(340 days)
No
The description mentions an "enhanced" SpO2 algorithm for greater tolerance, but does not explicitly state or imply the use of AI/ML. The lack of mention of training/test sets or AI/ML specific terms further supports this.
No
The device is described as a pulse oximeter intended for monitoring oxygen saturation and pulse rate, which are diagnostic functions, not therapeutic interventions.
Yes
Explanation: The device is a pulse oximeter, which measures vital signs (oxygen saturation and pulse rate). This information is used by healthcare professionals to monitor a patient's condition, which is a diagnostic activity. The intended use states it is for "monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate," and the device "will produce visual and aural alarms if these parameters vary beyond preset limits," indicating its role in identifying physiological deviations.
No
The device description explicitly states it is a "small, compact battery operated ambulatory pulse oximeter" and a "hand-held" device, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The INFINITY MICRO2+ is a pulse oximeter. It measures functional oxygen saturation of arterial hemoglobin and pulse rate non-invasively by using a sensor placed on the patient's body (typically a finger, toe, or earlobe). It does not analyze samples taken from the body.
- Intended Use: The intended use describes continuous, non-invasive monitoring of physiological parameters directly from the patient.
Therefore, the INFINITY MICRO2+ falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
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.
Product codes
DQA, DPZ
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.
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
neonatal, pediatric and adult
Intended User / Care Setting
health care environments where patient care is provided by licensed health care professionals.
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)
Clinical and bench testing performed demonstrate that the INFINITY MICRO2+ is as safe and effective as [Not Specified].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MICRO2 510(k) K913489, SC 7000/9000XL K980882
Reference Device(s)
SC 9000 K946306, SC 9000 Neonatal K962291, SC3000 WorkStation & Remote Display (MultiView WorkStation & Network) K955059, MVWS INFINITY Telemetry System K972714
Predetermined Change Control Plan (PCCP) - All Relevant Information
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) 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 | Product
Code | Class | Regulation
Number |
|--------------|-----------------|-------|----------------------|
| 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 Device
Siemens Medical Systems
MICRO2 | Predicate Device
Siemens Medical Systems
SC 7000/ SC 9000XL | Applicant
Siemens Medical Systems
INFINITY MICRO2+ | Explanation of Differences |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K913489 | K980882 | To be determined | |
| Intended Use | To non-invasively measure
functional oxygen saturation of
arterial hemoglobin and pulse rate
using a range of compatible sensors
and to produce visual and aural
alarms if these parameters vary
beyond preset limits. | The intended use of the SC 7000 and
SC 9000XL INFINITY Modular
Bedside Monitoring Series is to
measure heart rate, respiration rate,
invasive pressure, non-invasive
pressure, arrhythmia, temperature,
arterial oxygen saturation and pulse
rate, cardiac output, central apnea, ST
segment analysis, and 12-Lead ST
Segment Analysis. This device will
produce visual and audible alarms if
any of these parameters vary beyond
preset limits and produce timed or
alarm recordings. This device will
connect to a Siemens R50 Bedside
Recorder, either directly or via the
Infinity network. | 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. | Same SpO2 and
Pulse Rate algorithm
as K980882 with
modifications,
including motion
detection |
| Intended
Population | Adult/pediatric | Adult/pediatric/neonatal | Same as K980882 | |
| Intended
Environment | Clinical environment | For use in an environment where
patient care is provided by Healthcare
Professionals | Same as K980882 | |
| Clinical and non-
clinical testing | | | Clinical and bench testing performed
demonstrate that the INFINITY
MICRO2+ 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