ABL80 FLEX CO-OX with AQURE connectivity

K151856 · Sendx Medical, Inc. · CHL · Aug 6, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151856
• Device Name: ABL80 FLEX CO-OX with AQURE connectivity
• Applicant: Sendx Medical, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. The ABL80 FLEX CO-OX analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Device Story

Portable, automated blood gas analyzer; measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. Uses potentiometry, amperometry, conductometry, and spectrophotometry. Operated by trained clinicians in lab or point-of-care settings. Integrates with AQURE data management software for remote result display, device status monitoring, and remote initiation of system cycles (rinse, calibration, lock/unlock). Output provided to clinicians for diagnosis and treatment of metabolic and acid-base disorders. Benefits include rapid, point-of-care diagnostic data for life-threatening conditions.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to ensure software modification functions as intended without impacting core analyzer performance.

Technological Characteristics

Portable analyzer; potentiometry, amperometry, conductometry, and spectrophotometry sensing principles. Connectivity via AQURE system (Ethernet/RS232). Hardware includes 8.4" TFT-LCD touchscreen. Software runs on Windows XP Embedded. Risk management per ISO 14971.

Indications for Use

Indicated for use in clinical laboratory settings for blood gas, electrolyte, and co-oximetry analysis.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• ABL80 Flex CO-OX (K080370)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER: K151856

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable for the ABL80 FLEX CO-OX with AQURE connectivity:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) K080370 ABL80 FLEX CO-OX
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a software modification that adds remote control capabilities within the laboratory to some of the functions of the analyzer. Remote access to the analyzer by the software (called AQURE) supports the following device actions initiation functions:

- System Cycle (2 point calibration and automatic quality control)
- 2-point calibration
- Rinse
- Tubing refill
- Liquid sensor adjust
- Pump calibration
- Lock/Unlock analyzer
- Lock/Unlock parameter
- Set/Get analyzer message
- Enter/Exit standby

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and software.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the

{1}

Page 2 of 2

design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.