BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER

K131401 · Mercator Medsystems, Inc. · EOQ · Jul 2, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K131401
• Device Name: BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
• Applicant: Mercator Medsystems, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jul 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

The Blowfish Transbronchial Micro-Infusion Catheter is a single-operator, bronchoscope-guided device used to deliver therapeutic or diagnostic agents into the airway wall, including the bronchial adventitia. The device consists of a proximal hub with luer fittings, a composite shaft, a semi-rigid/semi-elastic polymer balloon, and a 34-gauge tapered stainless steel infusion port. The physician advances the catheter through a bronchoscope to a target location in the tracheobronchial tree. Upon inflation of the U-shaped balloon (controlled by a pressure relief valve at 2 atm), the micro-infusion port is pushed into the airway wall. Liquid therapeutic/diagnostic agents are then infused through the port. The device enables targeted local delivery of agents, potentially increasing local concentration while minimizing systemic exposure. It is intended for use in clinical settings by trained medical professionals.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (mechanical and fluid delivery performance, packaging, shelf-life), biocompatibility testing (per ISO 10993-1), and in-vivo safety studies using a porcine model. All tests met pre-determined acceptance criteria.

Technological Characteristics

Catheter features a 34-gauge stainless steel infusion port, U-shaped Parylene/Silicone balloon, and polymer shaft. Includes a pressure relief valve (max 2 atm). Dimensions: up to 145 cm length, compatible with 2.8 mm bronchoscope channels. Sterilization: E-beam. Single-use. Standalone device.

Indications for Use

Indicated for delivery of therapeutic and diagnostic agents into selected and sub-selected regions of the airway tree (airway, tracheal, or bronchial) in patients requiring such delivery.

Regulatory Classification

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.

Predicate Devices

• Olympus B5-2C/B7-2C Balloon Catheter (K962901)

Reference Devices

• Legally marketed device (K062752)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

| Contact Person: | Plamena Entcheva-Dimitrov, PhD, RAC |
|------------------|-----------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Facsimile: | [phone] |
| Email: | [e-mail] |
| 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 Accessories<br>21 CFR 874.4680<br>Product Code EOQ |
| Panel: | ENT |

#### Predicate Devices

| 510(k) Number | Product Name | Manufacturer |
|---------------|-----------------------------------------|--------------|
| K962901 | Olympus B5-2C/B7-2C<br>Balloon Catheter | Olympus |

#### 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.

#### 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

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.

#### 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 /<br>510(K) NUMBER | Blowfish Transbronchial Micro-<br>Infusion Catheter (Current<br>Submission) | Olympus B5-2C/B7-2C Balloon<br>Catheter / K962901 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | Mercator MedSystems | Olympus |
| INTENDED USE | Bronchoscope accessories in the<br>airway tree for medicine infusion. | Bronchoscope accessories in the<br>airway tree for medicine infusion. |
| INDICATIONS FOR USE | The BlowfishTM Transbronchial<br>Micro-Infusion Catheter is intended<br>to deliver therapeutic and<br>diagnostic agents that are indicated<br>or labeled for airway, tracheal or<br>bronchial delivery into selected and<br>sub-selected regions of the airway<br>tree. | Olympus B5-2C/B7-2C Balloon<br>Catheters are to be used for<br>selective endoscopic<br>bronchography, medicine<br>injection to bronchi, saline<br>injection associated with<br>bronchoalveolar lavage, foreign<br>body removal from bronchi and<br>bronchial hemostasis. |
| TARGETED LOCATION<br>INFUSION | Tracheobronchial Tree | Tracheobronchial Tree |
| Delivery Method into the<br>Bronchi | 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 relief<br>valve | No pressure relief valve |
| Shape (cross-section) | U-shaped balloon sheathing micro-<br>infusion port | O-shaped balloon surrounding<br>infusion 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 /<br>510(K) NUMBER | Blowfish Transbronchial Micro-<br>Infusion Catheter (Current<br>Submission) | Olympus B5-2C/B7-2C Balloon<br>Catheter / K962901 |
|----------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Length | Up to 145 cm | 105 cm |
| BRONCHOSCOPE<br>CHANNEL 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 –<br>40°C (50°F – 104°F)<br>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 [phone] or [phone] 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:

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.

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.