(27 days)
Not Found
No
The description mentions a "microprocessor-controlled device" and "system software which control and monitor the blood processing steps," but there is no mention of AI, ML, or related concepts. The device appears to be based on standard electromechanical and software control for a blood processing system.
No
The device separates and collects a plasma fraction, which is then used in a surgical procedure, but the device itself does not provide therapy or treatment to the patient.
No
The device is described as separating and collecting an autologous plasma fraction from whole blood, which is a processing function, not a diagnostic one. It doesn't perform analysis to identify diseases or health conditions.
No
The device description explicitly details reusable table-top apparatus with electromechanical components (centrifuge rotor, pumps, sensors, valves, etc.) and a single-use processing disposable set, indicating it is a hardware-based system with software control, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "separate and collect an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure." This is a processing step performed on blood outside the body, but it's for the purpose of preparing a component for reintroduction into the same patient. It's not for diagnosing a disease or condition.
- Device Description: The device is described as an "autotransfusion apparatus" and a "Concentration System." It involves physical separation techniques (centrifugation, filtration) to isolate specific components of blood. This aligns with blood processing, not diagnostic testing.
- Lack of Diagnostic Language: There is no mention of analyzing blood for biomarkers, detecting diseases, or providing diagnostic information.
IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's purpose is to prepare a therapeutic product from the patient's own blood.
N/A
Intended Use / Indications for Use
The Interpore Cross International Access™ System is intended to separate and collect an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.
Product codes
CAC, FJI
Device Description
The Interpore Cross International Access™ Concentration System consists of a table-top, autotransfusion apparatus provided with an ancillary filtration unit and a single-use processing disposable set designed to allow separation and collection of an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure. The Access™ System is comprised of two major components:
- a) Reusable table-top apparatus: The Access machine is an electromechanical microprocessor-controlled device contained in an enclosure which incorporates the following system components: the user display and function keys, centrifuge rotor, centrifuge chamber housing, peristaltic pumps, red blood cell sensors, bubble sensor, pinch valves, vacuum pump and power supply units. The system also includes electronic components and system software which control and monitor the blood processing steps.
- b) Single Use Processing Disposable set: The Access System Disposable Set consists of a separation chamber, a filter, holding and collection bags, and associated tubing, clamps, connectors and protective caps. Connection of this set to a whole blood reservoir allows the blood processing to be carried out.
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)
Based on the performance testing conducted, the proposed modified device has been demonstrated to be substantially equivalent to its predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
KO223Y8
510(k) SUMMARY
SUBMITTED BY
Ms. Prosie Rey-Fessler, RAC Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
July 18, 2002
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Autotransfusion Apparatus Common/Usual Name: Sequestration or Separation Device Product Classification: Class II Proprietary Name: Access™ System
PREDICATE DEVICE
The main predicate device is the Interpore Cross International Access™ Sequestration System under K012406 dated March 26, 2002. The predicate for the ancillary unit is the Interpore Cross International UltraConcentrator™ System under K011148 dated June 13, 2001.
INDICATIONS-FOR-USE
The Interpore Cross International Access™ System is intended to separate and collect an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.
DEVICE DESCRIPTION
The Interpore Cross International Access™ Concentration System consists of a table-top, autotransfusion apparatus provided with an ancillary filtration unit and a single-use processing disposable set designed to allow separation and collection of an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure. The Access™ System is comprised of two major components:
- a) Reusable table-top apparatus: The Access machine is an electromechanical microprocessor-controlled device contained in an enclosure which incorporates the following system components: the user display and function keys, centrifuge rotor, centrifuge chamber housing, peristaltic pumps, red
1
blood cell sensors, bubble sensor, pinch valves, vacuum pump and power supply units. The system also includes electronic components and system software which control and monitor the blood processing steps.
- b) Single Use Processing Disposable set: The Access System Disposable Set consists of a separation chamber, a filter, holding and collection bags, and associated tubing, clamps, connectors and protective caps. Connection of this set to a whole blood reservoir allows the blood processing to be carried out.
COMPARISON TO THE PREDICATE DEVICE
The Access™ System is substantially equivalent to the predicate devices. Based on the same intended use, technological characteristics and comparative performance, Interpore Cross International believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to its predicate.
SUMMARY OF TESTING
Based on the performance testing conducted, the proposed modified device has been demonstrated to be substantially equivalent to its predicates.
2
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2002
Interpore Cross International c/o Ms. Prosie Rey-Fessler, RAC Director, Quality Assurance and Regulatory Affairs 181 Technology Drive Irvine, CA 92618-2402
Re: K022348
Trade Name: Access™ System Regulation Number: 21 CFR 868.5830 and 876.5820 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC and FJI Dated: July 18, 2002 Received: July 19, 2002
Dear Ms. Rey-Fessler:
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 - Ms. Prosie Rey-Fessler, RAC
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,
Jasa
Bram D. Zuckerman, M.D
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Access™ System Device Name:
Indications for Use:
The Interpore Cross International Access™ System is intended to separate and collect an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(PER 21 CFR 801.109)
OR
(Division Sign-Off)
Division of Cardiovascular
and Resorniony Devices
8/1702
Over-The-Counter Use
(Optional Format 1-2-96)