(24 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms. The submission is an Abbreviated 510(k) based on conformity to a standard for catheters, further indicating a non-AI/ML device.
No
The device is described as a catheter used to deliver or withdraw fluids from the lung, which is a diagnostic or procedural aid rather than directly treating a condition.
No
The device description and intended use indicate that it is used for delivering or withdrawing fluids, which are therapeutic or interventional actions, not diagnostic ones. There is no mention of analysis, measurement, or identification of a condition.
No
The device description clearly outlines a physical catheter with lumens, a stylette, and luer hubs, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver fluids to or withdraw fluids from the lung" using a bronchoscope. This describes a procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a catheter designed for insertion into the body (via a bronchoscope). This is characteristic of a medical device used for intervention or access, not for analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
The device is clearly intended for use within the patient's body during a medical procedure.
N/A
Intended Use / Indications for Use
The Dual-Lumen Catheter is intended for use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.
Product codes
EOQ
Device Description
The proposed device consists of a two-lumen catheter with proximal bifurcation and luer hubs. The device will be supplied with a removable stylette in one of the lumens that is intended to provide support and prevent kinking as the catheter is inserted through the working channel of a bronchoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheobronchial tree
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
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Bistech, Inc. has provided information to demonstrate conformity with the following FDA-recognized consensus standard: ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) Summary
JAN 1 0 2003
| Trade Name: | Dual-Lumen Catheter |
|---|---|
| Sponsor: | Bistech, Inc. |
| 10A Roessler Road | |
| Woburn, MA 01801 | |
| Registration # not yet assigned |
Device Generic Name: Multi-Lumen Catheter
Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.
Predicate Devices:
| Product Name | 510(k) # | Manufacturer |
|---|---|---|
| Aspiration Needle Set | Unknown | Olympus |
| Stifcor Transbronchial | ||
| Aspiration Needle | K963252 | Boston Scientific – |
| Microvasive | ||
| Combicath Double | ||
| Plugged Telescoping | ||
| Catheter | K974632 | Plastimed |
Product Description:
The proposed device consists of a two-lumen catheter with proximal bifurcation and luer hubs. The device will be supplied with a removable stylette in one of the lumens that is intended to provide support and prevent kinking as the catheter is inserted through the working channel of a bronchoscope.
Indications for Use:
The Dual-Lumen Catheter is intended for use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Bistech, Inc. has provided information to demonstrate conformity with the following FDA-recognized consensus standard:
- . ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters
Conclusion:
Based on its indications for use, technological characteristics, and comparison to predicate devices, the Dual-Lumen Catheter has been shown to be safe and effective for its intended use.
1
| Product
Feature | Bistech Dual-
Lumen Catheter
(current
submission) | Olympus
Aspiration
Needle Set
(510(k) #
unknown) | BSC-Microvasive
Stifcor
Transbronchial
Aspiration Needle
(K963252) | Plastimed
Combicath
Double Plugged
Telescoping
Catheter
(K974632) |
|----------------------------|---------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Outer Diameter | 1.7 mm | 1.85 mm | 1.8 mm | 2.6 mm |
| Working Length | 100 cm | 105 cm | 150 cm | Unknown |
| # of Lumens | Two | One | One | Two |
| Design | Dual-lumen catheter | Reusable metallic
coil sheath;
single-use
disposable needle | Extendable coaxial
needle within
single lumen
catheter | Dual-lumen
catheter with distal
polyethylene glycol
plug |
| Packaging | Tyvek/Plastic Pouch | Tyvek/Plastic
Pouch | Tyvek/Plastic
Pouch | Tyvek/Plastic
Pouch |
| Sterile/
Non-Sterile | Sterile | Non-sterile
(reprocessable)
sheath;
Sterile needle | Sterile | Sterile |
| Single Use/
Reusable | Single Use | Reusable sheath;
Single use needle | Single Use | Single Use |
| Anatomical Sites
of Use | Tracheobronchial
tree | Tracheobronchial
tree | Tracheobronchial
tree | Tracheobronchial
tree |
| Indications for
Use | To deliver fluids
into or withdraw
fluids from the lung | To aspirate tissue
and cells from the
respiratory organs | Bronchial
aspiration | Mini-
bronchoalveolar
lavage; collection
of bronchoalveolar
samples |
Substantial Equivalence: Bistech Dual-Lumen Catheter
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures or lines representing people.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2003
Bistech, Inc. c/o Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K024165
Trade/Device Name: Bistech Dual-Lumen Catherer Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: December 5, 2002 Received: December 17, 2002
Dear Ms. Papineau:
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
3
Page 2 - Pamela Papineau, RAC
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) 594-4613. 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,
A. Joseph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bistech, Inc. Abbreviated 510(k) Premarket Notification
December 5, 2002 Dual-Lumen Catheter
Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Dual-Lumen Catheter
Indications for Use:
For use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use
Keven Baker
(Division Sian-C Division of Ophthalmic Nose and Throat Devi
5(i)(k) Number. K024165
000007