(389 days)
The Caldera Medical Benesta™ Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
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This document is an FDA 510(k) clearance letter for the Benesta™ Tissue Removal Device. It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The letter focuses on the regulatory aspects of the clearance, such as:
- Trade/Device Name: Benesta™ Tissue Removal Device
- Regulation Number: 21 CFR § 884.1690
- Regulation Name: Hysteroscope and Accessories
- Regulatory Class: II
- Product Code: HIH
- Indications for Use: Intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
To provide the information requested about acceptance criteria and a study proving device performance, you would need to refer to the 510(k) summary or the full 510(k) submission that was provided to the FDA by Caldera Medical, Inc. This public document (the clearance letter) confirms the regulatory status but does not typically detail the specific performance studies and acceptance criteria used for the clearance.
§ 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.