FADASIS MEDICAL FM-1 NO BLENDER

K011874 · Fadasis Medical, Inc. · MRO · Jul 20, 2001 · Anesthesiology

Device Facts

• Record ID: K011874
• Device Name: FADASIS MEDICAL FM-1 NO BLENDER
• Applicant: Fadasis Medical, Inc.
• Product Code: MRO · Anesthesiology
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5165
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FM-1 NO Blender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the FM-1 NO Blender is as a back up to a primary nitric oxide delivery system or for use with a self-inflating manual resuscitator bag. This intended use includes applications within a medical facility. The FM-1 NO blender is not intended for use as a primary NO delivery system for long term use.

Device Story

FM-1 NO Blender acts as a backup nitric oxide (NO) delivery system; mixes NO (in nitrogen balance) with oxygen gas at user-set concentrations/flows. Used in medical facilities; operated by clinicians. Device serves as a secondary source when primary systems fail or during manual resuscitation. Input: NO gas source and oxygen gas source. Output: Controlled NO/O2 gas mixture. Benefit: Ensures continuity of NO therapy during primary system downtime or manual ventilation. Device is a mechanical blender; no software or AI components.

Clinical Evidence

Bench testing only. Validation included FTIR testing of PEEK material, performance characteristics testing (5-15 lpm), validation with self-inflating manual resuscitator bags, concentration profile validation, regulator check function, failure testing, drop testing, and packaging/shipping validation. No clinical data presented.

Technological Characteristics

Mechanical gas blender. Capillary tubes constructed of PEEK. Designed to comply with CGA 626 (NO gas connections) and IEC 601-1 (general electrical safety). No software or electronic control algorithms.

Indications for Use

Indicated for patients requiring inhaled Nitric Oxide (NO) therapy when the primary delivery system is unavailable or for use with a self-inflating manual resuscitator bag in a medical facility setting. Not for long-term use as a primary delivery system.

Regulatory Classification

Identification

The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.

Special Controls

The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”

The special control developed by the agency is a guidance document, entitled Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. This guidance document identifies the risks associated with these types of devices and contains information that will help manufacturers address those risks. This document is available on FDA's website at http://www.fda.gov/cdrh/ode/1157.pdf.

Predicate Devices

• Fadasis FM-1 NO Blender (K003665)

Reference Devices

• Datex-Ohmeda INOvent Delivery System

Submission Summary (Full Text)

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**Fadasis**

**Medical,**

*Inc.*

JUL 2 0 2001

7601-B Murphy Drive, Middleton, W1 53562 Phone [phone], ext. 276, FAX [phone]

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the<br>Fadasis Medical FM-1 NO Blender |
|-------------------|---------------------------------------------------------------------------------------------------|
| Proprietary Name: | Fadasis Medical FM-1 NO Blender |
| Common Name: | Nitric Oxide Administration Apparatus - Back-up System |
| Classification: | Class II, 21CFR868.5165, MRO |
| Panel: | Anesthesiology |
| Contact Person: | Raymond Riddle, Vice President, Regulatory Affairs |

R. Riddle 6/12/01

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Fadasis Medical FM-1 NO Blender is substantially equivalent to the Fadasis FM-1 NO Blender, The 1 addis Incontaint I 1 1 rith 510(k) premarket notification number K003665. The purpose of this Which was clouded by I DA whan 2000 (EEK, rather than stainless steel, in the capillary tubes.

Indications for use: The FM-1 NO Blender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the FM-1 NO Blender is as a back up to a primary nitric oxide delivery pation. The intended use when a primary delivery device cannot be used. In this capacity, it system or tor site inflating manual resuscitator bag. This intended use includes applications within a can or used with a set manages of a medical facility. The FM-1 NO blender is not intended for use modions a primary NO delivery system for long term use. (Note: These indications for use are unchanged form K003665.

The Fadasis Medical FM-1 NO Blender was designed to comply with the limited applicable portions of the following:

- 1. CGA 626: Medical NO Gas Connections.
- 2. IEC 601-1: Medical Electrical Equipment (for general requirements).
- FDA Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery 3. Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer.

