(20 days)
The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-VP metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers.
The provided text describes a submission for a medical device (RTC 24-VP Metered Dose Inhaler Adapter) to the FDA, focusing on its substantial equivalence to a predicate device. However, it does not describe an AI/ML-driven device or study. Therefore, most of the requested fields regarding AI/ML device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable.
Below is the information that can be extracted or deduced from the provided text, primarily addressing the performance and comparison to a predicate device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant impact on the rate of flow through the device. | "The decreased inlet port size on the RTC 24-VP has no significant impact on the rate of flow through the device..." |
| No significant impact on circuit back pressure. | "...or on the circuit back pressure." |
| Demonstrate substantial equivalence to the predicate device (RTC 24-V MDI adapter) in terms of function, materials, and safety. | The device found "substantially equivalent" to the RTC 24-V MDI adapter (K091111). Similarities include function, materials (latex-free Polystyrene Butadiene body, Thermoplastic Rubber cap), functional dimensions (Outlet – 15mm I.D. / 22 mm O.D.), and markings (molded-in arrow for flow direction). Performance testing showed "very little difference...in peak circuit back pressure." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "When a range of flow rates is used to ventilate air through both the new RTC 24-VP MDI adapter and the original RTC 24-V MDI adapter...", but no specific number of trials, devices, or flow rates is mentioned.
- Data Provenance: The testing was described as "laboratory testing." No country of origin for data or retrospective/prospective nature is specified, but it implies internal R&D testing by the manufacturer (Instrumentation Industries, Inc., located in Bethel Park, PA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a mechanical MDI adapter, and the evaluation is based on engineering performance metrics (flow rate, back pressure), not expert interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML or diagnostic device requiring expert adjudication.
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 is not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or reference standard) in this context would be the measured physical properties: peak circuit back pressure and flow rate, as determined by laboratory instruments under controlled conditions. This is an objective measurement rather than a subjective interpretation.
8. The sample size for the training set
- Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for a mechanical device.
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KC101857
Section 5 – 510(k) Summary Special 510 (k) Submission Page 1 of 2
JUL 2 2 2010
2990 Industrial Boulevard • Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com
ﻟ
nstrumentation
dustries. Inc. We make Respiratory Care Work!
Date Prepared: June 30, 2010 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
SPECIAL 510(k) SUMMARY
... .. ...
for
RTC 24-VP Metered Dose Inhaler Adapter
| Trade Name | RTC 24-VP Metered Dose Inhaler Adapter | |
|---|---|---|
| CommonName | Actuator | |
| ClassificationName | Nebulizer | |
| Regulation | 21 CFR 868.5630 | |
| PredicateDevice | Instrumentation Industries, Inc. RTC 24-V (K091111) | |
| DeviceDescription | The Instrumentation Industries, Inc. RTC 24-VP metered dose inhaler adapteris an actuator for intermittent delivery of prescribed aerosol medicationdispensed in metered dose inhalers. | |
| Intended Useof the DeviceRTC 24-VPMetered DoseInhaler Adapter | The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator forintermittent delivery of prescribed aerosol medication dispensed in cylindrical-stylemetered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only whenconnected to ventilator tubing or tracheal tubes.The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who isventilator-dependent and to whom a metered dose inhaler has been prescribed. Theexpected clinical environment for the RTC 24-VP MDI Adapter is Critical Careand/or long term or short term ventilation.The RTC 24-VP MDI Adapter is intended for single patient reuse.This device is intended for sale by or on the order of a physician. | |
| TechnologicalCharacteristics | Similarities:The function and the materials of both the RTC 24-V predicate device and theRTC 24-VP are the same. Both the RTC 24-V and the RTC 24-VP will accept |
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Special 510 (k) Submission
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1 - 1 - 1 -
. . . . . . .
| plastic or metal tipped, cylindrically-shaped MDI canisters. All materials arelatex-free. | |
|---|---|
| Materials - Body – Polystyrene ButadieneCap – Thermoplastic Rubber | |
| Functional Dimensions - Outlet – 15mm I.D. / 22 mm O.D. | |
| Markings – Both the RTC 24-V and the RTC 24-VP are marked with amolded-in arrow defining direction of flow. | |
| Differences:The RTC 24-VP has a decreased inlet port size of 15 mm OD. The RTC 24-Vhas an inlet port of 22 mm ID. | |
| Performance | When a range of flow rates is used to ventilate air through both the new RTC24-VP MDI adapter and the original RTC 24-V MDI adapter, very littledifference is seen in peak circuit back pressure. The decreased inlet port sizeon the RTC 24-VP has no significant impact on the rate of flow through thedevice or on the circuit back pressure. |
| Conclusion: | In laboratory testing the RTC 24-VP MDI adapter is substantially equivalent to theRTC 24-V MDI adapter predicate device. |
. -
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Image /page/2/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" around the perimeter. Inside the circle is a stylized representation of an abstract symbol, possibly representing the essence of health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL 2.2 2010
Ms. Doris F. Walter Regulatory Affairs/Quality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102
Re: K101857
Trade/Device Name: RTC 24-VP Metered Dose Inhaler Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 30, 2010 Received: July 2, 2010
Dear Ms. Walter:
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.
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Page 2- Ms. Walter
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 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 vours.
Anthony O. Annett
Anthony D. Watson, B.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
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Section 4 - Indications for Use Special 510(k) Submission Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name:
RTC 24-VP Metered Dose Inhaler Adapter
Statement of Indications for Use:
RTC 24-VP Metered Dose Inhaler Adapter
The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation.
The RTC 24-VP MDI Adapter is intended for single patient reuse.
This device is intended for sale by or on the order of a physician.
| Prescription Use | √ | And/Or | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K101857 |
|---|---|
| ---------------- | --------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).