(459 days)
Perfadex Plus is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium used for rapid cooling, perfusion and storage of lungs in connection with transplantation.
The provided document is a 510(k) summary for a medical device called Perfadex Plus. It describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. While it mentions non-clinical testing and clinical data, it does not contain the detailed information needed to fill out all sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that non-clinical testing and clinical data "have shown the changes to the product do not produce any new safety or effectiveness issues." However, specific numerical acceptance criteria (e.g., pH within a certain range, osmolality within a range) and the corresponding reported performance values are not provided in this summary.
What is mentioned as tested are several parameters for stability studies and mechanical testing for the bag and port system. For example, for pH, Calcium, Osmolarity, Dextran, Glucose, and Particulate analysis, the document only says that these were included in stability studies, not what the criteria or results were. Similarly, for mechanical testing, it only lists the types of tests (e.g., pressure and leakage, resistance to dropping, penetration, tensile strength, flow testing) without detailing the criteria or observed performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Clinical Data: "Using a statistically powered sample size with p-values obtained from a federally mandated registry [UNOS] and from a clinical trial, Clinical data on Perfadex® supplemented at point of use with THAM and calcium ions (PTHCa) shows it is substantially equivalent in survival to Perfadex not supplemented with Calcium."
- Sample Size: Not specified quantitatively. It only states "a statistically powered sample size."
- Data Provenance: Federally mandated registry [UNOS] (likely United States) and a clinical trial. The type of clinical trial (retrospective/prospective) is not explicitly stated, but registry data often includes both retrospective and prospective elements depending on how it's utilized.
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):
This information is not provided as the study mentioned is related to organ survival, not an AI or imaging-based study requiring expert ground truth establishment in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as the study mentioned is related to organ survival, not an AI or imaging-based study.
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:
No, an MRMC comparative effectiveness study was not done. The device is a perfusion solution, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. The device is a perfusion solution.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical data, the ground truth was outcomes data, specifically "survival" of lung transplants.
8. The sample size for the training set:
This information is not applicable/provided. The document describes a medical solution used in organ transplantation, not a machine learning model that would require a "training set."
9. How the ground truth for the training set was established:
This information is not applicable/provided. As above, there is no training set for this type of medical device.
Summary of missing information:
The 510(k) summary provides high-level information about non-clinical and clinical testing but lacks the granular detail about acceptance criteria, specific test results, and detailed clinical study design (like exact sample sizes) that would be present in a full study report or a different type of medical device submission. It focuses on demonstrating substantial equivalence based on the safety and effectiveness of the modified perfusion solution compared to its predicate.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2018
XVIVO Perfusion AB % Kathleen Johnson President Medical Device Approvals, Inc. P.O. Box 421 Fairfield, Iowa 52556
Re: K170826
Trade/Device Name: Perfadex Plus Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: Class II Product Code: KDN Dated: May 24, 2018 Received: May 25, 2018
Dear Kathleen Johnson:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
Page 2 - Kathleen Johnson
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carolyn Y. Neuland -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K170826
Device Name Perfadex Plus
Indications for Use (Describe)
Perfadex Plus is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Section 7. 510(k) SUMMARY
| DATE: | June 22, 2018 |
|---|---|
| SUBMITTER: | XVIVO Perfusion ABMässans gata 10SE-41251 GöteborgSwedenContact: Kathleen JohnsonRegulatory Affairs Consultant610-527-0585kathleen@mdapprovals.com |
| REGULATION NAME: | Isolated kidney perfusion and transport system and accessories |
| COMMON ORUSUAL NAME: | Perfadex Plus® |
| REGULATIONNUMBER | 21 CFR §876.5880 |
| CLASSIFICATION: | Class II |
| PRODUCT CODE | KDN |
| PREDICATE DEVICE: | Perfadex® with THAM K091989 |
| DESCRIPTION: | Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40containing calcium used for rapid cooling, perfusion and storage of lungs inconnection with transplantation. |
| INDICATIONS FOR USE: | Perfadex Plus is indicated for the flushing, static cold storage andtransportation of isolated lungs after removal from the donor inpreparation for eventual transplantation into a recipient. |
| SUBSTANTIALEQUIVALENCE: | Perfadex® Plus is substantially equivalent to the predicate Perfadex®with THAM cleared under K091989. The devices have the sameintended use.The differences between Perfadex® Plus and the predicate devicePerfadex® with THAM (K091989) are the following:The subject device Perfadex® Plus, is buffered withTromethamine (THAM) and does not require buffering prioruse, while the predicate device Perfadex with THAM(K091989) has a slightly acidic pH and requires buffering prioruse. The predicate device is supplied with a sterile 50 ml glassbottle containing THAM.The subject device Perfadex® Plus contains calcium to furthermimic extracellular plasma concentration of electrolyteswhile the predicate device (K091989) does not containcalcium which is therefore often added at the clinics prior touse.Perfadex and Perfadex Plus both are packaged in the Ecobaghowever the Perfadex Plus Ecobag utilizes the "Click System" |
{4}------------------------------------------------
instead of a spike port. The connection to the bag is made with a connector that "clicks" onto the port rather than by inserting a spike into the rubber stopper as in the Perfadex Ecobag. Complete information on the "Click System" can be found in the Device Description.
- Package testing to ensure maintenance of the sterile barrier has been performed according to ISO 11607. The bags have been tested by the manufacturer for bag welding, port system welding, tube welding, and fill volume.
NONCLINICAL TESTING:
Nonclinical testing including biological safety including:
- · Cytotoxicity
- Intracutaneous Irritation
- · Sensitization
- · Hemolysis
- · Material Mediated Pyrogenicity
- · Leachables
As well as Stability Studies including: •pH •Calcium
- •Osmolality
- •Dextran
- •Glucose
- ·Particulate analysis
Additionally, mechanical testing on the new bag and port system includes:
- · Pressure and Leakage testing
- · Resistance to dropping
- · Penetration testing
- · Tensile strength testing
- · Flow testing
has shown the changes to the product do not produce any new safety or effectiveness issues.
- CLINICAL DATA: Using a statistically powered sample size with p-values obtained from a federally mandated registry [UNOS] and from a clinical trial, Clinical data on Perfadex® supplemented at point of use with THAM and calcium ions (PTHCa) shows it is substantially equivalent in survival to Perfadex not supplemented with Calcium. Therefore, we can conclude that supplementation with THAM and Calcium does not add any additional risk to patients receiving a lung transplant.
- CONCLUSION: The non-clinical testing conducted as well as clinical data and realworld evidence with the proposed device demonstrate that the proposed device does not raise any new issues of safety and effectiveness and is substantially equivalent to the predicate device.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).