(459 days)
Not Found
No
The summary describes a solution for organ preservation and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is used for the preservation and transportation of organs for transplantation, not for treating a disease or condition in a living patient. It is a preservation solution.
No
The device is described as a solution for flushing, cold storage, and transportation of isolated lungs for transplantation, and a pre-buffered, extracellular solution of dextran 40 containing calcium used for rapid cooling, perfusion and storage of lungs. This description indicates it is a preservation solution, not a device used for diagnosis.
No
The device description clearly states it is a "pre-buffered, extracellular solution," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." This describes a solution used outside the body to preserve an organ.
- Device Description: The description confirms it's a "pre-buffered, extracellular solution... used for rapid cooling, perfusion and storage of lungs." This further reinforces its use in an ex vivo (outside the living organism) context.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It's a preservation solution, not a diagnostic tool.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KDN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Perfadex® with THAM K091989
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
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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)
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Section 7. 510(k) SUMMARY
| DATE: | June 22, 2018 |
|---|---|
| SUBMITTER: | XVIVO Perfusion AB |
| Mässans gata 10 | |
| SE-41251 Göteborg | |
| Sweden |
Contact: Kathleen Johnson
Regulatory Affairs Consultant
610-527-0585
kathleen@mdapprovals.com |
| REGULATION NAME: | Isolated kidney perfusion and transport system and accessories |
| COMMON OR
USUAL NAME: | Perfadex Plus® |
| REGULATION
NUMBER | 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 40
containing calcium used for rapid cooling, perfusion and storage of lungs in
connection with transplantation. |
| INDICATIONS FOR USE: | 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. |
| SUBSTANTIAL
EQUIVALENCE: | Perfadex® Plus is substantially equivalent to the predicate Perfadex®
with THAM cleared under K091989. The devices have the same
intended use.
The differences between Perfadex® Plus and the predicate device
Perfadex® with THAM (K091989) are the following:
The subject device Perfadex® Plus, is buffered with
Tromethamine (THAM) and does not require buffering prior
use, while the predicate device Perfadex with THAM
(K091989) has a slightly acidic pH and requires buffering prior
use. The predicate device is supplied with a sterile 50 ml glass
bottle containing THAM.The subject device Perfadex® Plus contains calcium to further
mimic extracellular plasma concentration of electrolytes
while the predicate device (K091989) does not contain
calcium which is therefore often added at the clinics prior to
use.Perfadex and Perfadex Plus both are packaged in the Ecobag
however 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.