(18 days)
The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.
Tubing assembly with a 200 micron filter connected by tubing with clamp and luer on one end and a purchased piston syringe on the other end.
The provided text describes a 510(k) summary for the "200 Micron Blood Component Filter and Syringe Adapter" and regulatory correspondence from the FDA. This device is a blood filter, not an AI/ML-driven diagnostic or image analysis tool, therefore many of the requested categories (e.g., efficacy studies, MRMC studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, adjudication methods) are not applicable.
Here's an analysis based on the information provided, focusing on what is relevant to a non-AI medical device submission:
Acceptance Criteria and Device Performance
A direct table of acceptance criteria with reported device performance is not explicitly presented as a consolidated table in the document. However, the performance testing section states that the device is suitable for its intended use and performs equivalently to predicate devices. The acceptance criteria would be implicitly derived from the referenced standards and the comparison to the predicate devices.
| Acceptance Criteria Category | Details from Study/Regulatory Standards | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-4 (2002): Selection of Tests for Interaction with Blood ISO 10993-5 (2009): In Vitro Cytotoxicity ISO 10993-10 (2010): Irritation and Skin Sensitization ISO 10993-11 (2006): Systemic Toxicity Intracutaneous injection test ISO 10993-12 (2007): Sample Preparation and Reference Materials | The submission implies that the device met these biological evaluation standards. The statement "The 200 Micron Blood Component Filter and Syringe Adapter is substantially equivalent to the noted predicate devices based on the similarities in material, technological characteristics, indications and test results" suggests compliance to these biocompatibility requirements. |
| Functional Performance (Filtration) | ANSI/AAMI BF7: 2012: Blood Transfusion Filters Predicate Device Performance (Charter Medical, Ltd: 150 Micron Neonatal Syringe Set & Adult Blood Component Recipient Set) | "Results of the performance testing... established that the device is suitable for the intended use, to filter clots and other particles from blood and blood components for delivery and performs equivalently to Charter Medical, Ltd': 150 Micron Blood Component Recipient Sets." |
| Material & Technological Characteristics | Comparison to predicate devices regarding material, design, and function. | "The proposed device is composed of the same material, has the same technological characteristics and is similar in design and function when compared to the predicate devices." |
Study Details (where applicable for a non-AI device):
-
Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for an AI/ML system. Performance testing for this medical device would involve laboratory testing on a defined number of device units, potentially using simulated blood products or actual blood/blood components. The sample size for such engineering or biocompatibility tests is not specified in the summary but would be determined by the relevant ISO standards (e.g., for cytotoxicity, irritation, etc.) and good manufacturing practices. There is no "data provenance" in the sense of patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI systems (e.g., expert-labeled images) is not relevant here. The "ground truth" for this device would be its physical and chemical properties meeting the specified standards and performing its filtration function as intended.
-
Adjudication method for the test set: Not applicable. This is not an observational or diagnostic study requiring adjudication.
-
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 is a physical blood filter, not an AI system that interacts with human readers or clinical cases in that manner.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
-
The type of ground truth used: For this type of device, the "ground truth" is defined by adherence to recognized voluntary standards (e.g., ISO 10993 series for biocompatibility, ANSI/AAMI BF7 for filtration performance) and direct comparison of performance and characteristics to a legally marketed predicate device. This typically involves:
- Laboratory Testing Results: Demonstrating the device's physical properties, filtration efficiency, flow rates, and material compatibility.
- Predicate Device Comparison: Establishing substantial equivalence by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.
-
The sample size for the training set: Not applicable. No AI model is being trained.
-
How the ground truth for the training set was established: Not applicable. No AI model is being trained.
{0}------------------------------------------------
510(k) Summary
| Submitter: | Arteriocyte Medical Systems, Inc.45 South StreetHopkinton, MA 01748USA |
|---|---|
| Contact Person: | Ann CharestClinical and Regulatory Affairs ManagerPhone: 508-497-8964Fax: 508-497-8951email: acharest@arteriocyte.com |
| Trade/Device Name: | 200 Micron Blood Component Filter and Syringe Adapter |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Set, Blood Transfusion |
| Regulatory Class | II |
| Product Code: | BRZ |
| Common Name: | Fluid Reservoir and Delivery System |
| Predicate Device: | Charter Medical, Ltd: 150 Neonatal Syringe Set with 150Micron Filter - K000685Charter Medical, Ltd: Adult Blood Component RecipientSet with 150 Micron Filter - Pre-Amendment |
| Device Description: | Tubing assembly with a 200 micron filter connected bytubing with clamp and luer on one end and a purchasedpiston syringe on the other end. |
| Statement of Intended Use: | Indications for Use: The 200 Micron Blood ComponentFilter and Syringe Adapter is designed to filter clots andother particles from blood and blood components fordelivery. |
| SubstantialEquivalenceCharacteristics vs.Predicate: | The 200 Micron Blood Component Filter and SyringeAdapter is substantially equivalent to the noted predicatedevices based on the similarities in material, technologicalcharacteristics, indications and test results. |
| TechnologicalCharacteristics | The proposed device is composed of the same material, hasthe same technological characteristics and is similar in designand function when compared to the predicate devices. |
| OCT 0 4 2013 | |
| PerformanceTesting | Results of the performance testing of the 200 Micron BloodComponent Filter and Syringe Adapter established that thedevice is suitable for the intended use, to filter clots and otherparticles from blood and blood components for delivery andperforms equivalently to Charter Medical, Ltd': 150 MicronBlood Component Recipient Sets. |
.
{1}------------------------------------------------
ISO 10993-4 (2002), Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interaction with Blood, as amended 2006
ISO 10993-5 (2009), Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10 (2010), Biological Evaluation of Medical Devices - Part 10: Tests for Irradiation and Skin Sensitization
ISO 10993-11 (2006), Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity Intracutaneuous injection test - ISO (P10-3866-00A)
ISO 10993-12 (2007), Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
ANSI/AAMI BF7: 2012, Blood Transfusion Filters
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 4, 2013
Arteriocyte Medical Systems Manager Ms. Ann Charest Clinical and Regulatory Affairs Manager Pharmalink Technical Group 45 South Street Hopkinton MA 01748
Re: K132905
Trade/Device Name: 200 Micron Blood Component Filter and Syringe Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ Dated: September 23, 2013 Received: September 24, 2013
Dear Ms. Charest:
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.
{3}------------------------------------------------
Page 2 - Ms. Charest
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions 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 Division 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MarysBunner-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K132905
Device Name: 200 Micron Blood Component Filter and Syringe Adapter
Indications for Use: The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Image /page/4/Picture/9 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is a stylized version of the letters "FDA". The letters are made up of small, blocky shapes, giving the logo a textured appearance. The logo is in black and white.
Richard C. Chapman 2013.10.03 15:02:28 -04'00'
Page 1 of 1
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.