(241 days)
No
The description focuses on data management, transfer, reporting, and archiving, with no mention of algorithms that learn or adapt from data.
No
The device is a data management software that collects, reports, and archives oximetry trend data to provide information to a medical professional as a supplemental tool for decision support. It explicitly states it is "not a diagnosis tool" and is a "decision management support tool" and its purpose is to "help determine the best pulmonary treatment," not to directly provide treatment or therapy.
No
The document explicitly states: "The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool..."
Yes
The device is described as "OxiScan II Oximetry Data Management Software" and its function is solely to capture, transmit, store, and report oximetry data from a separate hardware device (a pulse oximeter). It does not include or modify the hardware itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- OxiScan II Function: The OxiScan II software manages data from a pulse oximeter. A pulse oximeter is a non-invasive device that measures oxygen saturation in the blood through the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states that the software collects, reports, and archives oximetry trend data to provide information to a medical professional as a supplemental tool to assist in identifying pulmonary needs. It explicitly states it is not a diagnosis tool.
- Device Description: The description reinforces that it collects and stores raw oximetry data captured by a pulse oximeter and prepares a report summarizing this data.
The OxiScan II software is a data management and reporting tool for a non-invasive medical device (pulse oximeter). It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture Oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.
The OxiScan II Oximetry Data Management Software is intended to collect, report and archive Oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.
The OxiScan II Oximetry Data Management Software is intended to (1) transfer Oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.
The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.
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
Healthcare Professional, medical personnel
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)
OxiScan II Oximetry Data Management Software test results demonstrate functionality, safety and effectiveness, including its substantial equivalence to the predicate device.
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.
K924626, K032949, K893221, K001930, K945290, K002690, K004044, K040831
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
Image /page/0/Picture/1 description: The image shows the logo for AirSep, a company that specializes in industrial and medical air separation equipment. The logo is a stylized version of the company name, with the letters "Air" in a bold, slanted font and the letters "EP" in a smaller, more traditional font. The words "Industrial & Medical Air Separation Equipment" are printed below the logo in a smaller font.
OCT 0 9 2008
AirSep Corporation
401 Creekside Drive 401 Greekside Brive
Buffalo, New York 14228-2085
(716) 691-0202
Fax (716) 691-0202
Fax (716) 691-4141
510(k) Summary
OxiScan II Oximetry Data Management Software
| Submitter: | AirSep Corporation |
|---|---|
| Address: | 401 Creekside Drive |
| Buffalo, NY 14228 | |
| Tel: (716) 691-0202 | |
| Fax: (716) 691-0707 | |
| Contact Name: | Peter Weisenborn |
| Vice President - Resources & Regulatory Affairs | |
| Date Prepared: | July 7, 2008 |
| Trade Name: | OxiScan II |
| Classification Name: | Pulse Oximeter Data Management Software |
| Classification: | Class II, 21 CFR 870.2700. |
| Product Code: | DQA |
| Predicate Device: | OxiScan II Oximetry Data Management Software is |
| substantially equivalent to Nonin Medicals "nVISION" | |
| software (K033307) | |
| Device Description: | OxiScan II Oximetry Data Management Software is an |
| accessory for use with compatible pulse oximeters. | |
| OxiScan II Oximetry Data Management Software | |
| collects and stores patient information containing raw | |
| oximetery data captured by a pulse oximeter. This | |
| information is transferred by a personal computer to an | |
| internet Web server where a report which summarizes | |
| and graphically presents the data is prepared. This | |
| report is delivered to a Healthcare Professional who | |
| then uses it along with other information to determine a | |
| course of pulmonary treatment. The report may be | |
| retrieved, reviewed, and retransmitted via the OxiScan | |
| II Oximetry Data Management Software web site. | |
| Technological | |
| Characteristics: | The OxiScan II Oximetry Data Management Software |
| operates on a personal computer using Windows XP | |
| with service pack 2 or later. Both the OxiScan II and | |
| the predicate can be used on a personal computer | |
| Functional and | |
| Safety Testing: | Representative samples of OxiScan II Oximetry Data |
| Management Software were successfully performance | |
| tested to verify compliance to appropriate functional | |
| characteristics. |
1
KOBO348
Intended Use:
OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture Oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.
The OxiScan II Oximetry Data Management Software is intended to collect, report and archive Oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.
The OxiScan II Oximetry Data Management Software is intended to (1) transfer Oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.
The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.
2
KO80348
Substantial Equivalence:
OxiScan II Oximetry Data Management Software does not have a significant descriptive difference. Based on our review, both the OxiScan II Oximetry Data Management Software and its predicate have similar intended uses, operation methods and performances specifications. Therefore, the OxiScan II Oximetry Data Management Software has been concluded as substantially equivalent to the predicate device.
Conclusion:
OxiScan II Oximetry Data Management Software test results demonstrate functionality, safety and effectiveness, including its substantial equivalence to the predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
OCT 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Weisenborn Vice President - Resources & Regulatory Affairs AirSep Corporation 401 Creekside Drive Buffalo, New York 14228-2085
Re: K080348
Trade/Device Name: OxiScan II Oximetry Data Management Software Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 24, 2008 Received: September 29, 2008
Dear Mr. Weisenborn:
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.
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mhamuele Lind, rms foe //
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
5
Image /page/5/Picture/0 description: The image shows the logo for AirSEP, a company that specializes in industrial and medical air separation equipment. The logo is in black and white and features the company name in a stylized font. The words "Industrial & Medical Air Separation Equipment" are printed below the logo in a smaller font. The logo is simple and professional, and it effectively communicates the company's focus on air separation technology.
Indications for Use
510(k) Number (if known): K080348
Device Name: OxiScan II Oximetry Data Management Software.
Indications For Use:
OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.
The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.
The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.
The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.
6
Compatible Devices And Associated 510[k]'s
| Make/Model | 510K Number |
|---|---|
| Novametrics 510 | K924626 |
| Novametrics 513 | K032949 |
| Nonin 8500 Hand Held Pulse Oximeter | K893221 |
| Nonin Model 8500 | K001930 |
| Nonin 8500a Pulse Oximeter | K945290 |
| Nonin PalmSat 2500, Hand Held | K002690 |
| Respironics 920M/Plus | K004044 |
| GE Ohmeda TruSat Pulse Oximeter, Ear | K040831 |
X Prescription Use _ (Part 21CFR 801 Subpart D)
. "
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lychimid.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K180348