(24 days)
Not Found
No
The summary describes a standard electrosurgical device with suction capabilities and does not mention any AI or ML components or functionalities.
No
The device is used for surgical procedures (coagulation and aspiration) but does not directly treat a disease or medical condition. Its function is descriptive of a surgical tool, not a therapeutic intervention.
No
Explanation: The device is described as an electrosurgical device used for coagulation and aspiration, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "hand held electrosurgical device" and mentions "hand controlled and foot controlled models," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to conduct electrosurgical energy to target tissue and remove surgical smoke and fluids during surgical procedures. This is an in vivo application, meaning it is used directly on a living organism.
- Device Description: The description reinforces its use as a hand-held electrosurgical device for coagulation and aspiration during procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. IVDs are designed for testing samples in a laboratory or point-of-care setting to diagnose, monitor, or screen for diseases or conditions.
Therefore, this device falls under the category of a surgical instrument used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.
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)
Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.
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.
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
KO72559
510(k) Summary Section 5
September 6, 2007
A. Submitter's Name / Address
Ronda K. Magneson Director, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Page 1 of 2
OCT 5, 2007
B. Contact Person
Primary: Ronda K. Magneson Director of Regulatory Affairs / Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
- Ihsan Samara Alternate: Quality Manager Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
C. Megadyne's Manufacturing Facility
Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Megadyne Medical Products, Inc. 510(k): Suction Coagulator
1
D. Device Name
Common Name:
Device, electrosurgical, cutting & coagulatio accessories
Trade Name:
Classification (if known):
21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
E. Predicate Devices
The predicate devices include the MegaDyne Suction Coagulator which was cleared for marketing via 510(k) # K946327 by FDA's Office of Device Evaluation on June-7, 1995; and Valleylab's Lectrovac which was cleared for marketing via 510(k) #K 791752 on October 4, 1979.
Suction Coagulator
F. Applicant Device Description
The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.
G. Applicant Device Intended Use
The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
H. Technological Characteristics
The proposed device shares the same technological characteristics found in the predicate devices. It is a handheld electrosurgical device used for coagulation and aspiration during electrosurgical procedures.
I. Safety information
Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other suction coagulators on the market. There are no new technologies incorporated into the device.
Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.
Megadyne Medical Products. Inc. 510(k): Suction Coagulator
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Megadyne Medical Products, Inc. % Ms. Ronda K. Magneson Director, Regulatory Affairs and Quality Assurance 11506 South State Street Draper, Utah 84020
OCT 5 2007
Re: K072559
Trade/Device Name: Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 06, 2007 Received: September 11, 2007
Dear Ms. Magneson:
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. Iisting 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.
3
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement
KO 42559 510(k) Number (if known): Device Name: Suction Coagulator
Indications for use:
The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
10(k) Number
Megadyne Medical Products, Inc. 510(k): Suction Coagulator
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