(72 days)
The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
The CellTrans 10 device consists of a sterile, double wrapped package, containing two needle and drain assemblies, a blood collection assembly with patient drain connection line and a compressible bellows collection vessel with twin outlet ports, and two blood Transfer bags. The patient and transfer bag lines are fitted with pinch clamps, and in addition the transfer bag connection luers are fitted with sealing caps, for use after a filled bag is removed from the collection vessel. The collection bellows and transfer bags are fitted with non-return valves to prevent backflow of exudate to the patient.
The drains are placed in the patient, and connected to the collection system via the twin drain Y-connector. The transfer bags are fitted to the collection vessel outlet ports. Blood collection is initiated by compressing the bellows to apply a low vacuum to the wound, the collected blood then transferring into one of the transfer bags, via the gross filter. When the baq is full, or in accordance with the American Association of Blood Banks Guidelines for Blood Recovery and Reinfusion in Surgery (AABB), the bag can be removed from the collection system, and transferred for reinfusion to the patient. Blood collection can continue with the second transfer bag.
Following use of the second bag, the device can be used as a wound drainage device if this is clinically desirable, by draining into a standard wound drainage bag.
This document describes the Summit Medical CellTrans™ Postoperative Autotransfusion System, a device for collecting and reinfusing a patient's own blood following surgery. The information provided outlines the safety and effectiveness testing conducted to demonstrate its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | Vacuum testing | Device meets criteria; specific values not provided. |
| Pressure leak decay tests | Device meets criteria; specific values not provided. | |
| Functional testing (water and time-expired blood) | Performs in accordance with design specifications. | |
| Mechanical Integrity | Mechanical testing of bonded joints | Device meets criteria; specific values not provided. |
| Sterilization | Microbiological bioburden validation | Validated. |
| Endotoxin validation | Validated. | |
| Gamma sterilization (ISO 11137, EN552) | Validated. | |
| Biocompatibility | Cytotoxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. |
| Sensitization (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Irritation or Intracutaneous Reactivity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Acute Systemic Toxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Subchronic Toxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Hemocompatibility | Hemocompatibility testing (ISO 10993-4) | Detailed evaluation of blood cell parameters demonstrated device meets applicable standards. |
2. Sample Size for Test Set and Data Provenance:
The provided document describes performance testing, sterilization validation, and biocompatibility testing, not a clinical study involving a "test set" of patient data in the typical sense for an AI/diagnostic device. For the hemocompatibility testing (ISO 10993-4), which involved comparing blood passed through the CellTrans™ system with homologous (banked) blood, the sample size for the blood cell parameter evaluation is not specified.
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is based in the UK (Summit Medical Ltd, Gloucestershire, UK). The nature of the testing suggests laboratory-based evaluations rather than retrospective or prospective clinical data collection from a patient population.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. The "test set" here refers to laboratory samples (e.g., blood cell parameters, materials for biocompatibility) and engineering tests, not a set of clinical cases requiring expert consensus or ground truth establishment by clinical experts.
4. Adjudication Method (Test Set):
Not applicable. This was not a clinical study requiring adjudication of expert interpretations. The results were likely evaluated against pre-defined engineering and biological specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is an autotransfusion system, not a diagnostic imaging or AI-assisted diagnostic device, and therefore this type of study is not relevant to its evaluation.
6. Standalone Performance Study:
Yes, the studies described are essentially standalone performance studies of the device itself. The performance testing (vacuum, pressure, functional, mechanical) evaluates the device's intrinsic capabilities. The sterilization validation ensures the device's sterility. The biocompatibility and hemocompatibility testing assesses the device's interaction with biological systems in a standalone manner, without human intervention as part of the primary performance metric.
7. Type of Ground Truth Used:
For the performance and validation tests, the "ground truth" was established by predetermined engineering specifications, international standards (e.g., ISO 11137, EN552, ISO 10993, ISO 10993-4), and regulatory guidance (FDA Blue Book Memo G95-1). For example, for hemocompatibility, the "ground truth" was the characteristics of homologous (banked) blood, against which the blood processed by the device was compared.
8. Sample Size for Training Set:
Not applicable. This device is not an AI/machine learning device that requires a "training set" for model development.
9. How Ground Truth for Training Set Was Established:
Not applicable, as no training set was used.
