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.

AI/ML Overview

This 510(k) summary describes a medical device, the Bistech Dual-Lumen Catheter, submitted for clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-powered devices.

Instead, this document is an Abbreviated 510(k) for a conventional medical device. The "Safety and Performance" section explicitly states: "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."

This means the device's "performance" and "safety" are demonstrated by its conformity to an established consensus standard (ISO 10555-1;1999) rather than a specific clinical performance study with acceptance criteria. The clearance is based on substantial equivalence to predicate devices.

Therefore, many of the requested details, such as sample size for test sets, expert ground truth, MRMC studies, and standalone performance, are not applicable or provided in this type of submission.

Here's a breakdown of the available information, noting what is not present:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly stated as numerical performance metrics with acceptance criteria in this document. Instead, the device performance is demonstrated by its compliance with the ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters standard and its substantial equivalence to predicate devices, based on various product features.

The table {1} compares the Bistech Dual-Lumen Catheter's features to predicate devices. This comparison implicitly shows that the physical characteristics and intended use are similar, implying comparable performance.

Product Feature	Bistech Dual-Lumen Catheter (current submission)	Predicate Devices (Average/Range) Implicit Performance
Outer Diameter	1.7 mm	1.8 mm - 2.6 mm (similar range)
Working Length	100 cm	105 cm - 150 cm (similar range)
# of Lumens	Two	One or Two (similar design)
Design	Dual-lumen catheter	Various (dual-lumen, single lumen, etc. with similar function)
Packaging	Tyvek/Plastic Pouch	Tyvek/Plastic Pouch (identical)
Sterile/Non-Sterile	Sterile	Sterile (similar, some components of predicates may be non-sterile)
Single Use/Reusable	Single Use	Single Use (similar, some components of predicates may be reusable)
Anatomical Sites of Use	Tracheobronchial tree	Tracheobronchial tree (identical)
Indications for Use	To deliver fluids into or withdraw fluids from the lung	Similar (e.g., aspirate tissue/cells, mini-bronchoalveolar lavage)

Acceptance Criteria: Conformity to ISO 10555-1;1999 (Amendment 1). The document states: "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." This standard sets the performance and safety benchmarks for this type of device. Specific quantitative acceptance criteria or results are not listed in this summary, as the submission relies on adherence to this recognized standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This submission relies on compliance with a consensus standard and comparison to predicate devices, not on a clinical performance study with a test set in the traditional sense for AI/ML devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No clinical ground truth derivation is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is a conventional medical device (catheter), not an AI/ML device, so no MRMC study or human reader improvement analysis would be relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. The "ground truth" for this device's safety and effectiveness is its adherence to the ISO 10555-1;1999 standard and its substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable/Not provided. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. No training set or ground truth for a training set is relevant to this device submission.

Summary

{0}------------------------------------------------

510(k) Summary

JAN 1 0 2003

Trade Name:	Dual-Lumen Catheter
Sponsor:	Bistech, Inc.10A Roessler RoadWoburn, MA 01801Registration # 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 TransbronchialAspiration Needle	K963252	Boston Scientific –Microvasive
Combicath DoublePlugged TelescopingCatheter	K974632	Plastimed

Product Description:

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}------------------------------------------------

ProductFeature	Bistech Dual-Lumen Catheter(currentsubmission)	OlympusAspirationNeedle Set(510(k) #unknown)	BSC-MicrovasiveStifcorTransbronchialAspiration Needle(K963252)	PlastimedCombicathDouble PluggedTelescopingCatheter(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 metalliccoil sheath;single-usedisposable needle	Extendable coaxialneedle withinsingle lumencatheter	Dual-lumencatheter with distalpolyethylene glycolplug
Packaging	Tyvek/Plastic Pouch	Tyvek/PlasticPouch	Tyvek/PlasticPouch	Tyvek/PlasticPouch
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 Sitesof Use	Tracheobronchialtree	Tracheobronchialtree	Tracheobronchialtree	Tracheobronchialtree
Indications forUse	To deliver fluidsinto or withdrawfluids from the lung	To aspirate tissueand cells from therespiratory organs	Bronchialaspiration	Mini-bronchoalveolarlavage; collectionof bronchoalveolarsamples

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)

Over-the -Counter Use

Keven Baker

(Division Sian-C Division of Ophthalmic Nose and Throat Devi

5(i)(k) Number. K024165

000007

Regulation Number and Section

§ 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.