The materials selected were primarily based upon the Datex-Ohmeda INOvent Delivery System. New validation and verification completed included the FTIR Testing of PEEK. Validation and verification for 510(k) K003665 included FM-1 NO Blender 5-15 lpm Performance Characteristics Testing, FM-1 NO Blender Validation with Self Inflating Manual Resuscitator Bags, FM-1 NO Blender Validation of the Concentration Profile When Used with Self Inflating Manual, Resuscitator Bags, FM-1 NO Blender Regulator Check Function, FM-1 NO Blender 5-15 Ipm Failure Testing, FM-1 NO Blender Material Compatibility Information, FM-1 NO Blender Drop Test and FM-1 NO Blender Packaging and Shipping Validation. All testing indicated the FM-1 NO Blender met its design input specifications, design output specifications, hazard analysis and risk control requirements.

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Device Name - Proprietary:

Device Name - Common: Device Name - Classification:

Nitric Oxide Mixer Nitric Oxide Administration Apparatus Back-up System

Fadasis Medical FM-1 NO Blender

Fadasis Medcial FM-1 NO Blender

To the best of Fadasis Medical's knowledge,

performance standards have not been promulgated

FDA 510(k) log number K003665

Device Panel:

Anesthesiology

Device Classification:

Class II 21CFR868.5165 Product Code: MRO

by FDA for this device.

Predicate Devices:

Performance Standards:

Owner/Operator Number:

9042308

Establishment Registration Number: 2135137

Facility Information:

Device Background:

Fadasis Medical, Inc. 7601-B Murphy Drive Middleton, WI 53562 Telephone: [phone] [phone] Fax:

The new FM-1 NO blender is identical to the predicate FM-1 NO blender with the exception of the capillary tube material, which has been changed to PEEK from stainless steel. The use of this material has been validated via FTIR testing, as required by FDA Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. The original device performance validation data was obtained using both stainless steel and PEEK capillary tubes. Because of inadequate testing of PEEK, the use of this material was removed from the original 510(k) until further testing was completed, thus prompting this Special 510(k).

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around the edge. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2001

Mr. Raymond T. Riddle Fadasis Medical, Inc. 7601-B Murphy Drive Middleton, WI 53562

Re: K011874

FM-1 NO Blender Regulation Number: 868.5165 Regulatory Class: II (two) Product Code: 73 MRO Dated: July 3, 2001 Received: July 9, 2001

Dear Mr. Riddle:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becally in the substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstant commerce stated in the enclosure) to logally markets of the Medical Device Amendments, or to devices that prior to May 20, 1970, the ensounces with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tourmaly, mercore, manovisions of the Act include requirements for annual provisions of the Act. "The goneral consults curing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see asono) anto additional controls. Existing major regulations (Fremarket Approval), it they of Sale of Federal Regulations, Title 21, Parts 800 to 895. affecting your do rece can or reamination assumes compliance with the Current Good A substantany equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the rood and Drag rummissault in regulatory action. In addition, FDA may publish comply with the GMT 10garation inde Federal Register. Please note: this response to your premarks octification submission does not affect any obligation you might

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Page 2 - Mr. Raymond T. Riddle

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin manoung your device to a legally marketed notification. THE IDA imania of succeantial organ device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice to Your do rice of ca. near contact the Office of Compliance at additionally 809.10 for in vito diagnestions on the promotion and advertising of your device, [phone]. Adultionally, for quest.chs on 1501) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Illionnation on your responsionals and its toll-free number [phone] or [phone] or at its Maindracturers / 1551bitters www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

N. Darl. Teth

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Fadasis Medical, Inc. FM-1 NO Blender Device Name:

Indications For Use:

The FM-1 NO Blender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a batient. The intended use for the FM-I NO Blender is as a back up to a primary nitrics of this associt patient. The intended use for the FMF I (O Dichice is a se a vice cannot be used. In this capacity, system of for short term attenced use when a practitator bag. This intended use includes applications it can be used with a sch-inthaing manual result and the lice if a medical facility. The FM-1 NO blender is not within a modious as a primary NO delivery system for long term use.

Note: These indications for use are unchanged from K003665

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Concurrence of CDRH, Office of Device Evaluation (ODE)

18 +

Oake Tell

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number: -

Prescription Use -(Per 21CFR801.109) OR

Over-The-Counter Use-(Optional Format 1-2-96)

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