(50 days)
No
The summary describes a system of surgical instruments and does not mention any AI or ML components.
Yes
The device is used in surgical procedures to remove nucleus pulposus, which directly treats a medical condition.
No
Explanation: The device is described as an assortment of surgical instruments used for minimally invasive percutaneous lumbar discectomy procedures, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states it is an "assortment of surgical instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an assortment of surgical instruments used in a surgical procedure (minimally invasive percutaneous lumbar discectomy). This is a direct intervention on the body, not a test performed on samples taken from the body.
- Device Description: It describes surgical instruments, which are used during surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
Product codes
Not Found
Device Description
The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
0
EMERALD MEDICAL, INC. Mill Lane Rd. Brimfield, MA 01010
JAN 28 1997
Premarket Notification EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System Confidential
964919
510 (k) Summary EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k), Premarket Notification, was in accordance with 21 CFR 807.87.
The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
The conclusion that the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is substantially equivalent to legally marketed predicate systems was reached through consideration of the requirements of substantial equivalence determinations. These requirements are set forth in the document, published on June 30, 1986 by the Center for Devices and Radiological Health (CDRH), entitled "Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program."
The new disc removal tools contain substantially equivalent technology and materials as the predicate disc removal tools utilized in the Acufex Microsurgical Interceptre Arthroscopic Discectorny System, 510 (k) K941709. and the Smith & Nephew Arthroscopic MicroDiscectorny System, AMD™. The proposed introduction kit contains the same components as the current instrument introduction systems developed by Acufex Microsurgical, Surgical Dynamics, Sofamor Danek, and Smith & Nephew Spine.
Based on the reasons provided, the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is substantially equivalent to legally marketed predicate minimally invasive percutaneous lumbar discectomy surgical instruments.