(14 days)
The Manan™ Biopsy Set for Bone and Bone Marrow is intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
In addition to the above, the pediatic bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiating resuscitative infusion or for aspirating marrow in pediatic patients.
These devices are intended for the purpose of harvesting bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone marrow speciment(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
In addition to the above, the pediatric bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiative infusion or for aspirating marrow in pediatric patients.
This document is a 510(k) summary for the Manan™ Biopsy Set for Bone and Bone Marrow, and a clearance letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
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§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.