(119 days)
Not Found
No
The summary describes a physical patient interface (nasal mask) with features focused on fit, seal, and comfort. There is no mention of software, algorithms, image processing, AI, DNN, or ML.
No.
The device is described as a patient interface accessory for CPAP and bilevel systems, which are used to treat conditions like OSA. The device itself does not directly provide therapy but rather facilitates the delivery of therapy from other systems.
No
Explanation: The device is a patient interface accessory for CPAP and bi-level systems, designed to maximize seal and comfort during treatment for Obstructive Sleep Apnea (OSA) and/or ventilatory support. It is used in treatment, not for diagnosing a condition.
No
The device description explicitly details physical components like nasal inserts, a leak port, and headgear, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "patient interface accessory for use with CPAP and bi-level systems." It's a physical component that connects to a patient's nose to deliver air pressure. It does not involve testing samples from the body.
- Lack of IVD Characteristics: The description doesn't mention any analytical or diagnostic procedures performed on biological samples. It focuses on physical fit, seal, and comfort for delivering therapy.
Therefore, this device falls under the category of a medical device used for therapy (respiratory support), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use and Multi-patient, multi-use
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The proposed nasal patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal inserts to assure a good fit
- . Integral fixed leak port
- . Headgear for attachment
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
Adults with OSA
Intended User / Care Setting
Hospitals, Home, sub-acute care settings, sleep labs
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)
Not Found
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.
InnoMed - Nasal Aire K022465
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
Premarket Notification 510(k) Section 5 – 510(k) Summary
RemGenic
Non-Confidential Summary of Safcty and Effectiveness
Page 1 of 2 22-Feb-08
JUN 2 3 2008
| RemGenic LLC |
|---|
| 3734 Lincoln Place Dr. |
| Des Moines, IA 50312 |
| Tel - 515-339-7722 | |
|---|---|
| Official Contact: | Russell Bird |
| Proprietary or Trade Name: | LaminAir CPAP nasal mask |
| Common/Usual Name: | Patient interface for use with CPAP systems |
| Classification Name: | Ventilator, non-continuous (respirator), accessory |
| BZD - 868.5905 | |
| Device: | CPAP nasal mask with pillows |
| Predicate Devices: | InnoMed - Nasal Aire K022465 |
Device Description:
The proposed nasal patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal inserts to assure a good fit
- . Integral fixed leak port
- . Headgear for attachment
| Indications for Use: | A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use and Multi-patient, multi-use |
|---|---|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings, sleep labs |
| Contraindications: | None |
. ﺔ ﺍﻟ
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 22-Feb-08
Comparative table:
| Features | Predicate InnoMed
Nasal Airc
K022465 | Proposed Device |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | An accessory to positive pressure
ventilation devices for patients
suffering from OSA requiring positive
pressure breathing therapy (i.e. CPAP,
bi-level) | A patient interface accessory for use with
CPAP and bi-level systems used in the
treatment of adult OSA and / or ventilatory
support. |
| Environment of Use | Home, Hospital, Sub-acute Institutions,
Sleep labs | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient, multi
use
Multi-patient, multi-
use | Yes under K022465 clearance | Yes |
| Multiple sizes of nasal
cushions | Yes - five | Yes - three |
| Components | Headgear
Nasal prongs
Tubing
Connector | Headgear
Nasal prongs
Tubing
Connectors |
| Dead space | Nasal pieces - 5 to 18 ml | Nasal piece - largest 23 ml |
| Fixed leak port | Yes | Yes |
| Materials | Polypropylene
PVC tubing
Silicone | Polypropylene
PVC tubing
Silicone |
Differences Between Other Legally Marketed Predicate Devices:
.
The proposed device is viewed as substantially equivalent to the predicate device, K022465.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
:
:
: :
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2008
RemGenic LLC C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K080516
Trade/Device Name: LaminAir CPAP Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 13, 2008 Received: May 14, 2008
Dear Mr. Dryden:
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.
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 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.
3
Page 2 – Mr. Dryden
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact 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 Division of 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,
Susan Runnes
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
4
Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name: LaminAir CPAP nasal mask
Indications for Use:
A patient interface accessory for use with CPAP and bilevel systems used in the treatment of adult OSA and / or ventilatory support.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080516