(210 days)
Not Found
No
The document describes a coated electrosurgical blade and does not mention any AI or ML components or functionalities.
No.
The device is an electrosurgical blade used for cutting and coagulation during surgical procedures, not for therapeutic purposes like treating a disease or condition.
No
The device is an electrosurgical blade used for cutting and coagulation during surgical procedures, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is a "coated stainless steel blade" with a "polyethylene sleeve," indicating it is a physical hardware device, not 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 for use in surgical procedures for cutting and coagulation. This is an in vivo application (within a living organism).
- Device Description: The description details a surgical electrode, not a device used to examine specimens from the body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The FAS-CLEAN Electrosurgical Coated Active Blade is intended for use by surgeous as an alternative to uncoated stainless steel blades or "non-stick" coated electrodes where monopolar electrosurgical cutting and coagulation blades are normally used.
The FAS-CLEAN Electrosurgical Coated Active Blade, a single use, sterile, monopolar, Emralon coated electrode is intended for use:
- In surgical procedures (general, neurosurgical, laparoscopic, orthopedic, and gynecologic) where monopolar electrosurgical cutting and coagulation are normally used.
- As an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes, which are used for these indications.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is a sterile, single use, coated stainless steel blade. The main parts of the device are the Emralon coated stainless steel blade and the insulated polyethylene sleeve.
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 data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation).
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.
Unimed Coated Blade Electrode (K962935), Valley Lab's EDGE (K962044), ConMed's UltraClean (K052104), Megadyne's EX Clean (K943055)
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
Page 1 of 2
510(k) Summary
JUL 2 3 2008
General Information: Submitter:
ELECTROMEDICS Co. LTD. 55 Anderson Avenue Moonachie, NJ 07074
Contact Person:
John Scholz Tel : 201-935-0770 201-935-2812 Fax:
Summary Date of Preparation:
December 1, 2007
Names:
Proprietary Name: Common Name: Classification Name: FAS-CLEAN Electrosurgical Coated Active Blade Electrosurgical Electrode Electrosurgical cutting and coagulation device and accessories
Predicate Devices:
Unimed Coated Blade Electrode (K962935) Valley Lab's EDGE (K962044) ConMed's UltraClean (K052104) Megadyne's EX Clean (K943055)
ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is substantially equivalent to the Unimed Coated Blade Electrode, Valley Lab EDGE, ConMed's Ultra Clean and Megadyne's EZ Clean electrode. The FAS-CLEAN Electrosurgical Coated Active Blade shares the same intended uses, indications for use and the same or similar characteristics including: single use, non-stick properties, sterilization method, and various configurations.,
Device Description
ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is a sterile, single use, coated stainless steel blade. The main parts of the device are the Emralon coated stainless steel blade and the insulated polyethylene sleeve.
Intended Use
The FAS-CLEAN Electrosurgical Coated Active Blade is intended for use by surgeous as an alternative to uncoated stainless steel blades or "non-stick" coated electrodes where monopolar electrosurgical cutting and coagulation blades are normally used.
1
KO 73616
Technological Characteristics
Page 2 of (2)
The FAS-CLEAN Electrosurgical Coated Active Blade is substantially equivalent in materials and operation to the predicate devices on the market. This device has been designed to comply with the Sterilization of health care products - Requirements for validation and routine control- radiation Sterilization, ISO 11137 and Biocompatibility ISO 10993. There are no new technological characteristics and therefore no new questions of safety and effectiveness.
Performance Data:
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A database search has been conducted to evaluate any adverse effects of the device that is currently marketed.
No data submitted for section 807.92 6[(b)(1)(2)(3c)]. See attached documentation of adverse effects.
Conclusion:
The FAS-CLEAN Electrosurgical Coated Active Blade is substantially equivalent to Unimed's Coated Blade Electrode, Valley Lab's EDGE, ConMed's Ultra Clean and Megadyne's EZ Clean Electrodes. The FAS-CLEAN Electrosurgical Active Coated Blade shares the same intended use, indications for use and same or similar technological characteristics as the predicate electrosurgical electrodes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2008
Electromedics Co., Ltd. % Mr. John Scholz 55 Anderson Avenue Moonachie, New Jersey 07074
Re: K073616
Trade/Device Name: FAS-CLEAN Electrosurgical Coated Active Blade Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 10, 2008 Received: April 11, 2008
Dear Mr. Scholz:
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 cither 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.
3
Page 2 - Mr. John Scholz
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 Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) K073616
Device Name: FAS-CLEAN Electrosurgical Coated Active Blade
Indications for Use:
The FAS-CLEAN Electrosurgical Coated Active Blade, a single use, sterile, monopolar, Emralon coated electrode is intended for use:
- In surgical procedures (general, neurosurgical, laparoscopic, orthopedic, and ● gynecologic) where monopolar electrosurgical cutting and coagulation are normally used.
- As an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes, . which are used for these indications.
Prescription Use X (Part 21 CFR 801 Subpart D)
And/Or
Over- The-Counter Use No (21 CFR 801 Subpart C)
R
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number