(88 days)
The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.
The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp. The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to force blood through the filter medium and to the desired level within the drip chamber. The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.
The provided text describes the Summit Medical Transfusion Filter and its substantial equivalence to a predicate device. It outlines performance testing conducted to demonstrate safety and effectiveness, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically associated with clinical or AI/software validation studies.
Instead, the document focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Pall Biomedical Products Co. SQ40 Blood Transfusion Filter, K960993) by showing it has the "same design principles, made of the same materials, and have the same indications and contraindications for use."
The performance testing mentioned is primarily related to manufacturing quality, biocompatibility, and sterility, which are standard for medical devices.
Therefore, I cannot populate the requested table and answer many of the questions as the specific details are not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Physical | |
| Bubble point test compliance | Achieved |
| Pressure leak test compliance | Achieved |
| Particulate cleanliness | Achieved |
| Mechanical testing of bonded joints | Achieved |
| Hydrostatic testing of bonded joints | Achieved |
| Biocompatibility | |
| Cytotoxicity | Compliant with ISO 10993 |
| Sensitization | Compliant with ISO 10993 |
| Irritation or Intracutaneous Reactivity | Compliant with ISO 10993 |
| Acute Systemic Toxicity | Compliant with ISO 10993 |
| Haemocompatibility | Compliant with ISO 10993 |
| Sterility | |
| Gamma sterilization validation | In accordance with ISO 11137 |
| Microbiological bioburden | Achieved |
| Endotoxin validation | Achieved |
Note: The document states that "The test results achieved demonstrate that the device meets the applicable standards, is biocompatible, and performs in accordance with design specifications." However, it does not provide the specific quantitative acceptance limits or thresholds for each of these tests.
Information Not Found in the Provided Text:
- Sample sizes used for the test set and data provenance: The document mentions "performance testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data beyond indicating it was performed on the device itself.
- Number of experts used to establish ground truth for the test set and their qualifications: This type of information is relevant for studies involving human interpretation or clinical endpoints. As this is a physical filter, such an expert panel for "ground truth" establishment in a diagnostic sense is not applicable to the reported tests.
- Adjudication method for the test set: Not applicable based on the type of testing described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable to a physical transfusion filter. MRMC studies are typically for evaluating diagnostic software or imaging modalities where human readers interpret results.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described are the established scientific and regulatory standards (e.g., ISO standards) for material properties, sterility, and biocompatibility.
- Sample size for the training set: Not applicable, as this is a physical device, not a machine learning model requiring training data.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence primarily through a comparison of design, materials, and indications for use with a predicate device, supported by standard medical device performance, biocompatibility, and sterility testing. It does not contain evidence of a study designed to validate performance against specific clinical acceptance criteria in a way that would require expert-established ground truth, human reader performance analysis, or AI/algorithm metrics.
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1622477
Summit Medical Ltd
Transfusion Filter 510(k) Attachment 7
510(k) Summary
Summit Medical Transfusion Filter
Manufacturer
Summit Medical Ltd Industrial Park Bourton on the Water Gloucestershire GL54 2HQ United Kingdom
Contact
James Bradbury Requlatory Affairs Manager E-mail: james.Bradbury@summit-medical.co.uk 011 (44) 1451 821311 Tel 011 (44) 1451 821092 Fax
Device Name
Transfusion Filter
Classification Name
Microfilter, Blood Transfusion
Predicate Product
SQ40 Blood Transfusion Filter, Pall Biomedical Products Co. (K960993)
Product Description
The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp.
The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to
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Summit Medical Ltd
Transfusion Filter 510(k) Attachment 7
force blood through the filter medium and to the desired level within the drip chamber.
The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.
Substantial Equivalence
The Summit Medical Transfusion Filter is substantially equivalent specifically to the Pall Biomedical Products Co. SQ40 Blood Transfusion Filter (K960993), in that they are designed with the same design principles, made of the same materials, and have the same indications and contraindications for use.
Indications for Use
The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surqical site or post-operative wound drainage.
Safety and Effectiveness
Performance testing carried out includes bubble point testing, pressure leak tests, particulate cleanliness, mechanical and hydrostatic testing of bonded joints, microbiological bioburden and endotoxin validation.
The device is Gamma sterilised, validation of which was carried out in accordance with ISO 11137.
Biocompatibility testing was carried out in accordance with ISO 10993, and includes Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity and Haemocompatibility.
The test results achieved demonstrate that the device meets the applicable standards, is biocompatible, and performs in accordance with design specifications.
No safety or effectiveness issues are raised when the Summit Medical Transfusion Filter is compared with the predicate product, and therefore the Summit Medical Transfusion Filter is substantially equivalent to the Pall SQ40 Blood Transfusion Filter (K960993).
James Bradbury
Regulatory Affairs Manager
Summit Medical
Date: 25 July 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Summit Medical Ltd. c/o Mr. Neil R. Armstrong MeddiQuest Ltrd. Business and Technology Centre, Bessemer Drive, Stevenage, SG1 2DX United Kingdom
Re: K022477
Summit Medical Transfusion Filter Regulation Number: 880.5440 Regulation Name: Microfilter, Blood Transfusion Regulatory Class: II (two) Product Code: 74 CAK Dated: July 26 2002 Received: July 29 2002
Dear Mr. Armstrong:
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. Neil R. Armstrong
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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
W
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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Summit Medical Ltd
Transfusion Filter 510(k) Attachment 8
dications for Use
510(k) Number:
Device Name:
Summit Medical Transfusion Filter
Indications for Use:
The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or postoperative wound drainage.
| (PLEASE DO NOT WRITE BELOW THIS LINE) | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |
| Division of Cardiovascular & Devices | |
| 510(k) Number | K062447 |
| Prescription Use | ✓ OR Over-the-counter Use |
| (Per 21 CFR 801.109) |
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Description
The transfusion filter is a free-flow, low priming volume device which provides a 40 micron absolute rated screen filter medium for the removal of potentially harmful blood component microaggregates and non-blood component particulate matter.
Indications
Transfusion of stored blood, packed red cells, platelet and granulocyte concentrations and filtration of ViaSpan® (Cold Storage Solution).*
- ViaSpan® is a registered trademark of Dupont-Merck.
§ 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.