(146 days)
Not Found
No
The description focuses on the electro-optical components and function of a pulse oximeter sensor, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a sensor that provides data for continuous external monitoring of arterial oxygen saturation and pulse rate, and it does not directly treat or prevent a disease or condition.
Yes
The device is described as providing "continuous non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate," which are used for monitoring a patient's physiological state, thus aiding in diagnosis or treatment decisions.
No
The device description clearly states that the device is an "electro-optical sensor" containing "two light emitting diodes (LED's)" and "one photodiode," which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the pulse oximeter sensor is used for continuous external monitoring of arterial oxygen saturation and pulse rate by being positioned across the tissue. This is a non-invasive measurement taken directly from the patient's body, not from a sample taken from the body.
- The device description focuses on electro-optical measurement of light absorption within the tissue. This is a physical measurement taken in vivo, not a chemical or biological analysis of a sample in vitro (in glass or outside the body).
Therefore, this device falls under the category of a medical device used for physiological monitoring, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
The subject devices are reprocessed pulse oximeter sensors model numbers Max-A and Max-N Pulse Oximeter Sensors originally manufactured by Nellcor.
The reprocessed pulse oximeter sensor is an electro-optical sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Please note that this submission only pertains to the sensor. It does not pertain to the pulse oximeter or connecting cable.
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SterilMed, Inc. Special 510(k)
SEP 2 3 2004
Reprocessed Pulse Oximeter Sensors
Image /page/0/Picture/3 description: The image contains a sequence of handwritten characters. The characters appear to be 'K041127'. The handwriting is somewhat stylized, with some characters slightly distorted or connected. The overall impression is that of a quickly written or informal label.
Appendix F
510(k) Summary
| Submitter: | SterilMed, Inc.
11400 73rd Ave. N
Minneapolis, MN 55369
ERN: 2134070 |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Bruce Lester
VP Research and Develpoment
SterilMed, Inc.
11400 73rd Avenue North
Minneapolis, MN 55369
Phone: (888) 856-4870
Fax: (763) 488-3350 |
| Date Prepared: | April 26, 2004 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Name
and Number: | 21 CFR 870.2700 |
| Product Code: | NLF |
| Predicate Device
Name and 510(k)
Number | Reprocessed Pulse Oximeter Sensors
K012677 |
| Device Description: | DEVICE DESCRIPTION
The subject devices are reprocessed pulse oximeter sensors
model numbers Max-A and Max-N Pulse Oximeter Sensors
originally manufactured by Nellcor.
The reprocessed pulse oximeter sensor is an electro-optical
sensor that uses an optical means to determine the light
absorption of functional arterial hemoglobin. The sensor
contains three optical components: two light emitting diodes
(LED's) that serve as light sources, and one photodiode, that
acts as a light receiver. The oximeter sensor is positioned so
that the LED's and photodiode oppose one another across the
tissue. The sensor is connected via cable to a pulse oximeter,
which provides continuous non-invasive, self-calibrated
measurements of both oxygen saturation of functional
hemoglobin and pulse rate. Please note that this submission
only pertains to the sensor. It does not pertain to the pulse
oximeter or connecting cable. |
| Intended Use: | Reprocessed Pulse Oximeter Sensors are used when continuous
external monitoring of arterial oxygen saturation and pulse rate
is required. |
| Statement of
Technological
Comparison | The subject reprocessed Pulse Oximeter Sensors have the
following similarities to the Reprocessed Pulse Oximeter
Sensor which previously received 510(k) clearance:
The same indicated use; The same operating principle; The same basic design; The same technical characteristics; The same clinical performance characteristics; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the subject device described in this submission is,
in the opinion of SterilMed, substantially equivalent to the
predicate device. |
| Conclusion: | The subject reprocessed pulse oximeter sensors are substantially
equivalent to the predicate reprocessed pulse oximeter sensors.
This conclusion is based upon the fact that this device is
substantially equivalent to the predicate device in terms of
functional design, indications for use, principles of operation
and test performance characteristics. |
04/26/04
1
04/26/04
、・
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers.
SEP 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Bruce Lester Vice President Research & Development SterilMed, Incorporated 11400 73rd Avenue, North Minneapolis, Minnesota 55369
Re: K041127
Trade/Device Name: Modification To: Reprocessed Pulse Oximeter Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: July 27, 2004 Received: July 29, 2004
Dear Dr. Lester:
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.
3
Page 2 - Dr. Lester
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Susan Russo
fa 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
4
Reprocessed Pulse Oximeter Sensors
Steri Med, Inc. Special 510(k)
Appendix B
Indications for Use Statement
| 510(k) Number (if known) | TBD |
|---|---|
| Device Name | Reprocessed Pulse Oximeter Sensors |
| Indications for Use | Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use ✓ | |||
| (Per 21 CFR 801. 109) | OR | Over-The-Counter Use _____ | |
| (Division Sign-Off) | |||
| Division of Anesthesiology, General Hospital, | |||
| Infection Control, Dental Devices | |||
| 510(k) Number: | K041127 |
Appendix B, Page 1
Confidential SterilMed Inc. Snecial S10/k) for Renrocessed Pulse Oximeter Sensors