(264 days)
Reprocessed guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
Reprocessed guidewires are constructed utilizing a metal alloy that is encapsulated in a striped covering and contains a radiopaque tip. The guidewires are manufactured in a wide range of diameters, lengths, tip angles, and stiffness.
This document is a 510(k) clearance letter from the FDA for reprocessed guidewires. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to predicate devices. It does not contain the detailed information needed to answer your questions about acceptance criteria and a specific study proving the device meets those criteria.
Here's a breakdown of why I cannot fully answer your request based on the provided text:
- No detailed acceptance criteria or performance study: The document states that "Reprocessed guidewires underwent bench testing to demonstrate appropriate functional characteristics" and that "Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging." However, it does not provide specific acceptance criteria, performance metrics, or the results of these tests. It only concludes that the device is "substantially equivalent."
- Focus on substantial equivalence, not detailed performance: The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving absolute safety and effectiveness through detailed studies with predefined acceptance criteria and performance reports in the same way a PMA (Premarket Approval) process would.
Therefore, I cannot provide the requested table or answer most of your detailed questions.
What I can infer or state based on the document:
- Device Name: Reprocessed Guidewire
- Intended Use: For selective cannulization of the biliary ducts (common bile, cystic, right and left hepatic ducts) during endoscopic biliary procedures for catheter introduction and exchanges.
- Predicate Devices: Jagwire™ guidewire (K922302) by Microvasive, and FlexFinder® Guidewire (K964955) by FlexMedics.
- Regulatory Clearance: 510(k) (K012556)
- Testing Mentioned (without details): Bench testing for functional characteristics, process validation for cleaning, sterilization, and packaging, and in-process visual and functional testing.
The information you requested that is not in the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details (effect size, human readers improvement).
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this specific information, you would typically need access to the full 510(k) submission, which includes detailed test reports and validation studies not summarized in this clearance letter.
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NOV 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bruce Lester, Ph.D. Vice President, Research and Development SterilMed, Inc. 11400 73td Avenue North MINNEAPOLIS MN 55369
Re: K012556 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: NML Dated: April 12, 2002 Received: April 16, 2002
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on April 29, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Page 2 - Bruce Lester, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Bruce Lester, Ph.D.
Attachment - Reprocessed Guidewires (KO12556)
.
Microvasive ર્સ્ટર્ રહરક ર્ક્ડકે રહ્મ્ડ્ રસ્રા રસ્વર રહ્ણ્ડ ડ્લ્લ્વ રસ્વર રસ્સ્સ્
.
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Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Guidewire
Indications For Use:
Reprocessed guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
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)
Nancy C Brogdon
Division Sign Off
(Division Sign-Off Division of Reproduct and Radiological Devi 510(k) Number
Page 1 of
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APR 2 9 2002
SECTION 2. SUMMARY AND CERTIFICATION
Ph: 888-856-4870 Fax: 763-488-3350
Reprocessed Guidewire
Guidewire
FGE & KOG
510(k) Summary A.
SterilMed, Inc. Submitter: Patrick Fleischhacker Contact Person: 11400 73rd Avenue North Minneapolis MN, 55369
August 6, 2001 Date Prepared:
Trade Name:
Classification Name: and Number:
Product Code:
Predicate Device(s):
Device Description:
Intended Use:
The reprocessed guidewire is substantially equivalent to the Jagwire™ guidewire (K922302) manufactured by Microvasive, and the FlexFinder® Guidewire (K964955) manufactured by FlexMedics.
Reprocessed guidewires are constructed utilizing a metal alloy that is encapsulated in a striped covering and contains a radiopaque tip. The guidewires are manufactured in a wide range of diameters, lengths, tip angles, and stiffness.
Class II, 21CFR §876.5010 & 21CFR §876.1500
Reprocessed guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
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Functional and Safety Testing:
Conclusion:
Representative samples of reprocessed guidewires underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
The reprocessed guidewire is substantially equivalent to the Jagwire™ guidewire (K922302) manufactured by Microyasive, and the FlexFinder® Guidewire (K964955) manufactured by FlexMedics.
This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and methods of construction.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.