(15 days)
Not Found
No
The device description focuses on mechanical components and endoscopic visualization, with no mention of AI or ML capabilities.
No.
The device is described as a surgical tool for tissue dissection and vessel harvesting, not for treating a disease or condition.
No
The device description indicates that the Vaso View™ Dissection/Vessel Harvesting System is used for tissue separation, vessel harvesting, and dissection during minimally invasive surgical procedures, not for diagnosing conditions or diseases.
No
The device description clearly outlines a physical, single-use medical device with components like a cannula, handle, valve body assembly, balloon, and syringe. It is designed for surgical procedures involving tissue dissection and vessel harvesting, which are hardware-dependent actions. There is no mention of software as the primary or sole component of this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vaso View™ Dissection/Vessel Harvesting System is a surgical tool used during a surgical procedure (endoscopic vessel harvesting and tissue dissection). It is used to create access, separate tissue, and visualize the surgical field.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is entirely mechanical and visual within the body.
The description clearly indicates it's a surgical instrument for minimally invasive procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The VasoView™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Product codes
GCJ
Device Description
The VasoView™ Dissection/Vessel Harvesting System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tissue separation. Initial tissue separation is performed under endoscopic visualization with the clear tapered tip. The elliptical bulb aids tissue separation, and insufflation holds open the cavity created.
The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear to allow for endoscopic visualization during tunneling. A handle is provided to assist with advancement of the cannula.
The device is configured to accept a 5mm endoscope through the inner lumen of the cannula.
The Origin BTT Port is used to provide a port of access for insertion of endoscopic instruments into an extremity or extraperitoneal space. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converter doors to allow insertion of instruments of different diameters than the main seal. The external distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extraperitoneal or subcutaneous extremity and thoracic space, saphenous vein, femoral vessels, parietal pleura
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)
Not Found
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
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
Guidant Corporation/ORIGIN "Special 510{k): Device Modification" VasoView ™ Dissection/Vessel Harvesting System
Class II
MAY 2 9 1998
:
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
21 CFR §807.92 a(1)
Guidant Corporation ORIGIN® Medsystems, Inc. Submitter: 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Cynthia G. Royster date prepared: May 19, 1998
21 CFR §807.92 a(2)
VasoView™ Dissection/Vessel Harvesting System Trade name:
| Common name: | Dissection Cannula |
|---|---|
| Classification name: | Distention Cannula |
21 CFR §807.92 a(3)
Identification of predicate(s): Substantial equivalence for the VasoView™ Dissection/Vessel Harvesting System is based on its similarities to predicate device : the ORIGIN System VasoView™ Balloon Dissection System. It shares similar material, and identical technological characteristics as the predicate device. It also is identical in intended use.
21 CFR §807.92 a(4)
Device Description-parts and function/concept: The VasoView™ Dissection/Vessel Harvesting System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tissue separation. Initial tissue separation is performed under endoscopic visualization with the clear tapered tip. The elliptical bulb aids tissue separation, and insufflation holds open the cavity created.
The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear to allow for endoscopic visualization during tunneling. A handle is provided to assist with advancement of the cannula.
1
KYA | 100 Guidant Corporation/ORIGIN "Special 510(k): Device Modification"
VasoView ™ Dissection/Vessel Harvesting System
Class II
The device is configured to accept a 5mm endoscope through the inner lumen of the cannula.
The Origin BTT Port is used to provide a port of access for insertion of endoscopic instruments into an extremity or extraperitoneal space. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converter doors to allow insertion of instruments of different diameters than the main seal. The external distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.
Device Description-materials/physical properties: a table of the patient contact components, with their respective materials, is provided below.
| Component Name | Patient Contact | Material | Predicate |
|---|---|---|---|
| Cannula | yes | Polycarbonate | Vaso View Balloon |
| Dissection Cannula | |||
| K964171 | |||
| Elliptical Bulb | yes | Polycarbonate | Vaso View Balloon |
| Dissection Cannula | |||
| K964171 | |||
| Adhesive | yes | Loctite™ | Vaso View Balloon |
| Dissection Cannula | |||
| K964171 | |||
| Manifold | yes | Polycarbonate | Vaso View Balloon |
| Dissection Cannula | |||
| K964171 |
The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.
2
Image /page/2/Picture/2 description: The image shows a document with the text "MAY-19-98 15:34 FROM" at the top. Below this text is a larger, handwritten string of characters that appears to be "K991700". The text is dark and contrasts with the lighter background of the document.
Guidant Corporation/ORIGIN "Special 510(k): Device Modification" Vaso View ™ Dissection/Vessel Harvesting System
Class II
21 CFR §807.92 a(5)
Intended use and relationship to predicate(s): The Vaso View™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The The VasoView™ Dissection/Vessel Harvesting System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
CFR §807.92 a(6)
Technological characteristics and relationship to predicate(s): The VasoView™ Dissection/Vessel Harvesting System is substantially equivalent to the Vaso View Balloon Dissection Cannula previously cleared product. The VasoView™ Dissection/Vessel Harvesting System shares the identical function, technological characteristics and similar materials as the
21 CFR §807.92 b
predicate device.
This submission's determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.
21 CFR §807.92 c
In accordance with the specifications of this subsection, this summary (3 pages) is its own section, and has been clearly identified as such.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head turned to the left, and its wings forming a curve. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1998
Ms. Cynthia G. Royster Manager Regulatory Affairs ORIGIN Medsystems, Incorporated 135 Constitution Drive Menlo Park, California 94025
Re : K981700 Vaso-View ™ Dissection/Vessel Harvesting Trade Name: System Requlatory Class: II Product Code: GCJ Dated: May 5, 1998 May 14, 1998 Received:
Dear Ms. Royster:
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 Regulations, Title 21, Parts 800 to 895. A 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your 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 requlations.
4
Page 2 - Ms. Royster
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) 594-4595. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| K981700 | |
|---|---|
| 510(k) Number (if known): | K964171 |
Vaso View™Balloon Dissection System Device Name: has applications in minimally invasive surgery Indications For Use: allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Optional Format 1-2-96) 4016