(56 days)
Not Found
No
The device description and intended use focus on a liquid quality control material for oxygen saturation meters, with no mention of AI or ML technologies.
No
This device is a quality control material intended to monitor the performance of oxygen saturation meters, not to treat or diagnose a disease.
No
This device, Oxicom Control, is a quality control material intended to monitor and evaluate the analytical performance of oxygen saturation meters. It does not diagnose medical conditions in patients.
No
The device description explicitly states that the device is a "suspension of polystyrene beads in an inorganic, aqueous buffer solution with dyes" and is "packaged in a glass bottle." This describes a physical, liquid control material, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For In Vitro Diagnostic Use" in the Intended Use section.
- The device is a "quality control material" used to monitor the performance of oxygen saturation meters, which are themselves IVD devices used to measure a parameter in a biological sample (blood).
- The description mentions it simulates the absorbance of light equivalent to that of whole blood.
These points clearly indicate that the Oxicom Control is intended for use in vitro (outside the body) to assess the performance of diagnostic tests performed on biological samples.
N/A
Intended Use / Indications for Use
Oxicom Control is intended for use as a quality control solution to evaluate Oxicom measurement at a range of clinically relevant oxygen saturation values.
Oxicom Control is intended to be used to monitor and evaluate the analytical performance of the Waters Oxicom models 2000, 2100 and 3000 oxygen saturation meters for the measurement of oxygen saturation. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The three levels of oxygen saturation provided by the controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The solutions in the 3-level Oxicom Control are a suspension of polystyrene beads in an inorganic, aqueous buffer solution with dyes to simulate the absorbance of light equivalent to that of whole blood at a range of oxygen saturation clinically relevant.
Oxicom Control provides a convenient method of performing periodic OC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle.
Oxicom Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted to verify specific performance requirements:
- a) Closed bottle stability
- b) Stability after opening
- c) Correlation to predicate device
- d) Test precision and range
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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BIONOSTICS FRANIS
JAN 2 6 2006
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
510(k) Summary1
Contact Person Kathleen Storro Sr.Director, QA & Regulatory Affairs (978) 772-7070 x 220
Date of preparation of this summary: 30 November 2005
- Oxygen Saturation Control (2) Device trade or proprietary name: Device common or usual name or classification name:
Oxygen Saturation Control
| PRODUCT NOMENCLATURE | CLASSIFICATION
NUMBER | CLASS | PANEL |
|------------------------------------------------|--------------------------|-------|-----------|
| Control, Single Analyte (Assayed or Unassayed) | 862.1660 (JJX) | I | Chemistry |
I. Substantial Equivalence
Oxygen Saturation Control for Waters Oxicom is substantially equivalent in function, safety and efficacy to other Bionostics products for the quality control evaluation of oxygen saturation.
| Characteristic | New Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Name: | Oxygen Saturation | |||
| Control for Waters | ||||
| Oxicom | Oxicom 2100 QC Filters | OPTI-Check Quality | ||
| Control | Multifunction Blood Gas | |||
| Control | ||||
| 510(k): | -- | K921519 | K974822 | K880447 |
| Description: | Aqueous solution | |||
| containing suspended | ||||
| styrene beads and | ||||
| dyes to simulate tHb | ||||
| and Oxygen | ||||
| Saturation | 1 translucent plastic | |||
| (QC1) and 2 precision | ||||
| glass (QC2, QC3) filters | ||||
| with discreet | ||||
| absorbance values | Aqueous solution | |||
| containing suspended | ||||
| styrene beads to | ||||
| simulate tHb and | ||||
| Oxygen Saturation | Aqueous solution | |||
| containing dyes to | ||||
| simulate tHb andOxygen | ||||
| Saturation | ||||
| Intended Use: | As a quality control | |||
| solution for use to | ||||
| verify the performance | ||||
| of the Waters Oxicom | ||||
| systems for | ||||
| measurement of | ||||
| Oxygen saturation | As a means to check | |||
| the calibration of the | ||||
| Oxicom system | As a quality control | |||
| solution to verify | ||||
| performance of AVL | ||||
| OPTI for measurement | ||||
| including oxygen | ||||
| saturation and tHb | As a quality control | |||
| solution for use to verify | ||||
| the performance of blood | ||||
| gas instruments for | ||||
| measurement including | ||||
| oxygen saturation and tHb | ||||
| Levels: | 3 | 3 | 3 | 3 |
| Analytes: | Oxygen Saturation | |||
| (SO2%) | Oxygen Saturation | |||
| (SO2%) | pH, PCO2, PO2, Na, K, | |||
| Cl, iCa, tHb, SO2% | pH, PCO2, PO2, Na, K, | |||
| Cl, iCa, tHb, SO2%, | ||||
| MetHb%, COHb% |
Comparison of Technological Characteristics with Predicate Device
l This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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II. Description of the new device
The Waters Oxicom family of oxygen saturation meters, (2000, 2100 and 3000) utilize light emitting diodes and a solid state detector to measure the absorbance of light by a whole blood sample contained in an optically clear cuvette at 2 wavelengths. The amount of IR light absorbed by the blood is rclatively independent of the blood's oxygenation. However, RED light absorption or optical density is strongly dependent on the oxygen saturation. The ratio of the optical densities at the two wavelengths is used to calculate the functional oxygen saturation. The Quality Control (QC) filters supplied with the Oxicom systems allows the user to check the calibration of the Oxicom. The set of filters consist of one translucent plastic filter (QCI), and two precision glass filters (QC2 and QC3). The optical densities of these filters are stored in the unit's microprocessor. When inserted into the sample chamber the Oxicom measures the optical density and compares it to the value stored. If the optical densities match, the display will read a %Sat value.
The solutions in the 3-level Oxicom Control are a suspension of polystyrene beads in an inorganic, aqueous buffer solution with dyes to simulate the absorbance of light equivalent to that of whole blood at a range of oxygen saturation clinically relevant.
Oxicom Control provides a convenient method of performing periodic OC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle.
Oxicom Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
(5) Intended use of the device
Oxicom Control is intended for use as a quality control solution to evaluate Oxicom measurement at a range of clinically relevant oxygen saturation values.
Oxicom Control is a three-level, liquid control solution with dyes and polystyrene beads to provide absorbance relative to a range of oxygen saturation values. The concentration of beads and dyes are optimized for the Waters Oxicom Systems to provide an improved range of oxygen saturation values in comparison to the existing, filter systems, and handling and measurement essentially equivalent to the measurement of whole blood.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements:
2
- a) Closed bottle stability
- b) Stability after opening
- c) Correlation to predicate device
- d) Test precision and range
- Summary of clinical tests submitted with the premarket notification for the (b) (2) device.
N/A
- Conclusions drawn from the clinical and non-clinical trials. (b) (3) Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 6 2006
Ms. Kathleen Storro Sr. Director, QA & Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, MA 01434
K053327 Re:
Trade/Device Name: Waters Oxicom Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 30, 2005 Received: December 1, 2005
Dear. Ms. Storro:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Guta
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K053327 510(k) Number (if known):
Device Name: Waters Oxicom Control
Indications For Use:
Oxicom Control is intended to be used to monitor and evaluate the analytical performance of the Waters Oxicom models 2000, 2100 and 3000 oxygen saturation meters for the measurement of oxygen saturation. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The three levels of oxygen saturation provided by the controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Ann Chappie
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
51 KOS3327