IT NASAL MASK
Device Facts
| Record ID | K050171 |
|---|---|
| Device Name | IT NASAL MASK |
| Applicant | Innomed Technologies |
| Product Code | BZD · Anesthesiology |
| Decision Date | May 4, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation i devices capable of generating pressures up to 20cm H₂O. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency. The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital i settings.
Device Story
The IT Nasal Mask is a patient interface accessory for CPAP and bi-level ventilators. It consists of a polycarbonate faceplate with a silicone cushion, a 360-degree rotating 90-degree elbow, and a detachable exhalation port/swivel. The mask is secured to the patient via a four-strap nylon cloth headset. In use, the mask is placed over the nose; pressurized air from the ventilator circuit enters the mask during inhalation, while exhaled air is vented through the exhalation port. It is intended for single-patient use in home or hospital settings. The device allows patients to receive prescribed positive-pressure therapy, aiding in the treatment of obstructive sleep apnea and respiratory insufficiency.
Clinical Evidence
Bench testing only. Performance characteristics including exhalation port flow rate, exhalation port resistance, and mask volume (deadspace) were tested and compared to predicate devices to demonstrate substantial equivalence.
Technological Characteristics
Materials: Polycarbonate plastic faceplate, silicone elastomer cushion, nylon cloth headset. Interface: Standard female 22mm fitting for breathing circuit connection. Design: 360-degree rotating elbow, seven available sizes. Operation: Passive interface for positive-pressure ventilation up to 20cm H2O. Biocompatibility: Meets industry standards for patient-contact materials.
Indications for Use
Indicated for adult patients (>30kg) requiring CPAP or bi-level positive-pressure ventilation (up to 20cm H2O) for obstructive sleep apnea or respiratory insufficiency in non-critical care home or hospital settings.
Regulatory Classification
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Predicate Devices
- Respironics Contour Nasal Mask (K991648)
- Respironics Comfort Classic Nasal Mask (K974453)
- ResMed Mirage Nasal Mask (K984428)
- Respironics Bipap Harmony S/T (K984407)
- HealthDyne Model 7700 Quantum Pressure Support Ventilator (K962517)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the text "MAY - 4 2005". The text is in a simple, sans-serif font. The text is black and the background is white. The text is slightly blurred, but still legible.
Image /page/0/Picture/1 description: The image shows the logo for InnoMed Technologies. The logo consists of a triangle made up of three smaller triangles, with the top triangle being black and the bottom two triangles being gray. The text "InnoMed" is written in large, bold letters to the right of the triangle, and the text "Technologies" is written in smaller letters below "InnoMed". There is also a handwritten number "1050111" at the top of the image.
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
### InnoMed IT Nasal Mask
InnoMed Technologies 506 Garden Street Greensburg, PA 15601
March 9, 2005
| Official Contact | Frank Pelc |
|---------------------|------------------------------------------------------------------------------------------------------------------|
| | Director, Regulatory Affairs |
| | InnoMed Technologies |
| | 506 Garden Street |
| | Greensburg, PA 15601 |
| | (After April 1, 2005): |
| | 6601 Lyons Road Suites B1-B4 |
| | Coconut Creek, FL 33073 |
| Classification Name | 21 CFR 868.5895, 73 MNS |
| Common/Usual Name | Ventilator, continuous, non-life supporting (accessory to) |
| Proprietary Name | IT Nasal Mask |
| Predicate Devices | K991648 -- Respironics Contour Nasal Mask |
| | K974453 -- Respironics Comfort Classic Nasal Mask |
| | K984428 -- ResMed Mirage Nasal Mask |
| | K984407 -- Respironics Bipap Harmony S/T, and accessories cleared with said ventilator |
| | K962517 - HealthDyne Model 7700 Quantum Pressure Support Ventilator and accessories cleared with said ventilator |
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Image /page/1/Picture/0 description: The image shows the logo for InnoMed Technologies. The logo consists of a stack of three triangles on the left, with the top triangle being black and the bottom two triangles being gray. To the right of the triangles is the text "InnoMed" in a bold, sans-serif font. Below "InnoMed" is the word "Technologies" in a smaller, sans-serif font.
