(88 days)
Not Found
No
The description details a physical filter and administration set with no mention of software, algorithms, or data processing.
No
The device is described as a "Transfusion Filter" intended for processing salvaged blood for reinfusion, and its function is to filter and prepare blood outside the body, not to directly treat a disease or condition in a therapeutic manner.
No
The device is described as a "Transfusion Filter" intended for the "filtration of ... salvaged blood" for reinfusion, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical filter assembly and administration set, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the filtration and reinfusion of salvaged blood. This is a therapeutic process involving the physical manipulation and administration of blood back into the patient.
- Device Description: The description details a filter assembly and administration set used to prepare and deliver blood to a patient. This aligns with a medical device used for treatment, not diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing blood or other biological samples to provide information about a patient's health status, disease, or condition. IVDs are designed to perform tests in vitro (outside the body) to aid in diagnosis.
Therefore, the Summit Medical Transfusion Filter is a medical device used for blood processing and administration, not an in vitro diagnostic device.
N/A
Intended 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 surgical site or post-operative wound drainage.
Product codes (comma separated list FDA assigned to the subject device)
74 CAK
Device 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 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 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.
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)
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.
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
§ 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.
0
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
1
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
2
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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1 of 2
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.