(147 days)
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.
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.
Here's an analysis of the provided text, focusing on the absence of information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance, and then answering the specific questions based on the available text:
The provided text, a 510(k) summary for a medical device called "MAC™ Two-Lumen Central Venous Access Kit with ARROWg+ard Blue®," does not contain explicit "acceptance criteria" for device performance in the way typically expected for a performance study. Nor does it describe a study specifically designed to prove that the device meets such acceptance criteria with quantitative results against those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "performance tests" listed are a series of laboratory and in-vitro tests conducted to ensure the modified device (with the ARROWg+ard Blue® coating) performs similarly to its predecessors and meets general safety and effectiveness standards, rather than proving performance against predefined clinical or quantitative acceptance thresholds specific to its intended use and antimicrobial claim.
The key points from the document regarding "performance" are:
- Intended Use: "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." This explicitly states that clinical data for the antimicrobial efficacy in vivo was not collected or submitted as part of this 510(k).
- Performance Tests: A list of 14 tests is provided (tensile, leak, elongation, flow rate, priming volume, flex, burst, in vitro efficacy zone of inhibition, in vitro safety elution profile, hemolysis, fatigue life, stability, and biocompatibility).
- Conclusions: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."
Therefore, the answers to your questions will largely reflect the absence of a detailed performance study against explicit acceptance criteria in this submission.
Here's the breakdown of the information requested, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|
| Not explicitly stated as quantitative criteria. | Based on laboratory tests, the device is "as safe and effective as the legally marketed predicate devices." Specific tests performed included: 1. Tensile 2. Leak 3. Elongation 4. Flow Rate with Catheter 5. Flow Rate without Catheter 6. Priming Volume 7. Flex 8. Burst 9. In vitro efficacy zone of inhibition 10. In vitro safety elution profile 11. Hemolysis 12. Fatigue life testing 13. Stability tests 14. Biocompatibility tests Regarding antimicrobial claim: "Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text for any of the listed performance tests.
- Data Provenance: The tests are described as "laboratory tests" and "in vitro" tests. No country of origin is specified for these tests, though the submitting company is based in Reading, Pennsylvania, USA. The data would be considered prospective for these specific tests, as they were conducted as part of the device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The listed performance tests are primarily objective physical and chemical measurements rather than requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None specified. The types of tests listed (e.g., tensile strength, leak, flow rate) typically have objective pass/fail criteria determined by measurement, rather than relying on an adjudication process involving multiple human observers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for diagnostic imaging devices where human interpretation is a key component, which is not the case for this central venous access device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (catheter kit) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance tests mentioned (tensile, leak, flow rate, etc.), the "ground truth" would be the direct physical or chemical measurements obtained from the tests themselves, compared against engineering specifications or established standards for intravascular catheters.
- For the antimicrobial claim, the document explicitly states: "Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device." This indicates that clinical outcomes data (which would be the ultimate ground truth for an antimicrobial claim) were not used in this submission. In vitro efficacy (zone of inhibition) and in vitro safety (elution profile) tests were performed in its place for the antimicrobial aspect.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
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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.
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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 withARROWg 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 CatheterFOZ, Class II at 21 CFR 880.5200, Intravascular Catheter |
Legally marketed devices to which the device is substantially equivalent:
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- K993933: Arrow 14 Fr & 12 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg*ard Blue® Antimicrobial Catheter for High Volume Infusions
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- K002507: Arrow Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port
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- 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.
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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:
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- Tensile
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- Leak
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- Elongation
-
- Flow Rate with Catheter
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- Flow Rate without Catheter
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- Priming Volume
-
- Flex
-
- Burst
-
- In vitro efficacy zone of inhibition
-
- In vitro safety elution profile
-
- Hemolysis
-
- Fatique life testing
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- Stability tests
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- Biocompatibility tests
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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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 ________________________________________________________________________________________________________________________________________________________________
§ 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).