(72 days)
Not Found
Not Found
No
The device description focuses on the physical design and function of a bipolar loop electrode for surgical cutting and coagulation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to "core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly," which describes a therapeutic action to treat a medical condition.
No
The device, a Bipolar Loop Electrode, is used for "coagulation/cutting systems" and to "core all types of brain and spinal cord neoplasms," indicating it is an interventional or surgical device, not a diagnostic one.
No
The device description clearly describes a physical electrode (Bipolar Loop Electrode) used for surgical procedures, which is a hardware component.
Based on the provided information, this device 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "Bipolar Loop Electrode" used for "coagulation/cutting systems" to "core all types of brain and spinal cord neoplasms". This is a surgical tool used directly on the patient's tissue during a procedure.
- Intended Use/Indications for Use: While "Not Found" is listed, the device description provides the intended use, which is a surgical procedure.
- Anatomical Site: The anatomical site is the "brain and spinal cord," which are internal organs, not samples taken from the body.
- Intended User/Care Setting: The intended user is a "surgeon" in a "surgical field," further indicating a surgical device, not an IVD.
Therefore, this device is a surgical instrument, not an in vitro diagnostic.
N/A
- Intended Use / Indications for Use: Not Found
- Product codes (comma separated list FDA assigned to the subject device): Not Found
- Device Description: Valley Forge Scientific Corp. plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.
- Mentions image processing: Not Found
- Mentions AI, DNN, or ML: Not Found
- Input Imaging Modality: Not Found
- Anatomical Site: brain, spinal cord
- 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): Not Found
- Reference Device(s): 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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters that appear to be alphanumeric. The string reads 'K955X64'. The characters are written in a cursive style, with some connections between the letters and numbers.
MAR - 1 1996
EXHIBIT VII, A
SUMMARY OF SAFETY AND EFFECTIVE INFORMATION
Dr. Leonard I. Malis, former Chairman of the Department of Neurosurgery at Mount Sinai School of Medicine, New York, NY and Neurosurgeon-in-Chief and Director of Neurosurgery of Mount Sinai Medical Center, first introduced his electrosurgical Bipolar Coagulator in the 1960's for use in micro and general surgery. The system utilized an aperiodic waveform with spark gap technology. The random spike components of the waveform produced excellent coagulation because there was no tissue destruction due to molecular resonance as produced by the periodic synchronous waveforms of monopolar electrosurgical systems. However, the overvoltage of the first spike in each pulse train of the original Malis system caused undesirable sparking at the forceps tips which results in excessive tissue charring, eschar (coagulum) build-up, and sticking at the forceps tips. This problem was overcome with the advent of microprocessor technology utilized in Dr. Malis' second generation solid state Bipolar Coagulator CMC-II introduced in 1985. (Please see the attached background article by Leonard I. Malis, M.D.)
Through bipolar coagulation surgeons have been effectively scaling vessels and coagulating tissue for over thirty years. One of the advantages of bipolar coagulation is the ability to coagulate under irrigation in the surgical field. Initially, surgeons used a bulb syringe to continuously irrigate the field. In 1985, a controlled Irrigation Module was introduced as an accessory product to be used with the Valley Forge Scientific coagulation systems. This enables the surgeon to irrigate while coagulating without the assistance of a second surgical assistant working the bulb syringe. (Please see the attached article, "The Value of Irrigation During Bipolar Coagulation")
Valley Forge Scientific Corp., the manufacturer of several Malis solid state bipolar coagulation/cutting systems, now plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.
1
Some of the effective safety features of Bipolar Electrosurgery are:
-
- Bipolar Technology eliminates the need for grounding pads and the possibility of patients burns.
-
- Bipolar Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current.
-
- Bipolar Technology works at voltages approximately 1/10th the voltage required for monopolar technique.
-
- Localized Bipolar Coagulation gives the surgeon precise control of the electric current at the tissue site.
-
- The System's patented waveform and exceedingly low Output Impedance provide superior Coagulation and the absence of charring and sticking even in a dry field.
-
- Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field.
-
- Unlike monopolar systems, the new Bipolar Electrosurgery System provides smooth, progressive coagulation with the option of precise, flow-controlled irrigation.
-
- The System permits the plysician to coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues.
-
- The waveform parameters of the Valley Forge Bipolar Electrosurgery System are programmed for the smoothest, most gentle, precise and efficient cutting and coagulation of tissue during any surgical procedure.
951114ssc