(340 days)
The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits.
The INFINITY MICRO2+ is a small, compact battery operated ambulatory pulse oximeter. The hand-held INFINITY MICRO2+ is a redesign of the MICRO2 (K913489) used for the noninvasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate with the use of an oxygen transducer (sensor). The SpO2 algorithm is essentially the same as that of the predicate (K980882), but enhanced for greater artifact, motion and low perfusion tolerance. A range of compatible sensors is available for use with the INFINITY MICRO2+. The INFINITY MICRO2+ can be connected to a Siemens INFINITY Telemetry transmitter (K972714) or to a customer's personal computer for the display and printing of SpO2 trend information. The device is intended to provide continuous. non-invasive SpO2 monitoring for neonatal, pediatric and adult patient populations in health care environments where patient care is provided by licensed health care professionals.
The provided document is a 510(k) summary for the INFINITY MICRO2+ Pulse Oximeter. It does not contain specific acceptance criteria, reported device performance data, sample sizes for test sets, details on ground truth establishment, or information about MRMC studies. The document primarily focuses on demonstrating substantial equivalence to predicate devices.
However, based on the information provided, here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. A 510(k) summary typically includes a summary of performance data in comparison to a predicate device, but specific acceptance criteria (e.g., accuracy +/- X% SpO2) and tables with reported device performance against those criteria are not detailed here. The document mentions "Assessment of non-clinical performance data for equivalence: Section S 7" and "Assessment of clinical performance data for equivalence: Section T 8," suggesting that this information exists in the full 510(k) submission, but it's not present in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document states "Clinical and bench testing performed demonstrate that the INFINITY MICRO2+ is as safe and effective as [predicate devices]," but no details about the sample size, type of study (retrospective/prospective), or data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. For a pulse oximeter, ground truth for SpO2 is typically established through co-oximetry of arterial blood samples. There would likely be a medical professional (e.g., physician, nurse, or clinical researcher) overseeing the blood draws and potentially confirming the patient's physiological state, but the expert qualifications in the context of "ground truth" for a medical imaging or diagnostic device (like radiologist expertise) are not directly applicable here in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically used when multiple experts are interpreting data and there's a need to resolve disagreements (e.g., in reading medical images). For a pulse oximeter performance study, the ground truth is usually an objective measurement (co-oximetry), so traditional adjudication between multiple human readers or experts is generally not applicable unless there were subjective assessments being made that required resolution.
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
This information is not applicable as the INFINITY MICRO2+ is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. It is a standalone device for measuring physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device's performance is inherently standalone in nature. A pulse oximeter algorithm processes raw sensor data to output SpO2 and pulse rate. The "SpO2 algorithm is essentially the same as that of the predicate (K980882), but enhanced for greater artifact, motion and low perfusion tolerance." This indicates that the algorithm's performance, operating without human intervention for the primary measurement, was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While explicitly stated, for pulse oximeters, the ground truth for oxygen saturation (SpO2) measurements in clinical studies is typically arterial blood gas analysis (ABG) measured by a co-oximeter. This provides the true arterial oxygen saturation (SaO2) which is then compared against the SpO2 reading from the device.
8. The sample size for the training set
This information is not provided. The document mentions a redesign and enhancement of the algorithm from a predicate device but does not detail any "training set" in the context of modern machine learning. In 2002, the development process for medical device algorithms like this would likely involve empirical testing and refinement rather than a distinct "training set" as understood in current AI/ML development.
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable in the modern sense of an AI "training set" given the device's approval date (2002). Algorithm development at that time would primarily involve physiological modeling, signal processing, and empirical validation against known physiological states (ground truth likely from co-oximetry, similar to for the test/validation).
{0}------------------------------------------------
510(k) Notification INFINITY MICRO2+ Pulse Oximeter JUL 2 3 2002
KC12))0
510(k) SUMMARY
as required per 807.92(c)
-
- Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: August 15, 2001
- Submitters Name, Address:
-
- Trade Name, Common Name and Classification Name: A. Trade Name:
INFINITY MICRO2+
- Trade Name, Common Name and Classification Name: A. Trade Name:
Common Name, Classification Name, Class and Regulation Number; B.
| Common Name | ProductCode | Class | RegulationNumber |
|---|---|---|---|
| Oximeter | 74 DQA | II | 870.2700 |
| Ear Oximeter | 74 DPZ | II | 870.2710 |
| Other Relevant Submissions | |
|---|---|
| SC 9000 | K946306 |
| SC 9000 Neonatal | K962291 |
| SC3000 WorkStation & Remote Display(MultiView WorkStation & Network) | K955059 |
| MVWS INFINITY Telemetry System | K972714 |
1
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
{1}------------------------------------------------
4. Device Description:
The INFINITY MICRO2+ is a small, compact battery operated ambulatory pulse oximeter.
