AC-1 SP02 ADAPTOR CABLE, MODEL AC-1

K033349 · Masimo Corp. · DQA · Jan 28, 2004 · Cardiovascular

Device Facts

• Record ID: K033349
• Device Name: AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
• Applicant: Masimo Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The AC -1 Adapter Cables used with Masimo LNOP Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilitics, mobile, and home environments.

Device Story

AC-1 Adapter Cable serves as interface between Masimo LNOP sensors and Nellcor-compatible pulse oximeter monitors; enables signal transmission from sensor to monitor; used in hospitals, mobile, and home environments; operated by clinicians or patients; facilitates noninvasive optical assessment of tissue oxygenation; output displayed on monitor for clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Clinical studies conducted on adult subjects under induced hypoxia conditions. Accuracy of AC-1 Adapter Cables with Masimo LNOP sensors compared against CO-Oximeter arterial blood samples. Results demonstrated SpO2 accuracy of <2% ARMS (70%-100% range) for adults, pediatrics, and infants, and <3% ARMS for neonates.

Technological Characteristics

Adapter cable for pulse oximetry; connects Masimo LNOP sensors to Nellcor-compatible monitors. Materials and components equivalent to predicate devices. Operates via non-invasive optical assessment using emitters and detectors. Electrical, mechanical, and environmental testing performed per 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 hospital, mobile, and home settings.

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 N-395 Pulse Oximeter (K991823)
• Nellcor N-200 Pulse Oximeter (K863784)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Masimo, along with their address and contact information. The address is 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686. There is also a number K033349 written on the top left of the image.

# 510(k) SUMMARY

JAN 2 8 2004

| Submitted by: | Masimo Corporation<br>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: | October 17, 2003 |
| Trade Name | AC-1 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 ^® series of Sensors and<br>Cables<br>510(k) Number - K031330<br>Nellcor N-395 Pulse Oximeter - K991823<br>Nellcor N-200 Pulse Oximeter - K863784 |

#### Device Description

The AC-1 Adapter Cable is fully conpatible oximetry cable that allows the use of Masimo LNOP Sensors with Nellow and Nellcor compatible pulse oximeter monitors. The cable represents a design change to the Masino patient cables.

The AC-1 Adapter Cable is similar in construction to the predicate device enabling the Masimo LNOP Sensors to be comected to Nelleor and Nellcor compatible pulse oximeter monitors.

### Intended Use

The AC -1 Adapter Cables used with Masimo LNOP Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilitics, mobile, and home environments.

### Technology Comparison

I'he AC-1 Adapter Cables used with Masimo LNOP 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.

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## 510(k) SUMMARY

The AC-1 Adapter Cable is designed, configured, and manufactured for full compatibility with Nellcor compatible The AC-1 Adapter cable is dongiled, comigated, and the constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the AC-1 Adapter Cables used with Masimo LNOP Sensors is cquivalent to those of the prodicale devices.

#### Performance Testing

Environmental Testing

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

#### Clinical Testing

Clinical studies were performed using the AC-1 Adapter Cables used with Masimo I.NOP Adult oximetry sensors on Challed studios were permined as a motion conditions who were subjected to a progressive induced lypoxia 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 SPO2.COM Adult and Reusable sensors resulted in an accuracy of less than 2% SpO2 Arsss in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% ARMS for neonates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 8 2004

Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Avenue Irvine, California 92614-5826

Re: K033349

Trade/Device Name: AC-1 Adapter Cable Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: January 21, 2004 Received: January 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. James J. Cronin

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basedan in that your device with other requirements mean that FTA has made a decermination administered by other Federal agencies. of the Act of ally receral statutes and regalates. Including, but not limited to: registration You must comply with an the Hee Here (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 067), lacelity systems (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 612 requirements as set form in the quality bysteins (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 mationing of substantial equivalence of your device to a premiarket notification. The PDF intents 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), If you desire specific advice to: Jour de at [phone]. Also, please note the regulation in 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 may obtain other general micrinational and Consumer Assistance at its toll-free Division of Binastic of Binastic [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clair Liu, Ph.D.

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

#### K033349 510(k) Number (if known):

AC-1 Adapter Cable Device Name:

Indications For Use:

The AC-1 Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional r no re a readion of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatic, infant, and neonatal patients in 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

S. Hinkle

Division of Anesthesiology, General Hospital,

510(k) Number: k633349

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