(242 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description mentions similar basic design and technology to the predicate, which is an older device. There is no mention of any features or capabilities that would suggest AI/ML is incorporated.
Yes
The device is used for the management of diabetes mellitus, which is a therapeutic purpose.
No
Explanation: The device description states its purpose is for "continuous delivery of insulin... for the management of diabetes mellitus." This indicates a therapeutic or management function rather than a diagnostic one. There is no mention of identifying, detecting, or evaluating a disease state.
No
The device description explicitly states "Insulin Pumps," which are hardware devices. The summary does not mention any software-only component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "continuous delivery of insulin... for the management of diabetes mellitus in persons requiring insulin." This describes a device that delivers a substance to the patient for therapeutic purposes.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro) to provide information about a person's health.
- Device Description: The description focuses on the physical device and its function of delivering insulin. There is no mention of analyzing samples or performing tests.
Therefore, an insulin pump, which delivers insulin directly to the patient's body, falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Product codes
LZG
Device Description
Not Found
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
Not Found
Intended User / Care Setting
home and clinical settings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic MiniMed 515
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
:
DEC 2 3 2005
K051041 510(k) Summary
Common / Usual Name: Classification Name: Class: Panel: Product Code:
External Insulin Infusion Pump Insulin Infusion Pump Class II; 21 CFR §880.5725 General Hospital 80 LZG
| Sponsor: | TheraSense, Inc.
1360 South Loop Road
Alameda, CA 94502 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person:
Title:
Telephone:
Facsimile: | Andrea L. Ruth
Sr. Associate, Regulatory Affairs
(510) 749-6360
(510) 239-2799 |
| Predicate Device | Medtronic MiniMed 515 |
| Predicate Device Manufacturer | Medtronic MiniMed,
18000 Devonshire St.,
Northridge, CA 91325 |
Establishment Information
Performance Standards, Section 514 of the Act
No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act.
Comparison of the Technological Features of the New Device and Predicate Device
The new and predicate devices have similar materials and basic design and technology.
Substantial Equivalence Comparison and Rationale
The Abbott Diabetes Care Insulin Pump (Pump) is substantially equivalent to the Medtronic MiniMed Paridigm 515.
The Pump has the same target users and operating environment as predicate devices. A comparison of product features and performance characteristics of the previously cleared Medtronic MiniMed Paridigm 515 [510(k) #K040676] and the TheraSense, Inc. Insulin Pump is provided within the substantial equivalence discussion below.
PROPRIETARY AND CONFIDENTIAL
PAGE 1 OF 2
57
1
510(k) K051041
The insulin pumps are all intended for use in home and clinical settings for the control of blood glucose levels in diabetes. The indication for use statement for the proposed Insulin Pump has the same elements as the predicate devices.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
DEC 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Rose Supervisor, Regulatory Affairs Abbott Diabetes Care, Incorporated 1360 South Loop Road Alameda, California 94502
Re: K051041
Ros1011
Trade/Device Name: Abbott Diabetes Care Insulin Pumps Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: December 6, 2005 Received: December 6, 2005
Dear Ms. Rose:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becaller been is substantially equivalent (for the referenced above and nave determined to legally marketed predicate devices marketed in indications for use stated in the cholorary to engineers date of the Medical Device interstate comments, or to tria, 20, 1978, as ssified in accordance with the provisions of Amendinents, of to devices that have obci (Act) that do not require approval of a premarket the Federal Pood, Drug, and Connexe : reacefore, market the device, subject to the general approval application (1 Mr.). - 1 ou - general controls provisions of the Act include controls provisions of the Fet. "The girling of devices, good manufacturing practice, requirements for animons against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see as 10) in a sontrols. Existing major regulations affecting (PNA), it may of Subject to Sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Oods no receints concerning your device in the Federal Register.
3
Page 2 - Ms. Rose
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a succearing with other requirements
mean that FDA has made a determination that your device Fodard agencies mean that FDA nas made a decemmandin that your avinistered by other Federal agencies.
of the Act or any Federal statutes and regulations administers and matter to: penstratio of the Act or any rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements, and monufacturing proctice You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Par and listing (ZT CFK Part 807), labeling (21 CFR Par every go
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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)
the success of the same of any and can and capital and sections of section of o This letter will anow you to begin mailed.ing your as is equivalence of your device to a premarket notification. The PDA miding of basiants of 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), If you desire specific advice for your device of the Also, please note the regulation
please contact the Office of Compliance at (240) 276-0115. please contact the Office of Comphation at (210) - 11 (21 CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 carter Act from the entitled, " Misoranding by reference to premation on your responsibilities under the tall for may obtain offer general mionnation on Jour Forpol Popper Assistance at its toll-free DIVISION of Sman Manufacts of 1) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syrita G. Michael Owens
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number : K 05104 |
Device Name: Abbott Diabetes Care Insulin Pumps Indications for Use: The Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) (Division Sign-Off)
Jd. Qull
for ADW.
12/23/05
05/04/