NC SP02 ADAPTER CABLE

K041204 · Masimo Corp. · DQA · Jun 29, 2004 · Cardiovascular

Device Facts

• Record ID: K041204
• Device Name: NC SP02 ADAPTER CABLE
• Applicant: Masimo Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The NC Adapter Cables used with Nellor Sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

NC Adapter Cable acts as interface between Nellcor pulse oximetry sensors and Masimo SET Radical pulse oximeter monitors; enables signal transmission from sensor to monitor; allows use of Nellcor sensors with Masimo technology; used in hospitals, mobile, and home environments by clinicians or patients; facilitates non-invasive optical assessment of tissue oxygenation; output displayed on Masimo monitor for clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers under non-motion conditions during progressive induced hypoxia. Accuracy compared against CO-Oximeter arterial blood samples. Results demonstrated accuracy <2% SpO2 in 70%-100% range for adults, pediatrics, and infants. Neonatal sensor accuracy validated on adults with 1% adjustment for fetal hemoglobin properties.

Technological Characteristics

Adapter cable for signal transmission between Nellcor sensors and Masimo monitors. Materials and components equivalent to predicate devices. Operates via non-invasive optical assessment using emitters and detectors. Environmental testing performed per November 1993 Reviewers Guidance.

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, 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

• Masimo SET® Radical Pulse Oximeter with SatShare™ and LNOP® series of Sensors and Cables (K031330)
• Nellcor Oximax Pulse Oximeter System with N-595 Pulse Oximeter (K012891)
• Nellcor N-200 Pulse Oximeter (K863784)

Reference Devices

• Siemens Infinity Modular Monitors (K022889)

Submission Summary (Full Text)

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JUN 29 2004

510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo for Masimo, followed by their address and contact information. The address is listed as 40 Parker, Irvine, CA 92618. The phone number is 949-297-7000, and the fax number is 949-297-7001.

Submitted by:

K041204

| | 2852 Kelvin Ave<br>Irvine, CA 92614-5826<br>[phone]<br>FAX [phone] |
|------------------------|----------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | May 6, 2004 |

| Trade Name | NC Adapter Cable |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Cable, Transducer and Electrode |
| Classification Name and Product Code: | Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Masimo SET® Radical Pulse Oximeter with SatShare™ and LNOP® se<br>of Sensors and Cables<br>510(k) Number - K031330<br>Nellcor Oximax Pulse Oximeter System with N-595 Pulse Oximeter -<br>K012891<br>Nellcor N-200 Pulse Oximeter - K863784 |

Masimo Corporation

#### Device Description

The NC Adapter Cable is fully compatible oximetry cable that allows the use of Nellcor Sensors with Masimo SET Radical pulse oximeter monitors. The cable represents a design change to the Masimo patient cables and the MS board.

Siemens Infinity Modular Monitors - K022889

The NC Adapter Cable is similar in construction to the predicate device enabling the Nellcor Sensors to be connected to Masimo SET Radical pulse oximeters.

#### Intended Use

The NC Adapter Cables used with Nellor Sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

#### Technology Comparison

The NC Adapter Cables used with Nellcor Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

033C

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# 510(k) SUMMARY

The NC Adapter Cable is designed, and manufactured for full compatibility with Masimo SET Radical pulse oximeters using Nellcor Sensors. The NC Adapter Cable is constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the NC Adapter Cables used with Nellcor 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.c. electrical, mechanical and environmental were performed and all tests passed

### Clinical Testing

Clinical studies were performed using the NC Adapter Cables used with Nellcor sensors on healthy adult volunteer subjects during no motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the Nellcor sensors resulted in an accuracy of less than 2% Sports in the range of 70%-100% SaO2 for adults, pediatrics and infants. The saturation accuracy of the neonatal sensors were validated on adult volunteers and 1% was added to account for the properties of fetal hemoglobin.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

JUN 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041204

Trade/Device Name: NC Adapter Cable Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 21, 2004 Received: June 22, 2004

Dear Mr. Cronin:

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. Cronin

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/dsma/dsmamain.html

Sincerely yours.

Ouls

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):

NC Adapter Cable Device Name:

### Indications For Use:

The NC Adapter Cable with Nellcor sensors are indicated for the continuous noninvasive monitoring of functional I its readiner of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediation informator of Liveral In hospitals, hospitals, hospital-type facilities, mobile, and home environments.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

KD41204/5001

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Infection Control, I.P.

510(k) Number:***_***_