(86 days)
Not Found
No
The summary describes a conventional electrosurgical instrument and does not mention any AI or ML capabilities.
No
The device is described as a monopolar electrosurgical accessory used for cutting and coagulation in surgical procedures, not as a therapeutic device. It is an alternative to conventional electrosurgical electrodes and is used to facilitate surgical tasks rather than to treat a disease or condition itself.
No
The device description clearly states its purpose is for electrosurgical cutting and coagulation in surgical procedures, not for identifying or diagnosing medical conditions.
No
The device description clearly states it is an "instrument" and a "monopolar electrosurgical accessory," which are physical hardware components used in surgical procedures.
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 for use in surgical procedures for cutting and coagulation of tissue. This is an in vivo application (within a living organism).
- Device Description: The description reinforces its use as a monopolar electrosurgical accessory for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not directly on the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrodes used for these indications.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Genesis is an instrument intended for use as a monopolar electrosurgical accessory. The device reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use.
Genesis devices are intended for use with monopolar electrosurgical accessories and will be packaged separately. Genesis instruments will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
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.
K962044, K991855, K913473, K062350, Exempt
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
§ 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 the word "MEDISISS" in bold, black letters. To the left of the word, there is a graphic of lines radiating outward, resembling a sunburst. A trademark symbol is located to the right of the word.
510(K) Summary of Safety & Effectiveness
AUG 2 8 2008
| Submitted By | MEDISISS
2747 SW 6th St.
Redmond, OR 97756 | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Contact Names | Brandi James
Director, Technical Services
P: 541-923-3310
F: 541-923-3375
E: bjames@medisiss.com | |
| Submission Date | June 2, 2008 | |
| Proprietary Device Name | GenesisTM | |
| Classification | Electrosurgical Electrodes, Class II, Electrosurgical cutting and
coagulation device and accessories, General and plastic surgery (21 CFR
878.4400), GEI | |
| Predicate Devices | Valleylab Uncoated Electrosurgical Blade (E1551X)
(Preamendment)
Valleylab EDGETM Coated Electrosurgical Blade ( E1450X):
Conmed Coated Electrosurgical Blade (139100)
Megadyne Coated Eelectrosurgical Blade (0012)
Surginetics AdvantageBlade Electrosurgical Blade
Myco Medical Surgical Blades (non-electrosurgical) | K962044
K991855
K913473
K062350
Exempt |
| Indications for Use | The Genesis is indicated for use in surgical procedures (general
neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where
monopolar electrosurgical cutting and coagulation are normally
used. The Genesis instruments are an alternative to conventional
monopolar electrosurgical electrodes used for these indications. | |
| Product Description | The Genesis is an instrument intended for use as a monopolar
electrosurgical accessory. The device reduces the smoke emitted into
the surgical area, uses lower power with less tissue damage and the
outer layer provides a surface that reduces tissue accumulations and
facilitates removing tissue residues, such as eschar, that may
accumulate during use.
Genesis devices are intended for use with monopolar electrosurgical
accessories and will be packaged separately. Genesis instruments
will also fit in currently marketed electrosurgical pencils offered by
other manufacturers. | |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
MEDISISS % Ms. Brandi James Director, Technical Services 2747 SW 6th Street Redmond, Oregon 97756
Re: K081559
·
Trade/Device Name: Genesis Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 5, 2008 Received: August 5, 2008
Dear Ms. James:
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 commerce prior 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 - Mc. Brandi James
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "MEDISISS" in black font. To the left of the word is a symbol that looks like a sun with rays coming out of it. To the right of the word is the trademark symbol.
4. Indications for Use
510(k) Number (if known): Not assigned at this time.
Device Name: Genesis
Indications For Use:
The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrodes used for these indications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K081559 |
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