K Number
K200916
Device Name
Patient Administration Set
Date Cleared
2020-09-01

(148 days)

Product Code
Regulation Number
892.1390
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.
Device Description
The Patient Administration Sets (PAS) consist of a flexible plastic tubing with a distal plastic connector which can be affixed to a radionuclide generator, a T-section connector with (2) one way valves which permits inhalation of the generated radionuclide gas and subsequent absorption of expelled gas during exhalation via a semipermeable microparticle filer. A mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal end of T-section connector for patient breathing.
More Information

Not Found

No
The description focuses on the physical components and function of a breathing circuit for radionuclide administration, with no mention of AI or ML.

No
This device is described as an accessory for a diagnostic procedure (lung ventilation imaging). Its purpose is to facilitate the administration of a radionuclide-labeled aerosol for imaging, not to provide therapy or treatment.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure." This indicates its role in a diagnostic procedure.

No

The device description clearly outlines physical components like plastic tubing, connectors, valves, and a mouthpiece, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's a "radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator." It's designed as a "conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure." This describes a system used in vivo (within the body) for imaging, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
  • Device Description: The description details a system for delivering a substance to a patient for breathing and managing exhaled gas. This aligns with an in vivo administration system, not an in vitro diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples outside the body.

Therefore, this device is an accessory used in a medical imaging procedure performed on a patient, not an IVD.

N/A

Intended Use / Indications for Use

The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.

Product codes

IYT

Device Description

The Patient Administration Sets (PAS) consist of a flexible plastic tubing with a distal plastic connector which can be affixed to a radionuclide generator, a T-section connector with (2) one way valves which permits inhalation of the generated radionuclide gas and subsequent absorption of expelled gas during exhalation via a semipermeable microparticle filer. A mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal end of T-section connector for patient breathing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lung

Indicated Patient Age Range

Not Found

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

Laboratory tests were conducted to establish the performance and reliability characteristics of the modified device. These tests confirmed device dimensions, tolerances, biocompatibility and structural integrity and ensure that the device remains compatible with the TechnegasPlus Technegas™ generator. Test results confirmed that the device is substantially equivalent with the specified predicate device.

Key Metrics

Not Found

Predicate Device(s)

K913416

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1390 Radionuclide rebreathing system.

(a)
Identification. A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

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September 1, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cyclomedica Australia Pty Ltd % Ms. Karen Wolfe-Kerker Official Correspondent Certus International, Inc. 1422 Elbridge Payne Road, Suite 200 CHESTERFIELD MO 63017

Re: K200916

Trade/Device Name: Patient Administration Set (PAS) Regulation Number: 21 CFR 892.1390 Regulation Name: Radionuclide rebreathing system Regulatory Class: Class II Product Code: IYT Dated: July 10, 2020 Received: July 28, 2020

Dear Ms. Wolfe-Kerker:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200916

Device Name PATIENT ADMINISTRATION SET

Indications for Use (Describe)

The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "cyclomedica" in lowercase, gray letters. To the right of the word is a graphic of a sphere with a network of lines and dots around it. The sphere is yellow and the lines and dots are gray. The graphic is slightly transparent.

COMPLETE RESPONSES to FDA HOLD ON 510(K) FILE REVIEW

510(k) Summary (As required by 21 C.F.R. §807.92)

| Submitted by: | Cyclomedica Australia Pty Ltd
Unit 4, 1 The Crescent
Kingsgrove NSW 2208
Australia |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company
Contact: | Ms. Niamh Mc Aree |
| Date of
Summary: | July 7, 2020 |
| Device Name | Patient Administration Set |
| Common Name | Radionuclide Rebreathing System |
| Classification | Class 2 |
| Regulation No. | 21 CFR 892.1390 |
| Product Code | IYT |
| Predicate Device | Patient Administration Set (510(k) # K913416 ) |
| Modifications | The modifications include:
• Labeling changes to identify the current device owner / manufacturer
as well as additional information to comply with current regulatory
requirements (e.g. UDI code)
• Exhalation Filter changes (new supplier, adopting industry-standard
filter composition and design)
• Packaging changes (from molded 'shrink-wrap' plastic to industry
standard loose plastic bag) |
| Device
Description | The Patient Administration Sets (PAS) consist of a flexible plastic tubing
with a distal plastic connector which can be affixed to a radionuclide
generator, a T-section connector with (2) one way valves which permits
inhalation of the generated radionuclide gas and subsequent absorption of
expelled gas during exhalation via a semipermeable microparticle filer. A
mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal
end of T-section connector for patient breathing. |
| Intended Use | The Patient Administration Set is a radionuclide rebreathing system
and an accessory intended solely for use with the TechnegasPlus
Technegas® Generator. It is designed for use as a conduit system to
contain a radionuclide-labeled aerosol and permit respiration by the
patient during a functional lung ventilation imaging diagnostic procedure. |
| Technological
characteristics | The PAS has the same technological characteristics as the legally marketed
predicate device. New design modifications include changes in the
exhalation filter composition to adopt industry standard radionuclide
absorption ability. |
| Design
Verification and
Validation
Testing | Laboratory tests were conducted to establish the performance and reliability
characteristics of the modified device. These tests confirmed device
dimensions, tolerances, biocompatibility and structural integrity and ensure
that the device remains compatible with the TechnegasPlus Technegas™
generator. Test results confirmed that the device is substantially equivalent
with the specified predicate device. |

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Image /page/4/Picture/0 description: The image shows the word "cyclomedica" in gray font. To the right of the word is a graphic of a molecule. The molecule is gray with a yellow center.

COMPLETE RESPONSES to FDA HOLD ON 510(K) FILE REVIEW