The hand-held INFINITY MICRO2+ is a redesign of the MICRO2 (K913489) used for the noninvasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate with the use of an oxygen transducer (sensor),
The SpO2 algorithm is essentially the same as that of the predicate (K980882), but enhanced for greater artifact, motion and low perfusion tolerance. A range of compatible sensors is available for use with the INFINITY MICRO2+.
The INFINITY MICRO2+ can be connected to a Siemens INFINITY Telemetry transmitter (K972714) or to a customer's personal computer for the display and printing of SpO2 trend information. The device is intended to provide continuous. non-invasive SpO2 monitoring for neonatal, pediatric and adult patient populations in health care environments where patient care is provided by licensed health care professionals.
5. Intended Use:
The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits
2
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
{2}------------------------------------------------
Table of Device Similarities and differences to predicate devi 9
| Manufacturer | Predicate DeviceSiemens Medical SystemsMICRO2 | Predicate DeviceSiemens Medical SystemsSC 7000/ SC 9000XL | ApplicantSiemens Medical SystemsINFINITY MICRO2+ | Explanation of Differences |
|---|---|---|---|---|
| 510(k) Number | K913489 | K980882 | To be determined | |
| Intended Use | To non-invasively measurefunctional oxygen saturation ofarterial hemoglobin and pulse rateusing a range of compatible sensorsand to produce visual and auralalarms if these parameters varybeyond preset limits. | The intended use of the SC 7000 andSC 9000XL INFINITY ModularBedside Monitoring Series is tomeasure heart rate, respiration rate,invasive pressure, non-invasivepressure, arrhythmia, temperature,arterial oxygen saturation and pulserate, cardiac output, central apnea, STsegment analysis, and 12-Lead STSegment Analysis. This device willproduce visual and audible alarms ifany of these parameters vary beyondpreset limits and produce timed oralarm recordings. This device willconnect to a Siemens R50 BedsideRecorder, either directly or via theInfinity network. | The MICRO2+ is intended for thecontinuous, non-invasive monitoringof functional oxygen saturation ofarterial hemoglobin and pulse rateduring both no motion and motionconditions, and for patients who arewell or poorly perfused, using a rangeof compatible sensors. The device willproduce visual and aural alarms ifthese parameters vary beyond presetlimits. | Same SpO2 andPulse Rate algorithmas K980882 withmodifications,including motiondetection |
| IntendedPopulation | Adult/pediatric | Adult/pediatric/neonatal | Same as K980882 | |
| IntendedEnvironment | Clinical environment | For use in an environment wherepatient care is provided by HealthcareProfessionals | Same as K980882 | |
| Clinical and non-clinical testing | Clinical and bench testing performeddemonstrate that the INFINITYMICRO2+ is as safe and effective as |
క
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
6 Electronics Avenue
Danvers, MA 01923
{3}------------------------------------------------
510(k) Notification INFINITY MICRO2+ Pulse Oximeter
Assessment of non-clinical performance data for equivalence: Section S 7.
Assessment of clinical performance data for equivalence: Section T 8.
-
- Biocompatability: Not applicable
-
- Sterilization: Not applicable
-
- Standards and Guidances: Section U
4
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its head facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Ms. Penelope H. Greco Siemens Medical Solutions USA, Incorproated Division of EM-PCS 16 Electronics Avenue Danvers, Massachusetts 01923
Re: K012770
Trade/Device Name: Infinity Micro2+ Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 25, 2002 Received: April 29, 2002
Dear Ms. Greco:
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.
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.
{5}------------------------------------------------
Page 2 - Ms. Greco
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runoe
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
KO12770 Indications for Use:
The MICRO2+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.
MRI Compatibility Statement:
The Siemens INFINITY MICRO2+ is not intended for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
SA Winterhesn
ntal, Infect
§ 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).