(88 days)
Not Found
Not Found
No
The summary describes a mechanical surgical tool made of stainless steel and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used for tissue removal during surgery, which is a diagnostic or surgical intervention, not a therapeutic treatment.
No
The device description states its use is for the removal of tissue during surgery, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states the device is made from stainless steel, indicating it is a physical hardware device.
Based on the provided information, the Coring Morcellator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Coring Morcellator Function: The description clearly states the Coring Morcellator is a surgical device used during laparoscopic surgery to remove tissue within the peritoneal cavity. This is an invasive surgical procedure performed on the body, not a test performed on a sample from the body.
The device is a surgical instrument, not a diagnostic test.
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 Coring Morcellator is used during laparoscopic surgery for the removal of a non-malignant fibroid tumor or other tissue within the peritoneal cavity. This device will be made from stainless steel. Stainless steel is widely accepted in the medical field, therefore, biocompatibility is assured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
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.
Not Found
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
K 960262
10
510(k) Premarket Notification Coring Morcellator Cook OB/GYN
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS l.
APR 1 5 1996
Submitted By:
Tammy Bacon Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 January 17, 1996
Device
Trade Name: Proposed Classification Name : Coring Morcellator Laparoscope, Gynecologic (and Accessories)
Predicate Devices:
The Coring Morcellator is substantially equivalent to other predicate devices in terms of indications for The Sorring Metobiance in the Serrated Edged Macro Morcellator (SEMM-Set) manufactured by Wisap and the Birtcher Endoscopic Corkscrew manufactured by Birtcher Electro Medical Systems. -
Device Description:
The Coring Morcellator is used during laparoscopic surgery for the removal of a non-malignant fibroid tumor or other tissue within the peritoneal cavity. This device will be made from stainless steel. Stainless steel is widely accepted in the medical field, therefore, biocompatibility is assured.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate device meets the requirements for section 510(k) substantial equivalence.