(27 days)
The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
The subject of this 510(k) submission is the Signature Edition® Gold Infusion System, which is also known as the Alaris® SE Pump (collectively referred to herein as "SE Gold Pump"). This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003 (first submitted as the Models EZ 1 and EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission.
The electrical volumetric pumps are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. Infusion pumps have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This document is a 510(k) premarket notification for the Cardinal Health Signature Edition® Gold Infusion System (Alaris® SE Pump). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific quantitative acceptance criteria through new clinical or performance studies.
Therefore, the provided text does not contain the information requested regarding acceptance criteria that would typically be found in a study demonstrating device performance for a novel or significantly modified device. The document explicitly states:
- "This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003"
- "With the exception of the device modification presented in this submission, the SE Gold Pumps are essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same."
- "The results of this comparison demonstrate that the modified SE Gold Pump is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered."
Since this is a substantial equivalence submission, studies with acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document. The "study" referenced is the comparison to the predicate device to establish substantial equivalence based on technological characteristics and intended use.
No information for the following points can be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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ATTACHMENT D
063288
SUMMARY OF SAFETY AND EFFECTIVENESS
Cardinal Health Alaris Products
Signature Edition® Gold Infusion System
(a.k.a. Alaris® SE Pump)
NOV 2 8 2006
| SUBMITTER'S NAME: | Cardinal Health 303, Inc.dba Cardinal Health, Alaris Products10221 Wateridge CircleSan Diego, CA 92121-2772(858) 458-7830(858) 458-6114 FAX |
|---|---|
| ------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| CONTACT PERSON: | Stacy L. Lewis |
|---|---|
| Principal Regulatory Affairs Specialist |
October 31, 2006 DATE PREPARED:
- DEVICE NAME: Proprietary Name: Signature Edition® Gold Infusion System (a.k.a. Alaris® SE Pump) Common Name: Infusion Pump Classification Name: Pump, Infusion, FRN (880.5725)
PREDICATE DEVICE: Signature Edition® Infusion System (K032147), July 25, 2003
DEVICE DESCRIPTION
The subject of this 510(k) submission is the Signature Edition® Gold Infusion System, which is also known as the Alaris® SE Pump (collectively referred to herein as "SE Gold Pump"). This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003 (first submitted as the Models EZ 1 and
60260
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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 3
EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission.
The electrical volumetric pumps are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. Infusion pumps have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
SUBSTANTIAL EQUIVALENCE
With the exception of the device modification presented in this submission, the SE Gold Pumps are essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same.
INTENDED USE
The intended use of this device has not changed from the original submissions in terms of content or intent:
The SE Gold Pumps are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The SE Gold Pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
5063288 2 of 3
65261
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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 3
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the SE Gold Pump and the predicate devices has been performed. The results of this comparison demonstrate that the modified SE Gold Pump is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered.
063288 3 of 3
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2006
Ms. Stacey L. Lewis Principal Regulatory Affairs Specialist Cardinal Health 303, Incorporated 10221 Wateridge Circle San Diego, California 92121
Re: K063288
Trade/Device Name: Signature Edition® Gold Infusion System Alaris® SE Pumps Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 31, 2006 Received: November 1, 2006
Dear Ms. Lewis:
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 - Ms. Lewis
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 (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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sasa Junn
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
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Attachment B INDICATIONS FOR USE
510(k) Number:
KOG 32888 (To Be Assigned By FDA)
Device Trade Names:
Signature Edition® Gold Infusion System Alaris® SE Pumps
Indications For Use:
The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
Prescription Use X OR (Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joell for now for CSL
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00256
§ 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).