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.

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.

AI/ML Overview

The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.

The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Characteristics:	Representative samples of OxiScan II successfully performance tested to verify compliance to appropriate functional characteristics.
- Ability to capture oximetry data from compatible oximeters.	The device uses a PC-based application to capture oximetry data from an oximeter. A list of approved oximeters appears in the Capture software.
- Secure and encrypted data transmission to central server.	Data is transmitted "in a secure encrypted file, via internet, to the central server."
- Generation of standard reports.	At the central server, data is used to "render a standard report."
- Transmission of reports to prescribing physician.	Reports are transmitted "via fax and/or email to the prescribing physician."
- Data archiving for unique patient records and tests.	Intended to "maintain unique records per patient and test of this pulse oximetry data."
- Accessibility and review of reports by healthcare professionals.	Reports can be "retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site."
Safety:	Representative samples of OxiScan II successfully performance tested to verify compliance to appropriate safety characteristics.
Effectiveness:	Representative samples of OxiScan II successfully performance tested to verify compliance to appropriate effectiveness characteristics.
Substantial Equivalence:	"OxiScan II Oximetry Data Management Software has been concluded as substantially equivalent to the predicate device [Nonin Medicals "nVISION" software (K033307)]" based on similar intended uses, operation methods, and performance specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.

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

No, an MRMC comparative effectiveness study was not done. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:

Expected data values/formats: Verifying that captured oximetry data matches the source.
Report accuracy: Confirming that generated reports correctly reflect the stored data.
System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
Compliance with specifications: Testing against pre-defined functional and technical requirements.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or applicable to this type of software, this information is not provided.

Summary

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K080348

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 DriveBuffalo, NY 14228Tel: (716) 691-0202Fax: (716) 691-0707
Contact Name:	Peter WeisenbornVice 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 issubstantially equivalent to Nonin Medicals "nVISION"software (K033307)
Device Description:	OxiScan II Oximetry Data Management Software is anaccessory for use with compatible pulse oximeters.OxiScan II Oximetry Data Management Softwarecollects and stores patient information containing rawoximetery data captured by a pulse oximeter. Thisinformation is transferred by a personal computer to aninternet Web server where a report which summarizesand graphically presents the data is prepared. Thisreport is delivered to a Healthcare Professional whothen uses it along with other information to determine acourse of pulmonary treatment. The report may beretrieved, reviewed, and retransmitted via the OxiScanII Oximetry Data Management Software web site.
TechnologicalCharacteristics:	The OxiScan II Oximetry Data Management Softwareoperates on a personal computer using Windows XPwith service pack 2 or later. Both the OxiScan II andthe predicate can be used on a personal computer
Functional andSafety Testing:	Representative samples of OxiScan II Oximetry DataManagement Software were successfully performancetested to verify compliance to appropriate functionalcharacteristics.

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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.

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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.

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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.

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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

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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:

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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

Regulation Number and Section

§ 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).