(31 days)
The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox® AFT25X Arterial Blood Finer is Interior is Interior of the only of the bypass circuit for up to 6 hours.
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The provided text is a 510(k) premarket notification for a medical device, the Capiox® AF125X Arterial Filter. This type of submission is used to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed predicate device. This process generally relies on comparing the new device's design, materials, and performance to a predicate device, rather than conducting new clinical studies to establish novel safety and effectiveness.
Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way one might expect for a de novo device or a more complex medical AI/ML product. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, and the "study" is a comparison conducted by the manufacturer, Terumo Cardiovascular Systems.
However, I will extract the relevant information and interpret it within the context of a 510(k) submission for this type of device.
Here's the breakdown of the requested information based on the provided text:
Acceptance Criteria and Study for Terumo Cardiovascular Systems Capiox® AF125X Arterial Filter
The Capiox® AF125X Arterial Filter obtained clearance through a 510(k) premarket notification, demonstrating substantial equivalence to a predicate device, the Capiox® AF200X Arterial Filter (cleared by FDA on September 6, 2000). The "acceptance criteria" and "study" are framed within this substantial equivalence pathway, focusing on design, technology, materials, and specifications, rather than new clinical trial performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Implied by Manufacturer's Comparison) |
|---|---|
| Intended Use: To filter non-biologic particles and microemboli during cardiopulmonary bypass (CPB) for up to 6 hours. | Intended Use: The Capiox® AF125X Arterial Blood Filter is intended to filter non-biologic particles and microemboli during a cardiopulmonary bypass circuit for up to 6 hours. (Identical to predicate and stated in 510(k)). This implies the device performed adequately for this intended use in internal assessments or comparisons. |
| Design, Technology/Principles of Operation, Materials, and Specifications: Substantially equivalent to the Capiox® AF200X Arterial Filter. | Design, Technology/Principles of Operation, Materials, and Specifications: "The device submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the Capiox® AF200X Arterial Filter." Differences were analyzed and "do not raise new questions of safety and effectiveness." (Specific details of the comparison are not provided in the extracted text but were part of the full 510(k) submission). |
| Biocompatibility: Meet relevant biocompatibility standards (implied by FDA Blue Book Memorandum G95-1). | Compliance with FDA Blue Book Memorandum G95-1 (Biocompatibility Evaluations) is stated as a guidance document used in preparation of the submission, implying the device meets biocompatibility requirements. |
Important Note: For a 510(k) submission of this nature, the "reported device performance" is primarily a demonstration of equivalence to the predicate, often through bench testing and material characterization, rather than a clinical study with specific performance metrics (e.g., sensitivity, specificity for an AI device). The document states "A comparison of the similarities and differences is presented in this submission," but the specific details of that comparison are not included in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the extracted text. For a medical device like an arterial filter seeking 510(k) clearance, the "test set" would typically refer to the samples used in bench testing (e.g., blood filtration efficiency, pressure drop, particle removal) and biocompatibility testing. The text mentions "A comparison of the similarities and differences is presented in this submission," which would detail the data used for the comparison, but these specifics are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or provided for this 510(k) submission. The assessment of an arterial filter's performance for substantial equivalence primarily relies on engineering specifications, material science, and bench testing, not expert-adjudicated ground truth as would be relevant for diagnostic AI.
4. Adjudication Method for the Test Set
This type of information is not applicable or provided for this 510(k) submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluation, which is not the primary focus of this 510(k) for an arterial filter.
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 relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, which is outside the scope of this device's function and regulatory pathway.
6. If a Standalone Performance Study Was Done
No, a standalone (algorithm only without human-in-the-loop performance) study in the context of AI/ML was not done. The "standalone performance" of the arterial filter would be evaluated through various bench tests (e.g., filtration efficacy, pressure drop, priming volume), which are part of the comparison demonstrating substantial equivalence, but specific details or results are not included in the provided text. The device itself is not an "algorithm."
7. The Type of Ground Truth Used
The "ground truth" for this device, within the context of a 510(k) for substantial equivalence, relies on:
- Engineering specifications and performance of the predicate device: The Capiox® AF200X Arterial Filter serves as the benchmark against which the new device is compared.
- Bench testing standards: Performance characteristics (e.g., filtration rates, pressure drop, particle capture efficiency) would be assessed against established engineering criteria, potentially informed by the predicate's performance.
- Biocompatibility testing: Compliance with established biocompatibility standards (e.g., as outlined in FDA Blue Book Memorandum G95-1).
There is no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense used for 'ground truth' in this document.
8. The Sample Size for the Training Set
This information is not applicable or provided. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned above, this device does not involve a training set as it is not an AI/ML algorithm.
