(79 days)
No
The summary describes a mechanical device for arterial access and does not mention any AI/ML components or functions.
No
The device is described as permitting access to the peripheral arterial circulation or other small vessels, indicating it is an access device, not one that treats a disease or condition.
No
The description states its purpose is to "permit access to the peripheral arterial circulation or to other small vessels," indicating it is a device for access, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like needles, wire guides, and catheters, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the peripheral arterial circulation or to other small vessels." This describes a device used in vivo (within the body) for accessing blood vessels.
- Device Description: The components (needle, wire guide, catheter) are all designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health.
IVD devices are specifically designed for testing samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is for accessing the circulatory system directly.
N/A
Intended Use / Indications for Use
The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
Product codes
DQY, DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial circulation or to other small vessels
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
Verification and validation testing to support safety and efficacy included the following: - Needle penetration - Component compatibility - Leak test - Package integrity - Tensile test - Pull testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
1/09 30 56
510(k) Summary
| DEC 1 8 2009 | |
|---|---|
| Submitter: | ARROW International, Inc. |
| 2400 Bernville Road | |
| Reading, PA 19605-9607 USA | |
| Contact person: | Christine Ford, Sr. Regulatory Affairs Specialist |
| Phone: 610-378-0131, ext. 3338 | |
| Fax: 610-478-3128 | |
| Email: 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 870.1250 |
| Class II, DQX, Wire, Guide, Catheter, 21 CFR 870.1330 | |
| Legally marketed device to which the device is | |
| substantially equivalent: | Arrow Radial Artery Catheterization Set, K810675 |
| Description of the device: | 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. | |
| Intended use of the device: | The Arrow Seldinger arterial catheterization devices permit access to the |
| peripheral arterial circulation or to other small vessels. | |
| Technological | |
| characteristics: | The proposed arterial catheterization devices use the same fundamental |
| technology as the predicate arterial catheterization device. | |
| Performance tests: | Verification and validation testing to support safety and efficacy |
| included the following: |
- Needle penetration - Component compatibility
- Leak test - Package integrity
- Tensile test - Pull testing |
| Conclusions: | The results of verification testing demonstrate substantial equivalence of
the Arrow Seldinger Arterial Catheterization device to the legally
marketed predicate Arrow Radial Artery Catherization device. The
differences between the proposed and predicate devices do not raise new
issues of safety and effectiveness. |
.
.
1
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.
2
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
3
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
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