(70 days)
The .035 LOC Guide Wire Extension is intended to provide the necessary length to allow the exchange of one catheter for another while maintaining the position of the guide wire in the artery. After the catheter exchange has been completed, the extension can be detached and the initial wire can be used as a conventional guide wire.
The Abbott branded .035 LOC Guide Wire Extension is 0.035" nominal in diameter and 115 cm long. The distal end consists of a stainless steel hypotube that is attached to a 0.0197" core wire. The proximal end is coated with a polyethylene (PE) jacket. Silicon is used to coat the entire length of the polyethylene tubing.
This 510(k) submission (K083713) is for a "Special 510(k)," which indicates that the device being submitted is a modification of a legally marketed device and that the modifications do not affect its safety or effectiveness. In such cases, extensive new performance studies are often not required if substantial equivalence to the predicate device can be demonstrated through other means.
Therefore, the submission you provided does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, data provenance, expert qualifications, adjudication methods, or MRMC studies.
Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device based on:
- Identical Intended Use: The device performs the same function.
- Identical Operating Principle: The mechanism of action is unchanged.
- Identical Guide Wire Design: The fundamental design of the guide wire remains the same.
- Identical Manufacturing Processes: The methods of production are consistent.
- Identical Materials: The components are made from the same materials (excluding packaging and labeling).
- Identical Shelf Life: The product's stability duration is the same.
- Identical Sterilization Method: The sterilization procedure is unchanged.
The only changes identified are to branding, packaging, and labeling. These types of changes are generally considered not to impact the fundamental performance or safety of the device itself.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study to prove it, as the provided document does not contain this type of performance data.
The document states: "No changes were made that could impact product performance. Only branding, packaging and labeling are affected by this submission." This statement is the core of the justification for substantial equivalence in this Special 510(k) submission, rather than a detailed performance study with acceptance criteria.
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FEB 2 3 2009
Attachment 2 - 510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
Submitter's Information
Abbott Vascular (351931722) 3200 Lakeside Drive Santa Clara, CA 95054
Phone: 951-914-3311 Fax: 951-914-0339
Contact Person
Nadine Smith, Regulatory Affairs Associate
Date Prepared
December 12, 2008
Device Information
Trade Name: .035 LOC Guide Wire Extension Common Name: Wire, guide, catheter Device Classification: Class II
Summary of Substantial Equivalence
The subject device, Abbott branded LOC Guide Wire Extension is the same devices as the predicate device, Mallinckrodt branded LOC Guide Wire Extension 115cm (which is manufactured by Abbott Vascular for distribution through Conidian/Mallinckrodt Medical, Inc.)
- Same intended use, 0
- Same operating principle, ಂ
- o Same guide wire design,
- O Same manufacturing processes.
- 0 Same materials (excluding packaging and labeling),
- 0 Same shelf life.
- Same sterilization method. o
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Device Description
The Abbott branded .035 LOC Guide Wire Extension is 0.035" nominal in diameter and 115 cm long. The distal end consists of a stainless steel hypotube that is attached to a 0.0197" core wire. The proximal end is coated with a polyethylene (PE) jacket. Silicon is used to coat the entire length of the polyethylene tubing.
Summary of Changes to Previously Cleared Device
Abbott Branding and labeling changes include:
- O IFU changed to: 40# Opaque Offset Insheet Style
- Label change to: 50# Transfer CIS with adhesive backing ତ
- Addition of a chipboard box (5 pouched guide wires in a box) ರ
- ·Addition of Scotch Tape 600 for sealing chipboard box 0
Intended Use:
Attachment of the LOC Guide Wire Extension to the Hi-Torque Guide Wire creates an extended length guide wire for the exchange of catheters.
Summary of Technological Characteristics Compared to Predicate Device:
No changes were made that could impact product performance. Only branding, packaging and labeling are affected by this submission.
Special 510(k) LOC Guide Wire Extension
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three talons, representing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591
FEB 2 3 2009
Re:
Trade/Device Name: . 035 LOC Guide Wire Extension Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: February 3, 2009 Received: February 4, 2009
Dear Ms. Smith:
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. Nadine Smith
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufaçturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
buna R. Vochner
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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Indications for Use Statement
510(k) Number (if known): K083713
Device Name: . . 035 LOC Guide Wire Extension
Indications for Use:
The .035 LOC Guide Wire Extension is intended to provide the necessary length to allow the exchange of one catheter for another while maintaining the position of the guide wire in the artery. After the catheter exchange has been completed, the extension can be detached and the initial wire can be used as a conventional guide wire.
Prescription Use XX (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dume R. V. Ames
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_k083713
§ 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.