(85 days)
POWER P.A.C. Implantable Venous Access Systems: The POWER P.A.C. implantable venous access systems are implantable vascular access devices designed to provide long term repeated access to the vascular system. Smiths Medical MD, Inc. POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media. the maximum recommended infusion rate is 5 ml/sec.
GRIPPER PLUS® POWER P.A.C. Needle: The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is designed for the administration into or withdrawal of fluids from implanted ports. The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with power injectable implantable venous access ports, the GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for power injection of contrast media.
POWER P.A.C. Implantable Venous Access Systems: The POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems and Power Injectable Implantable Infusion Port. They both are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. However, when used with a power indicated huber needle, the POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. The POWER P.A.C. implantable.vanous access systems can be placed in the chest or arm. The POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-sopina neede.
GRIPPER PLUS® POWER P.A.C. Needle: The GRIPPER PLUS® POWER P.A.C. Needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick in its protection in help not protect against other routes of bloodborne pathogen transmission. The GRIPPER PLUS® POWER P.A.C. Needle is indicated for power injection of contrast media.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Met all established acceptance criteria for performance testing and design verification testing. | Met all established acceptance criteria for performance testing and design verification testing. |
| Packaging and Sterilization systems are unchanged from predicate devices. | Packaging and Sterilization systems are unchanged from predicate devices. |
2. Sample Size and Data Provenance:
The document does not specify a separate "test set" in the context of clinical studies. The functional and design verification testing was performed on the devices themselves. There is no mention of country of origin or whether data was retrospective or prospective, as no clinical human data was collected.
3. Number of Experts and Qualifications:
Not applicable. No experts were used to establish ground truth for a test set, as no clinical studies were performed.
4. Adjudication Method:
Not applicable. No adjudication method was used as no clinical studies were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed. The submission explicitly states "Clinical studies ... were deemed not necessary".
6. Standalone Performance (Algorithm Only):
Not applicable. This device is a medical product (catheter/port and needle) and not an algorithm or AI. The performance studies were for the physical device.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance was established through functional testing and design verification testing against established engineering and design specifications. There was no pathological, outcomes data, or expert consensus ground truth in a clinical sense.
8. Sample Size for Training Set:
Not applicable. This device is a physical product, not an algorithm, so there is no "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established:
Not applicable. There was no training set for an algorithm. The "ground truth" for the device's development was based on engineering specifications and predicate device designs.
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K072657
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SMITHS MEDICAL MD, INC. 510(k) Premarket Notification
510(k) Summary
I. Applicant (Sponsor) Name and Address
Smiths Medical MD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 Establishment Reg. No.: 2183502
II. Contact Name and Phone
Brian L. Haugstad
DEC 1 4 2007
Senior Regulatory Affairs Associate
Company Phone: (651) 628-7513
Company Fax: (651) 628-7457
III. Device Trade/Proprietary Name
Catheter/Port
POWER P.A.C. Implantable Venous Access Systems
Needle
GRIPPER PLUS® POWER P.A.C. Safety Huber Needle
IV. Device Classification/Common Name/Panel
Catheter/Port
21 CFR Reference: §880.5965 21 CFR Common Name: Implanted Infusion Port Classification: Class II Product Code: LJT Panel: General Hospital
Needle
21 CFR Reference: $880.5440 21 CFR Common Name: Huber Needle Intravascular Administration Set Classification: Class II Product Code: FPA Review Panel: General Hospital and Personal Use
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SMITHS MEDICAL MD. INC. 510(k) Premarket Notification
510(k) Summary
V. Identification of Predicate Device
Smiths Medical MD, Inc. believes the POWER P.A.C. Implantable Venous Access Systems and GRIPPER PLUS® POWER P.A.C. Safety Huber Needles are substantially equivalent to the following devices and thus may market the devices under these equivalencies.
