The Blowfish™ Transbronchial Micro-Infusion Catheter is intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or bronchial delivery into selected and sub-selected regions of the airway tree.

Device Description

The Blowfish™ Transbronchial Micro-Infusion Catheter is a bronchoscope guided, single-operator, catheter that consists of a microscopic, tapered stainless steel infusion port, a semi-rigid/semi-elastic polymer balloon, a composite metal and polymer catheter shaft, a pressure relief valve and a proximal hub with standard luer attachment fittings. The device is designed to be advanced through a bronchoscope to a target location in the tracheobronchial three and inflated to move the micro-infusion port into the airway wall to deliver therapeutics to the bronchial tissue including the bronchial adventitia.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blowfish Transbronchial Micro-Infusion Catheter:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report or a direct description of acceptance criteria for a new AI/software device. Therefore, many of the requested categories for AI/software device evaluation (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable or explicitly stated for this type of medical device submission.

The "acceptance criteria" discussed in this document refer to the device meeting its mechanical performance requirements and biocompatibility standards for demonstrating substantial equivalence to a predicate device. It's a different type of evaluation than what's typically performed for a diagnostic AI algorithm.

Acceptance Criteria and Device Performance for Blowfish Transbronchial Micro-Infusion Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Source of Criteria / Standard Met	Reported Device Performance
Mechanical & Fluid Delivery Performance	"Product specification"	"All tests met the pre-determined acceptance criteria." (Specific details of the criteria and corresponding performance values are not provided in this summary.)
Packaging & Labeling Testing	(Implied regulatory requirements)	"All tests met the pre-determined acceptance criteria." (Specific details not provided.)
Shelf-Life Testing	(Implied regulatory requirements)	"All tests met the pre-determined acceptance criteria." (Specific details not provided.)
Biocompatibility	ISO 10993-1: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity	"was previously conducted with a legally marketed device (K062752)" and for the Blowfish, "materials included... were tested and demonstrated to be biocompatible and safe." (Specific test outcomes not detailed, but conformance to standard is asserted.)
In-vivo Safety (Porcine Model)	(Implied safety endpoints)	"Test results indicated that the catheter's materials, mode of action and procedure... are safe and do not raise different questions of safety and effectiveness compared to the predicate device." (No specific quantitative performance metrics provided; general statement of safety.)
Sterility	SAL 10-6	Sterile (SAL 10-6)
Single Use	(Design specification)	Yes
Target Diameter (Balloon)	(Design specification)	6.0 mm to 16.0 mm
Max Inflation Pressure (Balloon)	(Design specification)	2 atm controlled by pressure relief valve
Bronchoscope Channel ID	(Compatibility specification)	2.8 mm
Length	(Design specification)	Up to 145 cm

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in the summary. The performance data section refers generally to "bench, in vitro and in vivo animal studies" without providing specific subject counts for each test.
Data Provenance:
- Bench (laboratory, in vitro) studies.
- In vivo animal studies using a porcine model.
- No mention of human clinical data or geographical origin of data for these specific tests. The biocompatibility data references a previous 510(k) (K062752) for another device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a catheter, not a diagnostic algorithm. Therefore, there is no "ground truth" established by experts in the context of diagnostic interpretation. The evaluation is focused on engineering performance, material safety, and in-vivo physiological effects in an animal model.

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

Not Applicable. As above, no diagnostic "ground truth" requiring adjudication.

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. This is a hardware device, not an AI or diagnostic software.

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

Not Applicable. This is a hardware device, not an AI or diagnostic software.

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

Not Applicable / Reinterpreted: The "ground truth" for this device's evaluation is primarily established by:
- Engineering specifications: For mechanical and fluid delivery performance (e.g., meeting specific pressure, diameter, length requirements).
- Regulatory standards: For biocompatibility (ISO 10993-1).
- Physiological safety: Observed outcomes in the porcine animal model to ensure the device's interaction with tissue is safe and does not raise new safety concerns compared to the predicate.

8. The sample size for the training set:

Not Applicable. This device uses traditional engineering and biological testing, not machine learning, so there is no "training set."

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

Not Applicable. (See #8)

Summary

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KI 31401

510(k) Notification Blowfish Transbronchial Micro-Infusion Catheter

JUL 0 2 2013

5. 510(K) SUMMARY

510(k) Applicant Mercator MedSystems, Inc. 1670 Alvarado Suite # 4 San Leandro, CA 94577 Telephone: (510) 614-4550 Facsimile: (510) 614-4560

Contact Person:	Plamena Entcheva-Dimitrov, PhD, RAC
Phone:	(510) 614-4550
Facsimile:	(510) 614-4560
Email:	ped@mercatormed.com
Date of Summary:	27 June 2013
Device Overview
Trade Name:	Blowfish™ Transbronchial Micro-Infusion Catheter
Common Name:	Transbronchial Catheter
Classification:	Bronchoscope (flexible or rigid) and Accessories21 CFR 874.4680Product Code EOQ
Panel:	ENT

Predicate Devices

510(k) Number	Product Name	Manufacturer
K962901	Olympus B5-2C/B7-2CBalloon Catheter	Olympus

Device Description

Intended Use

Bronchoscope accessories in the airway tree for medicine infusion.

