TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM

{0} SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER k132072 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 Roche Diagnostic's previously cleared devices, the True Metrix Self and True Metrix Pro cleared under k120989. 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: 1. Adding the ability to tag results with six different event tags. The predicated device only has the ability to tag AST results. The following event tags were added: test was taken before a meal, test was taken 2 hours after the start of a meal, test was taken during or just after exercise, medication may have affected test result, test was taken when sick, any other reason that the test is unique or different in some way (e.g. stress, drinking alcohol, etc.). 2. Change the operating temperature range of the system from 43°F to 100°F to 41°F to 104°F. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. 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). {1} 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 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. The device is intended for single-patient and multiple-patient use. PDI Super Sani-Cloth wipes (EPA registration #9480-4) were validated through disinfection efficacy studies demonstrating complete inactivation of live virus using materials comprising the meter and lancing device. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the meter and lancing device (for use only with the single-patient use systems) after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 5 years of single-patient meter use, 3 years of lancing device use and 3 years of multiple-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. (Reviewer's Signature) (Date) Comments A search of the post market database did not reveal any information that would affect the 510(k) clearance of this device. No new infection control studies were required because no modifications were made to the exterior of the device. revised:8/1/03 "SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION | | Yes | No | | | --- | --- | --- | --- | | 1. Same Indication Statement? | ☑ | ☐ | If YES = Go To 3 | | 2. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness? | ☐ | ☐ | If YES = Stop NSE | | 3. Same Technological Characteristics? | ☑ | ☐ | If YES = Go To 5 | | 4. Could The New Characteristics Affect Safety Or Effectiveness? | ☐ | ☐ | If YES = Go To 6 | | 5. Descriptive Characteristics Precise Enough? | ☐ | ☑ | If NO = Go To 8 If YES = Stop SE | | 6. New Types Of Safety Or Effectiveness Questions? | ☐ | ☐ | If YES = Stop NSE | | 7. Accepted Scientific Methods Exist? | ☐ | ☐ | If NO = Stop NSE | | 8. Performance Data Available? | ☑ | ☐ | If NO = Request Data | | 9. Data Demonstrate Equivalence? | ☑ | ☐ | Final Decision: SE | Note: See http://eroom.fda.gov/eRoomReq/Files/CDRH3/CDRHPremarketNotification510kProgram/0_4148/FLOWCHART%20DECISION%20TREE%20.DOC for Flowchart to assist in decision-making process. Please complete the following table {2} and answer the corresponding questions. "Yes" responses to questions 2, 4, 6, and 9, and every "no" response requires an explanation. 1. Explain how the new indication differs from the predicate device's indication: 2. Explain why there is or is not a new effect or safety or effectiveness issue: 3. Describe the new technological characteristics: 4. Explain how new characteristics could or could not affect safety or effectiveness: 5. Explain how descriptive characteristics are not precise enough: A description of the device does not sufficiently demonstrate substantially equivalence to the predicate device because it does not demonstrate that the performance of the device is comparable to the predicate. 6. Explain new types of safety or effectiveness question(s) raised or why the question(s) are not new: 7. Explain why existing scientific methods can not be used: 8. Explain what performance data is needed: 9. Explain how the performance data demonstrates that the device is or is not substantially equivalent: The data submitted was usual and customary for this type of device and sufficiently demonstrated that the performance of the device was substantially equivalent.