(200 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
The provided document is a 510(k) summary for the Hamilton Medical ARABELLA® NCPAP Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing direct clinical effectiveness through a complex study with standalone performance metrics or controlled human reader studies.
Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment with experts, MRMC studies, and detailed statistical power are not applicable or not explicitly provided in this type of regulatory document. The "acceptance criteria" here are primarily about demonstrating that the new device performs comparably to the predicate and meets its own stated specifications.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K984254/K011516) | Reported Device Performance (Hamilton ARABELLA® NCPAP Masks) |
|---|---|---|
| Intended Use | Used with SensorMedics/EME Infant Flow System; provides CPAP with nasal mask; alternative to nasal prongs. | Used with Hamilton ARABELLA® infant nasal CPAP system; provides CPAP therapy with nasal mask; alternative to nasal prongs. |
| Indications | For nasal CPAP treatment of newborns and infants with RDS or recovering from RDS. | For nasal CPAP treatment of newborns and infants. |
| Environment | For use in hospitals. | For use in hospitals or other clinical settings. |
| Reuse | Single-patient use only. | Single-patient use only. |
| Fastening Means | Mechanism identical to nasal prongs. | Mechanism identical to nasal prongs. |
| Mask Sizes | Extra small and extra large (equivalent to small and medium ARABELLA, plus an additional large size for ARABELLA). | Small (size 0), medium (size 1), and large (size 2). |
| Mask Material in Contact with Face | Silicone rubber. | Latex-free silicone rubber. |
| Sterility at Shipment | Provided clean, non-sterile. | Provided clean, non-sterile. |
| Recommended Service Life | Not specified. | 1 week maximum; change when uncleanable. |
| Treatment Range | Up to 9 cm H2O. | Up to 7 cm H2O. |
| 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. |
Study Proving Device Meets Acceptance Criteria:
The document states: "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."
This paragraph describes the "study" (or rather, a collection of tests and comparisons) that supports the claim of substantial equivalence. The primary mechanism for meeting "acceptance criteria" here is demonstrating substantial equivalence to a predicate device through these various tests and comparisons.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated for specific tests. The comparison table lists mask sizes (Small, Medium, Large) for the ARABELLA masks and corresponding sizes for the predicate, implying that tests were conducted across these sizes.
- Data Provenance: Not specified, but given the nature of laboratory verification and validation, it would be laboratory-generated data rather than patient data from a specific country. It is retrospective in the sense that the data was collected for the purpose of the 510(k) submission after device development.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/Not provided. This type of information is typically found in studies involving diagnostic accuracy or clinical interpretation. The evaluation here is for a medical device accessory's performance characteristics (e.g., dead space, pressure range, material biocompatibility) and functional equivalence, not for diagnostic accuracy where expert ground truth is critical. Biocompatibility testing was done at a "nationally recognized biological testing laboratory," implying expert oversight in that specific area.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are for determining ground truth in cases of disagreement among interpreters, which is not relevant for the type of device performance testing described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an infant nasal CPAP mask, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device accessory, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on the specifications of the device, established engineering principles, and comparison to the predicate device's known performance.
- For performance metrics (e.g., dead space, treatment range), the "ground truth" would be measurements obtained through laboratory testing according to validated methods.
- For biocompatibility, the ground truth would be established through adherence to biocompatibility testing standards at a specialized laboratory.
- For functional equivalence, the ground truth is the performance and characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This refers to machine learning models. This document describes a physical medical device accessory. Design and testing would involve prototypes and production samples, not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no "training set" in the machine learning context for this device.
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SECTION 9: 510(K) SUMMARY
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- 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
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- Device Proprietary Name: ARABELLA® NCPAP Masks
Mask Sizes (Size #):
- Device Proprietary Name: ARABELLA® NCPAP Masks
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a. Small (0)
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b. Medium (1)
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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
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- 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.)
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- 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.
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- 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.
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- 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.
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- 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.
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| # | 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; providesCPAP 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 anasal mask; alternative to nasal prongs |
| 2 | indications | for nasal cpap treatment of newborns and infants withRDS 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 | fasteningmeans | 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 materialin contact withface | silicone rubber | latex-free silicone rubber |
| 8 | sterility atshipment | provided clean, non-sterile | provided clean, non-sterile |
| 9 | recommendedservice life | not specified | 1 week maximum; change when uncleanable |
| 10 | treatment range | up to 9 cm H2O | up to 7 cm H2O |
| 11 | effective deadspace | 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.
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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.
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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
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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_
§ 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).