(25 days)
The Signature Edition® Infusion System (Models 710X and 720X) is 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® Infusion System is 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.
The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (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.
This document is a 510(k) premarket notification for a medical device (infusion pump), not a study report. Therefore, it does not contain information about acceptance criteria, study design, or device performance against specific metrics as requested.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, meaning it asserts that the new device is as safe and effective as a previously cleared device. It states:
- "The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (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." (Page 0)
- "With the exception of the device modification presented in this submission, the Signature Edition® Infusion System is 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." (Page 1)
- "A comparison of the technological characteristics of the Signature Edition® Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the modified Signature Edition® Infusion System is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." (Page 2)
Therefore, I cannot provide the requested information, as these details are not present in the provided text.
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CARDINAL HEALTH, ALARIS PRODUCTS
ATTACHMENT D
FEB 2 3 2007
SUMMARY OF SAFETY AND EFFECTIVENESS
Cardinal Health Alaris Products
Signature Edition® Infusion System
Models 710X and 720X
SUBMITTER'S NAME: Cardinal Health 303, Inc. dba Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, CA 92121-2772 (858) 458-7830 (858) 458-6114 FAX
CONTACT PERSON: Stacy L. Lewis
Principal Regulatory Affairs Specialist
DATE PREPARED: January 26, 2007
Proprietary Name: DEVICE NAME: Signature Edition® Infusion System Common Name: Infusion Pump Classification Name: Pump, Infusion, FRN (880.5725)
PREDICATE DEVICE: Signature Edition® Infusion System (K931549), October 12, 1993
DEVICE DESCRIPTION
The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (submitted as the Models EZ 1 and EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device
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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 3
modification provided in this submission. Other prior submissions include K032147 (Signature Edition Infusion System), which covered minor aggregate changes to the Signature Edition Infusion System and included all Signature Edition models (700X, 710X, 720X, 713X and 723X).
The same device modification provided in this submission was also submitted for the Signature Edition® Gold Infusion System, Models 713X and 723X (K063288) and was cleared to market on November 28, 2006.
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 Signature Edition® Infusion System is 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 Signature Edition® Infusion System is 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.
070268
00171
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SUMMARY OF SAFETY AND EFFECTIVENESS Page 3 of 3
The Signature Edition® Infusion System is 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.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Signature Edition® Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the modified Signature Edition® Infusion System is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered.
070268
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2007
Ms. Stacey L. Lewis Principal Regulatory Affairs Specialist Cardinal Health 303, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772
Re: K070268
Trade/Device Name: Signature Edition® Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 26, 2007 Received: January 29, 2007
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,
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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Attachment B INDICATIONS FOR USE
510(k) Number:
K 070268 (To Be Assigned By FDA)
Device Trade Names:
Signature Edition® Infusion System
Indications For Use:
The Signature Edition® Infusion System (Models 710X and 720X) is 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® Infusion System is 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.
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony V. Watson
Anesthesiology, General Hospital,
Anesthesia, Medical Services
65166
§ 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).