(88 days)
Not Found
No
The description focuses on the physical filtration mechanism and biocompatible coating, with no mention of AI or ML technologies. Performance studies are bench tests of physical properties.
No
The device is described as a filter used during cardiopulmonary bypass procedures to remove microemboli, rather than directly treating a disease or condition for therapeutic benefit. Its function is to support a medical procedure, not to provide therapy itself.
No
The device is described as a filter used during cardiopulmonary bypass procedures to remove microemboli. Its function is to actively remove substances from the blood, not to diagnose or provide information about a medical condition.
No
The device description clearly indicates it is a physical filter designed to remove microemboli during cardiopulmonary bypass, and the performance studies focus on physical characteristics like filtration efficiency, pressure drop, and structural integrity. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiopulmonary bypass procedures... for the removal of particulate and gaseous microemboli." This describes a device used during a medical procedure on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description focuses on filtering blood during surgery and its physical characteristics (coating, sterility, etc.). It doesn't mention analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, etc.)
- Providing diagnostic information about a patient's health status.
This device is clearly intended for use as a medical device during a surgical procedure, not as a diagnostic test.
N/A
Intended Use / Indications for Use
The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
Product codes (comma separated list FDA assigned to the subject device)
DTM
Device Description
The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
The AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices.
The following performance tests were conducted:
- Blood Damage Testing ●
- Pressure Drop
- Structural Integrity
- Air Handling Capabilities
- Filtration Efficiency
- Burst Pressure
- Coating Integrity
- Priming Volume
- Particulate Shedding
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
K122760
1/2
7 2012 DEC
510(k) Summary of Safety and Effectiveness
| Date Prepared: | September 10, 2012 |
|---|---|
| Applicant: | Medtronic, Inc. |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establish Registration Number: 2184009 | |
| Contact Person: | Julia A. Nelson |
| Principal Regulatory Affairs Specialist | |
| Phone: (763) 514-9844 | |
| Fax: (763) 367-8361 | |
| E-mail: julia.a.nelson@medtronic.com | |
| Trade Name: | Affinity® AF100 Arterial Filter with Balance® Biosurface |
| Common Name: | Arterial Filter |
| Classification Name: | Cardiopulmonary bypass arterial line blood filter |
| Classification: | Class II, 21 CFR 870.4260 |
| Product Code: | DTM |
| Name of Predicate Device: | Affinity Arterial Filter with Trillium (20µm) Model 353T |
| (K033468) | |
| Device Description: |
The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
The AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.
Intended Use:
The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
Contraindications:
Do not use this device for any purpose other than indicated.
1
K122760
2/2
Comparison to Predicate Devices:
A comparison of Affinity AF100@Arterial Filter with Balance® Biosurface to the predicate device indicates the following similarities:
- . Same intended use
- Same technological characteristics .
- Same operating principle .
- Same design features .
- Similar materials with the exception of the housing material of the AF100 device. The . AF100 housing is made of a Bisphenol A-free (BPA-free) copolyester material, which differs from the polycarbonate material used in the predicate device.
- . Same shelf life
Summary of Performance Data
Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices.
The following performance tests were conducted:
- Blood Damage Testing ●
- Pressure Drop
- Structural Integrity
- Air Handling Capabilities
- Filtration Efficiency
- Burst Pressure
- Coating Integrity
- Priming Volume
- Particulate Shedding
Conclusion:
The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the Affinity® AF100 Arterial Filter with Balance® Biosurface is substantially equivalent to the legally marketed predicate device, Affinity Arterial Filter with Trillium (20um) Model 353T (K033468).
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image and is the only element present.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 7 2012
Medtronic Cardiovascular Julia A. Nelson, Principal Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View. MN 551112
Re: K122760
Trade/Device Name: Affinity AF100 Arterial Filter with Balance Biosurface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTM Dated: September 10, 2012 Received: September 12, 2012
Dear Ms. Nelson:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Julia A. Nelson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 10 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I va inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J!
for
Cavanaugh = Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Indications for Use Statement
K122760 510(k) Number (if known):
Device Name:
Affinity® AF100 with Balance® Biosurface
Indications for Use:
The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number