(36 days)
The Nonin® Model 3100 WristOx® Pulse Oximeter is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Nonin Model 3100 WristOx® is a small wrist-worn pulse oximeter. It has an electro-optical sensor that determines the light absorption of functional arterial hemoglobin. It is used to spot check patients, or it can be used to provide continuous data collection and recording of patients in situations where alarms are not required. The device turns on automatically when the sensor is placed on the finger and turns off when the finger is removed. It may be used with Nonin's 8000AA-WO articulated finger clip sensor or the 8000J-WO flex sensor. The WristOx is also memory capable in conjunction with nVision® data management software (K033307). It is capable of storing up to 33 hours of SpO2 and pulse rate data.
The provided text describes the Nonin Model 3100 WristOx® Pulse Oximeter, which was found substantially equivalent to a predicate device. However, the document does not contain explicit acceptance criteria or a detailed study report that proves the device meets specific performance criteria.
The 510(k) summary (K052829) states that the device "has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device." It also claims the device is "identical in everyway to the predicate device not with standing the changes specified in the labeling."
Without a specific study outlining performance metrics, acceptance criteria, and detailed methodologies, the requested information cannot be fully extracted. The submission focuses on demonstrating substantial equivalence, implying that its performance is comparable to the predicate device (Model 3100 WristOx® (K030668)), which would have previously met its own established criteria.
Therefore, for the current document, I can only report what is explicitly stated or implied about the testing, and cannot provide the detailed acceptance criteria and study particulars for the new device's performance.
Here's an attempt to answer based on the provided text, with many fields indicating "Not explicitly stated":
Acceptance Criteria and Device Performance
| Acceptance Criteria (Not explicitly stated for this device; assumed to be equivalent to predicate) | Reported Device Performance |
|---|---|
| Functional characteristics equivalent to predicate device (K030668) | "successfully undergone both bench and clinical testing" to demonstrate appropriate functional characteristics and substantial equivalence. |
| Principles of operation equivalent to predicate device (K030668) | "substantially equivalent to the predicate device in terms of functional design and principles of operation." |
Detailed Study Information:
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Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "clinical testing" but does not provide details on sample size, participant demographics, or data provenance (e.g., country of origin, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document does not describe the establishment of a ground truth for a test set, nor does it mention any expert involvement for this purpose.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. No adjudication method is mentioned in the provided text.
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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: Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. As such, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement tool (a pulse oximeter). Clinical and bench testing would have evaluated its performance independently. No human-in-the-loop performance evaluation in the context of an "algorithm" is applicable here. The device measures, displays, and stores SpO2 and pulse rate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a pulse oximeter, the ground truth for SpO2 measurement would typically involve a co-oximeter or blood gas analysis, but this is not detailed in the provided summary.
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The sample size for the training set: Not applicable and not explicitly stated. This device is not an AI/machine learning model that typically requires a "training set." Its functionality is based on electro-optical sensing principles.
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How the ground truth for the training set was established: Not applicable and not explicitly stated. See point 7.
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NOV 1 0 2005
NOV 16 2005
510(k) Summary K052829
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | Lori RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
| Date Prepared: | October 3, 2005 |
| Trade Name: | Model 3100 WristOx® Pulse Oximeter |
| Classification Name:and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | Model 3100 WristOx® is substantially equivalent tothe Model 3100 WristOx® (K030668), which is alsomanufactured by Nonin Medical. |
| Device Description: | The Nonin Model 3100 WristOx® is a small wrist-worn pulse oximeter. It has an electro-optical sensorthat determines the light absorption of functionalarterial hemoglobin. It is used to spot check patients,or it can be used to provide continuous data collectionand recording of patients in situations where alarmsare not required. The device turns on automaticallywhen the sensor is placed on the finger and turns offwhen the finger is removed. It may be used withNonin's 8000AA-WO articulated finger clip sensor orthe 8000J-WO flex sensor. The WristOx is alsomemory capable in conjunction with nVision® datamanagement software (K033307). It is capable ofstoring up to 33 hours of SpO2 and pulse rate data. |
| Intended Use: | The Nonin® Model 3100 WristOx® Pulse Oximeter isa small wrist-worn device indicated for use inmeasuring, displaying, and storing functional oxygensaturation of arterial hemoglobin (SpO2) and pulserate of adult and pediatric patients. It is intended forspot-checking and / or data collection and recording |
| of patients during both no motion and motionconditions, and for patients who are well or poorlyperfused. | |
| Functional andSafety Testing: | Nonin's Model 3100 WristOx® Pulse Oximeter hassuccessfully undergone both bench and clinicaltesting in order to demonstrate that it has appropriatefunctional characteristics and is substantiallyequivalent to the predicate device. |
| Conclusion: | Nonin's Model 3100 WristOx® Pulse Oximeter isidentical in everyway to the predicate device not withstanding the changes specified in the labeling. |
| This conclusion is based upon the fact that the Model3100 WristOx® Pulse Oximeter is substantiallyequivalent to the predicate device in terms offunctional design and principles of operation. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with three parallel lines extending from its head, resembling feathers or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2005
Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 154 Avenue North Plymouth, Minnesota 55441-5443
Re: K052829
Trade/Device Name: Model 3100 WristOx® Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 1, 2005 Received: October 13, 2005
Dear Ms. Roth:
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. Roth
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 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
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Indications for Use Statement
| 510(k)Number(if known) | |
|---|---|
| Device Name | Nonin Medical, Inc. Model 3100 WristOx® Pulse Oximeter |
| Indicationsfor Use | The Nonin® Model 3100 WristOx® Pulse Oximeter is a smallwrist-worn device indicated for use in measuring, displaying, andstoring functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate of adult and pediatric patients. It isintended for spot-checking and / or data collection and recordingof patients during both no motion and motion conditions, and forpatients who are well or poorly perfused. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
Quir, Siliom
on San-Qif) of Anesthesiology, General Hospital, otion Control, Dental Devices
Number: K552 829
§ 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).