(113 days)
Not Found
No
The device description focuses on mechanical components and their function, with no mention of AI or ML.
No
The device is described as a morcellator system used for cutting and extracting tissue, which is an interventional surgical tool, not a therapeutic device.
No
The device description indicates that the FemRx™ Morcellator System is used for cutting and extracting tissue, which is a surgical function, not a diagnostic one.
No
The device description clearly outlines a physical medical device with mechanical components (tissue cutting and extraction mechanism, rotating cutting blade, cylindrical housing, motor drive box, flexible drive) and disposable parts. It also mentions tissue-contacting materials. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses entirely on a surgical device used to cut and extract tissue from the body. There is no mention of testing samples outside the body (in vitro).
- Focus on tissue manipulation: The device's function is described as "tissue cutting and extraction mechanism" and "cut or core tissue as it is drawn up through the central lumen." This is a mechanical process performed on tissue within the body.
- Comparison to surgical devices: The predicate and reference devices are described as "Morcellator" and "Hysteroscopic and Urological Resectosocipic Systems," which are all surgical instruments used for tissue removal or manipulation during procedures.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health. This device's function is clearly surgical and in vivo.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps.
The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device.
The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ ores STARTM and TORSTAR™ Hysteroscopic and Urological Resectosocipic Systems [510(k) numbers K954648 and K962506].
All tissue contacting materials are standard medical grade and non-toxic.
- INTERNAL NON-ROTATING SLEEVE
- ROTATING CUTTER
- SHEATH
- ROTATING CUTTER
- SHEATH
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
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.
Not Found
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.
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
§ 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
The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps.
The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device.
The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ ores STARTM and TORSTAR™ Hysteroscopic and Urological Resectosocipic Systems [510(k) numbers K954648 and K962506].
All tissue contacting materials are standard medical grade and non-toxic.
- INTERNAL NON-ROTATING SLEEVE
- ROTATING CUTTER
- SHEATH
- ROTATING CUTTER
- SHEATH
FemRxTM Morcellator
Storz STEINER™ Morcellator