(35 days)
Not Found
No
The summary describes a gas blender with a simple mechanical change (capillary tube material) and does not mention any computational or learning capabilities.
Yes
The device is described as providing user-set concentrations of inhaled Nitric Oxide (NO) mixed into a constant flow of oxygen gas delivered to a patient, indicating a direct therapeutic action of administering a medicinal gas.
No
The device is a "NO Blender" designed to deliver specific concentrations of inhaled Nitric Oxide, not to diagnose a condition.
No
The device description explicitly states it is a "NO Blender" and describes physical components like capillary tubes and regulators, indicating it is a hardware device for gas mixing and delivery.
Based on the provided text, the FM-1 NO Blender is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides user-set concentrations of inhaled Nitric Oxide (NO) mixed into oxygen gas delivered to a patient. This indicates direct interaction with a living organism for therapeutic purposes.
- Device Description: The description focuses on the mechanical components and how it delivers gas to a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The FM-1 NO Blender does not perform any such analysis of specimens.
Therefore, the FM-1 NO Blender is a medical device used for delivering a therapeutic gas to a patient, not an in vitro diagnostic device.
N/A
Intended Use / 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 system or for short term unattended use when a primary delivery device cannot be used. In this capacity, it can be used 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.
Note: These indications for use are unchanged from K003665
Product codes (comma separated list FDA assigned to the subject device)
MRO
Device Description
The Fadasis Medical FM-1 NO Blender delivers user set concentrations of inhaled Nitric Oxide (NO), blended with nitrogen, into a user settable constant flow of oxygen gas to a patient. It is designed as a back-up system to a primary nitric oxide delivery device or for short-term use with a self-inflating manual resuscitator bag within a medical facility. The current device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5165 Nitric oxide administration apparatus.
(a)
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.(b)
Classification. Class II. 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.”
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Fadasis
Medical,
Inc.
JUL 2 0 2001
7601-B Murphy Drive, Middleton, W1 53562 Phone (608) 831-0025, ext. 276, FAX (608) 831-2202
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the
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:
-
- CGA 626: Medical NO Gas Connections.
-
- 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: (608) 831-0025 (608) 831-2202 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).
2
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
3
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, (301) 594-4040. 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 (800) 638-2041 or (301) 443-6597 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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| 1000
510(k) N
known)
) Number (11 | V All 274
1
S
A
and and the state of the same of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments |
| --------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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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