(128 days)
NOT_APPLICABLE
No K/DEN numbers provided
No
The description details a standard electrosurgical system with different operating modes and automatic power adjustments based on electrode type, which are typical features of such devices and do not indicate AI/ML. There is no mention of learning, adaptation, or complex data processing beyond basic sensor input and control logic.
Yes
The device is intended for tissue cutting, vaporization, and desiccation in gynecologic hysteroscopic electrosurgical procedures, which are therapeutic medical interventions.
No
The device description clearly states its purpose is for "tissue cutting, vaporization and desiccation" during electrosurgical procedures, not for diagnosis. It is a surgical tool.
No
The device description clearly outlines multiple hardware components including an electrosurgical generator, footswitch, electrodes, and a cable. It is a physical system, not solely software.
Based on the provided information, the Scuba device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Scuba is used for "tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures". This describes a surgical intervention performed directly on the patient's tissue in vivo.
- Device Description: The description details an electrosurgical system that applies energy to tissue for therapeutic purposes.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Scuba does not perform this function.
The Scuba is a surgical device used for therapeutic procedures, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.
Product codes
Not Found
Device Description
The Scuba is a bipolar electrosurgical system designed for hysteroscopic surgical correction of myomas, polyps, intrauterine adhesions, and septate uteri. It consists of an electrosurgical generator, a footswitch, three types of electrodes, and a cable connecting the electrode to the generator. The generator is designed to operate from any voltage source between 95-125V and 190-250V a.c. at 50 or 60Hz. It provides six modes of operation (i.e., six waveforms): three vaporize modes, two blend modes (a combination of vaporization and coagulation) and a desiccate mode similar to the traditional coagulation waveform. The generator controls the power settings from 1 to 200 Watts. A green fluorescent display provides up to 16 characters of alphanumeric information, including the selected mode of operation, the power settings, and other messages related to the operation of the generator. Like other electrosurgical equipment, the generator is designed to be located outside the sterile field, with adjustment of operating settings performed by ancillary operating staff. Three electrode configurations are available: the Spring, Ball and Twizzle. The electrodes are identical in construction except for the distal end and are designed for insertion down a 5 French or larger working channel of commercially available hysteroscopes. The electrodes are operated in a conductive (i.e., saline) fluid environment. When connected to the generator via the connector cable, the system detects the type of electrode attached and automatically adjusts the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. The electrodes are provided as sterile, single-use items. The connector cable is steam sterilizable, designed for twenty times reuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus (intrauterine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, ancillary operating staff / Operating room
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)
Non-clinical in vivo studies: Porcine animal model (stomach test model and skin flap model in live swine). Results showed the Scuba device vaporized and coagulated live tissue and effectively desiccated live tissue, preventing bleeding.
Clinical studies: Extirpated uteri. The Scuba system was compared to monopolar electrosurgery and laser surgery and found to be as effective in cutting and coagulating uterine tissue. In one study using ten extirpated uteri, the Scuba and Erbotom Generator were compared side-by-side. Both devices were effective in excising and coagulating uterine tissue. When using the small Scuba electrode, the field of view remained clear, and visualization was easy. There was no accumulation of debris. Histological evaluation showed similar tissue effects. Serosal temperature measurements showed no significant difference in uterine temperature between the two 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.
Erbotom Generator used with the Karl Storz Hysteroscopic Resectoscopy Accessories (electrodes). (No K/DEN numbers provided)
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
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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
K9624822
Pi92
GVMecare inc.
technology for women's bealthcare
235 Constitution Drive Menlo Park, CA 94025 Telephone: 415 614 2500 Fax: 415 462 6742
SCUBA SYSTEM 510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
GYNECARE, INC.
| Company: | Gynecare, Inc.
235 Constitution Drive
Menlo Park, CA 94025
Tel: (415) 614-2500
Fax: (415) 462-6742 |
|-------------------------|----------------------------------------------------------------------------------------------------------------|
| Company Representative: | Milton McColl, M.D.
Vice President & Medical Director |
| Date Prepared: | June, 1996 |
| Device Name: | Scuba System |
| Generic Name: | Hysteroscopic Electrosurgical Device |
| Classification Name: | Obstetrical and Gynecological Surgical Devices |
| Classification: | Class II |
The Scuba is a bipolar electrosurgical system designed for hysteroscopic surgical correction of myomas, polyps, intrauterine adhesions, and septate uteri. It consists of an electrosurgical generator, a footswitch, three types of electrodes, and a cable connecting the electrode to the generator. The generator is designed to operate from any voltage source between 95-125V and 190-250V a.c. at 50 or 60Hz. It provides six modes of operation (i.e., six waveforms): three vaporize modes, two blend modes (a combination of vaporization and coagulation) and a desiccate mode similar to the traditional coagulation waveform. The generator controls the power settings from 1 to 200 Watts. A green fluorescent display provides up to 16 characters of alphanumeric information, including the selected mode of operation, the power settings, and other messages related to the operation of the generator. Like other electrosurgical equipment, the generator is designed to be located outside the sterile field, with adjustment of operating settings performed by ancillary operating staff.
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Three electrode configurations are available: the Spring, Ball and Twizzle. The electrodes are identical in construction except for the distal end and are designed for insertion down a 5 French or larger working channel of commercially available hysteroscopes. The electrodes are operated in a conductive (i.e., saline) fluid environment. When connected to the generator via the connector cable, the system detects the type of electrode attached and automatically adjusts the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. The electrodes are provided as sterile, single-use items. The connector cable is steam sterilizable, designed for twenty times reuse.
The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.
Results from non-clinical studies in vivo studies using the porcine animal model, biocompatibility testing, and clinical studies have shown the Scuba system to be safe and effective in vaporizing and coagulating uterine tissue. In the porcine animal studies using a stomach test model and a skin flap model in live swine, the Scuba device was shown to vaporize and coagulate live tissue. The same electrode used for vaporization was shown to effectively desiccate live tissue and prevent bleeding.
In clinical studies using extirpated uteri, the Scuba system was compared to monopolar electrosurgery and laser surgery. The Scuba system was found to be as effective in cutting and coagulating uterine tissue as the monopolar and laser surgery devices. In one extirpated uteri study using ten uteri, the Scuba and Erbotom Generator were compared side by side in each uterus. Both devices were effective in excising and coagulating uterine tissue. When using the small Scuba electrode the field of view remained clear and all structures were easily visualized. There was no accumulation of debris to obstruct vision. Histological evaluation of the tissue effects showed both devices performed similarly. Serosal temperature measurements recorded throughout the procedure showed no significant difference in uterine temperature for the two devices.
These studies have demonstrated that the Scuba system is substantially equivalent to the Erbotom Generator used with the Karl Storz Hysteroscopic Resectoscopy Accessories (electrodes). Both devices have the same intended use and similar tissue effect. The bipolar features of the Scuba system do not pose new safety questions when compared to currently marketed electrosurgery generators and electrodes. There are actually fewer safety issues with bipolar surgery than with monopolar surgery. Bipolar surgery has been used safely for many surgical procedures, although it is not currently marketed for intrauterine electrosurgery.