(242 days)
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.
The new and predicate devices have similar materials and basic design and technology.
This K051041 document is a 510(k) summary for the Abbott Diabetes Care Insulin Pump, seeking substantial equivalence to the Medtronic MiniMed 515. The provided text does not include specific acceptance criteria or a study detailing device performance against such criteria. The document focuses on regulatory submission without performance data.
Therefore, I cannot provide the requested information from the given text.
The document states:
- No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act. This means the FDA has not set specific performance metrics that this device must meet in the same way some other medical devices might have.
- The new and predicate devices have similar materials and basic design and technology.
- 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. (However, the "discussion below" is not included in the provided snippets).
To answer your questions, I would need a section of the 510(k) submission that details the performance testing conducted for the Abbott Diabetes Care Insulin Pump to demonstrate its safety and effectiveness, and how that performance compares to specified acceptance criteria (which would likely be derived from the predicate device).
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:
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 RoadAlameda, CA 94502 |
|---|---|
| Contact Person:Title:Telephone:Facsimile: | Andrea L. RuthSr. 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
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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
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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.
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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
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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/
§ 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).