(147 days)
No
The summary describes a physical medical device (catheterization kit) with an antimicrobial coating. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies listed are standard physical and in-vitro tests for medical devices.
No.
The device facilitates venous access for catheter introduction but is explicitly stated not to be a treatment for existing infections, nor is it indicated for long-term use as a treatment. Its primary function is access, with an antimicrobial surface for infection prevention, not active treatment of disease.
No
Explanation: The device is described as a "Two-Lumen Central Venous Access Device" intended for "venous access and catheter introduction to the central circulation." Its purpose is to facilitate access and fluid delivery, not to diagnose a condition. The performance studies listed are for device safety and integrity, not diagnostic accuracy.
No
The device description clearly outlines physical components like a catheter, tray, and lidstock, and the performance studies include tests on physical properties like tensile strength, leak, and flow rate, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for venous access and catheter introduction to the central circulation, inserted into veins. This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a catheterization kit with an antimicrobial surface treatment. This is a medical device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The performance studies listed are related to the physical properties and safety of the device itself, not its ability to diagnose a condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used for therapeutic access and delivery, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The MAC™ Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Product codes
DBY, FOZ
Device Description
The proposed device is a modification to Arrow's Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve/Side Port, with the addition of ARROWg" ard Blue antimicrobial surface treatment. The proposed device was Arked to help provide protection against device-related infections. It is not intended to help provise a treatment for existing infections, nor is it indicated for long-term use.
The catheterization kit components are configured in a high-impact polystyrene (HIPS) tray, sealed with a Tyvek® lidstock, and sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, subclavian, or femoral veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance tests are included in the submission:
-
- Tensile
-
- Leak
-
- Elongation
-
- Flow Rate with Catheter
-
- Flow Rate without Catheter
-
- Priming Volume
-
- Flex
-
- Burst
-
- In vitro efficacy zone of inhibition
-
- In vitro safety elution profile
-
- Hemolysis
-
- Fatique life testing
-
- Stability tests
-
- Biocompatibility tests
Conclusions: The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
OCT 31 2001
SECTION 2. 510(k) SUMMARY
KO11761
P.O. Box 12888 Reading, PA 19612
Image /page/0/Picture/4 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, sans-serif font. Below it, in a smaller font, is the word "INTERNATIONAL". The logo is in black and white.
6
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Arrow International 2400 Bernville Road Reading, PA 19605
Research/Engineering 2400 Barnville Rood Reading, PA 19605
(610) 378-0131 FAX: (610) 478-3188
Contact person:
Submitter:
Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Phone: (610) 478-3137 (610) 478-3172 Fax: E-mail: tom.nickel@arrowintl.com
Date summary prepared:
| Device trade name: | MAC™Two-Lumen Central Venous Access Kit with
ARROWg ard Blue® and Hemostasis Valve/Side Port |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device common name: | Two-Lumen Central Venous Access device |
| Device classification name: | DBY, Class II at 21 CFR 870.1340, Introducer Catheter
FOZ, Class II at 21 CFR 880.5200, Intravascular Catheter |
Legally marketed devices to which the device is substantially equivalent:
-
- K993933: Arrow 14 Fr & 12 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg*ard Blue® Antimicrobial Catheter for High Volume Infusions
-
- K002507: Arrow Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port
-
- K940079: Arrow SUPER ARROWFLEX™ Percutaneous Sheath Introducer Kit with ARROWg ard Blue® and Arrow Raulerson Syringe
Description of device:
The proposed device is a modification to Arrow's Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve/Side Port, with the addition of ARROWg" ard Blue antimicrobial surface treatment. The proposed device was Arked to help provide protection against device-related infections. It is not intended to help provise a treatment for existing infections, nor is it indicated for long-term use.
The catheterization kit components are configured in a high-impact polystyrene (HIPS) tray, sealed with a Tyvek® lidstock, and sterilized.
1
Intended use of the device:
The MAC™ Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use..
Technological characteristics:
The proposed device has the same technological characteristics as the predicate devices.
Performance tests:
The following performance tests are included in the submission:
-
- Tensile
-
- Leak
-
- Elongation
-
- Flow Rate with Catheter
-
- Flow Rate without Catheter
-
- Priming Volume
-
- Flex
-
- Burst
-
- In vitro efficacy zone of inhibition
-
- In vitro safety elution profile
-
- Hemolysis
-
- Fatique life testing
-
- Stability tests
-
- Biocompatibility tests
Conclusions:
The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
2
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 stylized eagle with three stripes representing health, services, and people. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
OCT 3 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas D. Nickel Vice President, Regulatory Affairs & Quality Assurance Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605
Re: K011761
Trade/Device Name: MAC™ Two-Lumen Central Venous Access Kit with ARROWg+ ard, Blue® Access Device and Integral Hemostasis Valve Regulation Number: 870.1340 and 880.5200 Regulation Name: Introducer Catheter and Catheter, Intravascular short-term Regulatory Class: II Product Code: DYB and FOZ Dated: September 17, 2001 Received: September 18, 2001
Dear Mr. Nickel:
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.
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
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Page 2 - Mr. Nickel
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the For of all the Act's requirements, including, but not limited to: registration 1 ou must compry with are are and manufacturing (21 CFR Part 801); good manufacturing practice and insting (21 es result 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 This letter will and in your your 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
L. Alatorre A
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS
510(k) Number (if known): K011761
Device Name: MAC™Two-Lumen Central Venous Access Kit with ARROWgʻard Blue® Antimicrobial Surface and Integral Hemostasis Valve/Side Port.
Indications for Use: The MAC™Two-Lumen Central Venous Access Device with mulcations for ose. The hire in catheter introduction to the central ARROVE for blues permise the jugular, subdavian, or femoral veins. The Cliculation. It may be inscree into closed provide protection against cather-ARKONG arous technology 18 Thentse to no home to that demonstrate the use of the related intections. Glinical adia nave in decreasing catheter-related infections for this ARKOwg+arder animilatolial ochaoe in sereatment for existing infections, nor is it indicated for long-term use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Petrus Crescenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________