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510(k) Notification

Blowfish Transbronchial Micro-Infusion Catheter

Indications for Use

Comparison to Predicate Device

The Blowfish Transbronchial Micro-Infusion Catheter is substantially equivalent to the predicate. The Blowfish Transbronchial Micro-Infusion Catheter has the same intended use, methods of introduction and methods of operation. Risk analysis has shown that the Blowfish Transbronchial Micro-Infusion Catheter has the same risk profile as the predicate. The Indication for Use statement of the predicate is broader and includes selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveolar lavage, foreign body removal from bronchi and bronchial hemostasis, while the Indication for Use statement for the Blowfish Transbronchial Micro-Infusion Catheter is only limited to the medicine injection portion of the predicate. By selecting a narrower Indication for Use statement compared to the predicate. Mercator believes that the differences in the wording are not critical and thus the requirement of 807.92(a)(5) is met.

NAME /510(K) NUMBER	Blowfish Transbronchial Micro-Infusion Catheter (CurrentSubmission)	Olympus B5-2C/B7-2C BalloonCatheter / K962901
MANUFACTURER	Mercator MedSystems	Olympus
INTENDED USE	Bronchoscope accessories in theairway tree for medicine infusion.	Bronchoscope accessories in theairway tree for medicine infusion.
INDICATIONS FOR USE	The BlowfishTM TransbronchialMicro-Infusion Catheter is intendedto deliver therapeutic anddiagnostic agents that are indicatedor labeled for airway, tracheal orbronchial delivery into selected andsub-selected regions of the airwaytree.	Olympus B5-2C/B7-2C BalloonCatheters are to be used forselective endoscopicbronchography, medicineinjection to bronchi, salineinjection associated withbronchoalveolar lavage, foreignbody removal from bronchi andbronchial hemostasis.
TARGETED LOCATIONINFUSION	Tracheobronchial Tree	Tracheobronchial Tree
Delivery Method into theBronchi	Infusion via a Stainless Steel Port	Infusion via Polymer Port
Number of Delivery Ports	One (on the side)	One (at the tip)
Delivery Port Size	34 Gauge	Unknown
ACTUATOR / BALLOON
Material	Parylene and Silicone	Natural Rubber Latex
Target Diameter	6.0 mm to 16.0 mm	11 mm
Max Inflation Pressure	2 atm controlled by pressure reliefvalve	No pressure relief valve
Shape (cross-section)	U-shaped balloon sheathing micro-infusion port	O-shaped balloon surroundinginfusion port
Inflation medium	Liquid	Air (max 2.1 mL)
CATHETER
Material	Polymer	Unknown

Comparison of Kev Technological Characteristics

Section 5 Mercator MedSystems, Inc. Page 5-2

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510(k) Notification Blowfish Transbronchial Micro-Infusion Catheter

NAME /510(K) NUMBER	Blowfish Transbronchial Micro-Infusion Catheter (CurrentSubmission)	Olympus B5-2C/B7-2C BalloonCatheter / K962901
Length	Up to 145 cm	105 cm
BRONCHOSCOPECHANNEL ID	2.8 mm	2.0 - 2.8 mm
PACKAGING	Tyvek Pouch	Tyvek Pouch
STERILIZATION METHOD	E-beam	Ethylene Oxide
STERILITY	Sterile (SAL 10-6)	Sterile (SAL 10-6)
SINGLE USE	Yes	Yes
STORAGE	Room Temperature	Ambient temperature 10°C –40°C (50°F – 104°F)Relative Humidity 30 – 85%

Performance Data

Device performance of the Blowfish Transbronchial Micro-Infusion Catheter was tested in bench, in vitro and in vivo animal studies. Performance testing was conducted to verify that it meets the mechanical performance requirements defined by the product specification after exposure to E-Beam irradiation, aging and simulated distribution. All tests met the pre-determined acceptance criteria.

The testing included the following:

mechanical and fluid delivery performance .
. packaging and labeling testing
shelf-life testing .
biocompatibility per ISO 10993-1: cytotoxicity, sensitization, intracutanious . reactivity and acute toxicity, was previously conducted with a legally marketed device (K062752)
in-vivo safety studies using a porcine model .

Conclusion

When compared to the predicate device, the Blowfish Transbronchial Micro-Infusion Catheter has the same intended use and target location. Test results indicated that the catheter's materials, mode of action and procedure (i.e. via a bronchoscope) are safe and do not raise different questions of safety and effectiveness compared to the predicate device (Olympus B5-2C/B7-2C Balloon Catheter, K962901). The materials included in the Blowfish Transbronchial Micro-Infusion Catheter were tested and demonstrated to be biocompatible and safe. The Blowfish Transbronchial Micro-Infusion Catheter labeling contains instructions for use and any necessary cautions and warnings to assure safe and effective use of the device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue

Document Control Center - WO66-G609 Silver Spring, MD 20993-4002

July 2, 2013

Mercator MedSystems, Inc. c/o Mr. Mark Job Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo. MN 55313

Re: K131401

Trade/Device Name: Blowfish™ Transbronchial Micro-Infusion Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Transbronchial Catheter Regulatory Class: Class II Product Code: EOQ Dated: May 14, 2013 Received: May 15, 2013

Dear Mark Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.

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Page 2 - Mr. Mark Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director

Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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5 10(k) Notification

Blowfish Transbronchial Micro-Infusion Catheter

4. INDICATIONS FOR USE STATEMENT

510(k) Number: K131401

Device Name: BlowfishTM Transbronchial Micro-Infusion Catheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eric A. Mann -S

Section 4 Mercator MedSystems, Inc.

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.