(182 days)
The Origin Cardiac Stabilizer Occluder is indicated for use in cardiac surgery performed on the beating heart where local stabilization is required and a vessel may be temporarily occluded ... .
This Origin Cardiac Stabilizer Occluder is a single use sterile device. It consists of a stabilizer foot, and occluders. The Origin Cardiac Stabilizer Occluder may be used by attaching the stabilizer foot to the Origin Cardiac Stabilizer Clamp; then this assembly is attached to a self retaining rib retractor or sternal retractor or other stationary platform. The Origin Cardiac Stabilizer Occluder may also be used by suturing the stabilizer foot to the desired area of the heart. The stabilizer foot rests against the epicardium. Forceps may be used to position the occluder over the desired vessel. Once in position the occluder may be advanced toward the vessel and locked in place; to cause the vessel to be temporarily occluded. Following completion of the surgical procedure , the Origin Cardiac Stabilizer Occluder is removed.
The provided text is a 510(k) Summary for the "Origin Cardiac Stabilizer Occluder." This type of document is a premarket notification for new medical devices, aiming to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Key Observation: The document does not describe any clinical studies, performance data, or acceptance criteria for the device's technical performance. Instead, it focuses on the device's description, intended use, and its substantial equivalence to existing predicate devices.
Therefore, I cannot provide the requested information from the given text alone. The document is a regulatory submission for market clearance based on substantial equivalence, not a report of a performance study.
To answer your request, if such information were available, it would typically be found in:
- A separate clinical study report.
- A section within the 510(k) submission detailing specific performance testing (e.g., bench testing, animal studies, or clinical data if substantial equivalence cannot be entirely based on predicate devices without it).
- Post-market surveillance data.
Since the provided text does not contain this information, I must state that the acceptance criteria and studying proving the device meets them are not present in this document.
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3014804204 : #11/16
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION Origin Cardiac Stabilizer Occluder Class II
510/k) SUMMARY OF SAFETY & EFFECTIVENESS
This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR $807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
21 CFR §807.92 a(1)
Submitter:
AUG 1 9 1997
ORIGIN® Medsystems, Inc. 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Anthony Durso date prepared: February 13, 1997
21 CFR §807.92 a(2)
To Be Determined Trade name:
Common name: Clamp Classification name: Vascular Clamp $870.4450
21 CFR §807.92 a(3)
Identification of predicate(s); Substantial equivalence for the Origin Cardiac Stabilizer Occluder is based on its similarities to the predicate device : the CardioThoracic System's (CTS) Stabilizer and Pilling's Micro Anastomosis Clamp. It shares the technological characteristics as the predicate devices. The Origin Cardiac Stabilizer Occluder is also similar in intended use.
21 CFR §807.92 a(4)
Device Description-parts and function/concept: This Origin Cardiac Stabilizer Occluder is a single use sterile device. It consists of a stabilizer foot, and occluders. The Origin Cardiac Stabilizer Occluder may be used by attaching the stabilizer foot to the Origin Cardiac Stabilizer Clamp; then this assembly is attached to a self retaining rib retractor or sternal retractor or other stationary platform. The Origin Cardiac Stabilizer Occluder may also be used by suturing the stabilizer foot to the desired area of the heart. The stabilizer foot rests against the epicardium. Forceps may be used to position
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ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION Origin Cardiac Stabilizer Occluder Class II
the occluder over the desired vessel. Once in position the occluder may be advanced toward the vessel and locked in place; to cause the vessel to be temporarily occluded. Following completion of the surgical procedure , the Origin Cardiac Stabilizer Occluder is removed.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
AUG | 9 |997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Cynthia G. Royster Manager, Requlatory Affairs ORIGIN Medsystems, Inc. 135 Constitution Drive Menlo Park, California 94025
K970611 Re: Origin Cardiac Stabilizer Occluder Requlatory Class: II (two) Product Code: DXC Dated: June 16, 1997 Received: June 17, 1997
Dear Ms. Royster:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
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regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10(k) Number (if known):______________________________________________________________________________________________________________________________________________________ NA
Origin Cardiac Stabilizer Occluder )evice Name: ndications For Use: The Origin Cardiac Stabilizer Occluder is indicated for use in cardiac surgery performed on the beating heart where local stabilization is required and a vessel may be temporarily occluded ... . ..........
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Olatunji M. Aboa for TJC
(Division Sing off Divic. Tri . . . . . . . . . . . . . . and Sour in practical Option in 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).