(109 days)
To facilitate the placement of devices used during diagnostic and interventional procedures.
The proposed device is a silicone coated stainless steel guidewire. It consists of a coiled wire around a solid stainless steel core wire. The internal core wire is secured at both ends to the outer core wire. These guidewires are used to place intravascular catheters.
The provided submission K041740 is for a Silicone Coated Guidewire, a medical device. This type of device does not involve AI or algorithms, and therefore, many of the requested fields are not applicable. The device's performance is demonstrated through traditional engineering and material science tests rather than studies involving human readers or ground truth established by experts in an AI context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance tests conducted to demonstrate substantial equivalence to a predicate device. It doesn't explicitly state numerical acceptance criteria, but implies that the new device's performance met the standards set by the predicate device for each test.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Substantially equivalent to predicate device performance. | Demonstrated substantial equivalence. |
| Catheter Compatibility | Substantially equivalent to predicate device performance. | Demonstrated substantial equivalence. |
| Coating Durability/Lubricity | Substantially equivalent to predicate device performance. | Demonstrated substantial equivalence. |
| Flexing Test | Substantially equivalent to predicate device performance. | Demonstrated substantial equivalence. |
| Fracture Test | Substantially equivalent to predicate device performance. | Demonstrated substantial equivalence. |
| Tip Flexibility | Substantially equivalent to predicate device performance. | Demonstrated substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the 510(k) summary. For physical medical devices like guidewires, "test set" typically refers to the number of units tested for mechanical properties, not a dataset in an AI context. The tests are laboratory-based, not involving patient data.
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. This device is a physical medical device, not an AI/algorithm-based diagnostic tool. Ground truth is established through physical measurements and engineering standards, not expert assessments of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective interpretations, often in AI or clinical trial settings. The performance tests for a guidewire are objective engineering tests.
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:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for a physical medical device like this is based on engineering specifications, material science properties, and established performance benchmarks for similar predicate devices. For example, tensile strength would be measured against a required specification, not an expert's opinion.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical guidewire.
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510(k) Premarket Notification
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
|---|---|
| Contact person: | Suzanne SchorleRegulatory Affairs AssociatePhone: 610-378-0131, ext. 3443Fax: 610-478-3167Email: suzanne.schorle@arrowintl.com |
| Date summary prepared: | June 24, 2004 |
| Device trade name: | Silicone Coated Guidewire |
| Device common name: | Silicone Coated Guidewire |
| Device classification name: | Guidewire |
| Legally marketed devices towhich the device issubstantially equivalent: | K905581 Lake Region Mfg. Silicone Coated Guidewire |
| Description of the device: | The proposed device is a silicone coated stainless steelguidewire. It consists of a coiled wire around a solidstainless steel core wire. The internal core wire is securedat both ends to the outer core wire. These guidewires areused to place intravascular catheters. |
| Intended use of the device: | The Arrow guide wire will be used to facilitate theplacement of catheters during diagnostic andinterventional procedures. |
| Technologicalcharacteristics: | The proposed guidewires have the same technologicaldesign characteristics as the predicate devices. |
| Performance tests: | The following tests were performed to demonstratesubstantial equivalence:• Tensile Strength• Catheter Compatibility• Coating Durablity/Lubricity• Flexing Test• Fracture Test• Tip Flexibility |
| Conclusions: | The results of the laboratory tests demonstrate that theguidewires are substantially equivalent to the legallymarketed predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
OCT 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arrow International c/o Ms. Suzanne Schorle Regulatory Affairs Associate 2400 Bernville Road Reading, PA 19605
Re: K041740
Trade/Device Name: Silicone Coated Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 2, 2004 Received: September 3, 2004
Dear Ms. Schorle:
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 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
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Page 2 - Ms. Suzanne Schorle
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. product rainell 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 premarked 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 (240) 276-0120. 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,
Donna R. Lachner
6/\ 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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Silicone Coated Guidewire 4. - - - - - - - - - - -
| SECTION 3.0 INDICATIONS FOR USE STATEMENT | |
|---|---|
| 510(k) Number: | K041740 |
| Device Name: | Silicone Coated Guidewire |
To facilitate the placement of devices used during diagnostic Indications for Use: and interventional procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
una R. bochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K041740
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.