(37 days)
The Seldinger Safety Needle Introducer incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to introduce a guidewire (.018 inches maximum) into the vascular system.
Not Found
This document is a 510(k) clearance letter for a medical device called the "Seldinger Safety Needle Introducer." It is a regulatory document from the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance.
The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification... 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." This indicates that the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating performance against specific acceptance criteria.
Thus, the requested details such as:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size and ground truth establishment for the training set
cannot be found in this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HDC Corporation c/o Earl Smart Quality Assurance Manager 628 Gibraltar Court Milpitas. CA 95035
Re: K032404 Seldinger Safety Needle Introducer Regulation Number: 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: July 25, 2003 Received: August 11, 2003
Dear Mr. Smart:
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 - Mr. Earl Smart
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 (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 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) 594-4646. 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) you may obtain. 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 yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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| Indications for Use Statement | |
|---|---|
| 510(k) Number | K 032404 |
| Device Name | Seldinger Safety Needle Introducer |
| Indications for Use | The Seldinger Safety Needle Introducer incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to introduce a guidewire (.018 inches maximum) into the vascular system. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
, i
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
N.Q. Certu
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K032404
017
:
§ 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).