(70 days)
Not Found
No
The summary describes a "next dose calculator" and an "insulin titration algorithm," which are typically rule-based or algorithmic approaches, not explicitly AI/ML. There is no mention of AI, ML, or related terms, nor is there a description of training or test sets for an AI/ML model.
Yes
Explanation: The device is intended to calculate the best next dose of insulin to achieve a personal glucose target for diabetic patients, which directly impacts their health and treatment. It also references a predicate device that is a dosing system, further indicating its therapeutic purpose.
No
The device is described as an "insulin next dose calculator" that helps diabetic patients determine the "best next dose of insulin to achieve a personal glucose target." It does not diagnose a condition, but rather assists in managing an existing one by calculating a dose based on a known diagnosis.
Yes
The device description explicitly states it is a "next dose calculator" and mentions being available on "3 platforms (PALM, PC and WEB)", which are software environments. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "calculate the best next dose of insulin to achieve a personal glucose target." This is a therapeutic decision support tool, not a diagnostic tool.
- Device Description: It's described as a "next dose calculator." This reinforces its function as a tool for managing treatment, not for diagnosing a condition or measuring a substance in vitro.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Measuring a substance in a biological sample (like blood glucose).
- Providing information for the diagnosis, monitoring, or prognosis of a disease.
- Using reagents or other materials to perform a test on a sample.
The device uses existing glucose information (presumably obtained from a separate glucose monitoring device, which would be an IVD) to calculate a treatment dose. It doesn't perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.
Product codes (comma separated list FDA assigned to the subject device)
NDC
Device Description
My Insulin Doser/IDS is a next dose calculator for any insulin that can be used by patients with a prescription from a licensed prescriber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18-80 years old
Intended User / Care Setting
Diabetic Patient / Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Labeling Comprehension study for 55 patient users to implement and understand My Insuiln Doser system. The system was designed around a 6th grade reading comprehension level. Subjects ranged in age from 18-80 years old. Subjects were given My Insulin Doser/IDS users manual to read as well as given a demonstration of the software on any of the 3 platforms (PALM, PC and WEB).
Clinical Performance Data: The study was a Phase IV in which nursing home residents who were maintained on two or more OADs were converted to an insulin replacement algorithm. The insulin titration algorithm developed by Dimensional Dosing Systems, Inc. was employed to help stabilize blood glucose following conversion from OAD therapy.
Performance testing was performed and all tests showed satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Korsir
510(k) Executive Summary August 20, 2008
NOV - 7 2008
Company Name:
Dimensional Dosing Systems
Company Address
Telephone:
2465 Dogwood Drive Wexford, PA 15090 (724) 933-7874
Contact Person: John McMichael
Summary Preparation Date: September 4, 2007
Trade Name: My Insulin Doser/IDS
Common Name: Dosing Calculator
Classification Name: Calculator, Drug Dose
Predicate Device Identification: CFR21 868.1890 Dosing Calculator Product Code: NDC Device Class: II
| LEGALLY MARKETED EQUIVALENT DEVICE | ||
|---|---|---|
| Company | Product | 510(k) # |
| RxFiles | TRxF Intelligent Dosing System | K011571 |
DESCRIPTION OF DEVICE
My Insulin Doser/IDS is a next dose calculator for any insulin that can be used by patients with a prescription from a licensed prescriber.
INTENDED USE OF THE DEVICE
My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.
1
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE AS COMPARED TO PREDICATE DEVICE [
Predicate Product Comparison Table:
| Manufacturer | Dimensional Dosing
Systems | Dimensional Dosing Systems |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | "My Insulin Doser/IDS" | TRXF Intelligent Dosing System
(IDS) |
| K Number | | K011571 |
| Intended Use | My Insulin Doser/IDS allows
a diabetic patient to calculate
the best next dose of insulin
to achieve a personal glucose
target. | Software based drug dosing
calculator designed for use by
the physician to calculate next
dose of any drug to achieve a
desired target |
| Device
Description | My Insulin Doser/IDS a next
dose calculator for any insulin
that can be user by patients
with a prescription from a
licensed prescriber. | The IDS™ is a "next" dose
calculator for any drug that can
be used by physicians
to
calculate the next dose
for
patients. |
| Target
population | Diabetic Patient | Healthcare professional |
| Where used | Home | Healthcare facility |
| Human
Factors | Patient enters their own
glucose values and amounts
of insulin taken.
