(14 days)
The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures.
The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is a hardshell collection reservoir for venous blood and for blood recovered from Cardiotomy ouction room of for renease ices. The blood recovered by intracardiac suction ouslow and venthoular devices enters the reservoir through the top and passes through a filter media. The design of the reservoir is such that if, under normal operating a lume of less than 1000ml and if there is no foaming of the recovered blood, there is no blood contact with the open cell polyurethane defoamer. Venous there to ho blood comugh the top of the reservoir and is mixed with the filtered blood. As with the recovered Cardiotomy blood, under normal operating volume of less than 1000ml if there is no foaming of the venous blood entering the reservoir, there is no blood contact with the defoamer.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K021287 does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., a certain percentage of accuracy, sensitivity, or specificity). Instead, it relies on a determination of "substantial equivalence" to a predicate device.
However, based on the determination of substantial equivalence, we can infer the implicit "acceptance criteria" are that the new device, Trillium™ AFFINITY NT CVR with Filter with Trillium BioPassive Surface, performs at least as safely and effectively as the predicate devices and does not raise new safety or effectiveness concerns.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: No significant adverse biological effects compared to predicate. | "The biocompatibility [...] demonstrated that when compared to the predicate devices, the Trillium™ AFFINITY NT CVR does not significantly affect safety and effectiveness." |
| In vitro Bench Testing: Performance (e.g., blood collection, filtration, defoaming) is comparable to predicate, with no new safety/effectiveness concerns. | "The [...] in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium™ AFFINITY NT CVR does not significantly affect safety and effectiveness." |
| Substantial Equivalence: No new technological characteristics that raise new types of safety or effectiveness questions, and existing ones are assessed by acceptable scientific methods. | "The Trillium™ AFFINITY NT CVR has 'no new technological characteristics (e.g., materials and manufacturing processes)' from the currently marketed Cardiotomy/Venous Reservoir." "This technological characteristic 'could affect the safety and effectiveness of the device'. However, these 'technological characteristics do not raise new types of safety or effectiveness questions'. In addition, 'there are acceptable scientific methods which exist for assessing effects of these new technological characteristics'." "Performance data [...] demonstrate that the Trillium™ AFFINITY NT CVR is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a sample size for a test set in clinical trials or performance studies involving human subjects. The evaluation appears to be based on biocompatibility and in vitro bench testing.
- Sample Size: Not specified for any "test set" in the context of clinical performance. The testing mentioned is "biocompatibility and in vitro bench testing."
- Data Provenance: Not explicitly stated, but the submission is for a US FDA 510(k) clearance, implying the testing was conducted to US regulatory standards. It's likely a combination of preclinical lab studies. The text does not indicate retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. The device is a physical medical device (venous reservoir), not an AI/diagnostic software. Therefore, there's no "ground truth" establishment by experts in the typical diagnostic sense. The "ground truth" for material compatibility and functional performance would be established through established scientific and engineering testing protocols.
4. Adjudication Method for the Test Set
This is not applicable or provided. As stated above, this is a physical medical device, and the evaluation relies on biocompatibility and bench testing, not expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems where human readers interpret medical images or data. The device in question is a component of an extracorporeal perfusion circuit.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI system was not done. This device is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Established scientific and engineering metrics: For biocompatibility (e.g., cytotoxicity, hemocompatibility, sensitization testing) and in vitro bench testing (e.g., flow rates, filtration efficiency, defoaming effectiveness, structural integrity).
- Comparison to predicate device performance: The "ground truth" for safety and effectiveness is largely anchored to the established performance profile of the predicate devices. If the new device performs equivalently or better in these established tests, it meets the "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical product, not a machine learning model, so there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As there is no training set for a machine learning model, there is no ground truth established for one.
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SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY AND CONTACT PERSON
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 (763) 391-9533 Tel: FAX: (763) 391-9603
Preeti Jain, Senior Manager, Regulatory/Clinical Affairs
DEVICE NAME
Trillium™ AFFINITY NT CVR with Filter with Trillium BioPassive Surface
name of predicated or legally marketed device
AFFINITY Cardiotomy Venous Reservoir (K936003) Al TiNTT | Oardlotomy vonous with Trillium™ Biopassive Surface (K973760)
DESCRIPTION OF DEVICE
The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is a hardshell collection reservoir for venous blood and for blood recovered from Cardiotomy ouction room of for renease ices. The blood recovered by intracardiac suction ouslow and venthoular devices enters the reservoir through the top and passes through a filter media. The design of the reservoir is such that if, under normal operating a lume of less than 1000ml and if there is no foaming of the recovered blood, there is no blood contact with the open cell polyurethane defoamer. Venous there to ho blood comugh the top of the reservoir and is mixed with the filtered blood. As with the recovered Cardiotomy blood, under normal operating volume of less than 1000ml if there is no foaming of the venous blood entering the reservoir, there is no blood contact with the defoamer.
STATEMENT OF INTENDED USE
The Trillium™ AFFINITY NT CVR with Trillium BoPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The AFFINITY Cardiotomy/Venous Reservoir is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures
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STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the AFFINITY Cardiotomy/Venous Reservoir. The modification to the currently marketed Cardiotomy/Venous Reservoir : "The mounted surfaces with Trillium"".
The Trillium™ AFFINITY NT CVR is being compared to the following marketed devices:
- AFFINITY Cardiotomy Venous Reservoir (K936003) .
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
The Trillium™ AFFINITY NT CVR has the same indications statement and intended uses as the:
-
AFFINITY Cardiotomy Venous Reservoir (K936003) .
The Trillium™ AFFINITY NT CVR has "no new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed Cardiotomy/Venous Reservoir. The technological characteristic is solely the coating material of the blood pathway: -
Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows: -
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".
"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium" AFFINITY NT CVR is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices.
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The biocompatibility and in vitro bench testing demonstrated that when compared to the
predicate devices, the Trillium" AFFINITY NT CVR does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices.
- September 19.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
Mr. Preeti Jain Senior Manager, Regulatory/Clinical Affairs Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428
Re: K021287
Trade Name: Trillium™ AFFINITY NT Cardiotomy Venous Reservoir Regulation Number: 21 CFR 840.4400 Regulation Name: Cardiotomy Reservoir Regulatory Class: II (two) Product Code: DTN Dated: April 22, 2002 Received: April 23, 2002
Dear Mr. Jain:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Preeti Jain
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with are in your e FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Trillium™ AFFINITY NT Cardiotomy Venous Reservoir Device Name:
Indications for Use:
The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter use
Division of Cardiovascular & Respiratory Devices
510(k) Number K031287
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.