(79 days)
The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.
The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits
The provided document is a 510(k) premarket notification summary for the OxiMax™ NPB-40 Pulse Oximeter. It states that the device is substantially equivalent to legally marketed predicate devices and demonstrates this through performance data. However, it does not contain specific acceptance criteria with numerical targets or detailed results of a study that directly proves the device meets those criteria, as typically presented in a table with performance metrics.
The document broadly mentions "performance data includes results from environmental testing, in-house clinical studies and laboratory testing" to evaluate "oxygen saturation and pulse rate accuracy... during non-motion and motion conditions as well as low perfusion levels." It concludes that this data "demonstrates substantial equivalence" to predicate devices.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's an attempt to answer based on the available information, with clear indications where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Oxygen Saturation Accuracy (non-motion) | Not specified in numerical terms. Document states "evaluated... and demonstrates substantial equivalence." |
| Pulse Rate Accuracy (non-motion) | Not specified in numerical terms. Document states "evaluated... and demonstrates substantial equivalence." |
| Oxygen Saturation Accuracy (motion) | Not specified in numerical terms. Document states "evaluated... and demonstrates substantial equivalence." |
| Pulse Rate Accuracy (motion) | Not specified in numerical terms. Document states "evaluated... and demonstrates substantial equivalence." |
| Oxygen Saturation Accuracy (low perfusion) | Not specified in numerical terms. Document states "evaluated... and demonstrates substantial equivalence." |
| Pulse Rate Accuracy (low perfusion) | Not specified in numerical terms. Document states "evaluated... and demonstrates substantial equivalence." |
| Electromagnetic Compatibility | "Environmental testing includes testing for electromagnetic compatibility." (Result: Meets standards, implied by conclusion of substantial equivalence). |
| Electrical Safety | "Environmental testing includes testing for ... electrical safety." (Result: Meets standards, implied by conclusion of substantial equivalence). |
| Reliability | "Environmental testing includes testing for ... reliability." (Result: Meets standards, implied by conclusion of substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to as "in-house clinical studies and laboratory testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the methodology for establishing ground truth within the context of expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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. This device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence. The performance data mentioned (clinical and non-clinical laboratory testing for oxygen saturation and pulse rate accuracy) refers to the performance of the device itself (the "algorithm only" in this context) under various conditions. The document states this testing "was conducted to evaluate oxygen saturation and pulse rate accuracy of the OxiMax NPB-40." This implies a standalone evaluation of the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For oxygen saturation and pulse rate accuracy, the ground truth in such studies typically comes from arterial blood gas analysis (ABG) for oxygen saturation and a simultaneous ECG or direct measurement for pulse rate, often used in conjunction with a controlled desaturation study in human subjects (for SpO2). While the document doesn't explicitly state "ABG," it is the standard reference method for validating pulse oximeter accuracy.
8. The sample size for the training set:
- Not applicable. This device is a pulse oximeter, which relies on established physiological principles and sensor technology, not a machine learning algorithm that requires a separate "training set" in the conventional sense of AI/ML devices.
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
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:Ilcor r uritan Bennett AUG 1 1 2005
4280 Hacıenda Drive Pleasanton, CA 94588-2719
Tele: 925 463-4000 Fax: 925 463-4420
510(k) Summary
Submitted by:
Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton, CA 94588 FAX: (925) 463-4020
Company Contact:
Sarah Harrington, Regulatory Affairs Manager (925) 463-4151 sarah.harrington(a)tycohealthcare.com
Date Prepared:
OxiMax™ NPB-40 Pulse Oximeter Trade Name:
May 20, 2005
Oximeter (DQA)
21 CFR 870.2700
Pulse Oximeter Common/Usual Name:
Classification Name:
Substantially Equivalent Devices:
Nellcor Puritan Bennett NPB-40 Handheld Pulse Oximeter, K963707 Nellcor Puritan Bennett N-550 Pulse Oximeter, K021090
Device Description
The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits
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Intended Use
The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.
Technological Characteristics
The OxiMax NPB-40 shares the same intended use and indications for use as the predicate devices. The NPB-40 is indicated for spot check use, while the N-550 is intended for continuous use. The NPB-40 four button configuration panel has been redesigned and replaced with a new seven button panel to accommodate the additional OxiMax functionality. The N-550 also incorporates the OxiMax technology. Both the OxiMax NPB-40 and the N-550 have visual and audible alarms with adjustable limits.
Performance Data
Performance data includes results from environmental testing, in-house clinical studies and laboratory testing. Environmental testing includes testing for electromagnetic compatibility, electrical safety and reliability.
Clinical and non-clinical laboratory testing was conducted to evaluate oxygen saturation and pulse rate accuracy of the OxiMax NPB-40 during non-motion and motion conditions as well as low perfusion levels.
The performance data demonstrates substantial equivalence between the OxiMax NPB-40 and the legally marketed predicates, the NPB-40 and the N-550 oximeters.
Conclusion
The technological characteristics and the results of the performance data demonstrate that the OxiMax NPB-40 Handheld Pulse Oximeter is as safe and effective and performs as well or better than the legally marketed predicate devices.
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AUG 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sarah Harrington Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K051352
Trade/Device Name: OXIMAX NPB-40 Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 2, 2005 Received: August 3, 2005
Dear Ms. Harrington:
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 - Ms. Harrington
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,
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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Nellcor Puritan Bennett
Statement of Indications for Use
K OS1362 510(k) Number (if known):
OxiMax™ NPB-40 Pulse Oximeter Device Name:
Indications For Use: -
The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.
Prescription Use _ X (Part 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Teresa Osborne
| (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| K051352 |
510(K) NHOP BENDB 40 510(k) KOST 75 CONFIDENTIAL
§ 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).