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Section I: General Information Terumo Cardiovascular Systems Capiox® AF125X Arterial Filter
SEP 1 2 2005
Capiox® AF125X Arterial Filter
Device Name: Capiox® AF125X Arterial Filter Proprietary Name: CPB Arterial Line Blood Filter Common Name:
Device Classifications: Device Classification Name: Device Classification:
Cardiopulmonary Bypass Arterial Line Blood Filter Cardlopumionary Bypass Fridal Filter is classified as a Class II device per 21 CFR § 870.4260 21 CFR § 870.4260
Regulation Number:
Device Product Code(s):
Device Product Code(s):
The Capiox® AF125X Arterial Filter is identified by Terumo Cardiovascular Systems as product code CX*AF125X.
The FDA product code for Arterial Line Blood Filters is DTM.
Review Panel: Cardiovascular (74)
Device Intended Use:
Device Intended Use:
The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox® AFT25X Arterial Blood Finer is Interior is Interior of the only of the bypass circuit for up to 6 hours.
Reason For Premarket Notification:
Reason For Premarket Nottjication:
The Capiox® AF125X Arterial Filter is submitted as required by the United States Food and The Capiox® AF125X Arterial Filter is submitted by and Onits Artistian Filter is a
Drug Administration when marketing a tina Santa modification of Any existing, Jegally Drug Administration when marketing a new product. The Capital of any existing, legally marketable products offered by Terumo.
Statement of Equivalence to Predicate Device:
Statement of Equivalence to Predicale Device - Substantially equivalent in intended use, design, The device submitted in this STO(K) is substantaily "operations to the Capics" AF200X Arterial
technology/principles of operation, materials and specifications to the Clapic technology/principles of operation, materials and specifications of any appear of any was cleared by FDA on September 6, 2000.
A comparison of the similarities and differences is presented in this submission. The differences of safety and A comparison of the similarities and differences is presented in also and issues of safety and effectiveness.
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Section 514, Special Controls:
Section 514, Special Controls:
To the best of our knowledge, no performance standards have been established for Arterial Line To the best of our knowledge, no performance statualus inate been beach and of the best of the best of the following genered, in
Blood Filters. The following guidance documen Blood Finers. The forewing garation of this submission:
- Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions. FDA
1000 . Guidance Jor Caratopain February 21, 2000 - FDA Blue Book Memorandum G95-1 (Biocompatibility Evaluations) .
Establishment Registrations:
| Establishment Registrations:Contact Person: | Garry A. Courtney, MBA, RACTerumo Cardiovascular Systems Corp.125 Blue Ball RoadElkton, MD 21921Registration No. 1124841Phone: 1-800-283-7866, Extension 7420(410) 398-6079Fax: |
|---|---|
| Manufacturer/Sterilizer: | Ashitaka Factory of Terumo Corporation150 Maimaigi-choFujinomiya city, Shizuoka Pref.Japan 418-0015Registration No. 9681834 |
| Owner Operator: | Terumo Corporation44-1, 2-chome, Hatagaya,Shibuya-ku, TokyoJapan 151-0072Registration No. 8010026 |
| Distributor (in U.S.): | Terumo Medical Corporation2101 Cottontail LaneSomerset, NJ 08873Registration No. 2243441 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing the wings and two curved lines representing the tail feathers.
Public Health Service
SEP 1 2 2005
Food and Drug Administratic 9200 Corporate Boulevard Rockville MD 20850
Mr. Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Corp. 125 Blue Ball Road Elkton, MD 21921
K052205 Re:
Trade/Device Name: CAPIOX® AF125X Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: II Product Code: DTM Dated: August 1, 2005 Received: August 12, 2005
Dear Mr. Courtney:
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.
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
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Page 2 - Mr. Garry A. Courtney, MBA, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR 100 (2006) (2006) (21 consisted on 521-542 of the Act); 21 CFR 100 forth in the quality systems (QS) regulation (2 - CFR 1 a ct the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Action Section 5 product radiation control provisions (Sections 35 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leg This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inning if your device and his permits y premarket notification. The FDA finding of substantial equive 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), please
rs the register and and and 101 - Alge - Alge - Alge - plasse note the regu If you desire specific advice for your ue vice on our nooning nease note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the r contact the Office of Compliance at (240) 270 - 1200 Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reterence to prematicalities under the Act from the Division of Small
other general information on your responsibilities under the Acc from the Division of Sm other general information on your responsibilities and its toll-free mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (fi Manufacturers, International and Consumer Assistance at lo con in o an in e a.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Oma R. Holmes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Unkown at time of Submission K0 5 22 6 S
CAPIOX® AF125X Arterial Filter _______________________________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox" AFT25X Arterial Blood Thich is Interior is Intended to Theath a cardiopulmonary bypass circuit for up to 6 hours.
Larry A. Courtney, MBA, RAC 8/01/2005
Terumo Cardiovascular Systems
XX Prescription Use _ (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vc lanes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) number K052205
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”