(90 days)
OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
The OCS Lung Solution is a colorless, sterile, pyrogen-free solution for cold flushing, storage and transport of donor lungs for transplantation. The OCS Lung Solution is a colloid-based extracellular low potassium solution for cold flushing and storage of donor lungs for transplantation. The OCS Lung Solution is used to flush and store a lung after removal from the donor. Administration of the solution at the recommended temperature will effectively cool the organ to reduce its metabolic requirements.
This document, K211314, is an FDA 510(k) Premarket Notification for the OCS™ Lung Solution. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies typically associated with AI/ML evaluations.
Therefore, the information required to answer your prompt about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is largely not present in this 510(k) summary.
Specifically, the document states:
- "Software Verification and Validation Testing: Not applicable. The device contains no software."
- "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device."
- "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."
This indicates that this is a medical solution (a chemical product), not an AI/ML device, and thus the type of performance evaluation typically performed for AI/ML devices (e.g., assessing accuracy, sensitivity, specificity, or human reader improvement with AI assistance) was not conducted.
However, I can extract information regarding the "device" as described in this 510(k) submission, even if it doesn't align with an AI/ML context:
1. A table of acceptance criteria and the reported device performance
Since this is a solution and not an AI/ML device, typical "performance" metrics like accuracy, sensitivity, or specificity are not applicable. The closest aspects to "acceptance criteria" for a solution would be its chemical composition, sterility, and shelf life. The document focuses on demonstrating substantial equivalence to an existing predicate device (Perfadex®) rather than meeting defined performance criteria through a study.
| Acceptance Criteria (Implied for a Chemical Solution) | Reported Device Performance (as per 510(k)) |
|---|---|
| Similar Indications for Use | Identical to predicate device (Perfadex®): "flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." |
| Chemical Composition | Nearly identical chemical composition to predicate device (Perfadex®) in terms of electrolytes and Dextran 40. Minor differences: addition of 1 gram more glucose in OCS Lung Solution. Both adjusted to same pH prior to use. |
| Biocompatibility | Biocompatibility established for the final finished form (solution and solution bag) as it's identical to a previously marketed device in formulation, processing, sterilization, and geometry, with no added chemicals. Testing includes: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity (material mediated and bacterial endotoxin), and in vitro hemolysis. (Studies performed per ISO-10993). |
| Sterility | Terminally sterilized using steam sterilization process to a SAL of ≤10⁻⁶. Each lot tested for endotoxins and labeled as pyrogen-free. |
| Shelf Life | Labeled with a 24-month shelf life. |
| Packaging Material | Uses a polypropylene bag compared to a PVC bag for the predicate device. This is noted as a "technological difference" but doesn't raise new safety/effectiveness questions. |
| Electrical Safety / EMC | Not applicable. Device contains no electrical components. |
| Software Verification / Validation | Not applicable. Device contains no software. |
| Clinical Performance | Not applicable. No clinical studies were deemed necessary to establish substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no "test set" in the context of an AI/ML algorithm was used. The evaluation for this device focused on bench testing (chemical analyses) and demonstrating similarity to a predicate device.
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 applicable. No ground truth for an AI/ML test set was established. The "ground truth" for this product type is its chemical composition, sterility, and demonstrated biocompatibility, which are verified through standard laboratory testing methods and comparison to an established predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No test set or expert adjudication was performed in the context of an AI/ML device.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a solution, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm, so no standalone performance testing was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since this is a medical solution and not a diagnostic AI/ML device, the concept of "ground truth" as typically defined for AI/ML is not directly applicable. For this product, "ground truth" would relate to:
- Chemical Analysis: Verifying the exact composition of the solution.
- Sterility Testing: Verifying the absence of microorganisms.
- Biocompatibility Testing: Verifying that the materials do not elicit adverse biological responses.
- Bench Testing: Comparison to established standards for solutions for organ preservation.
8. The sample size for the training set
This information is not applicable. There is no AI/ML model, and therefore no training set.
9. How the ground truth for the training set was established
This information is not applicable. There is no AI/ML model or training set.
{0}------------------------------------------------
Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2021
TransMedics, Inc. % Christy Foreman, M.B.E. Senior Consultant, Medical Devices Biologics Consulting Group, Inc. 1555 King Street. Suite 300 Alexandria, Virginia 22314
Re: K211314
Trade/Device Name: OCSTM Lung Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: MSB Dated: April 29, 2021 Received: April 30, 2021
Dear Christy Foreman:
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.
{1}------------------------------------------------
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 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.
