(120 days)
The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
BioValve Technologies proposes to market a disposable pump for the basal and bolus delivery of insulin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BioValve Insulin Delivery Systems (BIDS):
Overall Assessment:
The provided document set is a 510(k) summary and the FDA's clearance letter for the BioValve Insulin Delivery Systems (BIDS). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific performance metrics against pre-defined acceptance criteria in the same way a clinical trial for a new drug or an AI-powered diagnostic might.
Therefore, many of the requested elements for a detailed study report (like sample sizes, ground truth establishment, MRMC studies, standalone performance metrics, etc.) are not present in this type of regulatory submission. The "performance data" mentioned in the 510(k) summary refers to demonstrating that the device functions equivalently to its predicate, often through bench testing and engineering comparisons, not necessarily through a clinical study with detailed statistical outcomes.
Acceptance Criteria and Device Performance Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness equivalent to predicate devices | Stated to be "substantially equivalent" to predicate devices like the Insulet iXL Diabetes Management System (K031373) and other Insulin Infusion Pumps/Subcutaneous Insulin Infusion Sets in terms of performance. |
| Ability to deliver insulin at set and variable rates | The device is "indicated for the continuous delivery of insulin, at set and variable rates." Performance data supports that "the performance of the pumps is equivalent to the predicate devices." |
| Absence of electronic power/components/software control | Confirmed: "this device does not use electronic power or components nor is it software controlled." |
| Compliance with general controls (GMP, labeling, registration, etc.) | FDA's clearance letter explicitly states: "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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820)." |
Explanation:
The acceptance criteria are not explicitly listed in numerical targets (e.g., "accuracy > 95%"). Instead, the primary acceptance criterion is substantial equivalence to existing legally marketed devices, particularly the Insulet iXL Diabetes Management System (K031373). The reported device performance is that it meets this substantial equivalence. The "performance data" mentioned is to demonstrate this equivalence, likely through engineering tests, comparison of materials, and functional testing to show it operates similarly for continuous insulin delivery.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided documents. In a 510(k) for a mechanical device like this, the "test set" would typically refer to bench testing or engineering verification rather than a clinical dataset of patients.
- Data Provenance: Not specified. Again, for this type of device, the "provenance" would relate to where the engineering tests were conducted, not patient data from a specific country or whether it was retrospective/prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/specified. This type of regulatory submission for a simple mechanical device typically relies on engineering and functional testing, not expert consensus on ground truth labels for a dataset.
- Qualifications of Experts: Not applicable/specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/specified. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements in expert labeling of data, which is not relevant for this type of device submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a non-AI, mechanical insulin pump. MRMC studies are specific to evaluating diagnostic algorithms, often AI-powered, and their impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is a mechanical pump and does not involve an "algorithm" in the sense of a software-based diagnostic or decision support tool. Its performance is inherent in its mechanical function.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a device like this, the "ground truth" for its performance would be based on engineering specifications and validated functional tests. This would include parameters like:
- Accuracy of insulin delivery (flow rate, dose per actuation).
- Reliability (consistent performance over time, resistance to occlusion).
- Safety (leakage, biocompatibility of materials).
- These are validated against established industry standards and the performance of predicate devices. It is not "expert consensus," "pathology," or "outcomes data" in the context of clinical diagnostics.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. As this is not an AI/ML device, there is no "training set" in the computational learning sense. The device is designed, built, and tested based on engineering principles.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. There is no training set for this mechanical device.
Summary of what the documents do tell us:
The 510(k) summary and FDA letter confirm that the BioValve Insulin Delivery Systems (BIDS) achieved substantial equivalence to predicate devices. This means the FDA determined that the device is as safe and effective as other legally marketed insulin infusion pumps. This determination was based on "Performance Data" which, in this context, refers to engineering and functional testing demonstrating that the BIDS operates similarly to existing devices for its intended use (continuous insulin delivery at set and variable rates), despite having different technological characteristics (no electronic power or software).
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510(K) SUMMARY
9.0 Summary of Safety and Effectiveness
| 9.1 Submitted By: | Scott Huie |
|---|---|
| Vice President of Operations | |
| Biovalve Technologies, Inc | |
| Date Prepared: | April 15, 2005 |
| 9.2 Trade/Proprietary Name: BioValve Insulin Delivery Systems (BIDS) | |
| 9.3 Common/Usual Name: | Disposable Insulin Infusion Pump |
| 9.4 Classification Name: | Pump, Infusion, Insulin/Set, Administration, Intravascular |
| 9.5 Classification: FDA has classified Infusion Pumps and Intravascular Catheters inClass II. Final Order was published in the Federal Register on October 21, 1980 afterreview by the General Hospital and Personal Use Devices Classification Panel. | |
| Panel: 80 Procodes: | LZG External Insulin Infusion PumpFPA Intravascular Administration Set |
| 9.6 Purpose of SubmissionBioValve Technologies proposes to market a disposable pump for the basal and bolusdelivery of insulin. |
9.7 Substantial Equivalence
The BioValve Insulin Delivery Systems (BIDS) is substantially equivalent to the Insulet iXL Diabetes Management System (K031373) as well as other Insulin Infusion Pumps and Subcutaneous Insulin Infusion Sets.
9.8 Technological Characteristics
The technological characteristics for these devices differ from the predicate devices in as much as this device does not use electronic power or components nor is it software controlled.
9.9 Performance Data
The information provided supports that the performance of the pumps is equivalent to the predicate devices.
9.10 Conclusion
Biovalve, Inc. concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA.
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AUG 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Huie Vice President of Operations BioValve Technologies, Incorporated 155 Flanders Rd. Westborough, Massachusetts 01581
Re: K050971
Trade/Device Name: BioValve Insulin Delivery Systems (BIDS) Regulation Number: 21 CFR 880.5725 Regulation Name: Insulin Infusion Pump Regulatory Class: II Product Code: LZG Dated: June 30, 2005 Received: July 1, 2005
Dear Mr. Huie:
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 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.
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Page 2 - Mr. Huie
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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,
Chiu Lin, Ph.D. Director Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050971
Device Name:
BioValve Insulin Delivery Systems (BIDS)
Indications For Use:
The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
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 Device Evaluation (ODE)
Chr
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of
510(k) Number:
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).