(97 days)
Not Found
No
The device description and performance studies focus on the cable's compatibility and accuracy in transmitting SpO2 and pulse rate data, with no mention of AI or ML processing.
No.
Explanation: The device is an adapter cable for noninvasive monitoring of oxygen saturation and pulse rate. It does not directly treat or diagnose a condition but rather facilitates the function of a monitoring device.
Yes.
The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used to assess a patient's physiological state, fitting the definition of a diagnostic device.
No
The device description explicitly states it is an "Adapter Cable" and describes its physical construction and compatibility with hardware components (oximetry cable, sensors, monitors). It also mentions environmental testing, which is typically performed on hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate". This is a physiological measurement taken directly from the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is described as an "oximetry cable" that connects sensors to monitors. This further supports its role in direct patient monitoring.
- No mention of testing samples: The description and intended use do not involve analyzing blood, urine, tissue, or any other biological sample.
Therefore, the AC-1 Adapter Cable, 8 pin and 12 pin Philips is a non-invasive patient monitoring accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, o pur and 12 pm Introl of the cable represents a design change to the Masimo AC-1.
The AC-1 Adapter Cables, 8 pin 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74DSA, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, infant, and neonatal patients
Intended User / Care Setting
hospital-type facilities, mobile, and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
40 Parker
Irvine, CA 92618
(949) 297-7218
FAX (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
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
1
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%.
2
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.
3
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
4
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: