(71 days)
Not Found
Not Found
No
The device description and intended use focus on a mechanical blower for clearing fluids, with no mention of AI/ML technologies, image processing, or data-driven algorithms.
No
The device aids in surgical visualization by clearing fluids, but it does not directly treat or diagnose a disease or condition. Its function is to improve the surgical environment, not to have a therapeutic effect on the patient's body.
No
The device is designed to improve visibility during surgery by clearing bodily fluids and preventing desiccation, which are functional tasks during a procedure, not diagnostic ones.
No
The device description clearly outlines physical components such as a handle, shaft, nozzle, and connectors, indicating it is a hardware device.
Based on the provided information, the FlexiView CO2 Blower is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- FlexiView CO2 Blower Function: The FlexiView CO2 Blower is used during surgical procedures, directly on the surgical site within the body (in vivo). Its purpose is to improve visibility by clearing fluids, not to analyze bodily fluids for diagnostic purposes.
- Intended Use: The intended use clearly states it's for improving visibility at surgical sites and assisting in surgical procedures. It does not mention any diagnostic testing of samples.
- Device Description: The description focuses on its mechanical function of blowing CO2 and optionally saline mist at the surgical site.
- Lack of IVD Indicators: There is no mention of analyzing samples, diagnostic results, or any of the typical characteristics of an IVD device.
Therefore, the FlexiView CO2 Blower is a surgical device used in vivo to facilitate surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization.
It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass.
The Flexi View CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.
Product codes (comma separated list FDA assigned to the subject device)
FOH
Device Description
The FlexiView CO2 Blower With Mist is a sterile, single patient use instrument designed to improve visibility at an anastomotic site or other surgical sites by providing an adjustable flow of CO2 to clear blood or obscuring fluid away and assist in maintaining an open incision or arteriotomy. The optional saline mist helps to prevent desiccation of the graft and surrounding tissue.
The FlexiView CO₂ Blower consists of a handle, a 6" malleable shaft with a nozzle, and connectors for hook up to standard CO2 source and saline.
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 where opaque bodily fluid interferes with visualization.
tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass.
open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.
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)
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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
K973803 Dec. 16, 1997
Appendix A 510(k) Summary of Safety and Effectiveness
Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
---|---|
Device description | The FlexiView CO2 Blower With Mist is a sterile, single patient use instrument designed to improve visibility at an anastomotic site or other surgical sites by providing an adjustable flow of CO2 to clear blood or obscuring fluid away and assist in maintaining an open incision or arteriotomy. The optional saline mist helps to prevent desiccation of the graft and surrounding tissue. |
The FlexiView CO₂ Blower consists of a handle, a 6" malleable shaft with a nozzle, and connectors for hook up to standard CO2 source and saline. | |
Indication for use statement | The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization. |
It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass. | |
The FlexiView CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures. |
Continued on next page
Continued on next page
1
Appendix A 510(k) Summary of Safety and Effectiveness,
Continued
| Technological
characteristics | The technological characteristics of the New Device are the same as the
Predicate Device. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
data | Pre-clinical laboratory evaluations were performed to ensure that the device
can be used as designed. The studies demonstrated acceptable performance to
the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the
information provided herein, we conclude that the New Device is substantially
equivalent to the Predicate Device under the Federal Food, Drug and
Cosmetic Act. |
| Contact | Lonnie Pace
Project Manager
Regulatory Affairs Department
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | October 2, 1997 |
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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. Inside the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1997
Ms. Lorri Chavez Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road 45242-2839 Cincinnati, Ohio
Re : K973803 Flexview CO2 Blower With Mist Trade Name: Requlatory Class: II Product Code: FOH October 2, 1997 Dated: October 6, 1997 Received:
Dear Ms. Chavez:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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
3
Page 2 - Ms. Chavez
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 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) 594-4618. 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
K 973803
Indications for Use Statement Appendix B
Following is the Indications for Use Statement: Statement
510(k) Number: K_973803 Device Name: FlexiView CO2 Blower With Mist
Indications for Use:
The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization.
It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass.
The Flexi View CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.
Pauline Cassanet
and Gen 5 i O(k) Number
Ethicon Endo-Surgery, Inc. FlexiView CO2 Blower With Mist
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