(32 days)
No
The device description focuses on mechanical components and there is no mention of AI, ML, image processing, or data sets for training/testing.
No.
The intended use of the device is to facilitate placement and positioning of other medical devices (guide wires/catheters) within the peripheral vasculature, not to treat a disease or condition itself.
No
The device's intended use is to facilitate the placement and positioning of guidewires/catheters, not to diagnose a medical condition.
No
The device description clearly outlines multiple physical components (catheter shaft, guide, RHV, deployment handle) which are hardware elements, not software.
Based on the provided information, the Outback® Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate placement and positioning of guide wires/ catheters within the peripheral vasculature." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a catheter with a guide, shaft, valve, and handle. These are components of a medical device used for interventional procedures, not for analyzing biological samples.
- Anatomical Site: The device is intended for the "peripheral vasculature," which is a part of the human body. IVD devices typically analyze samples taken from the body (like blood, urine, tissue).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
In summary, the Outback® Catheter is a medical device used for a therapeutic or procedural purpose within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Outback® Catheter is intended to facilitate placement and positioning of guidewires/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 comprised of four primary elements: 1) guide 2) catheter shaft 3) rotating hemostasis valve (RHV) and 4) deployment handle or control knob. The guide is a single-lumen, steel braided polyimide shaft that can be extended or retracted by the control knob. The tubular catheter shaft houses this guide and is also steel braided polyimide in composition. The rotating hemostasis valve (RHV) has two functions: a one way valve allows for flushing of the catheter while a locking hub at the proximal end of the RHV controls the retracted position of the guide. The fourth component is the deployment handle/control knob that is used to extend or retract the guide. This control knob also functions as a port with a luer fitting for flushing of the guide wire lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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
Not Found
Key Metrics
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
2. 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 |
|---|---|
| ---------------- | ----- |
Applicant Information:
| Date Prepared: | July 23, 2003 |
|---|---|
| ---------------- | --------------- |
| 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:
Abbott Laboratories Outback® Catheter (K001577) Abbott Laboratories Outback® Catheter (K014117)
Device Description:
The Outback catheter is comprised of four primary elements: 1) guide 2) catheter shaft 3) rotating hemostasis valve (RHV) and 4) deployment handle or control knob. The guide is a single-lumen, steel braided polyimide shaft that can be extended or retracted by the control knob. The tubular catheter shaft houses this guide and is also steel braided polyimide in composition. The rotating hemostasis valve (RHV) has two functions: a one way valve allows for flushing of the catheter while a locking hub at the proximal end of the RHV controls the retracted position of the guide.
1
The fourth component is the deployment handle/control knob that is used to extend or retract the guide. This control knob also functions as a port with a luer fitting for flushing of the guide wire lumen.
Intended Use:
The Outback Catheter is intended to facilitate placement and positioning of guidewires/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 essentially identical to the Abbott Laboratories Outback® Catheter (K014117). This Abbott device was originally cleared via 510(k) K001577. After LuMend's reacquisition of the Outback® Catheter from Abbott, a few minor changes have been made (see detailed device description below). However, the principle of operation, intended use, design, materials, and function of the product remains virtually unchanged. This version of the Outback Catheter is clearly substantially equivalent to the aforementioned predicate devices.
Summary:
Based upon the indication for use and the design and engineering data provided in this pre-market notification, the Outback® Catheter has been shown to be substantially equivalent to a currently marketed predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, composed of three curved lines that suggest movement and wings. The bird is encircled by text that follows the curve of the circle. The text is somewhat blurred, making it difficult to read the exact words.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2003
LuMend, Inc. c/o Mr. Michael A. Daniel 400 Chesapeake Drive Redwood, CA 94063
Re: K032298
Outback® Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 23, 2003 Received: July 25, 2003
Dear Mr. Daniel:
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.
3
Page 2 - Ms. Lynn Jensen
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 (OS) 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. 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,
Brian D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. INDICATIONS FOR USE FORM
11 032298 TBD 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Outback® Catheter Device Name:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Utility Exams
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032298
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)