200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

K132905 · Arteriocyte Medical Systems, Inc. · BRZ · Oct 4, 2013 · General Hospital

Device Facts

• Record ID: K132905
• Device Name: 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
• Applicant: Arteriocyte Medical Systems, Inc.
• Product Code: BRZ · General Hospital
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

Device consists of tubing assembly with 200-micron filter, clamp, luer connector, and piston syringe; used to filter clots and particles from blood/blood components during delivery; manual operation by healthcare provider; provides physical filtration to ensure delivery of clean blood components; benefits patient by preventing infusion of particulate matter.

Clinical Evidence

Bench testing only. Performance testing established the device is suitable for filtering clots and particles from blood and blood components and performs equivalently to predicate devices.

Technological Characteristics

Tubing assembly with 200-micron filter, clamp, luer, and piston syringe. Complies with ANSI/AAMI BF7: 2012 for blood transfusion filters. Biocompatibility testing performed per ISO 10993-4, 10993-5, 10993-10, 10993-11, and 10993-12.

Indications for Use

Indicated for filtering clots and particles from blood and blood components during delivery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Charter Medical, Ltd: 150 Neonatal Syringe Set with 150 Micron Filter (K000685)
• Charter Medical, Ltd: Adult Blood Component Recipient Set with 150 Micron Filter (Pre-Amendment)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter: | Arteriocyte Medical Systems, Inc.<br>45 South Street<br>Hopkinton, MA 01748<br>USA |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann Charest<br>Clinical and Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| 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 150<br>Micron Filter - K000685<br>Charter Medical, Ltd: Adult Blood Component Recipient<br>Set with 150 Micron Filter - Pre-Amendment |
| Device Description: | Tubing assembly with a 200 micron filter connected by<br>tubing with clamp and luer on one end and a purchased<br>piston syringe on the other end. |
| Statement of Intended Use: | Indications for Use: The 200 Micron Blood Component<br>Filter and Syringe Adapter is designed to filter clots and<br>other particles from blood and blood components for<br>delivery. |
| Substantial<br>Equivalence<br>Characteristics vs.<br>Predicate: | The 200 Micron Blood Component Filter and Syringe<br>Adapter is substantially equivalent to the noted predicate<br>devices based on the similarities in material, technological<br>characteristics, indications and test results. |
| Technological<br>Characteristics | The proposed device is composed of the same material, has<br>the same technological characteristics and is similar in design<br>and function when compared to the predicate devices. |
| | OCT 0 4 2013 |
| Performance<br>Testing | Results of the performance testing of the 200 Micron Blood<br>Component Filter and Syringe Adapter established that the<br>device is suitable for the intended use, to filter clots and other<br>particles from blood and blood components for delivery and<br>performs equivalently to Charter Medical, Ltd': 150 Micron<br>Blood Component Recipient Sets. |

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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

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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Richard C. Chapman 2013.10.03 15:02:28 -04'00'

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