Warnings are presented
when values are out of range
and/or insulin doses are 20% of the most recent
dose. | Physicians enter patient's
glucose values and amounts of
insulin. Warnings are
presented when values are out
of range and/or insulin doses
are 20% of the most
recent dose. |
| Performance | Performance testing was
performed and all tests
showed satisfactory results. | Performance testing was
performed and all tests showed
satisfactory results. |
| Software
based | Yes | Yes |
| Dose
calculation | Yes | Yes |
2
Discussion of Similarities and Differences with the Predicate Product:
The Intelligent Dosing System (IDS) for Physicians was chosen as a substantially equivalent device. My Insulin Doser/IDS has the following similarities to those of the predicate device:
- Uses the same algorithm .
- Uses the same operating principles .
- Uses a similar graphical user interface. �
- Available via the Palm, PC or Website. .
- User enters same variables. .
The only modifications made are:
- . Single Patient only
- . Insulin only
Conclusion:
My Insulin Doser/IDS is identical to the predicate device in functionality except for a few features that allow the device to be a single patient dosing calculator devised for insulin dosing only. The predicate device, the Intelligent Dosing System IDS) was developed as a dosing calculator for the healthcare professional and was approved for all drugs, including insulin. The IDS for Insulin takes the same software and technology and is a dosing calculator developed for a single patient and single drug. This device allows the patient to participate in insulin dosing, but has the added benefit of a remote patient management that allows the healthcare professional to view patient data anytime from anywhere with internet access
My Insulin Doser/IDS uses the same fundamental technology features as the Intelligent Dosing System and delivers the same level of effectiveness. Therefore, it is concluded that there is no significant difference in the basic function, safety and effectiveness between the Intelligent Dosing System (Predicate Device) and My Insulin Doser/IDS.
NON-CLINICAL PERFORMANCE DATA AND CONCLUSIONS FROM NON-CLINICAL TESTS
Labeling Comprehension study for 55 patient users to implement and understand My Insuiln Doser system. The system was designed around a 6th grade reading comprehension level. Subjects ranged in age from 18-80 years old.
Subjects were given My Insulin Doser/IDS users manual to read as well as given a demonstration of the software on any of the 3 platforms (PALM, PC and WEB),
3
CLINICAL PERFORMANCE DATA AND CONCLUSIONS FROM CLINICAL TESTS
The study was a Phase IV in which nursing home residents who were maintained on two or more OADs were converted to an insulin replacement algorithm. The insulin titration algorithm developed by Dimensional Dosing Systems, Inc. was employed to help stabilize blood glucose following conversion from OAD therapy.
| SOFTWARE INFORMATION | |
|---|---|
| Software Documentation | Concern |
| Level of Concern | Major |
| Software Description | Provided |
| Device Hazard Analysis | Provided |
| Software Requirements Specifications | Provided |
| Architecture Design Chart | Provided |
| Software Design Specifications | Provided |
| Traceability Analysis | Provided |
| Software Development Environment Description | Provided |
| Verification and Validation Documents | Provided |
| Revision Level History | Provided |
| Unresolved Anomalies (Bugs or Defects) | Provided |
SOFTWARE INFORMATION
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black line drawing, and the text is also in black. The overall design is clean and professional.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Dimensional Dosing Systems C/O Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Rc: K082512
Trade/Device Name: My Insulin Doser/IDS Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: August 29, 2008 Received: August 29, 2008
Dear Mr.Smith:
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 ffor 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.
5
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sxythe y. Michino ms
FOR DR. CHIU LIN
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(K) Number:
Device Name: My Insulin Doser/IDS
Intended Use Statement:
My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Centering Di non
Page of
flo
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ancolnoon - O.
Infection Control, Dental Devices
K # 8 2512____________________________________________________________________________________________________________________________________________________________________ 510(k) Number: _