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.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study used to demonstrate it:

First, it's important to note that this 510(k) summary is for an adapter cable, not a complete medical device (like an oximeter with a sensor). Therefore, the performance criteria and studies are geared towards demonstrating the cable's compatibility and equivalence, rather than establishing the primary efficacy of an oximetry system from scratch.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Environmental Testing: Applicable environmental testing per Reviewers Guidance for Premarket Submissions - November 1993.	"Applicable environmental were perform(ed) and all tests passed." (Specific parameters or thresholds are not detailed in this summary, but the general acceptance is successful completion according to guidance.)
Clinical Performance (SpO2 Accuracy): Accuracy of less than 2% SpO2 Arms (presumably Root Mean Square, RMS) in the range of 70%-100% SpO2 for LNOP sensors (except LNOP TC-1).	"Clinical testing of the LNOP sensors... resulted in an accuracy of less than 2% SpO2 Arms in the range of 70%-100% SpO2." (This directly meets the specified criterion.)
Clinical Performance (SpO2 Accuracy for LNOP TC-1): Accuracy of less than 3.5% SpO2 Arms in the range of 70%-100% (with an added factor for fetal hemoglobin properties).	"Clinical testing of the LNOP TC-1... resulted in an accuracy of less than 3.5% SpO2 Arms in the range of 70% - 100%." (This directly meets the specified criterion for the specific sensor type.)
Equivalence to Predicate Device (General):	"The accuracy of the AC-1 Adapter Cables used with Masimo LNOP Sensors is equivalent to those of the predicate devices." (This is a meta-statement, implied to be proven by the clinical accuracy results.)
Compatibility: Full compatibility with Nellcor and Nellcor compatible monitors.	"The AC-1 Adapter Cable is designed, and manufactured for full compatibility with Nellcor and Nelloor compatible monitors" (This states the design intent and implies successful demonstration, though specific testing details are not provided in the summary beyond environmental testing.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Testing: Not explicitly stated. The summary mentions "Clinical studies were performed using the AC-1 Adapter Cables... on patients who were subjected to progressive induced hypoxia." However, it does not provide the number of patients or individual measurements.
Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. However, the description of "progressive induced hypoxia" implies a controlled, prospective clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Ground Truth Establishment: The ground truth for SpO2 was established by CO-Oximetry of arterial blood samples. This is an objective, laboratory-based method, not reliant on expert interpretation of images or clinical findings.
Number of Experts/Qualifications: Not applicable, as CO-Oximetry is a direct measurement, not an expert-based assessment.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by direct measurement (CO-Oximetry), which does not require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This is not applicable to an adapter cable and its primary function of connecting an oximeter sensor to a monitor, where the output is a numerical SpO2 value. There are no "readers" in the context of interpretation that would benefit from AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Study: Yes, in essence. The clinical performance testing described is a standalone evaluation of the device system (cable + sensor + oximeter) against a "gold standard" (CO-Oximetry). There is no human intervention or interpretation of the raw signal being assessed; the device provides a direct numerical output.

7. The Type of Ground Truth Used

Type of Ground Truth: Pathology (specifically, laboratory analysis of arterial blood samples via CO-Oximetry).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is an adapter cable, which is a hardware component. There is no mention or indication of any machine learning algorithms or a "training set" in the context of its function as described.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary

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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 Corporation40 ParkerIrvine, CA 92618(949) 297-7218FAX (949) 297-7001
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

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 (301) 443-6597 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:

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:

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).