(239 days)
The Interpore Cross International Access™ Sequestration System is intended to separate and construct an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.
The Access™ Sequestration System is comprised of two major components: a) Reusable separation apparatus: The Access sequestration 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 pump, red blood cell sensors, bubble sensor, pinch valves, and the power supply unit. In addition, the system includes the electronic components and system software which controls and monitors the blood processing procedure. b) Single Use Processing Disposable set: The Access Sequestration Disposable Set consists of the separation chamber, two holding bags, and the associated tubing, clamps, connectors and protective caps.
The provided text does not contain detailed acceptance criteria, device performance data, or a description of a study designed to prove the device meets specific criteria. The document is a 510(k) summary for the "Access™ Sequestration System," focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study against acceptance criteria.
The key points from the document regarding a "study" are:
- SUMMARY OF TESTING: "SUMMART OF TESTING Conducted, the proposed device has been demonstrated to be substantially equivalent to the predicate device." This statement is very general and does not provide details about what tests were conducted, what the acceptance criteria were, or what the reported performance was.
Without further information from the original submission, it is not possible to fill out the requested table and answer the specific questions about acceptance criteria and a study proving their fulfillment. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report with specific metrics.
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MAR 2 6 2002
APPENDIX 5
510(K) SUMMARY
FOR
Interpore Cross International ACCESS™ SEQUESTRATION SYSTEM
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510(k) SUMMARY
SUBMITTED BY
Prosie Rey-Fessler, RAC Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
July 27, 2001
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™ Sequestration System
PREDICATE DEVICE
The predicate device is the Dideco Compact-A and Compact-M Autotransfusion Systems which was cleared under 510(k) K963759.
INDICATIONS-FOR-USE
IT WEET I TOT I ON ON ON Sequestration System is intended to separate and The anterpore explosible in action rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.
DEVICE DESCRIPTION
The Access™ Sequestration System is comprised of two major components:
- a) Reusable separation apparatus: The Access sequestration 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 pump, red blood cell sensors, bubble sensor, pinch valves, and the power supply unit. In addition, the system includes the electronic components and system software which controls and monitors the blood processing procedure.
- b) Single Use Processing Disposable set: The Access Sequestration Disposable Set consists of the separation chamber, two holding bags, and the associated tubing, clamps, connectors and protective caps.
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COMPARISON TO THE PREDICATE DEVICE
COMI ANDON TO THE PREDICE substantially equivalent to Dideco Compact-A and The Access - Bequestration Systems that is currently manufactured and distributed by Compact-in Autonalistancer by stimbed use, technological characteristics and Sommentive performance, Interpore Cross International believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to the existing legally marketed device.
SUMMARY OF TESTING
SUMMART OF TESTING Conducted, the proposed device has been demonstrated to be substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
Mr. Prosie Rey-Fessler, RAC Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, CA 92618-2402
Re: K012406
Trade Name: Access™ Sequestration System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: March 8, 2002 Received: March 11, 2002
Dear Mr. 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 - Mr. Prosie Rey-Fessler, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I fours of actived that x = = mination that your device complies with other requirements of the Act that I Dr Hab Intact and regulations administered by other Federal agencies. You must of any 1 coclar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Far 6077; laoomig (21 OFF Part 820); and if applicable, the electronic forth in the quality by routisions (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) I mis letter will and w your to begal finding of substantial equivalence of your device to a legally promated predicated 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 Compinatee at (301) 597 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Togation on the responsibilities under the Act may be obtained from the Oinci general miorination of 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,
D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Access™ Sequestration System Device Name:
Indications-For-Use:
The Interpore Cross International Access™ Sequestration System is The Interpore Crooss international and ologous plasma fraction rich in Intended to separate and construct 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)
Division of Cardiovascular & Respiratory Devices
510(k) Number 2012406
Prescription Use
(PER 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).