Submission Summary (Full Text)

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# 510(k) SUMMARY

MAY 11 2005 KOSQ2252

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo, the address "40 Parker, Irvine, CA 92618" is printed. The phone number "949-297-7000" and fax number "949-297-7001" are also listed.

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>[phone]<br>FAX [phone] |
|---------------------------------------|---------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | April 16, 2005 |
| Trade Name | AC-1 Adapter Cable, 8 Pin and 12 Pin Philips |
| Common Name | Cable, Transducer and Electrode |
| Classification Name and Product Code: | Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | AC-1 Adapter Cable - K033349 |

#### Device Description

The AC-1 Adapter Cable, 8 pin and 12 pin Philips is fully compatible oximetry cable that allows the MacDon The AC-1 Adapter Cable, o pur and 12 pm Introl of the cable represents a design change to the Masimo AC-1.

The AC-1 Adapter Cable, 8 pin and 12 pin Philips is similar in construction to the predicate device enabling the Masimo LNOP The AC-T Adapter Cubter Cable, o pin and compatible pulse oximeter monitors from Philips.

### Intended Use

The AC-1 Adapter Cables, 8 pin and 12 pin Philips used with Masimo LNOP Sensors are intended for an Sm(), sensor for adult The AC-1 Adapter Cables, 8 pm and 12 pm I milips used with history of the environmed by an SpO-sensor) for adult,
monitoring of functional oxygen saturation of arterial hemog monitoring of tunctional oxygen saturation of interior neinegoeds (1) in the environments.

### Technology Comparison

The AC-1 Adapter Cables, 8 pin and 12 pin Philips used with Masimo LNOP Sensors are substantially equivals of non-invasyve The AC-1 Adapter Cables, o pin and 12 pm Philips ased williends in Crice Censer and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

The AC-1 Adapter Cable is designed, and manufactured for full compatibility with Nellcor and Nelloor compatible The AC-1 Adapter Cable is designed, and manufacturer for roll computed of smilar materials and components of equivalent specifications as used in the predicate devices.

175

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## 510(k) SUMMARY

The accuracy of the AC-1 Adapter Cables used with Masino LNOP Sensors is equivalent to those of the predicate devices.

#### Performance Testing

Environmental Testing

Applicable environmental testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. Applicable environmental were performental were performed and all tests passed

#### Clinical Testing

Clinical studies were performed using the AC-1 Adapter Cables, 8 pin and 12 pin Philips used with Masimo LNOPP Clinical sudies were performed using the RC-1 Adapts, or poston conditions who were subjected to apcogressive oximelly sensors on neasuring the arterial hemoglobin saturation value with the instruments against the alterial induced hypoxia and measuring the arterial blood samples with a CO-Oximeter. Clinical testing of the LNOP sensors nemoglobin 03ygen delemilied in an accuracy of less than 2% Spoz Agas in the range of 70%-100% Sales I NOP TC I (except the LNOF TC-1) resulted in an accuracy of toss that a sepatal sensors. Clinical testing of the LNOP TC-I
added to account for the properties of fetal hemoglobin for t added to account for the soft less than 3.5% SpO2 Arms in the range of 70% -100%.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

## MAY 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James J. Cronin Mice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618

Re: K050252

Trade/Device Name: AC-1 Adapter Cable, 8 Pin and 12Pin Phillips Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 18, 2005 Received: April 21, 2005

Dear Mr. Cronin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because mined the device is substantially equivalent (for the relerenced above and have and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do rovies that natio Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppreation (1 the Act. The general controls provisions of the Act include controls provisions of the manual 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 If your device is classified (oos as additional controls. Existing major regulations affecting (FMA), it may be subject to back addr of Federal Regulations, Title 21, Parts 800 to 898. In your device can or tound in the Seas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Cronin

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC s ibstained on that your device complies with other requirements Incall that ITA has made a detectand regulations administered by other Federal agencies. of the Act of ally I edelar statutes and regisements, including, but not limited to: registration You must comply with an the Her b recess required (1); good manufacturing practice and listing (21 CFR Purt 007), laceling (21 CFR Part 820), and if requirements as set forth in the quality by seems (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) This letter will anow you to begin mailitimal equivalence of your device to a premiarket notification. - The PDF 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), il you desire specific advice tor your de 100 2002 276-0120. Also, please note the regulation prease contact the Other or Ochiphian premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general missmallers, International and Consumer Assistance at its toll-free DIVIsion of Binar-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carls

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):

AC-1 Adapter Cable, 8 pin and 12 pin Philips Device Name:

Indications For Use:

The AC-1 Adapter Cable, 8 pin and 12 pin Philips is indicated for the continuous noninvasive monitoring of flunctic oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO3 sensor) for use will, adult, pediatric, infant, and neonatal patients in hospital-type facilities, mobile, and home environments.

Prescription Use J X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cura Sullom

(Division Sian-K Division of Anesthe Infection Control, De

510(k) Number: