(64 days)
Not Found
No
The description focuses on mechanical components for blood collection and filtration, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the collection, filtration, and reinfusion of blood lost postoperatively, which directly contributes to the treatment and recovery of a patient after surgery, making it a therapeutic device.
No
The device description and intended use clearly state that it is for the collection, filtration, and reinfusion of blood lost postoperatively, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly details physical components like collection sets, filters, and packaging, indicating it is a hardware-based medical device.
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 collection, filtration, and reinfusion of blood lost postoperatively. This is a process performed on the patient's blood outside the body, but it's for therapeutic purposes (transfusion) rather than for diagnosing a condition or providing information about a patient's health status.
- Device Description: The description details a system for handling and processing blood for reinfusion. It doesn't mention any components or processes related to analyzing blood for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples to detect or measure substances.
- Providing information for diagnosis, monitoring, or prognosis.
- Using reagents or assays.
The device is clearly intended for a therapeutic procedure involving blood handling and reinfusion, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
The CellTrans™ Postoperative Autotransfusion Set consists of two individually sterilized packages, containing the Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) and the Summit Medical Transfusion Filter (K022477) respectively, presented for ease of handling and reordering in a non-sterile. polythene slide lock transit bag. Inside the transit bag the CellTrans™ device is double-wrapped, whilst the Transfusion Filter is single wrapped, both using Tyvek & Film packaging.
The transit bag also contains an additional copy of the CellTrans™ Instructions For Use to facilitate use of the Transfusion Filter.
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)
Not Found
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
§ 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).
0
FEB 1 4 2003
Summit Medical Ltd
510(k) Premarket Notification
for the
CellTrans™ Postoperative Autotransfusion Set
Attachment 7
510(k) Summary
Attachment 7 Page 2 of 4
1
510(k) Summary
Summit Medical CellTrans™ Postoperative Autotransfusion Set
Manufacturer
Summit Medical Ltd Bourton on the Water Gloucestershire GL54 2HQ United Kingdom.
Contact
James Bradburv Regulatory Affairs Manager
| Phone: | 011 (44) 1451 821311 |
|---|---|
| Fax: | 011 (44) 1451 821092 |
| E-mail: | james.bradbury@summit-medical.co.uk |
Device Name
CellTrans™ Postoperative Autotransfusion Set
Classification Name
Autotransfusion Apparatus
Predicate Product(s)
- Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) .
- Summit Medical Transfusion Filter (K022477) ●
Product Description
The CellTrans™ Postoperative Autotransfusion Set consists of two individually sterilized packages, containing the Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) and the Summit Medical Transfusion Filter (K022477) respectively, presented for ease of handling and reordering in a non-sterile. polvethylene slide lock transit bag. Inside the transit bag the CellTrans™ device is double-wrapped, whilst the Transfusion Filter is single wrapped, both using Tyvek & Film packaging.
The transit bag also contains an additional copy of the CellTrans™ Instructions For Use to facilitate use of the Transfusion Filter.
Attachment 7 Page 3 of 4
2
Substantial Equivalence
The Summit Medical CellTrans™ Autotransfusion Set is substantially equivalent to the Summit Medical CellTrans™ Autotransfusion System (K022489) and Summit Medical Transfusion Filter (K022477).
Indications for Use
The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
Safety and Effectiveness
No safety or effectiveness issues are raised when the Summit Medical CellTrans™ Postoperative Autotransfusion Set is compared to the predicate products and therefore the CellTrans™ Postoperative Autotransfusion Set is substantially equivalent to the Summit Medical CellTrans™ Postoperative Autotransfusion System and the Summit Medical Transfusion Filter.
Cacely
James Bradbury Regulatory Affairs Manager Summit Medical Ltd.
04.12.02
Date
Attachment 7 Page 4 of 4
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and head. The eagle is facing to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Summit Medical Ltd. c/o Mr. Neil R. Armstrong Managing Director MeddiQuest Ltd. Business and Technology Center Bessemer Drive Stevenage, Hertfordshire, SG1 2DX United Kingdom
Re: K024097
Trade Name: Summit Medical CellTrans™ Postoperative Autotransfusion Set Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: December 4, 2002 Received: December 12, 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. Iisting 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.
4
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 (OS) 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), please contact the Office of Compliance at (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
W. Walter Telle
am D. Zuckerman, M.D. Director Division of Carediovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Summit Medical Ltd CellTrans™ Postoperative Autotransfusion Set 510(k) Attachment 8
Indications for Use
| 510(k) Number: | 024097 |
|---|---|
| Device Name: | Summit Medical CellTrans ™ Postoperative Autotransfusion Set |
Indications for Use:
The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly 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) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | 12024097 |
|---|---|
| --------------- | ---------- |
| Prescription Use | OR | Over-the-counter Use | |
|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- |
(Per 21 CFR 801.109)
Attachment 8
Attachment 8 Page 3 of 3