PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM

K040628 · Abbott Laboratories · NBW · Mar 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040628
• Device Name: PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The revised Precision Link Diabetes Management System is a data management tool intended to collect and report information to assist with diabetes management.

Device Story

Precision Link Diabetes Management Software; data management tool for diabetes care. Inputs: blood glucose data from MediSense sensors via direct PC communication. Transformation: software processes, collects, and reports glucose data to assist clinical management. Used in clinical or home settings by patients or healthcare providers. Output: reports and data summaries for diabetes management decision-making. Modifications include OS updates, sensor compatibility, and improved PC connectivity.

Clinical Evidence

No clinical data. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of software modifications.

Technological Characteristics

Software-based data management system. Connectivity: PC-based interface for MediSense blood glucose sensors. Risk management per ISO 14971-1:1998(E).

Indications for Use

Indicated for people with diabetes and healthcare professionals to upload, view, analyze, and print blood glucose and blood ketone results from MediSense Products meters. Requires basic understanding of personal computers. Suitable for home and professional use.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Precision Link® Blood Glucose Data Management System (K952279)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER : K040628 "Special"

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 (delete/add items as necessary):

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.)
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.
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 consolidation of a series of modifications incorporated into the Abbott Precision Link Diabetes Data Management Software. Modifications include operating system updates, compatibility with more recent model MediSense Blood Glucose sensors, and more direct communication between MediSense Blood Glucose Sensors and personal computers.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and like the predicate device (K952279) the revised Precision Link Diabetes Management System is a data management tool intended to collect and report information to assist with diabetes management.
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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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. Risk Analysis was performed in accordance with ISO 14971-1:1998(E) and FDA Guidance for Medical Device Use – Safety: Incorporating Human Factors Engineering into Risk Management (2000). The result of this analysis showed that the hazards introduced by the software changes were linked to incorrect user input of date/time and patient identification information. These hazards were identified as having moderate risk severity. The submitter has provided the 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.