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CellTrans™ 510(k) Attachment 7
510(k) Summary
Summit Medical CellTrans™ Postoperative Autotransfusion Device
Manufacturer
Summit Medical Ltd Industrial Park Bourton on the Water Gloucestershire GL54 2HQ nk
Contact
James Bradbury Regulatory Affairs Manager
011 (44) 1451 821311 Phone: Fax: 011 (44) 1451 821092 james.Bradbury@summit-medical.co.uk e-mail:
Device Name
CellTrans 100 Postoperative Autotransfusion Transfusion System
Classification Name
Autotransfusion Apparatus
Predicate Product
Betatrans Orthopaedic Autotransfusion System (K951592), Duxbury Scientific Inc.
Product Description
The CellTrans 10 device consists of a sterile, double wrapped package, containing two needle and drain assemblies, a blood collection assembly with patient drain connection line and a compressible bellows collection vessel with twin outlet ports, and two blood Transfer bags. The patient and transfer bag lines are fitted with pinch clamps, and in addition the transfer bag connection luers are fitted with sealing caps, for use after a
Attachment 7 Page 3 of 5
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filled bag is removed from the collection vessel. The collection bellows and transfer bags are fitted with non-return valves to prevent backflow of exudate to the patient.
The drains are placed in the patient, and connected to the collection system via the twin drain Y-connector. The transfer bags are fitted to the collection vessel outlet ports. Blood collection is initiated by compressing the bellows to apply a low vacuum to the wound, the collected blood then transferring into one of the transfer bags, via the gross filter. When the baq is full, or in accordance with the American Association of Blood Banks Guidelines for Blood Recovery and Reinfusion in Surgery (AABB), the bag can be removed from the collection system, and transferred for reinfusion to the patient. Blood collection can continue with the second transfer bag.
Following use of the second bag, the device can be used as a wound drainage device if this is clinically desirable, by draining into a standard wound drainage bag.
Substantial Equivalence
The Summit Medical CellTrans™ Postoperative Autotransfusion System is substantially equivalent to a number of legally marketed Autotransfusion systems, specifically the Duxbury Scientific Inc. Betatrans Orthopaedic Autotransfusion system (K951592), in that they are designed with the same design principles, made of similar materials, and have the same indications and contraindications for use.
Indications for Use
The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
Safety and Effectiveness
Performance testing carried out includes vacuum testing, pressure leak decay tests, functional testing using both water and time-expired blood, mechanical testing of bonded joints, microbiological bioburden and endotoxin validation.
The CellTrans TM device is Gamma sterilised, validation of which was carried out in accordance with ISO 11137 and EN552.
Biocompatibility testing was carried out in accordance with ISO 10993 and FDA Blue Book Memo G95-1, including Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity and Haemocompatibility.
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Detailed Haemocompatibility testing was carried out in accordance with ISO 10993-4, with the focus of the testing on the evaluation of a number of blood cell parameters, comparing blood collected and passed through the CellTrans™ system with homologous (banked) blood.
The test results achieved demonstrate that the CellTrans™ device meets the applicable standards, is biocompatible, performs in accordance with design specifications.
No safety or effectiveness issues are raised when the Summit Medical CellTrans™ is compared with the predicate product, and therefore the Summit Medical CellTrans™ is substantially equivalent to the Duxbury Scientific Betatrans Orthopaedic Autotransfusion System (K951592).
Javes Brooks
James Bradbury Regulatory Affairs Manager Summit Medical Ltd.
- July 2002
Date
Attachment 7 Page 5 of 5
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The text is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 9 2002
Summit Medical Ltd. c/o Mr. Neil R. Armstrong MeddiQuest Ltd. Business and Technology Centre Bessemer Drive Stevenage SG1 2DX United Kingdom
Re: K022489
Cell Trans™ Postoperative Autotransfusion System Regulation Number: 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: II (two) Product Code: CAC 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 yours,
l Qalath
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
Indications for Use
510(k) Number:
KO22489
Device Name:
Summit Medical CellTrans™ Postoperative Autotransfusion System
Indications for Use:
The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use
(Per 21 CFR 801.109)
ાર Over-the-counter Use _
Division of Cardiova 510(k) Number
Attachment 8 Page 3 of 3
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).