Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.

Device Description

The purpose of a drug nebuliser device is to facilitate the nebulisation of respiratory drugs and non-pharmacological (placebo) solutions and to allow the transfer of these preparations to patients via the drug nebuliser. Usage is predominantly for patients receiving treatment in anaesthetic and intensive care settings within hospital theatres, intensive care units, and accident and emergency departments. Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.

AI/ML Overview

The provided documentation describes the Armstrong Medical Spirale Drug Delivery System (Spirale DDS), which is a nebulizer accessory. The 510(k) submission (K111246) focuses on demonstrating substantial equivalence to a predicate device, the Trudell Aerovent collapsible Holding Chamber. This type of submission relies on non-clinical tests to show that the new device is as safe and effective as the predicate, rather than extensive clinical studies with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical Tests)	Reported Device Performance
Working Environment: Device must withstand insertion and removal forces associated with normal use.	"All tests were carried out and passed." (Implies the device met this criterion.)
Handling and Transportation Conditions: Must withstand temperature range of -40°C to +20°C.	"All tests were carried out and passed." (Implies the device met this criterion. Note: The document states 200°C, which is likely a typo and should be 20°C based on typical device handling conditions. I will assume 20°C as a more plausible figure for normal handling and transportation.)
Physical Requirements: Jet orifice and canister interface to be designed to be geometrically equivalent to Aerovent chamber from Trudell Medical to ensure safety and effectiveness.	"Key elements are the same such as jet orifice diameter, total volume collapsed and expanded, distance of nozzle travel canister depression and manufacturing material." (Implies this was met by design and confirmed.)
Physical Requirements: Spirale connectors and supplied adaptors to be compatible with existing Armstrong Medical ventilator circuit connections.	"Spirale DDS is compatible with circuits marketed under the 510(k) reference numbers listed below: K922789 (KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT), K920885 (VITAL SIGNS, INC. VENTILATOR CIRCUIT), K812774 (HUDSON OXYGEN THERAPY SALES CO. VENTILATOR CIRCUIT)." (Implies this was met.)
Product Testing: Glued seams to be leak-free at pressures up to 60cmH2O in both the open and closed/locked positions to withstand normal operating conditions.	"Spirale must be airtight to ensure no leakage of respiratory drugs and non-pharmacological solutions... "All tests were carried out and passed." (Implies the device met this criterion.)
Product Testing: Collapsible.	"Product must also expand and collapse during use without any difficulty... "All tests were carried out and passed." (Implies the device met this criterion.)
Product Testing: Lock and unlock positions easily identifiable, easily released from locked.	"All tests were carried out and passed." (Implies the device met this criterion.)
Functional Equivalence: Device performs as safe and effective as the predicate.	"As the predicate devices have been on the market for many years with no reportable incidences in this time, we can assumed from the bench tests carried out to evaluate the performance of the device under actual clinical working conditions, that the Spirale DDS will perform as safe and effective as the predicate." (This is the overall conclusion based on the non-clinical tests and predicate device history.)

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of a patient population for clinical trials. The evaluation was primarily based on non-clinical bench tests performed on the Spirale DDS device itself. Therefore, the "sample size" would refer to the number of devices tested during these non-clinical evaluations. This information is not explicitly provided in the summary.

Data provenance is also not applicable in the traditional sense of patient data. The non-clinical tests were conducted by Armstrong Medical Ltd. in Northern Ireland.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the evaluation was based on non-clinical bench testing for product performance and design specifications, not expert interpretation of clinical data or images. Ground truth for these types of tests typically relies on engineering specifications and direct measurement.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring expert adjudication. The non-clinical tests likely followed internal Armstrong Medical protocols for verification and validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is a physical medical device (drug delivery system), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this 510(k) submission was primarily based on:

Engineering specifications and design requirements: For criteria like jet orifice diameter, volume, and material compatibility.
Measured performance against predefined thresholds: For tests such as leak-free performance at specified pressures, temperature resistance, and ease of collapse/lock.
Equivalence to a legally marketed predicate device: The fundamental "ground truth" for substantial equivalence is that the new device performs at least as safely and effectively as the predicate, which has a history of safe use.

8. The Sample Size for the Training Set

This information is not applicable. There was no "training set" in the context of machine learning or AI models. The device's design and manufacturing process would have undergone various development and testing phases, but these are not referred to as training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8. The "ground truth" for the device's design and manufacturing was established through engineering principles, regulatory requirements, and established industry standards for medical device development and quality control.

Summary

{0}------------------------------------------------

K 111246

Armstrong
Medical

Section 5 510(K) Summary Spirale Drug Delivery System

5.1 Applicants Name and Address

AUG 1 0 2012

Armstrong Medical Ltd Wattstown Business Park Newbridge Road Coleraine Northern Ireland

5.2 Applicants Contact Details

Ian Stewart Development and Quality Systems Engineer.

Tel No: +44 (0) 2870356029 Fax No: +44 (0) 2870356875

5.3 Date Summary was prepared April 2011, revised July 2012.

5.4 Device Name Spirale DDS

5.5 Classification. Class II FDA Classification 21CFR 868.5630 Product Code: CAF

5.6 Legally marketed device to which Equivalence is claimed

Aerovent collapsible Holding Chamber, product code: 85951. Manufactured by: MONAGHAN MEDICAL CORP, 5 latour ave., suite1600, p.o.box 2805, Plattsburgh, NY 12901 and distributed by Trudell Medical 725 Third Street, London, Ontario, Canada, N5V 5G4

5.7 Description of the Device.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Armstrong Medical. The logo features a large, bold letter 'A' on the left side. To the right of the 'A' are the words 'Armstrong' and 'Medical' stacked on top of each other. The word 'Armstrong' is in a larger, bolder font than the word 'Medical'.

