(28 days)
The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) (measured by an SpO2 sensor) for use with Masimo SET pulse oximeters for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The LNOPv Ad L and Pd L Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET pulse oximeter monitors. They represent a design change to the Masimo LNOPv Oximetry Sensors. The LNOPv Ad L and Pd L disposable sensors are similar in construction to the predicate devices LNOPv In and LNOPv Ne except that the LNOPv Ad L and Pd L have a shorter tail and the emitter and detector position is switched. The LNOPv Ad-Land Pd-L use the same emitters (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) as used in Masimo's LNOPv In and Ne sensors. The patient contacting materials in the LNOPv Ad-L and Pd-L disposable sensors are the same that is used in Masimo's LNOPv In and Ne sensors. The LNOPv Ad-L and Pd-L disposable sensors are supplied non sterile for single patient use. The LNOPv Ad L and Pd-L disposable sensors have the same electrical, optical, and material components as the LNOPv In and Ne disposable sensors.
The provided text describes the performance testing of the LNOPv Ad-L and Pd-L Oximetry Sensors. Here's a breakdown of the acceptance criteria and study details based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| Non-toxic | Demonstrated non-toxic |
| Non-irritating | Demonstrated non-irritating |
| Non-sensitizing | Demonstrated non-sensitizing |
| Environmental Testing: | |
| Electrical | All tests passed |
| Mechanical | All tests passed |
| Environmental | All tests passed |
| Clinical Accuracy (SpO2): | |
| < 2% SpO2 ARMS in range 70-100% SaO2 | < 2% SpO2 ARMS in range 70-100% SaO2 for adults and pediatrics |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "healthy adult volunteer subjects" is stated, but an exact number is not provided.
- Data Provenance: The study was conducted on "healthy adult volunteer subjects" during "motion and no motion conditions." It is a prospective clinical study. Country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The text does not mention the use of experts to establish ground truth in the traditional sense of image interpretation.
- Instead, the ground truth for SpO2 was determined by "measuring the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This is a direct physiological measurement, not an expert interpretation.
4. Adjudication Method for the Test Set
- None applicable in the context of expert adjudication, as the ground truth was derived from direct physiological measurement (CO-Oximeter).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the oximetry sensors against a gold standard (CO-Oximeter) for SpO2 measurement, not on AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done for the device itself (the LNOPv Oximetry Sensors). The study evaluated the device's accuracy in measuring SpO2 without human interpretation or intervention in the measurement process.
7. The Type of Ground Truth Used
- The ground truth used was outcomes data from a CO-Oximeter, which directly measures arterial hemoglobin oxygen from arterial blood samples. This is considered a gold standard for blood oxygen saturation.
8. The Sample Size for the Training Set
- The text does not mention a separate training set or its sample size. This type of device (oximetry sensor) typically undergoes calibration during manufacturing and validation through clinical testing, rather than an explicit "training set" like an AI algorithm would.
9. How the Ground Truth for the Training Set was Established
- As no training set is explicitly mentioned or relevant in the context of this device's validation as described, this question is not applicable.
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rEB - 9 2005 510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo, the text "4 D Parker Irvine, CA 92618 Tel: 949-297-7000 Fax: 949-297-7001" is displayed. This text provides the address and contact information for the company's Irvine, California location. The phone number is 949-297-7000 and the fax number is 949-297-7001.
| Submitted by: | Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001 |
|---|---|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | February 7, 2005 |
| Trade Name | LNOPv Ad-L and Pd-L Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices: | LNOPv and LNOP x Oximetry Sensors - K042346 |
Device Description
The LNOPv Ad L and Pd L Oximetry Sensors are fully compatible disposable sensors for use with Masino SET THE INOF PHE Hand I & H Chulse oximeter monitors. They represent a design change to the Masimo LNOPv Oximetry Sensors.
The LNOPv Ad L and Pd L disposable sensors are similar in construction to the predicate devices LNOPv In and I NO v Ne except that the LNOPv Ad L and Pd L have a shorter tail and the emitter and detector position is switched. The LNOPv Ad-Land Pd-L use the same emitters (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) as used in Masimo's LNOPv In and Ne sensors. The patient contacting materials in the wavelengal of 500 mm/ as about in hasim ore the same that is used in Masimo's LNOPv In and Ne sensors. The LNOPv Ad-L and Pd-L disposable sensors are supplied non sterile for single patient use.
The LNOPv Ad L and Pd-L disposable sensors have the same electrical, optical, and material components as the LNOPv In and Ne disposable sensors.
Predicate Devices
| LNOPv Sensor Line | Masimo Predicate LNOP Sensors- in K04236 |
|---|---|
| LNOPv Ad-L - Adult Disposable Sensor | LNOPv Ne |
| LNOPv Pd-L - Pediatric Disposable Sensor | LNOPv In |
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510(k) SUMMARY
Intended Use
The LNOPv Ad-L and Pd-L Oximetry Sensors are intended for the continuous nonitorial or functions of finish I he LNOF V Ad-L and I d-L Oximory Donoso are eate (measured by an SpO2 sensor) for adult and , pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.
Technology Comparison
The LNOPv Ad-L and Pd-L Oximetry 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.
The LNOPv Ad-L and Pd-L Oximetry Sensors are designed, and manufactured for full compatibility with Masino THE LINOF V AC-2 and For D Oximedy Delivers. The LNOP v Ad-L and Pd-L Oximetry Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.
The accuracy of the LNOPv Ad-L and Pd-L Oximetry Sensors is equivalent to those of the predicate devices.
Performance Testing
Biocompatibility
All the patient contacting materials used in the LNOPv Ad-L and Pd-L Oximetry Sensors are the same materials that are All the pation on the sensors. Test results demonstrated that the materials were non-toxic, non-irritating, and non sensitizing.
Environmental Testing
Applicable environmetal 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 LNOPv Oximetry Sensors on healthy adult volunteer subjects during motion ond no motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin and no no howith the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the LNOPv Oximetry Disposable sensors resulted in an accuracy of less than 2% SpO2 ARMS in the range of 70%-100% SaO2 for adults and pediatrics.
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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 a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
FEB - 9 2005
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: K050068
Trade/Device Name: LNOPv Ad-L Oximetry Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 10, 2005 Received: January 12, 2005
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ching-Lin, 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
510(k) Number (if known):
LNOPv Ad-L and Pd-L Oximetry Sensors Device Name:
Indications For Use:
The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional I he LNOY Ad-L allo FU-L Oxincily Schools are mailsee to: measured by an SpO2 sensor) for use with and oxygen saturation of arterial nemogrom (OPO)) this pass tate for patients who are well or poorly perfused in podiatio passital-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) 000 €
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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§ 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).