(89 days)
No
The description mentions a "software based program" but provides no details suggesting AI/ML capabilities. There are no mentions of AI, DNN, ML, training sets, test sets, or performance metrics typically associated with AI/ML devices. The focus is on standard electrosurgical functions and compliance with electrical safety standards.
Yes
The device is used in surgery for cutting and coagulating tissue, which are therapeutic interventions.
No
Explanation: The device is described as an Electrosurgical Unit (ESU) used to generate electrical power for cutting and coagulating in surgery. Its function is to perform surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states that the software and electrical components are housed within a combination metallic and thermoplastic enclosure, indicating the presence of physical hardware beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating". This describes a surgical tool used directly on a patient, not a device used to examine specimens (like blood, tissue, or urine) outside of the body to diagnose a condition.
- Device Description: The description details an electrosurgical unit that generates electrical current for surgical procedures. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
In vitro diagnostics are devices used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is entirely focused on performing surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
Aesculap's Nelson delix Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.
Product codes
79 GEI
Device Description
Aesculab's Nelson dollar Electrosurgical Unit is an Electrosurgical unit (ESU) capable of generating high frequency electrical current, driven through a software based program, for use in monopolar and bipolar electrosurgery. The Nelson asunt Electrosurgical Unit is equipped with two monopolar and two biopolar outlets. All software and electrical components are housed within a combination metallic and thermoplastic enclosure and the product is provided with a universal power cord, which automatically adapts to voltages ranging from 100-240 volts. A monopolar or bipolar cord connects the instruments to the coagulator. The unit is activated by means of a foot control or hand piece.
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Nelson deliver Electrosurgical Unit conforms to applicable IEC standards and the requirements of the Canadian Standards Association (CSA), for medical electrical equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981220, K953738, K933002, K944602
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Nelson deluxe Electrosurgical Unit Page 1 of 1
| MAR 1 9 2002 | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990 |
| -------------- | ------------------------------------------------------------------------------- |
|---|
Nelson goluxe Electrosurgical Unit
December 18, 2001
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate
800-258-1946 (phone)
610-231-3713 (fax)
lisa.millington@aesculap.com (email) |
| TRADE NAME: | Nelson deluxe Electrosurgical Unit |
| COMMON NAME: | Monopolar / Bipolar Coagulator, Electrosurgical Unit |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 79 GEI |
| CLASSIFICATION: | 878.4400 - Electrosurgical Cutting & Coagulation Device & Accessories |
| REVIEW PANEL: | General & Plastic Surgery |
INTENDED USE
Aesculap's Nelson delix® Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.
DEVICE DESCRIPTION
Aesculab's Nelson dollar Electrosurgical Unit is an Electrosurgical unit (ESU) capable of generating high frequency electrical current, driven through a software based program, for use in monopolar and bipolar electrosurgery. The Nelson asunt Electrosurgical Unit is equipped with two monopolar and two biopolar outlets. All software and electrical components are housed within a combination metallic and thermoplastic enclosure and the product is provided with a universal power cord, which automatically adapts to voltages ranging from 100-240 volts. A monopolar or bipolar cord connects the instruments to the coagulator. The unit is activated by means of a foot control or hand piece.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Nelson deliver Electrosurgical Unit conforms to applicable IEC standards and the requirements of the Canadian Standards Association (CSA), for medical electrical equipment.
SUBSTANTIAL EQUIVALENCE
The Nelson ellectrosurgical Unit described in this premarket notification share similar features and functions such as intended use, labeling, and basic operating principles to the following predicate devices: Conmed / Aspen Laboratories' System 7500 ABC Electrosurgical Unit (#K981220), Erbe's Erbotom ICC 300 & 350 (#K953738 & #K933002), and ValleyLab's Force FX (#K944602).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of thick, curved lines that give it a modern and abstract appearance. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2002
Ms. Lisa Millington Regulatory Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
K014172 Trade/Device Name: Nelson Electrosurgical Unit, Model GN640 Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation Device and accessories Regulatory Class: II Product Code: GEI Dated: December 18, 2001 Received: December 20, 2001
Dear Ms. Millington:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are basedon to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Lisa Millington
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to orgin maxioning of substantial equivalence of your device to a legally premail.cr notification: "The Pro Pression for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific acrise for for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0671. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 1 1891 - 1852 - 15 - 15 - 1639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your respational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification
Nelson deluxe Electrosurgical Unit Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
014172
Nelson deluxe Electrosurgical Unit. Device Name:
Indication for Use:
Aesculap's Nelson deluxe Electrosurgical is intended to be used in surgery to Accenter electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.
Miriam C. Provost
on Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
or Over-the-Counter Use Prescription Use (per 21 CFR 801.109)