(148 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Patient Administration Set" (PAS). It primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device.
Therefore, the document does NOT contain the information needed to answer the questions about acceptance criteria and a study proving a device meets them in the context of an AI/ML-driven medical device performance study (e.g., diagnostic accuracy, human-AI collaboration).
The Patient Administration Set is described as a "radionuclide rebreathing system" and an accessory for a radionuclide generator used in lung ventilation imaging. The "modifications" mentioned are related to labeling, exhalation filter changes (new supplier, industry-standard composition), and packaging. The "Design Verification and Validation Testing" performed consists of laboratory tests to confirm dimensions, tolerances, biocompatibility, and structural integrity, ensuring compatibility with the Technegas™ generator. These are engineering design verification tests, not performance studies as typically understood for AI/ML devices.
Here's why the requested information cannot be extracted from the provided text:
- No AI/ML Component: The device described is a physical medical device (tubing, connectors, filter, mouthpiece) for administering a radionuclide. There is no mention of any artificial intelligence or machine learning component.
- Performance Metrics for AI/ML are Absent: Questions about sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, training/test set sample sizes, and ground truth establishment are relevant to AI/ML diagnostic or predictive tools, not to a physical radionuclide administration set.
- "Acceptance Criteria" in this context: The "acceptance criteria" for this device (the Patient Administration Set) would be related to its physical and functional integrity (e.g., no leaks, correct dimensions, proper flow, biocompatibility, filter efficiency) and compliance with regulatory standards. These are verified through the "Design Verification and Validation Testing" which are laboratory tests, not clinical performance studies comparing diagnostic accuracy or clinical outcomes.
- No "Study" as requested: The "study" mentioned ("Design Verification and Validation Testing") is a series of engineering tests, not a clinical trial or performance study involving human subjects or AI model evaluation.
In summary, the provided FDA document is a regulatory clearance for a physical medical device, not a performance study report for an AI/ML diagnostic or therapeutic device. Therefore, it does not contain the information required to answer your specific questions.
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September 1, 2020
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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 LtdUnit 4, 1 The CrescentKingsgrove NSW 2208Australia |
|---|---|
| CompanyContact: | Ms. Niamh Mc Aree |
| Date ofSummary: | 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 / manufactureras well as additional information to comply with current regulatoryrequirements (e.g. UDI code)• Exhalation Filter changes (new supplier, adopting industry-standardfilter composition and design)• Packaging changes (from molded 'shrink-wrap' plastic to industrystandard loose plastic bag) |
| DeviceDescription | The Patient Administration Sets (PAS) consist of a flexible plastic tubingwith a distal plastic connector which can be affixed to a radionuclidegenerator, a T-section connector with (2) one way valves which permitsinhalation of the generated radionuclide gas and subsequent absorption ofexpelled gas during exhalation via a semipermeable microparticle filer. Amouthpiece (choice of soft silicone or hard plastic) is affixed to the proximalend of T-section connector for patient breathing. |
| Intended Use | The Patient Administration Set is a radionuclide rebreathing systemand an accessory intended solely for use with the TechnegasPlusTechnegas® Generator. It is designed for use as a conduit system tocontain a radionuclide-labeled aerosol and permit respiration by thepatient during a functional lung ventilation imaging diagnostic procedure. |
| Technologicalcharacteristics | The PAS has the same technological characteristics as the legally marketedpredicate device. New design modifications include changes in theexhalation filter composition to adopt industry standard radionuclideabsorption ability. |
| DesignVerification andValidationTesting | Laboratory tests were conducted to establish the performance and reliabilitycharacteristics of the modified device. These tests confirmed devicedimensions, tolerances, biocompatibility and structural integrity and ensurethat the device remains compatible with the TechnegasPlus Technegas™generator. Test results confirmed that the device is substantially equivalentwith the specified predicate device. |
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COMPLETE RESPONSES to FDA HOLD ON 510(K) FILE REVIEW
N/A