Section 5 510(K) Summary Spirale Drug Delivery System

The aim of treatment with a nebuliser is to deliver a therapeutic dose of the drug as an aerosol in the form of respirable particles and to obtain a response from the interaction between drug molecules and lung cell receptors, within a fairly short period of time, usually 5 to 10 minutes. Nebulisers are useful when large doses of inhaled drugs are needed, when patients are too ill or otherwise unable to use hand-held inhalers, and when drugs are not available in hand-held inhalers.

5.8 Intended Use

5.9 Substantial Equivalence

We are claiming substantial equivalence to the Trudell Aerovent collapsible Holding Chamber (Monaghan Medical). Both products are connected onto the inspiratory limb of a ventilator circuit; both can be collapsed when not in use.

Key elements are the same such as jet orifice diameter, total volume collapsed and expanded, distance of nozzle travel canister depression and manufacturing material.

No adverse advent has been reported on either type of product; therefore both products are safe and effective for use during treatment of a patient.

5.10 Materials used in

1. K-Resin® Styrene-Butadiene Copolymers.
1. 40646C TRANSPARENT PURPLE MASTER.
1. Metallocene polyethylene reinforced with a polypropylene helix.
1. LOCTITE® 3106™.
1. 7132M 1/32" white medical grade foam tape.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo with a large, bold letter 'A' on the left side. To the right of the 'A', there is text that reads 'Arms' on the top line and 'Medical' on the bottom line. The text is in a smaller font size compared to the letter 'A'. The logo appears to be for a medical company or organization.

In summary, Armstrong Medical has demonstrated that the Spirale Drug delivery system is substanically equivalent to the Trudell Aerovent collapsible Holding Chamber. It has been proven that the products are safe and effective while in use.

Spirale must be airtight to ensure no leakage of respiratory drugs and non-pharmacological solutions; the foam disk feature comes into use when the product is collapsed this design feature will ensure no medical gases are leaking from the circuit when the Spirale is attached to the circuit. Product must also expand and collapse during use without any difficulty. These features are 100% examined during assembly of the product.

5.11 Non-Clinical Tests.

They following tests were carried out on the Spirale DDS before approval to manufacture and market the devices;

1. Working Environment: Device must withstand insertion and removal forces associated with normal use
1. Handling and Transportation Conditions: Must withstand temperature range of -40°C to + ૨૦૦૮
1. Physical Requirements: Jet orifice and canister interface to be designed to be geometrically equivalent to Aerovent chamber from Trudell Medical to ensure safety and . effectiveness.
1. Physical Requirements: Spirale connectors and supplied adaptors to be compatible with existing Armstrong Medical ventilator circuit connections.
1. Product Testing: Glued seams to be leak free at pressures up to 60cmH2O in both the open and closed/locked positions to withstand normal operating conditions.
1. Product Testing: Collapsible.
1. Lock and unlock positions easily identifiable, easily released from locked.

All tests were carried out and passed, therefore product was approved for manufacture and marketing. Spirale DDS is compatible with circuits marketed under the 510(k) reference numbers listed below:

{3}------------------------------------------------

Image: Armstrong Medical logo	Section 5510(K) SummarySpirale Drug Delivery System
K922789	KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
K920885	VITAL SIGNS, INC. VENTILATOR CIRCUIT
K812774	HUDSON OXYGEN THERAPY SALES CO. VENTILATOR CIRCUIT

As the predicate devices have been on the market for many years with no reportable incidences in this time, we can assumed from the bench tests carried out to evaluate the performance of the

device under actual clinical working conditions, that the Spirale DDS will perform as safe and effective as the predicate.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by a few bold, black lines, with its wings outstretched.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver-Spring, MD 20993-0002 -

AUG-1-0-2012

Mr. Jan Stewart Development and Quality Systems Engineer Armstrong Medical Limited Wattstown Business Park, Newbridge Road Coleraine Northern Ireland BT52 1BS

Re: K111246

Trade/Device Name: Spirale DDS (Drug Delivery System) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 24, 2012 Received: July 27, 2012

Dear Mr. Stewart:

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.

{5}------------------------------------------------

Page 2- Mr. Stewart

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 (QS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours,

Antionm O. nart.

Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Armstrong Medical. The logo consists of a large letter A on the left, with the words "Armstrong Medical" to the right of the letter. The word "Armstrong" is above the word "Medical".

Section 4 510(K) Indications For Use Statement Spirale Drug Delivery System

Indications for Use Form

510(k) Number (if known): _K111246

Spirale DDS (Drug Delivery System) Device Name: _

Indications for Use:

Prescription Use Prescription Use

(Part 21 CER 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 In Vitro Diagnostic Devices (OIVD)
Division Sign-OffOffice of In Vitro Diagnostic DeviceEvaluation and Safety	(Division Sign-Off)Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k)	510(k) Number: K111246
Page 1 of 1

Regulation Number and Section

§ 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).