(11 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the Guidant FLEXView™ System. It states that "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." However, it does not provide specific details regarding the acceptance criteria themselves, the reported device performance, or the study design information (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or specific study types like MRMC or standalone performance).
Therefore, based only on the provided text, a comprehensive answer to your request is not possible beyond what is explicitly stated in the "Performance data" section.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "meets the established acceptance criteria and performs in a manner equivalent to the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document refers to "verification testing" but does not detail how ground truth was established or if experts were involved in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: Not specified. This device is not an AI-assisted diagnostic tool, but rather a surgical instrument system, so an MRMC study as typically understood for AI in imaging is unlikely to be relevant.
- Effect size of human improvement with AI: Not applicable, as this is not an AI device for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense for an algorithm. The "verification testing" refers to the performance of the physical device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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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 DriveSanta 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 theGuidant FLEXView™ System are substantially equivalent to the predicatedevices: 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 CannulaAssembly (with fixed, integrated visualization lens), the Routing Snare, and theRetrieval Tool.The Cannula Assembly mates a plastic lens to the tip of a Guidant 7mmExtended Length Endoscope, to enable visualization of anatomy in dry or wetenvironments (including in contact with tissue). This Cannula is delivered to thesurgical site by way of a surgical port. The Cannula Assembly has a total ofthree lumens.The largest of these receives the 7mm Extended LengthEndoscope. The other two lumens are intended to receive the Routing Snare,which consists of a sheathed wire with loops at either end, and then subsequentlythe Retrieval Tool, which is a sheathed stainless steel shaft with an exposedstainless steel ball at its tip. After delivering the Routing Snare via the serviceport to the position of interest within the thoracic space, the Retrieval Toolenables capture of the Snare by providing a retaining feature for engagement.The Routing Snare can then be used to route and place another surgicalinstrument such as the Guidant Microwave Ablation Probe. The FLEXView™ System is a single use device, supplied sterile. |
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Kob 2052
Guidant Corporation Cardiac Surgery
510(k) Premarket Notification FLEXView™ System 2
510(k) SUMMARY (continued)
| Indications forUse | The FLEXView™ System is indicated for use in minimally invasive surgeryallowing access for delivery and placement of surgical instruments (e.g., GuidantMicrowave Ablation Probe). It is indicated for patients requiring bluntdissection of tissue including structures in the thoracic space. |
|---|---|
| Technologicalcharacteristics | The Guidant FLEXView™ System incorporates similar fundamental scientifictechnology as its predicate devices. |
| Performancedata | The results of verification testing demonstrate that the FLEXView™ Systemmeets the established acceptance criteria and performs in a manner equivalent tothe predicate devices. |
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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.
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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
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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 forUse | The Guidant FLEXView™ System is indicated for use in minimally invasive surgeryallowing access for delivery and placement of surgical instruments (e.g., GuidantMicrowave Ablation Probe). It is indicated for patients requiring blunt dissection oftissue 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_
§ 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.