(41 days)
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire. A peripherally inserted central catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
The Peripherally Inserted Central Catheter Kits contains many of the components required for the user to place the PICC. An introducer needle is used to gain access to the vein. A guidewire is then placed through the introducer to provide a track for the remaining devices. After removal of the introducer needle from the vein, the guide wire is left in place and a dilator/peel-away introducer assembly is advanced into the vessel thereby enlarging the subcutaneous track. When positioned, the dilator is removed and the peel-away introducer remains along with the guide wire. The PICC is placed through the introducer catheter. After catheter positioning is confirmed, the guide wire and peel-away introducer are removed. A "Stat-Lock" catheter fixation device secures the catheter during use.
The provided text describes a 510(k) summary for the Arrow Echogenic Introducer Needle, a component of Peripherally Inserted Central Catheter Sets. It includes information about the device, its intended use, and performance tests conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria and a study report with performance metrics in numerical form as requested in the prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the questions related to sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance. The document focuses on establishing substantial equivalence through a general statement of "Performance tests: Tests were performed to demonstrate substantial equivalence in the following areas: - Needle penetration - Hub bond tensile strength test" and a conclusion that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."
This type of submission typically relies on comparing the device's physical and functional characteristics to a legally marketed predicate device rather than presenting a detailed clinical study with numerical performance metrics against pre-defined acceptance criteria.
{0}------------------------------------------------
| 510(k) Summary | |
|---|---|
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
| Contact person: | William G. McLainManager, Regulatory AffairsPhone: 610-378-0131, ext. 3323Fax: 610-478-3188Email: bill.mclain@arrowintl.com |
| Date summary prepared: | January 16, 2004 |
| Device trade name: | Arrow Echogenic Introducer Needle, a component of PeripherallyInserted Central Catheter Sets |
| Device common name: | Introducer Needle |
| Device classificationname: | DQX; 21 CFR Part 870.1330; Accessory to Catheter Guidewire |
| Legally marketeddevices to which thedevice is substantiallyequivalent: | Arrow International, Inc.'s PICC Two-Lumen Peripherally InsertedCentral Catheter Set (K930129).Cook's 21Ga needle will also be used as a predicate. 510(k)number unknown. |
| Description of thedevice: | The Peripherally Inserted Central Catheter Kits contains many ofthe components required for the user to place the PICC. Anintroducer needle is used to gain access to the vein. A guidewire isthen placed through the introducer to provide a track for theremaining devices. After removal of the introducer needle from thevein, the guide wire is left in place and a dilator/peel-awayintroducer assembly is advanced into the vessel thereby enlargingthe subcutaneous track. When positioned, the dilator is removedand the peel-away introducer remains along with the guide wire.The PICC is placed through the introducer catheter. After catheterpositioning is confirmed, the guide wire and peel-away introducerare removed. A "Stat-Lock" catheter fixation device secures thecatheter during use. |
| Intended use of thedevice: | An introducer needle allows access to the vasculature forintroduction of a guidewire. |
| A peripherally inserted Central Catheter permits venous access tothe central circulation through a peripheral vein. | |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate device(s). |
| Performance tests: | Tests were performed to demonstrate substantial equivalence in thefollowing areas:- Needle penetration- Hub bond tensile strength test |
| Conclusions: | The results of the laboratory tests demonstrate that the device is assafe and effective as the legally marketed predicate devices. |
{1}------------------------------------------------
:
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing protection and service. The eagle is stylized with three distinct lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Mr. William G. McLain Manager, regulatory Affairs ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K040100
Trade/Device Name: Arrow Echogenic Introducer Needle a Component of Peripherally Inserted Cental Catheter Sets Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: January 20, 2004 Received: January 20, 2004
Dear Mr. McLain:
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.
{3}------------------------------------------------
Page 2 - Mr. McLain
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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Chiu-Ling, 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
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number: K040100 Arrow Echogenic Introducer Needle, a component of Device Name: Peripherally Inserted Central Catheter Sets Indications for Use: The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire. A peripherally inserted central catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Irene Naveran for WMB
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040100
PRESCRIPTION USE X
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.