Catheter/Port
Device Name:
-
- Smiths Medical MD, Inc.: PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems and Gripper Plus® POWER P.A.C. Needle
-
- Smiths Medical MD, Inc.: P.A.S. Port® T2 Implantable Venous Access System
- Smiths Medical MD, Inc.: PORT-A-CATH® II 7 French, Dual Lumen Low ProfileTM 3. Implantable Venous Access System
-
- Medcomp : Power Injectable Implantable Infusion Port
Needle
Device Name:
-
- Smiths Medical MD, Inc. PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems and Gripper Plus® POWER P.A.C. Needle
VI. Device Description -------------------------------------------------------------------------------------------------------------------------------------------------------
POWER P.A.C. Implantable Venous Access Systems
The POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems and Power Injectable Implantable Infusion Port. They both are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. However, when used with a power indicated huber needle, the POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. The POWER P.A.C. implantable.vanous access systems can be placed in the chest or arm.
The POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-sopina neede.
GRIPPER PLUS® POWER P.A.C. Needle
The GRIPPER PLUS® POWER P.A.C. Needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick in its protection in help not protect against other routes of bloodborne pathogen transmission.
The GRIPPER PLUS® POWER P.A.C. Needle is indicated for power injection of contrast media.
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16072657
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SMITHS MEDICAL MD, INC. 510(k) Premarket Notification
510(k) Summary
VII. Intended Use of the Device
The intended use of each device has not changed from that of the predicate.
POWER P.A.C. Implantable Venous Access Systems
The POWER P.A.C. implantable venous access systems are implantable vascular access devices designed to provide long term repeated access to the vascular system.
GRIPPER PLUS® POWER P.A.C. Needle
The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is designed for the administration into or withdrawal of fluids from implanted ports.
VIII. Indications for Use
POWER P.A.C. Implantable Venous Access Systems
Smiths Medical MD, Inc. POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media. the maximum recommended infusion rate is 5 ml/sec.
GRIPPER PLUS® POWER P.A.C. Needle
The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with power injectable implantable venous access ports, the GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for power injection of contrast media.
IX. Summary of Studies
A. Functional Testing
The POWER P.A.C. Implantable Venous Access Systems and GRIPPER PLUS® POWER P.A.C. Needle met all established acceptance criteria for performance testing and design verification testing. Packaging and Sterilization systems are unchanged from predicate devices.
B. Clinical Studies
Clinical studies for the POWER P.A.C. Implantable Venous Access Systems and GRIPPER PLUS® POWER P.A.C. Safety Huber Needle were deemed not necessary due to their similarity in materials, design and function to current Smiths Medical MD, INC. devices and other commercially available systems.
C. Conclusions Drawn from the Studies
Based upon the information provided; the POWER P.A.C. Implantable Venous Access Systems and GRIPPER PLUS® POWER P.A.C. Safety Huber Needle met all acceptance criteria for performance testing and design verification testing. Therefore, these products are considered acceptable for human use.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
DEC 1. 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian L. Haugstad Senior Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
Re: K072657
Trade/Device Name: GRIPPER PLUS™ POWER P.A.C. Safety Huber Needle and POWER P.A.C. Implantable Venous Access Systems Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: September 18, 2007 Received: September 20, 2007
Dear Mr. Haugstad:
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. Haugstad
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 (OS) 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,
Century D. Nester her
Christian, 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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SMITHS MEDICAL MD, INC. 510(k) Premarket Notification
Indications for Use
510(k) Number: (OOQLS7
Device Name:
Smiths Medical MD, Inc. POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR
Over-The Counter Use ___________Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Anten Omz
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
大472657 FORH, Office of Device Evaluation (ODE)
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SMITHS MEDICAL MD, INC. 510(k) Premarket Notification
Indications for Use
2.67
1078657 510(k) Number:
GRIPPER PLUSTM POWER P.A.C. Safety Huber Needle Device Name:
The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
When used with power injectable implantable venous access ports, the
GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for power injection of contrast media.
Prescription Use OR Over-The Counter Use _ _ _ Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(K) Numberoncurrence of CDRH, Office of Device Evaluation (ODE)
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.