(247 days)
Not Listed
Not Found
No
The summary describes a mechanical blood collection and reinfusion system with filtration capabilities, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for the post-operative collection, filtration, and reinfusion of a patient's own blood, which directly contributes to the treatment and recovery of the patient.
No
Explanation: The device is indicated for the collection, filtration, and reinfusion of blood, which are therapeutic actions, not diagnostic ones. It reduces substances in the blood (lipids, leukocytes, C3a) but does not analyze or interpret patient data for diagnosis.
No
The device description clearly indicates it is a system for collecting, filtering, and reinfusing blood, which involves physical components and processes, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is designed to collect, filter, and reinfuse blood from a patient back into the same patient. This is a therapeutic procedure, not a diagnostic test performed on a sample outside the body to gain information about a patient's health status.
- Intended Use: The intended use clearly describes a process of collecting and reinfusing blood, not analyzing a sample for diagnostic purposes.
- Device Description: The description reinforces the function of collecting, filtering, and reinfusing blood.
Therefore, the device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery. They are indicated for the post-operative collection of blood from an orthopedic surgery patient's wounds and body cavities, filtration of that blood, and reinfusion of the same patient. Thus, the DONOR has the same intended use and general indications as its predicate devices.
In addition, The DONOR significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it. The 510(k) notice includes bench data that substantiates each of these claims.
Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.
Product codes
CAC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's wounds and body cavities
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
The Donor was tested in accordance with ANSVAAMI/AT-6 (1991) and found to comply with that standard. Bench data substantiates the DONOR's leukocyte, lipid, and C3a reduction claims.
Key Metrics
Not Found
Predicate Device(s)
Zimmer Hemovac, Gish Biomedical, Inc.'s Orthofusor Wound Drainage/Autotransfusion System, Richards' Solocotrans, Stryker Surgical's CBC-ConstaVac®
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the text "K022167" in a handwritten style. Below this, the date "MAR 07 2003" is printed in a clear, sans-serif font. The date indicates the month, day, and year in that order.
Attachment 7
510(k) SUMMARY
PALL's DONOR® Pre-evacuated Post-Operative Autologous Blood Transfusion System
Submitter's Name, Address, Telephone Number, Contact Personand Date Prepared
Pall Medical 2200 Northern Boulevard East Hills, NY 11548 Phone: 516-484-5400 516-801-9059 Fax:
Contact Person: Leonard S. Berman. Ph.D.
Date Prepared: June 28,2002]
Name of Device
Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System
Common or Usual Name: Autotransfusor
Classification Name: Autotransfusion Apparatus
Predicate Devices:
- Zimmer Hemovac ●
- Gish Biomedical, Inc.'s Orthofusor Wound Drainage/Autotransfusion System ●
- Richards' Solocotrans .
- Stryker Surgical's CBC-ConstaVac® ●
1
Intended Use / Indications for Use
The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery. They are indicated for the post-operative collection of blood from an orthopedic surgery patient's wounds and body cavities, filtration of that blood, and reinfusion of the same patient. Thus, the DONOR has the same intended use and general indications as its predicate devices.
In addition, The DONOR significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it. The 510(k) notice includes bench data that substantiates each of these claims.
Performance Data
The Donor was tested in accordance with ANSVAAMI/AT-6 (1991) and found to comply with that standard. Bench data substantiates the DONOR's leukocyte, lipid, and C3a reduction claims.
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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
MAR 0 7 2003
Pall Corporation c/o Leonard S. Berman, Ph.D. Director of Scientific Affairs 2200 Northern Boulevard East Hills, NY 11548
Re: K022167
Trade Name: Pall Donor® Pre-evacuated Post-Operative Autologous Blood Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: December 15, 2002 Received: December 17, 2002
Dear Dr. Berman:
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.
3
Page 2 - Leonard S. Berman, Ph.D.
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), 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) you may obtain. 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,
M.A.B. D. Zakeri, M.D.
Bram D. Zuckerman. M.D. Director Division of Cardiovascualr Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 8
Indications for Use Statement
510(k) Number (if known):
Medical
Device Name: Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System
Indications for Use: Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number K022167
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)