(86 days)
Not Found
No
The document describes a standard central venous catheter and its intended uses and performance characteristics. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is indicated for the "treatment of diseases or conditions requiring central venous access," which directly relates to therapeutic use. It is used for administering fluids, medications, chemotherapy, TPN, and blood products for treatment purposes.
No
The document states that the device is "indicated to permit short-term (
No
The device description clearly describes a physical catheter made of radiopaque polyurethane, with specific dimensions and lumen configurations. It also mentions being provided in sterile kit configurations. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a catheter for providing central venous access for various medical treatments and procedures (infusion of fluids, medications, TPN, blood sampling, etc.). These are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The device description details the physical characteristics of a catheter designed for insertion into a vein.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. This is the core function of an IVD.
Therefore, the ARROWg+ard Blue® and Arrow catheters are medical devices used for therapeutic and diagnostic procedures performed directly on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use is the same as the predicate devices.
The Indications for Use were expanded to include:
"The injection of contrast media. When used for the pressure injection of contrast media, do not exceed the maximum labeled flow rate. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi."
The ARROWg+ard Blue® antimicrobial catheter is indicated to permit short-term (
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
K071538
Traditional
Traditional 510(k)
SECTION 4 – 510k Summary:
AUG 3 0 2007
In accordance with 21 CFR 807.87(h), the following 510(k) summary has been presared per 21 CFR 807.92.
| Pressure Injectable Central Venous Catheter 510(k) Summary | |
|---|---|
| Submitter: | ARROW International, Inc. |
| 2400 Bernville Road | |
| Reading, PA 19605-9607 USA | |
| Contact person: | Kirsten Stowell |
| Regulatory Affairs Specialist | |
| Phone:610-378-0131, ext. 3514 | |
| Fax: 610-478-3128 | |
| Email: kirsten.stowell@arrowintl.com | |
| Date summary prepared: | June 1, 2007 |
| Device trade name: | Arrow Central Venous Catheter |
| ARROWg+ard Blue® Central Venous Catheter | |
| ARROWg+ard Blue PLUS® Central Venous Catheter | |
| Device common name: | Central Venous Catheter (CVC) |
| Device classification: | Catheter, intravascular, therapeutic, short-term less than |
| 30 days; Product Code FOZ; | |
| 21 CFR 880.5200, Class II | |
| Legally marketed devices to | |
| which the device is | |
| substantially equivalent: | Arrow Standard Multiple Lumen CVC with Blue FlexTip® |
| (K862056, SE date 8/25/1986) | |
| ARROWg+ard Blue® CVC | |
| (K900263, SE date 7/24/1990 and K962577, SE date | |
| 8/27/1997) | |
| ARROWg+ard Blue PLUS® CVC | |
| (K993691, SE date 3/8/2000) | |
| Bard Access System, Inc PowerHickman | |
| (K061179, SE date 8/9/2006) | |
| Arrow Berman Angiographic Catheter devices | |
| (K892530, SE date 9/26/1989) | |
| Description of the device: | The Arrow CVC have the following characteristics: |
| Radiopaque polyurethane catheters16Ga, 1 Lumen7Fr through 8.5Fr, 2 through 4-LumensUsable lengths of 16 - 20cmCatheters are provided sterile kit configurations.The catheter is labeled with the maximum flow rating on the catheter distal hub to facilitate the proper use of the device. | |
| Intended use of the device: | The intended use is the same as the predicate devices. |
| Indications for use: | The Indications for Use were expanded to include: |
| "The injection of contrast media. When used for the pressure injection of contrast media, do not exceed the maximum labeled flow rate. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi." | |
| Technological characteristics: | The proposed central venous catheters have the same technological design characteristics as the predicate CVC devices. |
| Performance tests: | The following tests were performed to demonstrate substantial equivalence: |
| Flow rate Qualification Test Repeat Injection Test Catheter Burst Pressure Test | |
| Assessment of non-clinical performance data: | The Arrow Pressure Injectable CVC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of the bench tests demonstrate that Arrow's central venous catheters are as safe and effective as compared to the currently marketed predicate catheters. |
| Assessment of clinical performance data: | Two studies evaluated the feasibility, safety and efficacy of the use of the Arrow International's central venous catheters for the purpose of power injection of contrast media during diagnostic imaging procedures. Arrow International's Pressure Injectable CVC devices have been demonstrated to be safe and effective for the high pressure administration of contrast media when hospital guidelines and injection protocol are followed. |
| Summary | Arrow International's central venous catheter has the same intended use as the predicate devices. Based on the assessment of non-clinical and clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrow's central venous catheter is substantially equivalent to the legally marketed predicate devices. |
1
K07-1538
Traditional 510(k)
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kirsten Stowell Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road, PO Box 12888 Reading, Pennsylvania 19605
AUG 3 0 2007
Re: K071538
Trade/Device Name: ARROWg+ard Blue® Central Venous Catheter ARROWg+ard Blue PLUS® Central Venous Catheter Arrow Central Venous Catheter Regulation Number: 880.5200
Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 4, 2007 Received: June 5, 2007
Dear Ms. Stowell:
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 -- Ms. Stowell
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.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k)
Indications for Use Statement
510(k) Number (if known): K07/538
Device Name: ARROWg+ard Blue® Central Venous Catheter
The ARROWg+ard Blue® antimicrobial catheter is indicated to permit short-term (