(28 days)
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.
The provided text describes a 510(k) premarket notification for the WaveSense Jazz Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to a predicate device (K072413), rather than presenting a de novo clinical study with detailed acceptance criteria and performance data as typically seen for novel devices, especially those incorporating AI.
Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving device performance (especially for an AI/ML context) is largely absent from this specific 510(k) summary. The document primarily discusses the intended use, technological comparison to a predicate, and the modifications made (new colors, new data management feature), implying that much of the performance data would have been established for the original predicate device.
However, I can extract the relevant information that is present and indicate where information is not available from the provided text.
Here's an attempt to answer based on the provided document, acknowledging its limitations for an AI/ML-centric request:
Acceptance Criteria and Device Performance (based on the provided 510(k) Summary for a Glucose Monitoring System)
It's crucial to understand that this 510(k) pertains to a Blood Glucose Monitoring System, which is a hardware-based diagnostic device, not an AI/ML-powered software or imaging device. Therefore, many of the typical questions regarding AI/ML clinical studies (MRMC, expert consensus for ground truth, training set details, etc.) are not applicable to this type of submission.
The "study" referenced in the provided text is primarily focused on verification and validation (V&V) of the modifications made to an existing predicate device, rather than a large-scale clinical trial to establish novel performance.
1. Table of Acceptance Criteria and Reported Device Performance
For a Blood Glucose Monitoring System, acceptance criteria usually relate to accuracy standards (e.g., ISO 15197 for point-of-care testing), precision, and other analytical performance characteristics. The provided 510(k) summary does not explicitly list these numerical acceptance criteria or the specific performance results in a table. It instead states that "verification and validation results" were sufficient to establish substantial equivalence.
However, based on typical FDA requirements for Blood Glucose Monitoring Systems, the implicit acceptance criteria would relate to:
| Acceptance Criteria Category | Typical Standard (from relevant guidance/standards, NOT explicitly in provided text) | Reported Device Performance (NOT explicitly detailed in provided text) |
|---|---|---|
| Analytical Accuracy | Meets ISO 15197:2013 standards for BGM systems (e.g., x% readings within ±15% of lab reference for glucose < 100 mg/dL, and within ±15 mg/dL for glucose < 100 mg/dL) | Stated as "verification and validation results" that support substantial equivalence to predicate. Specific numerical performance data is not included in this summary. |
| Precision/Repeatability | Coefficient of Variation (CV) within acceptable limits (e.g., < 5%) | Stated as "verification and validation results" that support substantial equivalence. |
| Interfering Substances | No significant interference from common substances at specified concentrations | Implied by V&V for substantial equivalence. |
| Hematocrit Range | Accurate across specified hematocrit range | Implied by V&V for substantial equivalence. |
| Operating Conditions (Temp, Humidity) | Stable performance across environmental conditions | Implied by V&V for substantial equivalence. |
| Usability | Device is safe and effective for intended OTC use | "usability engineering evaluations" were conducted. |
| Firmware Functionality | New data management feature operates as intended | "firmware functional testing" was conducted. |
| Robustness | Device withstands typical use and handling | "robustness testing" was conducted. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "verification and validation results" and "firmware functional testing and usability engineering evaluations" but does not specify the sample size for any test sets.
- Data Provenance: Not explicitly stated, but typically for such devices, the data would be collected from human subjects (e.g., finger-stick blood samples). The document does not specify country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a modified device, it's likely a combination of bench testing (prospective), and potentially limited human use testing (prospective) to validate the specific changes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable in the context of a Blood Glucose Monitoring System where the "ground truth" for glucose concentration is established by a laboratory reference method (e.g., hexokinase method on a central laboratory analyzer), not by human expert interpretation (like a radiologist for imaging).
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or subjective assessment that would require adjudication for a glucose reading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of Human Improvement with AI vs. Human without AI Assistance
This is not applicable. This is a hardware-based diagnostic device for measuring glucose, not an AI-powered system designed to assist human readers in, for instance, interpreting images or making clinical diagnoses.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This is not applicable. The device is the "algorithm" and measurement system. Its performance is measured directly against a reference method. It's not an AI algorithm that produces an output that then needs to be compared to human performance.
7. The Type of Ground Truth Used
For a Blood Glucose Monitoring System, the primary ground truth for glucose concentration is laboratory reference methods (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or similar enzymatic methods traceable to national/international standards), typically using venous blood plasma samples.
8. The Sample Size for the Training Set
This concept of a "training set" is primarily relevant for machine learning/AI models. For a traditional electrochemical glucose sensor, there isn't a "training set" in the same sense. The device is calibrated during manufacturing based on known glucose concentrations, and its accuracy is verified and validated. No information on a "training set" is provided or applicable here.
9. How the Ground Truth for the Training Set was Established
As above, the concept of a "training set" and its associated ground truth is not applicable for this type of device.
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June 6, 2024
AgaMatrix Dave Valcourt Regulatory Affairs Manager 7C Raymond Ave Salem, New Hampshire 03079
Re: K241304
Trade/Device Name: WaveSense Jazz Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 9, 2024 Received: May 9, 2024
Dear Dave Valcourt:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
K241304 Device Name
WaveSense Jazz Blood Glucose Monitoring System
Indications for Use (Describe)
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared on: 2024-06-04
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
| Applicant Name | AgaMatrix |
|---|---|
| Applicant Address | 7C Raymond Ave Salem NH 03079 United States |
| Applicant Contact Telephone | 603-328-6079 |
| Applicant Contact | Dave Valcourt |
| Applicant Contact Email | dvalcourt@agamatrix.com |
21 CFR 807.92(a)(2)
| Device Trade Name | WaveSense Jazz Blood Glucose Monitoring System |
|---|---|
| Common Name | Blood Glucose Monitoring System |
| Classification Name | System, Test, Blood Glucose, Over the Counter |
| Regulation Number | 862.1345 |
| Product Code(s) | NBW |
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K072413 | WaveSense Jazz Blood Glucose Monitoring System | NBW |
21 CFR 807.92(a)(4)
The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.
21 CFR 807.92(a)(5)
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at
blood from the fingerstick, palm and/orforearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
Indications for Use Comparison
The indications for use of the candidate device are the indications for use of the predicate device with the following changes: the candidate device is not indicated for prescription use and is not indicated for clinical use.
Technological Comparison
The candidate WaveSense Jazz BGMS has the same fundamental scientific technology as the predicate WaveSense Jazz BGMS. The differences between the candidate WaveSense Jazz BGMS and the predicate are the introduction of new colors on the top housing and the introduction of a new data management feature.
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Activities to verify and validate the modification and robustness testing, firmware functional testing and usability engineering evaluations.
Based on the verification and validation results, the candidate WaveSense Jazz Blood Glucose Monitoring System is substantially equivalent to the predicate WaveSense Jazz Blood Glucose Monitoring System (K072413).
§ 862.1345 Glucose test system.
(a)
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.(b)
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.