(236 days)
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No
The 510(k) summary describes a mechanical device (trocar and sleeve) and does not mention any software, image processing, AI, or ML capabilities.
No
The device is described as a trocar and sleeve device intended to provide access for surgical instrumentation, not to treat a specific medical condition.
Yes
The device is intended to provide access for diagnostic instrumentation, which implies it facilitates diagnostic procedures.
No
The device description explicitly states it is a "trocar and sleeve device," which are physical, hardware components used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing access during minimally invasive surgery for operative and diagnostic instrumentation. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its function as a trocar and sleeve for surgical access.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
Therefore, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
The ability of the Family of Balloon Cannulas to meet its intended function includes the function and employment of the balloon and the control disc to assure an adequate anchor to allow for instrumentation access and removal during minimally invasive surgery. Furthermore, the balloon's tamponage effect, trap door and seals minimize the loss of CO2 gas during minimally invasive operative procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS BALLOON CANNULA
The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
Indications
The ability of the Family of Balloon Cannulas to meet its intended function includes the function and employment of the balloon and the control disc to assure an adequate anchor to allow for instrumentation access and removal during minimally invasive surgery. Furthermore, the balloon's tamponage effect, trap door and seals minimize the loss of CO2 gas during minimally invasive operative procedures.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Substantial Equivalency Information
The Family of Balloon Cannula are similar to the Hasson Stabilizing Access Cannula (SACun).
| Hasson SAC tm | Balloon Cannula | |
|---|---|---|
| Materials | ||
| - Balloon | Silicone | Silicone |
| - Cannula/Body | Thermoplastic | Thermoplastic |
| - Trocar | Stainless Steel | Aluminum |
| Sizes | 10/12 and 5mm | Range: 2-15mm |
| Functions | ||
| - Anchor System | Balloon / Cone | Balloon Disc |
| Sterilization | Gamma | |
| SAL 10-6 | Gamma | |
| SAL 10-6 |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Family of Balloon Cannula are comparable to that of the Hasson Stabilizing Access Cannula (SAC"m).