(79 days)
The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
The Arrow Seldinger arterial catheterization devices are comprised of an introducer needle, a spring wire guide, and an arterial catheter assembly. The catheter assembly consists of a polyurethane arterial catheter molded to a winged catheter juncture hub. An extension tubing segment is molded to the proximal end of the winged catheter hub. The proximal end of the extension tubing segment is molded to a luer-locking hub. A slide clamp is provided on the extension segment.
The provided document is a 510(k) summary for the Arrow® Seldinger Arterial Catheterization Device. It does not describe an AI/ML medical device, but rather a traditional medical device (catheterization device). Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment for training, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.
However, I can extract the available information regarding the device's acceptance criteria and the study that supports it within the context of a traditional medical device submission.
Acceptance Criteria and Study for the Arrow® Seldinger Arterial Catheterization Device
Study Overview:
The study performed for the Arrow® Seldinger Arterial Catheterization Device was a series of in-house verification and validation tests to demonstrate the safety and efficacy of the device. The conclusion of this testing was to demonstrate substantial equivalence to a legally marketed predicate device, the Arrow Radial Artery Catheterization Set (K810675).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Needle penetration | Verification testing demonstrated the device met the required performance for needle penetration. (Specific quantitative pass/fail criteria are not detailed in this summary, but the general conclusion implies satisfactory performance.) |
| Component compatibility | Verification testing confirmed compatibility among the device's components. (No specific metrics provided, but successful compatibility is implied.) |
| Leak test | Verification testing demonstrated the device passed leak tests. (Quantitative leak rates or thresholds are not detailed, but the general conclusion implies satisfactory performance.) |
| Package integrity | Verification testing confirmed the integrity of the device's packaging. (No specific metrics provided, but successful integrity is implied.) |
| Tensile test | Verification testing demonstrated the device met required tensile strength. (Specific yield strengths or breakage points are not detailed, but the general conclusion implies satisfactory performance.) |
| Pull testing | Verification testing demonstrated the device met required pull strengths. (Specific pull-off forces or displacement limits are not detailed, but the general conclusion implies satisfactory performance.) |
| Overall Conclusion | The results of verification testing demonstrate substantial equivalence of the Arrow® Seldinger Arterial Catheterization device to the legally marketed predicate. The differences between the proposed and predicate devices do not raise new issues of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance tests.
- Data Provenance: The data is from in-house "Verification and validation testing." This suggests prospective testing conducted by the manufacturer, Arrow International, Inc., likely at their facilities in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable to this type of device and study. The "ground truth" for a physical device like a catheterization kit is established through engineering and quality control specifications, not expert interpretation of outputs like images. Performance is measured against predefined technical specifications.
4. Adjudication Method for the Test Set:
- This is not applicable as the tests are objective physical performance measurements against specifications, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human reader performance is being evaluated with and without AI assistance. This device is a physical medical instrument.
6. Standalone (Algorithm Only) Performance:
- No, a standalone (algorithm only) performance study was not done. This device is not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance tests is based on engineering specifications and industry standards for similar medical devices. These specifications would dictate acceptable ranges for parameters like "needle penetration force," "leak rate," "tensile strength," etc. The comparison to the predicate device also forms a "ground truth" for equivalence in fundamental technology and expected performance.
8. Sample Size for the Training Set:
- This is not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable as there is no training set for this type of medical device.
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1/09 30 56
510(k) Summary
| DEC 1 8 2009 | |
|---|---|
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
| Contact person: | Christine Ford, Sr. Regulatory Affairs SpecialistPhone: 610-378-0131, ext. 3338Fax: 610-478-3128Email: christine.ford@teleflexmedical.com |
| Date summary prepared: | September 29, 2009 |
| Device trade name: | Arrow® Seldinger Arterial Catheterization Device |
| Device common name: | Arterial catheterization device |
| Device classification name: | Class II, DQY, Catheter, Percutaneous, 21 CFR 870.1250Class II, DQX, Wire, Guide, Catheter, 21 CFR 870.1330 |
| Legally marketed device to which the device issubstantially equivalent: | Arrow Radial Artery Catheterization Set, K810675 |
| Description of the device: | The Arrow Seldinger arterial catheterization devices are comprised of anintroducer needle, a spring wire guide, and an arterial catheter assembly.The catheter assembly consists of a polyurethane arterial cathetermolded to a winged catheter juncture hub. An extension tubing segmentis molded to the proximal end of the winged catheter hub. The proximalend of the extension tubing segment is molded to a luer-locking hub. Aslide clamp is provided on the extension segment. |
| Intended use of the device: | The Arrow Seldinger arterial catheterization devices permit access to theperipheral arterial circulation or to other small vessels. |
| Technologicalcharacteristics: | The proposed arterial catheterization devices use the same fundamentaltechnology as the predicate arterial catheterization device. |
| Performance tests: | Verification and validation testing to support safety and efficacyincluded the following:- Needle penetration - Component compatibility- Leak test - Package integrity- Tensile test - Pull testing |
| Conclusions: | The results of verification testing demonstrate substantial equivalence ofthe Arrow Seldinger Arterial Catheterization device to the legallymarketed predicate Arrow Radial Artery Catherization device. Thedifferences between the proposed and predicate devices do not raise newissues of safety and effectiveness. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles, possibly suggesting care and community. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Arrow International, Inc. c/o Ms. Christine Ford Sr. Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605
DEC 1 8 2009
Re: K093050
Arrow Seldinger Arterial Catheterization Devices Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY, DQX Dated: November 25, 2009 Received: November 27, 2009
Dear Ms. Ford:
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 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. Christine Ford
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Duma R. Vainer
A~Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
| Indications for Use Statement | |
|---|---|
| 510(k) Number (if known) | K093050 |
| Device Name | Arrow ® Seldinger Arterial Catheterization Devices |
| Indications for Use | The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels. |
Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use __________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093050
·
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).