(119 days)
Not Found
No
The summary describes a mechanical device for surgical dissection and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for forming elongated working cavities during thoracoscopic procedures for exposure and dissection, which is a surgical tool, not a therapeutic device.
No
The device is described as a surgical tool used to form working cavities during thoracoscopic procedures, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a tubular body, balloon, luer extension, and syringe, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- VasoView™ Balloon Dissection System Function: The description clearly states that this device is used during surgery to create working cavities within the body. It is a surgical tool used for dissection and visualization inside the patient.
The VasoView™ Balloon Dissection System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall. The VasoView™ Balloon Dissection System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
Product codes
Not Found
Device Description
The VasoView™ Balloon Dissection System is a single-use device which consist of a, tubular body with a distal transparent conical tapered tip, an elastomeric balloon adjacent to the tapered tip, luer extension, and syringe. It is designed to accept a 5mm diameter rigid endoscope for visualization through the tapered tip. The VasoView™ Balloon Dissection System is provided sterile This dissection cannula is used to advance along specific anatomic tracts to isolate structures. After the cannula advancement, sequential balloon inflation forms an elongated cavity in the desired location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall, extraperitoneal space or extremities
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
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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): 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
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION
VasoView
Class II
Class II
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)
Submitter:
ORIGIN® Medsystems, Inc. 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Anthony Durso date prepared: October 3, 1996
| 21 CFR §807.92 a(2) | |
|---|---|
| Trade name: | VasoViewTM Balloon Dissection System |
| Common name: | Dissection Cannula |
|---|---|
| Classification name: | Distention Balloon |
21 CFR 8807.92 a(3)
Identification of predicate(s): Substantial equivalence for the VasoView™ Balloon Dissection System is based on its similarities to predicate device : the ORIGIN Tapered Tip Balloon Dissection Cannula . It shares the identical material, and technological characteristics as the predicate device. VasoView™ Balloon Dissection System is also similar in intended use.
21 CFR 8807.92 a(4)
Device Description-parts and function/concept: The VasoView™ Balloon Dissection System is a single-use device which consist of a, tubular body with a distal transparent conical tapered tip, an elastomeric balloon adjacent to the tapered tip, luer extension, and syringe. It is designed to accept a 5mm diameter rigid endoscope for visualization through the tapered tip. The VasoView™ Balloon Dissection System is provided sterile This dissection cannula is used to advance along specific anatomic tracts to isolate structures. After the cannula advancement, sequential balloon inflation forms an elongated cavity in the desired location.
1
Class II
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 | Tapered Tip Balloon
Dissection Cannula
K953377 |
| Balloon | yes | Silicon Latex
Rubber | Tapered Tip Balloon
Dissection Cannula
K953377 |
| Adhesive | yes | Loctite™ | Tapered Tip Balloon
Dissection Cannula
K953377 |
The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.
21 CFR §807.92 a(5)
Intended use and relationship to predicate(s): The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall. The predicate device (Tapered Tip Balloon Dissection Cannula) has applications in minimally invasive surgery and is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space or extremities.
The VasoView™ Balloon Dissection System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
2
Class II
CFR §807.92 a(6)
Technological characteristics and relationship to predicate(s): The VasoView™ Balloon Dissection System is substantially equivalent to the Tapered Tip Balloon Dissection Cannula previously cleared product. The VasoView™ Balloon Dissection System shares the identical function, technological characteristics and materials as the predicate device.
21 CFR §807.92 b
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.