Patient Administration Set

K200916 · Cyclomedica Australia Pty, Ltd. · IYT · Sep 1, 2020 · Radiology

Device Facts

• Record ID: K200916
• Device Name: Patient Administration Set
• Applicant: Cyclomedica Australia Pty, Ltd.
• Product Code: IYT · Radiology
• Decision Date: Sep 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1390
• Device Class: Class 2

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.

Device Story

Patient Administration Set (PAS) functions as a conduit system for radionuclide-labeled aerosol delivery; used exclusively with Technegas® Generator. Device consists of flexible plastic tubing, distal connector for generator attachment, T-section connector with two one-way valves, and a mouthpiece (silicone or plastic). During diagnostic procedures, patient inhales radionuclide gas through the system; exhaled gas is captured via a semipermeable microparticle filter. Device facilitates lung ventilation imaging by ensuring controlled aerosol containment and respiration. Operated by clinical staff in imaging environments. Output is the delivery of aerosol to the patient for diagnostic visualization. Benefits include enabling functional lung imaging.

Clinical Evidence

Bench testing only. Laboratory tests verified device dimensions, tolerances, biocompatibility, structural integrity, and compatibility with the Technegas® Generator. No clinical data provided.

Technological Characteristics

Radionuclide rebreathing system; flexible plastic tubing; T-section connector with two one-way valves; mouthpiece (silicone or plastic); semipermeable microparticle exhalation filter. Mechanical device; no energy source or software. Sterilization and material standards are implied by industry-standard compliance.

Indications for Use

Indicated for patients undergoing functional lung ventilation imaging diagnostic procedures requiring the inhalation of radionuclide-labeled aerosol.

Regulatory Classification

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.

Predicate Devices

• Patient Administration Set (K913416)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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<br>Unit 4, 1 The Crescent<br>Kingsgrove NSW 2208<br>Australia |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company<br>Contact: | Ms. Niamh Mc Aree |
| Date of<br>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:<br>• Labeling changes to identify the current device owner / manufacturer<br>as well as additional information to comply with current regulatory<br>requirements (e.g. UDI code)<br>• Exhalation Filter changes (new supplier, adopting industry-standard<br>filter composition and design)<br>• Packaging changes (from molded 'shrink-wrap' plastic to industry<br>standard loose plastic bag) |
| Device<br>Description | The Patient Administration Sets (PAS) consist of a flexible plastic tubing<br>with a distal plastic connector which can be affixed to a radionuclide<br>generator, a T-section connector with (2) one way valves which permits<br>inhalation of the generated radionuclide gas and subsequent absorption of<br>expelled gas during exhalation via a semipermeable microparticle filer. A<br>mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal<br>end of T-section connector for patient breathing. |
| Intended Use | The Patient Administration Set is a radionuclide rebreathing system<br>and an accessory intended solely for use with the TechnegasPlus<br>Technegas® Generator. It is designed for use as a conduit system to<br>contain a radionuclide-labeled aerosol and permit respiration by the<br>patient during a functional lung ventilation imaging diagnostic procedure. |
| Technological<br>characteristics | The PAS has the same technological characteristics as the legally marketed<br>predicate device. New design modifications include changes in the<br>exhalation filter composition to adopt industry standard radionuclide<br>absorption ability. |
| Design<br>Verification and<br>Validation<br>Testing | Laboratory tests were conducted to establish the performance and reliability<br>characteristics of the modified device. These tests confirmed device<br>dimensions, tolerances, biocompatibility and structural integrity and ensure<br>that the device remains compatible with the TechnegasPlus Technegas™<br>generator. Test results confirmed that the device is substantially equivalent<br>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