(79 days)
Not Found
No
The summary describes a mechanical device for stabilizing the heart during surgery and does not mention any AI or ML components or functionalities.
Yes
The device is used to isolate and immobilize a target vessel on a beating heart during minimally invasive cardiac surgery, which is a therapeutic intervention.
No
The device is described as a stabilizer that isolates and provides local immobilization of a target vessel during surgery. This indicates a therapeutic or assistive function, not a diagnostic one.
No
The device description clearly outlines physical components (curved shaft, articulating foot, mount) and mentions functional bench, animal, and histology testing, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for use during minimally invasive cardiac surgery to stabilize a vessel on a beating heart. This is a surgical tool used directly on a patient's organ.
- Device Description: The description details a mechanical device with a shaft, foot, and mount. It's designed for physical manipulation and stabilization.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. This device does not interact with specimens or perform diagnostic tests.
- Anatomical Site: The device is used on the "heart," which is an organ within the body, not a specimen.
Therefore, the CTS Vacuum Assist Stabilizer is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
Product codes
MWS
Device Description
The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
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)
Functional bench, animal and histology testing has been conducted and the results of the testing verified that the Vacuum Assist Stabilizer performs as designed and is suitable for its intended use.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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510(k) Summary CardioThoracic Systems, Inc. Vacuum Assist Stabilizer 510(k) Notification K_________________________________________________________________________________________________________________________________________________________
GENERAL INFORMATION
| Manufacturer: | CardioThoracic Systems, Inc.
10600 North Tantau Avenue
Cupertino, California
(408) 342-1700
(408) 342-1717 FAX
Est. Reg. No. 9027735 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Billig
Vice President, Regulatory, Quality, and Clinical Research |
| Date Prepared: | August 1999 |
DEVICE DESCRIPTION
| Classification: | Cardiovascular Surgical Instruments (21 CFR section
870.4500) |
|----------------------|------------------------------------------------------------------|
| Trade Name: | CTS Vacuum Assist Stabilizer |
| Generic/Common Name: | Cardiovascular Surgical Instrument |
PREDICATE DEVICES
Octopus2 Tissue Stabilization System manufactured by Medtronic (K964445)
INTENDED USE
The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima OPCAB System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
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PRODUCT DESCRIPTION
The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.
SUBSTANTIAL EQUIVALENCE
The safety and effectiveness of the Vacuum Assist Stabilizer is substantially equivalent to the predicate device (Medtronic's Octopus2 Tissue Stabilization System; K964445) in regards to intended use, technology, functionality, applicable patient population and performance. Any differences between the CTS Vacuum Assist Stabilizer and its predicate device does not raise any new issues of safety and effectiveness.
Functional bench, animal and histology testing has been conducted and the results of the testing verified that the Vacuum Assist Stabilizer performs as designed and is suitable for its intended use.
SUMMARY
As contained in this 510(k) summary, the CTS Vacuum Assist Stabilizer is substantially equivalent to the predicate device identified in that the Vacuum Assist Stabilizer has a similar intended use, technology, functionality, patient population and performance as the predicate device.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or birds in flight.
Public Health Service
NOV 1 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael J. Billig Vice President, Regulatory, Quality and Clinical Research CardioThoracic Systems, Inc. 10600 North Tantau Avenue Cupertino, CA 95014-0739
Re: K992833 CTS Vacuum Assist Stabilizer Trade Name: Regulatory Class: I Product Code: MWS Dated: August 20, 1999 August 23, 1999 Received:
Dear Mr. Billig:
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 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Mr. Michael J. Billig
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 regulations.
This letter will allow you to begin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Nancy C brogdon for
Celia M Witter Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CardioThoracic Systems, Inc. CTS Vacuum Assist Stabilizer 510(k) Premarket Notification
STATEMENT OF INDICATIONS FOR USE
The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
A. Cattay for C. Sloan
(Division Sign-Off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number