## InnoMed IT Nasal Mask
### Substantial Equivalence
This premarket notification section 510(k) submission demonstrates that the InnoMed IT Nasal Mask is substantially equivalent to the Respironics Contour and Comfort Classic Nasal Masks, and the ResMed Mirage Nasal Mask. Each of these devices is used as a patient interface accessory for currently-marketed CPAP and bi-level ventilatory devices. These devices are constructed of equivalent materials, have similar designs and configurations, and operate in the same manner.
Testing was conducted to demonstrate that the performance of the InnoMed IT Nasal Mask, when used as prescribed, is as safe and effective as that of the legally marketed predicate device. Testing demonstrated that the important clinical performance characteristics were equivalent to those of the predicate devices. The characteristics tested included exhalation port flow rate, exhalation port resistance, and mask volume (or "deadspace").
The major functional components of the InnoMed IT Nasal Mask are constructed of the same materials (polycarbonate plastic and silicone elastomer) as the predicate devices. These materials have been demonstrated to meet industry standards for patient-contact biocompatibility. The cleaning methods prescribed for the InnoMed IT Nasal Mask are the same as those provided for the predicate devices, and have been shown to be effective for single-patient use.
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### Intended Use/Indications for Use
The InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation i devices capable of generating pressures up to 20cm H₂O. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency.
The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital i settings.
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Image /page/2/Picture/0 description: The image shows the logo for InnoMed Technologies. The logo consists of a stack of three triangles on the left, with the top triangle being black and the two bottom triangles being gray. To the right of the triangles is the text "InnoMed" in a bold, sans-serif font. Below "InnoMed" is the word "Technologies" in a smaller, sans-serif font.
#### Manufacturer
The IT Nasal Mask is commercially distributed in the United States by InnoMed Technologies, Inc.
### Summary Device Description
The IT Nasal mask consists of a polycarbonate faceplate shaped to fit around the patient's nose, and a silicon cushion covering the edge of the faceplate where the mask makes contact with the patient's face. At the front of the mask's faceplate is a 90-degree elbow attached so as to allow it to rotate 360 degrees relative to the faceplate.
The other end of the elbow is configured as a standard female 22mm fitting for the attachment of a separate exhalation port/swivel that is supplied with each IT Nasal Mask. This exhalation port is configured so as to sufficiently exhaust exhaled air from the patient at a proper flow rate. The other end of the exhalation port/swivel allows connection to a CPAP or bi-level positive pressure ventilator's flexible breathing circuit tubing.
The IT Nasal mask is available in seven different sizes in order to accommodate a broad range of facial feature variations.
The IT Nasal Mask is secured to the patient by a single-piece nylon cloth headset. The headset has four straps which allow the mask to be adjusted for proper fit and patient comfort, and provide for quick removal of the mask.
To use the IT Nasal Mask, the exhalation port/swivel is attached to the mask, then connected to the ventilatory device's breathing circuit per the manufacturer's instructions. The headset is secured to the mask, and the mask placed over the patient's face with the ventilator running. The headset is adjusted so that the mask fits comfortably and provides an adequate seal.
The patient can now breathe normally and receive the prescribed therapy. Upon inhalation, pressurized air from the breathing circuit enters the mask and is breathed in through the patient's nose. As the patient exhales, exhaled air passes through the mask and out into the breathing circuit. The patient can continue to wear the mask for the prescribed period as long as the ventilatory device continues to operate properly
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three curved lines representing its wings and body, and two wavy lines representing its legs. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
MAY - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Pelc Regulatory Affairs Director InnoMed Technologies, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073
Re: K050171
Trade/Device Name: InnMed Technologies IT Nasal Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Pelc:
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 received as a cross 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 mendments, 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 (1 WI ), it may of be color in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.
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#### Page 2 - Mr. Pelc
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. or the For of all , I outh all the Act's requirements, including, but not limited to: registration Tod Intell CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and libeing (21 certer in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as better in 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) I mis letter will and n yoursely and ing of substantial equivalence of your device to a premiumer nourselves 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), 11 you donto the Office of Compliance at (240) 276-0120. 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 from the maj overall 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/industry/support/index.html.
Sincerely yours,
Sujete Y. Michaud md.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
#### 510(k) Number (if known): K050171
Device Name: InnoMed Technologies IT Nasal Mask
Indications For Use:
The InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation devices capable of generating pressures up to 20cm H₂O. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency.
The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital settings.
× Prescription Use (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)
Andrew J. Watkins for AAG
resorior. Caperal Hospital, Intertion Control Denta Devices
510(k) Nun:ber.
K050171
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