(11 days)
Not Found
No
The description focuses on mechanical components and visualization, with no mention of AI/ML terms or functionalities.
No
The device is indicated for use in minimally invasive surgery to provide access for delivery and placement of other surgical instruments, and for blunt dissection of tissue. It is an access and visualization tool, not a device that directly treats a condition.
No
The device is used for surgical access, visualization, and instrument delivery, not for diagnosing medical conditions.
No
The device description explicitly lists physical components (Cannula Assembly, Routing Snare, Retrieval Tool) and describes their physical interaction and function in a surgical procedure. It also mentions a "plastic lens" and "stainless steel shaft," indicating hardware.
Based on the provided information, the Guidant FLEXView™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive surgery allowing access for delivery and placement of surgical instruments" and "blunt dissection of tissue". This describes a surgical tool used in vivo (within the body) for procedural purposes.
- Device Description: The description details components like a cannula, endoscope, snare, and retrieval tool, all designed for surgical manipulation and visualization within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide diagnostic information about a patient's health.
- Input Imaging Modality: While it uses a visualization lens with an endoscope, this is for real-time viewing during surgery, not for analyzing samples for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The FLEXView™ System's function is entirely procedural and surgical.
N/A
Intended Use / Indications for Use
The FLEXView™ System is indicated for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., Guidant Microwave Ablation Probe). It is indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The FLEXView™ System includes the following components: the Cannula Assembly (with fixed, integrated visualization lens), the Routing Snare, and the Retrieval Tool.
The Cannula Assembly mates a plastic lens to the tip of a Guidant 7mm Extended Length Endoscope, to enable visualization of anatomy in dry or wet environments (including in contact with tissue). This Cannula is delivered to the surgical site by way of a surgical port. The Cannula Assembly has a total of three lumens. The largest of these receives the 7mm Extended Length Endoscope. The other two lumens are intended to receive the Routing Snare, which consists of a sheathed wire with loops at either end, and then subsequently the Retrieval Tool, which is a sheathed stainless steel shaft with an exposed stainless steel ball at its tip. After delivering the Routing Snare via the service port to the position of interest within the thoracic space, the Retrieval Tool enables capture of the Snare by providing a retaining feature for engagement. The Routing Snare can then be used to route and place another surgical instrument such as the Guidant Microwave Ablation Probe. The FLEXView™ System is a single use device, supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
minimally invasive surgery
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)
The results of verification testing demonstrate that the FLEXView™ System meets the established acceptance criteria and performs in a manner equivalent to the predicate devices.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Kobzoro
Guidant Corporation Cardiac Surgery
510(k) Premarket Notification FLEXView™ System
510(k) SUMMARY
JUL 3 1 2006
| Submitter | Guidant Corporation, Cardiac Surgery |
|---|---|
| Submitter's Address | 3200 Lakeside Drive |
| Santa Clara, CA 95054 | |
| Telephone | (408) 845-1813 |
| Fax | (408) 845-2077 |
| Contact Person | Christina L. Rowe |
| Date Prepared | July 11, 2006 |
| Device Trade Name | Guidant FLEXView™ System |
| Device Common Name | Endoscope, accessories |
| Device Classification Name | Endoscope, accessories |
| Device Classification | Class II |
| Summary of substantial equivalence | The design, materials, method of delivery, features, and intended use of the |
| Guidant FLEXView™ System are substantially equivalent to the predicate | |
| devices: VasoView® Endoscopic Vessel Harvesting System (VV4), (K030512, | |
| cleared on May 10, 2003) and VasoView® 6 Harvesting Cannula (K041981, | |
| cleared on August 20, 2004). | |
| Device description | The FLEXView™ System includes the following components: the Cannula |
| Assembly (with fixed, integrated visualization lens), the Routing Snare, and the | |
| Retrieval Tool. |
The Cannula Assembly mates a plastic lens to the tip of a Guidant 7mm
Extended Length Endoscope, to enable visualization of anatomy in dry or wet
environments (including in contact with tissue). This Cannula is delivered to the
surgical site by way of a surgical port. The Cannula Assembly has a total of
three lumens.
The largest of these receives the 7mm Extended Length
Endoscope. The other two lumens are intended to receive the Routing Snare,
which consists of a sheathed wire with loops at either end, and then subsequently
the Retrieval Tool, which is a sheathed stainless steel shaft with an exposed
stainless steel ball at its tip. After delivering the Routing Snare via the service
port to the position of interest within the thoracic space, the Retrieval Tool
enables capture of the Snare by providing a retaining feature for engagement.
The Routing Snare can then be used to route and place another surgical
instrument such as the Guidant Microwave Ablation Probe. The FLEXView™ System is a single use device, supplied sterile. |
. T
1
Kob 2052
Guidant Corporation Cardiac Surgery
510(k) Premarket Notification FLEXView™ System 2
510(k) SUMMARY (continued)
| Indications for
Use | The FLEXView™ System is indicated for use in minimally invasive surgery
allowing access for delivery and placement of surgical instruments (e.g., Guidant
Microwave Ablation Probe). It is indicated for patients requiring blunt
dissection of tissue including structures in the thoracic space. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The Guidant FLEXView™ System incorporates similar fundamental scientific
technology as its predicate devices. |
| Performance
data | The results of verification testing demonstrate that the FLEXView™ System
meets the established acceptance criteria and performs in a manner equivalent to
the predicate devices. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. Inside the circle are three stylized human profiles facing to the right, with wavy lines below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
Boston Scientific % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 E. Trimble Road San Jose, California 95131-1230
Re: K062050
Trade/Device Name: Guidant FLEXView" System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 18, 2006 Received: July 20, 2006
Dear Mr. Christensen:
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. Iisting 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements. including, but not limited to: registration and fisting (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
Page 2 - Mr. Morten Simon Christensen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(x) / marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ontain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Halud Semer no
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K06 2050
Guidant Corporation Cardiac Surgery
510(k) Premarket Notification FLEXView™ System
INDICATIONS FOR USE STATEMENT
| 510(k)
number
| (if known) | The 510(k) number has not been issued yet. |
|---|---|
| Device name | Guidant FLEXView™ System |
| Indications for | |
| Use | The Guidant FLEXView™ System is indicated for use in minimally invasive surgery |
| allowing access for delivery and placement of surgical instruments (e.g., Guidant | |
| Microwave Ablation Probe). It is indicated for patients requiring blunt dissection of | |
| tissue including structures in the thoracic space. |
Prescription Use X (21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Sumner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K062050 510(k) Number_