(27 days)
The Haemonetics 40μ RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.
The Haemonetics 40µ RBC Filter Bag is described as a blood transfusion microfilter with FDA Product Code CAK in the FDA Guidance Document for Intravascular Administration Sets 510(k)s dated April 15, 2005. It is defined as a Class II medical device in 21 CFR 880.5440 and is included as a component for an Intravascular Administration Set.
The provided text describes a 510(k) submission for the Haemonetics® 40µ RBC Filter Bag. While it states that performance testing was conducted, it does not provide specific acceptance criteria or details about the study that proves the device meets them in the format requested.
Here's an breakdown of the information that is available and what is missing:
The document confirms that "Haemonetics has conducted testing to verify the safety and performance of the 40u RBC Filter Bag. A detailed list with summaries of testing is provided with the test protocols and reports." However, these detailed lists, summaries, protocols, and reports are not included in the provided text.
Therefore, many of the requested details cannot be extracted from the given input.
Here's what can be gathered and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The text mentions the filter is for "microaggregates greater than 40 microns," which implies a filtration efficiency criterion, but no specific percentage or threshold is given.
- Reported Device Performance: Not explicitly stated in the provided text beyond the general statement of testing for "safety and performance."
2. Sample size used for the test set and the data provenance
- Sample Size: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The device is a filter, and its performance would likely be assessed through laboratory testing (e.g., particle counting, flow rates) rather than expert review of images or clinical cases that require ground truth from human experts.
4. Adjudication method for the test set
- Not applicable/not provided. See point 3.
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 physical filter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Since the device filters particles greater than 40 microns, the ground truth would likely be established through physical measurements of particle size and count before and after filtration, using methods like microscopy or automated particle counters. However, the specific type of ground truth used is not specified in the provided text.
8. The sample size for the training set
- Not applicable. This device is a physical filter. It does not use a "training set" in the context of machine learning or AI. Testing would involve a specific number of filter units tested under defined conditions. This number is not provided.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence to a predicate device for regulatory approval. It mentions that performance testing was conducted, but it does not include the details of those tests, such as specific acceptance criteria or the study results, that would fulfill your request. These details would typically be found in the accompanying test protocols and reports referenced within the document but not included in your input.
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Section 5 - 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
Submitter
Haemonetics Corporation 400 Wood Road Braintree, MA. 02184-9114
Contact
Gabriel J. Muraca, Jr. RA Project Manager Haemonetics Corporation 355 Wood Rd. Braintree, MA. 02184-9114 T: 781-356-9553 F: 781-356-3558 Email: gmuraca@haemonetics.com MAY 17 2006
Device Name
Proprietary Name: Haemonetics® 40u RBC Filter Bag Common Name: Blood Transfusion Microfilter Classification Name: Intravascular Administration Set (component)
Predicate Device
The predicate device is the Filter Bag, BF-40, of the Harvest® BloodStream® Recovery System. The Harvest Filter Bag device was cleared in K942844 on 4/26/96. Haemonetics acquired this product line from Harvest in August 2004.
Description
The Haemonetics 40µ RBC Filter Bag is described as a blood transfusion microfilter with FDA Product Code CAK in the FDA Guidance Document for Intravascular Administration Sets 510(k)s dated April 15, 2005. It is defined as a Class II medical device in 21 CFR 880.5440 and is included as a component for an Intravascular Administration Set.
COMPANY CONFIDENTIAL
HAEMONETICS
21 CFR 807
5961103
Page 1 of 2
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KO61143 Page 2 of 2
The Haemonetics 40u RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns (40μ). It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion. The 40μ RBC Filter Bag has a similar intended use as the predicate device. It is designed to be used by trained hospital personnel under the direction of a physician. Therefore, it is to be used as a prescription medical device, which is indicated by the symbol on the labeling as "Rx Only".
Indications for Use
The Haemonetics 40u RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.
Performance Testing - Bench
Haemonetics has conducted testing to verify the safety and performance of the 40u RBC Filter Bag. A detailed list with summaries of testing is provided with the test protocols and reports.
Substantial Equivalence
The substantial equivalence of the 40p RBC Filter Bag is supported by its similarities in intended use and performance characteristics, as compared to the currently marketed Harvest BloodStream Recovery System, Filter Bag, BF-40. They are similar in design, materials of construction, and manufacturing processes. Verification and validation testing has been completed on the 40u RBC Filter Bag and provides valid scientific evidence to demonstrate the devices are substantially equivalent in accordance with applicable standards referenced in the reports.
Gabriel C. Murray, Jr.
Gabriel J. Muraca, Jr. Regulatory Affairs Project Manager Haemonetics Corporation
Date: March 8, 2006
COMPANY CONFIDENTIAL
HAEMONETICS
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
Haemonetics Corporation C/O Mr. Tamas Borsai Responsible Third Party Official TUV Rheinland of North America, Incorporated 1279 Quarry Lane, Suite A Pleasanton, California 94566
Re: K061103
Trade/Device Name: Haemonetics® 40μ RBC Filter Bag Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: CAK Dated: May 1, 2006 Received: May 2, 2006
Dear Mr. Borsai:
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 - Mr. Borsai
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 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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aemonetics® 40u RBC Filter Bag
Section 4 - Indications for Use Statement
Indications for Use
510(k) Number (if known): ____ K06 } / $3
Device Name:
Haemonetics® 40μ RBC Filter Bag
Indications for Use:
The Haemonetics 40μ RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.
Anter Vrmate
: Bion Sion-Off) Cryision of Anesthesiology, General Hospital, Infection Control, Dental Devices
512(k) Number: 496 01 4
Prescription Use X and/or (Part 21 CFR 801 Subpart D)
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)
HAEMONETICS
COMPANY CONFIDENTIAL
§ 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.