(200 days)
No
The summary describes a nasal CPAP mask and its components, with no mention of AI or ML capabilities. The performance studies focus on comparing the mask to nasal prongs and verifying specifications.
Yes.
The device is part of a system intended to provide CPAP therapy, which is a therapeutic intervention for newborns and infants.
No
The device is described as an infant nasal CPAP mask intended for providing CPAP therapy, which is a treatment, not a diagnostic act.
No
The device description clearly states it is a physical mask intended for use with a hardware system (tubing, support set, and oxygen/air mixer). It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide CPAP therapy to newborns and infants using a nasal mask or prongs. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a nasal mask used as part of a CPAP system. It is a physical device used for delivering air pressure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hamilton Medical ARABELLA® NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA® infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer. This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.
Product codes
BZD
Device Description
The ARABELLA® NCPAP Masks are single-patient use only infant nasal CPAP masks which can be used with the Hamilton ARABELLA tubing and support set (K945740) as an alternative to the NCPAP prongs. The tubing and support set has been designed to work with the ARABELLA Monitoring Oxygen/Air Mixer (K990293 and K960359). The items covered by K945740 and K990293/K960359 together form the Hamilton Medical ARABELLA infant NCPAP system.
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
Newborns and infants
Intended User / Care Setting
Hospitals or other clinical settings
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)
The 510(k) submission included: (a.) device description, (b.) comparison to the legally marketed predicate device, (c.) human factors information, (d.) laboratory verification and validation testing of the device specifications, and (e.) comparison testing of NCPAP mask performance to NCPAP prong performance within the ARABELLA infant NCPAP system. The testing demonstrated compliance with the mask specifications and showed no difference in the performance, safety or effectiveness between the nasal masks and the nasal prongs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 9: 510(K) SUMMARY
-
- Summary Preparation Date: February 17, 2003
K030563
- Summary Preparation Date: February 17, 2003
2. Applicant Information:
Name: Hamilton Medical AG Via Nova CH-7403 Rhaezuens Switzerland FDA Establishment Registration Number: 3001421318 Contact Person: J. David Thompson, General Manager Hamilton Medical, Inc. PO Box 30008 Reno, NV 89502 775-858-3200 Fax: 775-856-5621 email: thompson@hammed1.com
-
- Device Proprietary Name: ARABELLA® NCPAP Masks
Mask Sizes (Size #):
- Device Proprietary Name: ARABELLA® NCPAP Masks
-
a. Small (0)
-
b. Medium (1)
-
c. Large (2)
Common/Usual Name: Infant Nasal CPAP Masks (Single-Patient Use Only) Classification Name: Noncontinuous Ventilator Accessories Classification Panel: Anesthesiology Classification Code: BZD
-
- BZD Device Identification: (per 21 CFR Part 868.5905): 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. [The subject device is an accessory to a noncontinuous ventilator (FDA product code BZD.)
-
- Regulatory Status: Noncontinuous ventilators and their accessories (FDA product code BZD) have been classified by the FDA as class II. There are currently no mandatory performance standards or special control requirements for any of these devices.
-
- General Device Description: The ARABELLA® NCPAP Masks are single-patient use only infant nasal CPAP masks which can be used with the Hamilton ARABELLA tubing and support set (K945740) as an alternative to the NCPAP prongs. The tubing and support set has been designed to work with the ARABELLA Monitoring Oxygen/Air Mixer (K990293 and K960359). The items covered by K945740 and K990293/K960359 together form the Hamilton Medical ARABELLA infant NCPAP system.
1
-
- Intended Use: The Hamilton Medical ARABELLA® NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA® infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer. This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.
-
- Device Materials: The ARABELLA® NCPAP Masks are constructed of latex-free silicone rubber. This material has successfully undergone biocompatibility testing at a nationally recognized biological testing laboratory.
Among the information and data presented in the 510(k) submission to support the equivalency of the ARABELLA® NCPAP Masks to the predicate device are: (a.) device description, (b.) comparison to the legally marketed predicate device, (c.) human factors information, (d.) laboratory verification and validation testing of the device specifications, and (e.) comparison testing of NCPAP mask performance to NCPAP prong performance within the ARABELLA infant NCPAP system. The testing demonstrated compliance with the mask specifications and showed no difference in the performance, safety or effectiveness between the nasal masks and the nasal prongs.
2
| # | Characteristic | SensorMedics/EME Infant Flow Nasal CPAP Masks | Hamilton ARABELLA® NCPAP Masks |
|---|---|---|---|
| 1 | intended use | used with the SensorMedics/EME Infant Flow System, | |
| consisting of a Driver and NCPAP Generator; provides | |||
| CPAP with a nasal mask; alternative to nasal prongs | used with the Hamilton ARABELLA® infant nasal cpap sys- | ||
| tem which consists of (a.) the tubing and support set and (b.) | |||
| the monitoring oxygen/air mixer; provides CPAP therapy with a | |||
| nasal mask; alternative to nasal prongs | |||
| 2 | indications | for nasal cpap treatment of newborns and infants with | |
| RDS or who are recovering from RDS | for nasal cpap treatment newborns and infants | ||
| 3 | environment | for use in hospitals | for use in hospitals or other clinical settings |
| 4 | reuse | single-patient use only | single-patient use only |
| 5 | fastening | ||
| means | mechanism identical to nasal prongs | mechanism identical to nasal prongs | |
| 6 | mask sizes* | extra small and extra large | small (size 0), medium (size 1), and large (size 2) |
| 7 | mask material | ||
| in contact with | |||
| face | silicone rubber | latex-free silicone rubber | |
| 8 | sterility at | ||
| shipment | provided clean, non-sterile | provided clean, non-sterile | |
| 9 | recommended | ||
| service life | not specified | 1 week maximum; change when uncleanable | |
| 10 | treatment range | up to 9 cm H2O | up to 7 cm H2O |
| 11 | effective dead | ||
| space | extra small: 0.6 ml. | ||
| extra large: 1.1 ml. | small: 0.6 ml. | ||
| medium: 1.1 ml. | |||
| large: 1.2 ml. |
*The extra small EME mask corresponds most closely to the small ARABELLA Mask; corresponds most closely to the medium ARABELLA Mask; the large ARABELLA Mask is for larger infants than are covered by the EME sizes.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
SEP - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Thompson Hamilton Medical Incorporated P.O. Box 30008 Reno, Nevada 89502
Re: K030563
Trade/Device Name: Hamilton Medical ARABELLA NCPAP Masks Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator, Accessory Regulatory Class: II Product Code: BZD Dated: June 12, 2003 Received: June 13, 2003
Dear Mr. Thompson:
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.
4
Page 2 – Mr. David Thompson
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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/dsma/dsmamain.html.
Sincerely yours,
Susan Tanner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name: Hamilton Medical ARABELLA® NCPAP Masks
Indications For Use:
The Hamilton Medical ARABELLA® NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA® infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer. This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Patoche for JXH 9/19/03
510(k) Number: K030563
Prescription Use
(Per 21 CFR 801.109) $\checkmark$
OR
Over-The-Counter Use_