(30 days)
No
The device description focuses on mechanical components and fluoroscopic guidance, with no mention of AI, ML, or related concepts.
No.
The device facilitates the placement and positioning of other devices (guide wires/catheters) within the peripheral vasculature. It does not directly treat a disease or condition.
No
The device is described as facilitating placement and positioning of guidewires/catheters and does not mention any diagnostic functions such as identifying or assessing a disease or condition.
No
The device description clearly outlines a physical catheter with multiple components (guide tip, deployment shaft, catheter shaft, deployment handle, control knob, nosecone) and describes mechanical actions (proximal retraction, advancement). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Outback® Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Outback® Catheter Function: The description clearly states the Outback® Catheter is used to facilitate the placement and positioning of guide wires and catheters within the peripheral vasculature. It is an invasive device used directly on the patient's circulatory system.
- No Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and procedural within the body.
Therefore, the Outback® Catheter falls under the category of a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Outback® Catheter is intended to facilitate placement and positioning of guide wires / catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.
Product codes
DQY
Device Description
The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved ip is positioned coaxially within the nosecone. In this configuration the catherer may be tracked over a guide wire to the sclected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance.
Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance.
Anatomical Site
peripheral vasculature. Not intended for use in the coronary or cerebral vasculature.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
3. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | TBD K043534 |
|---|---|
| ---------------- | ------------- |
Applicant Information:
- Date Prepared: December 20, 2004
Name: LuMend, Inc. Address: 400 Chesapeake Drive Redwood, CA. 94063 Office: 650-364-1400
| Contact Person: | Michael A. Daniel |
|---|---|
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | (925) 254-5187 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Outback® Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Devices:
The Outback® Catheter is substantially equivalent in intended use and method of operation to the following predicate devices:
LuMend Outback® Catheter cleared via 510(k) K040771 on 4/23/04 and K032298 on 8/26/03
Device Description:
The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved ip is positioned coaxially within the nosecone. In this configuration the catherer may be tracked over a guide wire to the sclected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance.
LuMend, Inc. Outback Catheter 510(k) Submission. December 20, 2004
1
Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.
Intended Use:
The Outback® Catheter is intended to facilitate placement and positioning of guide wires / catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.
Comparison to Predicate Device(s):
The LuMend Outback® Catheter is very similar to the previously cleared LuMend Outback Catheter cleared via 510(k) K0407771. A few minor changes have been made (see detailed device description), however, the principle of operation, intended use, fundamental design, and function of the product remains basically the same. Additional material options have been added. This version of the Outback® Catheter is clearly substantially equivalent to the previously cleared Outback device.
Summary:
Based upon the indication for use and the design and engineering data provided in this premarket notification, the Outback® Catheter has been shown to be substantially equivalent to a currently marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LuMend, Inc. c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, CA 94063
Re: K043534
Trade Name: Outback® Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 20, 2004 Received: December 22, 2004
Dear Mr. Daniel:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 910(x) premantee nearly equivalent (for the indications referenced above and nave uctchined the acresed predicate devices marketed in interstate for use stated in the encrosure) to regary manatism of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactified in accordance with the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the United devices that have been recured in accordance while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or of the and Cosment Act (Act) that do not require appro the seneral controls provisions of the Act. The You may, therefore, market the devreet, books requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (Sec above) into ettier on a or regulations affecting your device can be may be subject to such additional controls. Extrong may on 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
3
Page 2 – Mr. Michael A. Daniel
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issualled of a babevice complies with other requirements of the Act that FDA has made a determination that your stered by other Federal agencies. You must of any rederal statutes and regalations and admited to: registration and listing (21 comply with an the Act 3 requirements, moraling, were and acturing practice requirements as set a CFK Part 807), adomig (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (sveting your device as described in your Section 510(k) This letter with anow you to begin maxical equivalence of your device to a legally premaired notineadon. The PDF mailing sification 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 If you desire specific davice 10. Jour as 1) 594-4646. Also, please note the regulation entitled, connact the Office of Comphanes as (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Diana R. Vachner
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a combination of letters or a unique design. The character is drawn with curved lines and has a flowing, interconnected structure.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K043534
Qutback® Catheter Device Name:
Indications For Use:
The Outback® Catheter is intended to facilitate placement and positioning of guide wires/ The Outback "Catherer is Inchieva to laciniano provinces "Catheter is not intended for use in the coronary or cerebral vasculature.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Dma D. bachner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K04 3534
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