(112 days)
The Smartport CT MPPort Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The Smartport CT MP port can accommodate a 3 ml/sec injection rate of contrast agent when used with a 19 or 20 gauge power injectable infusion set.
The 19 or 20 gauge LifeGuard Infusion Set can accommodate power injection when used with Smartport CT ports.
The LifeGuard® CT Safety Infusion Set is indicated for use in the access of implanted vascular ports for the administration of fluids and drugs, as well as blood sampling.
The 20ga and 19ga LifeGuard® CT Safety Infusion Sets are also indicated for power injection of contrast media when used with Smartport CT power injectable port access systems.
Not Found
The provided text is a 510(k) summary for a medical device (Smartport CT MP Port Access System and LifeGuard® CT Safety Infusion Set) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on:
- Device Identification: Proprietary and common names, classification, product codes, regulatory class.
- Legally Marketed Predicate Devices: Devices to which equivalence is claimed.
- Intended Use / Indications: What the device is designed for.
- FDA Communication: The clearance letter from the FDA confirming substantial equivalence to predicate devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Kø72375 (f1 of2)
4.0 510(k) Summary
Date: August 6, 2007
DEC 1 3 200
Sponsor of the 510(k)
Angiodynamics, Inc. 603 Queensbury Ave Queensbury, NY 12801 Establishment Registration number 1319211 Contact: Brian Kunst, Vice President, Regulatory Affairs and Quality Assurance 518-798-1215, x1123
Smartport CT MP 510(k) August 6, 2007
Confidential
Page 10 of 39
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K472375 (1.2002)
Device Identification:
| Proprietary Name: | Smartport CT MP Port Access System |
|---|---|
| Common Name: | Vascular access port |
| Classification Name: | Subcutaneous, implanted, intravascular infusion port &catheter |
| Classification Number: | 21 CFR §880.5965 |
| Classification Panel: | General Hospital |
| Product Code: | LJT |
| Regulatory Class: | II |
| Proprietary Name: | LifeGuard® CT Safety Infusion Set |
| Common Name: | Port Access Infusion set |
| Classification Name: | Set, administration, intravascular |
| Classification Number: | 21 CFR §880.5440 |
| Classification Panel: | General Hospital |
| Product Code: | FPA |
| Regulatory Class: | II |
Legally marketed device to which equivalence is claimed:
C.R. Bard PowerPort, 510(k) K060812 Angiodynamics Smartport CT and LifeGuard Needle, 510(k) K062414 Vortex MP Vascular Access Port, 510(k) K033473, K032754
Intended Use / Indications
The Smartport CT MPPort Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The Smartport CT MP port can accommodate a 3 ml/sec injection rate of contrast agent when used with a 19 or 20 gauge power injectable infusion set.
The 19 or 20 gauge LifeGuard Infusion Set can accommodate power injection when used with Smartport CT ports.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three flowing lines emanating from the head, representing the department's mission to protect the health of all Americans and provide essential human services.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Kunst Vice President, Regulatory Affairs and Quality Assurance ANGIODYNAMICS, Incorporated 603 Queensbury Avenue Queensbury, New York 12804
Re: K072375
Trade/Device Name: LifeGuard® CT Safety Infusion Set Regulation Number: 21 CFR 880. 5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: November 28, 2007 Received: November 29, 2007
Dear Mr. Kunst:
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 - Mr. Kunst
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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 (if known):
LifeGuard® CT Safety Infusion Set Device Name:
Indications for Use:
The LifeGuard® CT Safety Infusion Set is indicated for use in the access of implanted vascular ports for the administration of fluids and drugs, as well as blood sampling.
The 20ga and 19ga LifeGuard® CT Safety Infusion Sets are also indicated for power injection of contrast media when used with Smartport CT power injectable port access systems.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Ank On
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K473325
Smartport CT MP 510(k) August 6, 2007
Confidential
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.