(88 days)
The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation.
The OCS Lung Donor Flush Set is a sterile single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation. It is comprised of an already 510(k) cleared cannula (K132811, Sarns Soft-Flow Extended Aorta Cannula) along with the donor flush lines subassembly. The donor flush line assembly consists of silicone tubing, clamps and two spike connectors to enable connection between donor lungs and bags of organ preservation solution. The clamps are used to control the gravity flow of solution from bags to the donor organ.
The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.
The provided FDA 510(k) summary document for the TransMedics, Inc. OCS™ Lung Donor Flush Set focuses on establishing substantial equivalence to a predicate device for medical device clearance, not on providing a study proving a device meets specific clinical performance acceptance criteria in the context of an AI/algorithm-based device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they pertain to the evaluation of AI or algorithmic performance, which is not the subject of this medical device submission.
The document describes a physical medical device used for organ preservation, not an AI or software-driven diagnostic or treatment tool. The "performance data" section refers primarily to bench testing, biocompatibility, sterilization, and shelf-life, which are standard for physical medical devices.
Here's an attempt to answer the questions based only on the provided document, noting where information is not available or not applicable:
Acceptance Criteria and Study for the OCS™ Lung Donor Flush Set
This document describes the 510(k) submission for the OCS™ Lung Donor Flush Set, a physical medical device. The "study" referenced in the document is primarily bench testing to verify product requirements, not a clinical trial or AI performance study.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Performance testing was done to verify that OCS Lung Donor Flush Set meets all of its product requirements. The testing demonstrated that all acceptance criteria were met and that the OCS Lung Donor Flush Set was acceptable for clinical use."
However, the specific "acceptance criteria" (e.g., tensile strength, flow rate, leak integrity) and the detailed results of "reported device performance" are not explicitly listed in the provided 510(k) summary. These details would typically be found in the full submission, but are summarized as met for the purpose of demonstrating substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Acceptable, based on components from PMA-approved or 510(k)-cleared devices. |
| Sterility Assurance Level | 10⁻⁶ (stated as met). |
| Shelf Life | 26 months (labeled as met). |
| Bench Testing | All product requirements and acceptance criteria were met. (Specific criteria and results not detailed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of an AI/algorithm test set. The "test set" for this physical device was likely a series of units manufactured for bench testing. The document does not specify the number of units tested. The data provenance would be from internal lab testing by TransMedics, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI/diagnostic device that requires expert ground truth for image or data interpretation.
4. Adjudication Method for the Test Set
Not applicable. (See #3)
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI systems where human readers interpret cases. The OCS™ Lung Donor Flush Set is a physical device for organ preservation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is its adherence to engineering specifications, material properties, and functional performance (e.g., flow rates, leak integrity, sterility) as verified through design verification and validation testing, often against established standards (e.g., ISO for biocompatibility and sterilization). It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
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November 18, 2022
TransMedics, Inc. Miriam Provost VP. Global Regulatory Affairs 200 Minuteman Road Suite 302 Andover, Massachusetts 01810
Re: K222535
Trade/Device Name: OCS Lung Donor Flush Set Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System and Accessories Regulatory Class: II Product Code: MSB Dated: August 19, 2022 Received: August 22, 2022
Dear Miriam Provost:
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
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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 medical devices and radiation-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,
Jade M. Noble -S 2022.11.18 15:03:58 -05'00' for Gema Gonzalez, M.S. Acting 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
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Indications for Use
510(k) Number (if known) K222535
Device Name OCSTM Lung Donor Flush Set
Indications for Use (Describe)
The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation.
| 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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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the TransMedics, Inc. OCS™ Lung Donor Flush Set is provided below.
1. SUBMITTER
| Applicant: | TransMedics, Inc.200 Minuteman Road, Suite 302Andover, MA 01810 |
|---|---|
| Contact: | Miriam Provost, Ph.D.VP, Global Regulatory AffairsTransMedics, Inc978-494-7897mprovost@transmedics.com |
| Date Prepared: | August 18, 2022 |
2. DEVICE
| Device Trade Name: | OCS™ Lung Donor Flush Set |
|---|---|
| Common Name | Organ perfusion cannula and tubing |
| 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: | K203262 |
|---|---|
| Device Name: | Cannula for Organ Perfusion |
| Submitter: | Bridge to Life Ltd. |
| Regulation Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation: | 21 CFR 876.5880 |
| Regulatory Class: | Class II |
| Product Code: | KDN, MSB |
REASON FOR 510(K) SUBMISSION 4.
The OCS Lung Donor Flush Set is a new device.
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5. DEVICE DESCRIPTION
The OCS Lung Donor Flush Set is a sterile single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation. It is comprised of an already 510(k) cleared cannula (K132811, Sarns Soft-Flow Extended Aorta Cannula) along with the donor flush lines subassembly. The donor flush line assembly consists of silicone tubing, clamps and two spike connectors to enable connection between donor lungs and bags of organ preservation solution. The clamps are used to control the gravity flow of solution from bags to the donor organ.
The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.
INTENDED USE/INDICATIONS FOR USE 6.
The OCS Lung Donor Flush Set is a sterile single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation.
SUBSTANTIAL EQUIVALENCE 7.
Comparison of Indications
The OCS Lung Donor Flush Set has an indication for use statement that is identical to the predicate device (Bridge to Life Ltd Cannula for Organ Perfusion) with the exception of additional explanatory text at the end of the predicate device indication, which is not necessary for an indication for use statement and the limitation that the OCS Lung Donor Flush Set is indicated for donor lungs, while the predicate device is indicated for general donor organs.
Like the predicate device, the OCS Lung Donor Flush Set is indicated for hypothermic flushing and replacement of residual blood in donor organs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation.
Technological Comparisons
The technological characteristics of the subject device are nearly identical to the predicate device. The main difference is that the OCS Lung Donor Flush Set includes the donor flush lines subassembly to facilitate connection between the preservation and the donor lung, while the user must utilize off-the-shelf tubing and connectors for the predicate device. This difference is simply an added convenience for the user and does not impact on safety or substantial equivalence.
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PERFORMANCE DATA 8.
Biocompatibility Testing
The OCS Lung Donor Flush Set consists of components and materials that were either PMAapproved or were 510(k)-cleared, therefore, biocompatibility testing is not necessary to demonstrate substantial equivalence.
Sterilization and Shelf Life
The OCS Lung Donor Flush Set is sterilized using Ethylene Oxide (ETO) to a sterility assurance level of 10°. The OCS Lung Donor Flush Set is labeled with a 26 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
Performance testing was done to verify that OCS Lung Donor Flush Set meets all of its product requirements. The testing demonstrated that all acceptance criteria were met and that the OCS Lung Donor Flush Set was acceptable for clinical use.
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.
CONCLUSION 9.
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. Bench testing has demonstrated acceptable performance of the device, that it meets all acceptance criteria and that the OCS Lung Donor Flush Set is acceptable for clinical use.
§ 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).