(29 days)
The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.
The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
The provided text describes a Special 510(k) submission for a modification to an existing device, the Bio-Probe Disposable Blood Flow Probe. The modification involves coating the blood contact surfaces with Trillium™. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria or conduct a new clinical study with acceptance criteria in the traditional sense typically associated with new device approvals.
Therefore, the information requested in your prompt related to specific acceptance criteria, studies proving those criteria, sample sizes, expert involvement, and ground truth establishment, is largely not applicable in the context of this specific 510(k) submission.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This 510(k) is for a modification (adding a coating) to an already cleared device. The submission focuses on demonstrating that the modification does not affect safety or effectiveness and that the new device remains substantially equivalent to the predicate. There are no explicit "acceptance criteria" for novel performance metrics discussed. Instead, the focus is on comparability.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Provided. The text mentions "biocompatibility and in vitro bench testing" but does not specify sample sizes for these tests, nor does it provide details on data provenance (country, retrospective/prospective).
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):
- Not Applicable/Not Provided. The testing described is "biocompatibility and in vitro bench testing," which typically involves laboratory analyses rather than interpretation by human experts to establish ground truth in the way a diagnostic AI might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. The described testing does not involve human adjudication in the context of diagnostic interpretation.
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:
- Not Applicable. This device is a blood flow probe, not an AI-powered diagnostic tool, and the submission is not for a clinical effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable/Implied by testing. The "ground truth" for the in vitro bench testing would be established by the defined analytical methods for "Coating Characteristics," "Physical Characteristics," and "Performance Characteristics," and comparing those to established specifications or predicate device characteristics.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable.
Summary of Device Performance (as stated in the 510(k) for substantial equivalence):
The submission concludes that:
- "The biocompatibility and in vitro bench testing demonstrated that when compared to the ... predicate devices, the Trillium™ Bio-Probe Disposable Blood Flow Probe does not [present new questions of safety or effectiveness] and are substantially equivalent to other [legally marketed] extracorporeal cardiopulmonary devices."
- The in vitro bench testing included analysis of:
- Coating Characteristics
- Physical Characteristics
- Performance Characteristics
This 510(k) is an example of a "Special 510(k)" which is used for modifications to a manufacturer's own legally marketed device where the modification does not raise new questions of safety and effectiveness, and where established methods exist to assess the impact of the change. In such cases, the "study" is often a series of bench tests and biocompatibility assessments to confirm that the modified device performs comparably to the predicate and does not introduce new risks.
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SEP 1 4 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY AND CONTACT PERSON
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: (763) 391-9183 FAX: (763) 391-9603
Marie L. Holm, Associate Product Regulations Manager, Regulatory Affairs
DEVICE NAME
Trillium™ Bio-Probe Disposable Blood Flow Probe
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
Bio-Probe Disposable Blood Flow Probe (K830858) ലിറ്റ് Tribe Biopodable Diosa provith Trillium™ Biopassive Surface (K973760)
DESCRIPTION OF DEVICE
The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
STATEMENT OF INTENDED USE
The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The Bio-Probe Disposable Blood Flow Probe is a single use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
Special 510(k) Notification Medtronic, Inc.
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DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the Bio-Probe Disposable Blood Flow Probe. The modification to the current Bio-Probe Disposable Blood Flow Probe is to coat the blood contact surfaces with Trillium™.
The Trillium™ Bio-Probe Disposable Blood Flow Probe is being compared to the following Marketed Devices:
- Bio-Probe Disposable Blood Flow Probe (K830858) ●
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
The Trillium"" Bio-Probe Disposable Blood Flow Probe has the same indications statement and intended uses as the:
-
Bio-Probe Disposable Blood Flow Probe (K830858) .
The Trillium™ Bio-Probe Disposable Blood Flow Probe has "no new technological characteristics (e.g., materials and manufacturing processes)" from the Bio-Probe Disposable Blood Flow Probe. 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" Bio-Probe Disposable Blood Flow Probe is substantially equivalent to other marketed extracorporeal cardiopulmonary devices.
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The biocompatibility and in vitro bench testing demonstrated that when compared to the The bloompatibility and in Willie benon tool Disposable Blood Flow Probe does not predioute donooo, the wand effectiveness and are substantially equivalent to other Significally direct career and or oreal cardiopulmonary devices. The in vitro bench testing included analysis of:
- Coating Characteristics .
- Physical Characteristics .
- Performance Characteristics .
Special 510(k) Notification Medtronic, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
SEP 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie L. Holm Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088
Re: K012747
Trade Name: Trillium™ Bio-Probe Disposable Blood Flow Probe (DP38T and DP38PT) Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II (two) Product Code: DPT Dated: August 15, 2001 Received: August 16, 2001
Dear Ms. Holm:
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 - Ms. Marie L. Holm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast of advisou that I Drivision that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I colorated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in and quality by overns (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 mis letter with and h your e FDA finding of substantial equivalence of your device to a legally promated predicated 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 additionally 21 Of 1 1 1 1 1 1 1 - 4646. Additionally, for questions on the promotion and advertising of Compliance 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 Oivision 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,
James E. Dillard III 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: K012747 -
Device Name: Trillium™ Bio-Probe Disposable Blood Flow Probe
The Trillium™ Bio-Probe Disposable Blood Flow Probe is designed for use in the Bio-Probe Blood Flow Monitoring System.
Indications for Use:
The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012747
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter use _
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).