(36 days)
No
The summary describes a physical medical device (a catheter) and its performance characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device facilitates venous access for introducing other devices and helps protect against infection, but it does not directly treat a disease or condition. Its purpose is access and prevention, not therapy.
No
The device is described as a venous access catheter used for introducing catheters to the central circulation and providing protection against access device-related infections. It facilitates access but does not diagnose conditions.
No
The device description clearly describes a physical catheter with multiple lumens and an antimicrobial surface, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "permits venous access and catheter introduction to the central circulation." This describes a device used in vivo (within the body) for accessing the circulatory system.
- Device Description: The description details a "venous access catheter" with lumens and ports for accessing the bloodstream. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, this device is a medical device used for accessing the central venous system, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Arrow Three-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation. The ARROWg+ard antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Product codes
DYB, FOZ
Device Description
The Arrow MAC™ with ARROWg+ard Blue® is a venous access catheter with the functionality of three segregated internal pathways. The hemostasis valve and distal lumen can accommodate a thermodilution catheter, or similar device, 7 to 8 Fr in size while the remaining space is utilized as a flow lumen through the distal port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central circulation
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed to demonstrate substantial equivalence in the following areas:
- Flow rate
- Leak test
- Tensile test
- Fatigue test
- Flex modulus test
The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arrow MAC™ 2 Lumen Central Venous Access Kit with ARROWg+ard Blue® Antimicrobial Surface (K011761), Baxter Multiple-Lumen Access Products (K981909)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K032962
OCT 2 9 2003
| 510(k) Summary | |
|---|---|
| Submitter: | ARROW International, Inc. |
| 2400 Bernville Road | |
| Reading, PA 19605-9607 USA | |
| Contact person: | Elizabeth Price, Regulatory Associate |
| Phone: 610-378-0131, ext. 3220 | |
| Fax: 610-374-5360 | |
| Email: elizabeth.price@arrowintl.com | |
| Date summary prepared: | 9/22/03 |
| Device trade name: | MAC™ 3 Lumen Central Venous Access Kit with ARROWg+ard |
| Blue® Antimicrobial Surface. | |
| Device common name: | Catheter introducer; intravascular catheter |
| Device classification | |
| name: | DYB, Class II, 21 CFR 870.1340, Catheter, introducer, short term. |
| FOZ, Class II, 21 CFR 880.5200, Catheter, Intravascular, short term | |
| Legally marketed | |
| devices to which the | |
| device is substantially | |
| equivalent: | Arrow MAC™ 2 Lumen Central Venous Access Kit with |
| ARROWg+ard Blue® Antimicrobial Surface (K011761). | |
| Baxter Multiple-Lumen Access Products (K981909). | |
| Description of the | |
| device: | The Arrow MAC™ with ARROWg+ard Blue® is a venous access |
| catheter with the functionality of three segregated internal | |
| pathways. The hemostasis valve and distal lumen can | |
| accommodate a thermodilution catheter, or similar device, 7 to 8 Fr | |
| in size while the remaining space is utilized as a flow lumen through | |
| the distal port. | |
| Intended use of the | |
| device: | The Arrow Three-Lumen Central Venous Access device permits |
| venous access and catheter introduction to the central circulation. | |
| The ARROWg+ard antimicrobial surface is intended to help provide | |
| protection against access device-related infections. 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 device(s). | |
| Performance tests: | Tests were performed to demonstrate substantial equivalence in the |
| following areas: |
- Flow rate
- Leak test
- Tensile test
- Fatigue test
- Flex modulus test |
| Conclusions: | The results of the laboratory tests demonstrate that the device is as
safe and effective as the legally marketed predicate devices. |
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- The state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Ms. Elizabeth Price Regulatory Affairs ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605
Re: K032962
Trade/Device Name: MAC™ 3 Lumen Central Venous Access Kit with ARROWg ard Blue® antimicrobial surface Regulation Number: 880.5200, 870.1340 Regulation Name: Intravascular Catheter, Catheter Introducer Regulatory Class: II Product Code: FOZ, DYB Dated: September 22, 2003 Received: September 29, 2003
Dear Ms. Price:
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 - Ms. Price
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 (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 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 STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
K, 032962
MAC™ 3 Lumen Central Venous Access Kit with ARROWg*ard Blue® antimicrobial surface
The Arrow Central Venous Access Product permits venous access and catheter introduction to the central circulation. The ARROWg+ard Blue® antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrica Cuenite
(Division Sian-Off) Division of Anesthesiology. General Hospital. Infection Control, Dental Devices
510(k) Number. K032962