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211314
Device Name OCS™ Lung Solution
Indications for Use (Describe)
OCS™ Lung Solution is intended for flushing, 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)
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}------------------------------------------------
K211314 Page 1 of 4
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the TransMedics, Inc. OCS™ Lung Solution is provided below.
1. SUBMITTER
| Applicant: | TransMedics, Inc.200 Minuteman Road, Suite 302Andover, MA 01810 |
|---|---|
| Contact: | Miriam Provost, Ph.D.VP, Global Regulatory Affairs978-494-7897mprovost@transmedics.com |
| Submission Correspondent: | Christy Foreman, M.B.E.Senior Consultant, Medical DevicesBiologics Consulting Group, Inc.1555 King Street, Suite 300Alexandria, VA 22314Phone: 301-325-4245Email: cforeman@biologicsconsulting.com |
| Date Prepared: | April 29, 2021 |
2. DEVICE
| Device Trade Name: | OCS TM Lung Solution |
|---|---|
| Common Name | Organ perfusion and preservation solution |
| Regulation Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation: | 21 CFR 876.5880 |
| Regulatory Class: | Class II |
| Product Code: | MSB |
PREDICATE DEVICE 3.
The subject device claims equivalence to the following legally marketed predicate device:
| 510(k) Number: | K000881 |
|---|---|
| Device Name: | Perfadex® |
| Submitter: | VitroLife Sweden AB (now distributed by the subsidiary XvivePerfusion AB) |
{4}------------------------------------------------
| Regulation Name: | Isolated kidney perfusion and transport system and accessories |
|---|---|
| Regulation: | 21 CFR 876.5880 |
| Regulatory Class: | Class II |
| Product Code: | MSB |
DEVICE DESCRIPTION 4.
The OCS Lung Solution is a colorless, sterile, pyrogen-free solution for cold flushing, storage and transport of donor lungs for transplantation. The OCS Lung Solution is a colloid-based extracellular low potassium solution for cold flushing and storage of donor lungs for transplantation. The OCS Lung Solution is used to flush and store a lung after removal from the donor. Administration of the solution at the recommended temperature will effectively cool the organ to reduce its metabolic requirements.
The subject 510(k) involves the class II use of the OCS Lung Solution. More specifically, the OCS Lung Solution is indicated for hypothermic flushing, storage and transportation of donor lungs for transplantation (21 CFR 876.5880, Class II Product Code MSB). The OCS Lung Solution is identical to the device approved as a component of the OCS Lung System, approved under P160013. However, as a class II device, the OCS Lung Solution is a stand-alone medical device.
INTENDED USE/INDICATIONS FOR USE 5.
OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
6. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
The OCS Lung Solution has an indication for use statement that is identical to the predicate device (Perfadex). Like the predicate device, the OCS Lung Solution is indicated for flushing. storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Technological Comparisons
The OCS Lung Solution is substantially equivalent to the Perfadex Solution cleared under K000881. The chemical composition is nearly identical between the two products in terms of electrolytes and Dextran 40. Both products are adjusted to the same pH prior to use by 1 mmol THAM/TRIS or bicarbonate. The differences are the addition of one more gram of glucose in the OCS Lung solution, and the use of a polypropylene bag compared to a PVC bag for the predicate device.
{5}------------------------------------------------
7. PERFORMANCE DATA
Biocompatibility Testing
Biocompatibility testing for the OCS Lung Solution was performed in accordance with the guidance, "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The duration of contact with the lung for the subject device is less than 24 hours. The level of contact was considered direct since the OCS Lung Solution is in direct contact with the donor lung. The testing to support the substantial equivalence included cytotoxicity testing, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity (material mediated and bacterial endotoxin) and in vitro hemolysis. As the OCS Lung Solution in its final finished form (both solution and solution bag) is identical to the previously marketed device in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents), biocompatibility of the OCS Lung Solution has been established.
Sterilization and Shelf Life
After formulation and filling, the OCS Lung Solution bags are terminally sterilized using a steam sterilization process to a SAL of ≤106. Each lot (or batch) of the OCS Lung Solution is tested for endotoxins prior to lot release and the product is labeled as pyrogen-free.
This OCS Lung Solution is labeled with a 24-month shelf life.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Not applicable. The device contains no software.
Bench Testing
Bench testing consisted of chemical analyses of the OCS Lung Solution.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
{6}------------------------------------------------
CONCLUSION 8.
The substantial equivalence information provided in this submission demonstrates that the subject device is substantially equivalent to the predicate device in both indications for use and technological characteristics. The minor technological differences do not raise new or different questions of safety and effectiveness.
§ 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).