(66 days)
Not Found
No
The device description and performance studies focus on mechanical function (gas and saline flow) and do not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training/test set" sections are explicitly marked as "Not Found".
No
Explanation: The device is described as clearing a surgical site for improved visibility, which is a supportive function during surgery rather than directly treating a disease, injury, or condition or restoring body functions.
No
The device is intended to clear a surgical site for improved visibility, which is an interventional or preparatory function, not a diagnostic one. It does not analyze or interpret data to identify a disease or condition.
No
The device description clearly states it is comprised of a handpiece and malleable shaft with connectors, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "clear an anastomotic site or other surgical sites for improved visibility." This is a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a handpiece, shaft, and connectors for gas and saline sources, all consistent with a surgical instrument used for clearing a surgical field.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's health condition.
- Using reagents or other substances to perform a test on a sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical/physical to improve visibility during surgery.
N/A
Intended Use / Indications for Use
The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.
Product codes
FQH
Device Description
The CTS Blower/Mister is comprised of a handpiece and malleable shaft enabling positioning of the device near the targeted site. Connectors on the device allow for hook-up to standard gas and saline sources. The device permits both an adjustable flow of gas and a mist of saline to be deposited at the targeted site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anastomotic site or other surgical sites
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
Functional bench testing has been conducted and the results of the testing verified that the Blower / Mister performs as designed and is suitable for its intended use.
Key Metrics
Not Found
Predicate Device(s)
ClearView Blower/Mister manufactured by Medtronic, FlexiView CO2 Blower with Mist manufactured by Ethicon
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
NOV 1 3 1998
510(k) Summary CardioThoracic Systems, Inc. Blower/Mister 510(k) Notification K983135
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: | September 03, 1998 |
|---|---|
| ---------------- | -------------------- |
DEVICE DESCRIPTION
| Classification: | Jet Lavage 21 CFR 880.5475 |
|---|---|
| Trade Name: | CTS Blower/Mister |
| Generic/Common Name: | Lavage or irrigation device |
PREDICATE DEVICES
ClearView Blower/Mister manufactured by Medtronic FlexiView CO2 Blower with Mist manufactured by Ethicon
INTENDED USE
The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.
1
PRODUCT DESCRIPTION
The CTS Blower/Mister is comprised of a handpiece and malleable shaft enabling positioning of the device near the targeted site. Connectors on the device allow for hook-up to standard gas and saline sources. The device permits both an adjustable flow of gas and a mist of saline to be deposited at the targeted site.
SUBSTANTIAL EQUIVALENCE
The CTS Blower/Mister is intended to clear a wound or surgical site for improved visibility. The Blower/Mister is substantially equivalent to Medtronic's ClearView Blower/Mister and Ethicon's FlexiView CO2 Blower with Mist in regards to intended use, patient population, functionality and performance.
Functional bench testing has been conducted and the results of the testing verified that the Blower / Mister performs as designed and is suitable for its intended use.
SUMMARY
As contained in this 510(k) summary, the CTS Blower/Mister is substantially equivalent to the predicate device identified in that the Blower/Mister has a similar intended use, patient population and performance as the predicate device.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three swooping lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the bird figure in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Mr. Michael J. Billig Vice President, Regulatory, Quality, and Clinical Research CardioThoracic Systems, Incorporated 10600 North Tantau Avenue Cupertino, California 95014
Re : K983135 Blower/Mister Trade Name: Regulatory Class: II Product Code: FQH September 3, 1998 Dated: September 8, 1998 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 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 The general controls provisions of the Act 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 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. 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 regulations.
3
Page 2 - Mr. Billig
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (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 (301) 443-6597 or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K983/35
CardioThoracic Systems, Inc. CTS Blower/Mister 510(k) Premarket Notification
STATEMENT OF INDICATIONS FOR USE
The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.
Patricia Cuccurullo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 4963135