(237 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of an oxygen mask, with no mention of AI or ML technologies.
Yes
The device is used to administer oxygen and aerosol therapy via nebulizer, which are therapeutic interventions.
No
Explanation: The device is an oxygen mask used for administering oxygen and aerosol therapy. Its function is therapeutic, not diagnostic.
No
The device description lists numerous physical components (mask, strap holes, swivel, inlets, outlets, tubing, etc.), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer oxygen and aerosol therapy via nebulizer by being placed over the nose and mouth. This is a direct therapeutic intervention on a patient.
- Device Description: The description details a physical mask and its components for delivering gases and aerosols to the respiratory system.
- Performance Studies: The performance studies focus on the delivery of oxygen and aerosolized drugs to a human model, and biocompatibility testing. These are related to the device's function in delivering therapy, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Rollins 7 Oxygen Mask does not perform this function. It is a therapeutic device used for delivering treatment.
N/A
Intended Use / Indications for Use
The Rollins7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Rollins 7 Oxygen Mask consists of the following features: 1) mask, 2) strap holes, 3) swivel, 4) oxygen inlet, 5)oxygen inlet cap, 6) oxygen outlet diverter, 7) adapter body, 8) fenestration opening slits on both sides of the mask, 9) opening at the chin area, 10) MDI (metered dose inhaler) port hole inlet and insert locks in place, 11) adapter inlet bottom cap, 12) nebulizer inlet, 13) oxygen tubing, 14) oxygen mask inlet for connecting the adapter, and 15) design nipples (left and right) 16) oxygen tubing with one end universal connector and the other end standard oxygen connector 17) oxygen flow rate to FiO2 label attached to universal connector end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult
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)
A flow rate study was performed to ensure Rollins7 Oxygen mask provided the same FIO2 at various liters per minute settings as the predicate devices. The results demonstrated that the Rollins7 Oxygen mask delivers similar results at all settings.
Two cascade impactor studies were performed comparing the Rollins7 Oxygen Mask to the Hudson RCI Neb-U-Mask to ensure similar delivery of respirable particle dose for several highly used respiratory drugs. The results demonstrated that the Rollins7 Oxygen Mask had similar delivery of respirable particle dose of each drug tested as those of the predicate devices.
Performance Testing:
- ISO 10993-5 Cytotoxicity Test Agar Diffusion (Section 15)
- Flow Rate Testing (Section 18)
- Cascade Impactor Study Comparing the Adult Rollins7 Oxygen Mask and Predicate Mask from Hudson RCI on a Human Model
No clinical tests were conducted.
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Sponsor: | Rollins Medical Solutions, Inc. | 807.92(a)(1) |
|---|---|---|
| Company Address: | 1930 Village Center Circle PMB 3-314 Las Vegas, NV 89134 | |
| Telephone: | 702-686-1803 | |
| Contact Person: | Michael Schlachter, MD | OCT 09 2013 |
| Summary Preparation Date: | October 8, 2013 | |
| Device Name: | 807.92(a)(2) | |
| Trade Name: | Rollins 7 Oxygen Mask | |
| Common/Usual Name: | Oxygen Mask | |
| Classification Name: | Mask, Oxygen | |
| Regulation Number: | 21 CFR 868.5630 | |
| Product Code: | CAF | |
| Device Classification: | Class II | |
| Review Panel: | Anesthesiology |
Predicate Device
| and the country of the state of the same of the same of the secure of
| Manufacturer : " " " " " " " | . Brand Name | . 310 (k) Number 510(k) Number 100 (k) |
|---|---|---|
| Teleflex Medical, Inc. | Neb-U-Mask® | K080230 |
Device Description
The Rollins 7 Oxygen Mask consists of the following features: 1) mask, 2) strap holes, 3) swivel, 4) oxygen inlet, 5)oxygen inlet cap, 6) oxygen outlet diverter, 7) adapter body, 8) fenestration opening slits on both sides of the mask, 9) opening at the chin area, 10) MDI (metered dose inhaler) port hole inlet and insert locks in place, 11) adapter inlet bottom cap, 12) nebulizer inlet, 13) oxygen tubing, 14) oxygen mask inlet for connecting the adapter, and 15) design nipples (left and right) 16) oxygen tubing with one end universal connector and the other end standard oxygen connector 17) oxygen flow rate to FiO2 label attached to universal connector end.
1
Indications for Use
The Rollins7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
Contraindication: Rollins 7 Oxygen Mask should not be used with Metered Dose Inhalers.
Substantial Equivalent Comparison
807.92(a)(6)
Discussion of technical characteristics between the Rollins7 Oxygen Mask and the Predicate Oxygen Mask
A flow rate study was performed to ensure Rollins7 Oxygen mask provided the same FIO2 at various liters per minute settings as the predicate devices. The results demonstrated that the Rollins7 Oxygen mask delivers similar results at all settings.
Rollins 7 Oxygen Mask has a feature that allows for the use of a Naso-gastric tube, suctioning, oral care, endoscopies, and drinking through a straw by providing an opening in the chin area of the mask. This feature is fully describe in Section 11 11.2 and is a feature of convenience for the healthcare professional and does not in any way negatively affect its use as a simple oxygen mask or aerosol mask.
Comparative Non-Clinical Testing
Two cascade impactor studies were performed comparing the Rollins7 Oxygen Mask to the Hudson RCI Neb-U-Mask to ensure similar delivery of respirable particle dose for several highly used respiratory drugs. The results demonstrated that the Rollins7 Oxygen Mask had similar delivery of respirable particle dose of each drug tested as those of the predicate devices.
Performance Testing
807.92(b)(1)
- ISO 10993-5 Cytotoxicity Test Agar Diffusion (Section 15) o
- Flow Rate Testing (Section 18) .
- Cascade Impactor Study Comparing the Adult Rollins7 Oxygen Mask and Predicate Mask . from Hudson RCI on a Human Model
Clinical Testing
807.92(b)(2)
No clinical tests were conducted.
2
807.92(b)(3)
Conclusions
Based on the predicate product comparison table of similar indications for use, product features, performance claims, discussion of the technological differences of the Rollins7 Oxygen Mask versus the predicate masks and the results of flow rate testing and cascade impactor studies Rollins Medical Solutions has concluded that the Rollins7 Oxygen Mask is substantially equivalent to the predicate devices and introduces no new issues of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2013
Rollins Medical Solutions, Incorporated C/O Mr. EJ Smith Consultant Smith Associates 1468 Harwell Avenue CROFTON, MD 21114
Re: K130379
Trade/Device Name: Rollins7 Oxygen Mask Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 29, 2013 Received: September 6, 2013
Dear Mr. Smith:
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.
4
Page 2 - Mr. Smith
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Image /page/4/Picture/6 description: The image shows a signature block. It includes the phrase "Sincerely yours," followed by the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." The acronym "DAGRID" is also present, along with the name "Kwame Ulmer M.S." and the word "FOR."
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130379
Device Name: Rollins7 Oxygen Mask
Indications for Use:
The Rollins 7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anya C
-S
y
Digitally signed by Anya C. Harry -S
DN: C=US, O=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Anya C. Harry -S,
0.9.2342.19200300.100.1.1=0011315590
Date: 2013.10.09 08:47:44 -04'00'
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