(54 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of bipolar forceps, with no mention of AI or ML.
Yes
The device is indicated for use in bipolar procedures to grasp, manipulate, coagulate, and/or transect tissues in various surgical specialties, which are applications within therapeutic interventions.
No
The device is described as an accessory for bipolar procedures used to grasp, manipulate, coagulate, and/or transect tissues. Its function is to perform surgical actions, not to diagnose conditions.
No
The device description explicitly states "Metal and plastic construction" and describes a physical "tweezer assembly" with connections for hardware components (electrosurgical generator and ultrasonic surgical aspirator). This indicates a physical medical device, not a software-only one.
Based on the provided information, the Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in "bipolar procedures to grasp, manipulate, coagulate and/or transect tissues" in various surgical specialties. This describes a device used on a patient during a surgical procedure, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a surgical instrument with connections for electrosurgery and ultrasonic aspiration, designed for direct interaction with tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, mampulate, coagulate and/or transect tissues in the following specialities: Neurosurgery Plastic and Reconstructive Surgery General Surgery
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Metal and plastic construction that approximates a tweezer assembly. Includes provision for connection to the output of a standard bipolar electrosurgical generator. Also includes provision for mechanical attachment to an ultrasonic surgical aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit.
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)
- Non-Clinical Tests Performed for Determination of Substantial Equivalence:
- Life Tests
- Input Power Measurements
- EMI Tests
- Dielectric Tests on Mains Circuits
- Patient Current Leakage and Patient Sink Current Measurements
- Power Line Ground Leakage Measurements
- Dielectric Tests on Patient Circuits
- RF Cautery Life Tests
- Dielectric Tests with RF Cautery Unit Attached
- RF Cautery Unit Ouput Power Tests
- Temperature testing with tips closed for prolonged period of time
- In Vitro Tests Performed:
- Testing of bipolar effect on animal tissue (bench top)
- Temperature testing of forceps during prolonged bench testing
- Surgeon assisted trial on animal tissue (bench top) for clinician feedback
- Key results: Testing confirmed that forceps did not alter expected output characteristics of any generator tested. The device poses no new issues of safety or efficacy for coagulating and transecting tissue.
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
K 052702
Page 1 of (4)
510(k) SUMMARY - Misonix Inc. FS-1000-RF Bipolar Forceps Exhibit E Accessory
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification
| Submitter's Name: | MISONIX INCORPORATED |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald R. Manna |
| Date Prepared: | August 22, 2005 |
2. Name of Device
一
| Proprietary Name: | Misonix Inc. FS-1000-RF Bipolar Forceps
Accessory |
|--------------------|-------------------------------------------------------------------|
| Common/Usual Name: | Electrosurgical cutting and coagulation
device and accessories |
| Product Code: | GEI |
| Classification: | Class II |
3. Predicate Device Information
4
| Predicate Devices | Boston Surgical Products Inc. Disposable Bipolar
Coagulating Forceps K942710
Olsen Electrosurgical Inc. Teflon Coated Electrodes
for Electrosurgical Handles K913108
Guenter Bissinger Medizintechnik GmbH Claris
Non Stick Bipolar Forceps K051429 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Metal and plastic construction that approximates a
tweezer assembly. Includes provision for
connection to the output of a standard bipolar
electrosurgical generator. Also includes provision
for mechanical attachment to an ultrasonic surgical |
1
052702
Page 2 of (4)
aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit.
- Intended Use:
The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, mampulate, coagulate and/or transect tissues in the following specialities:
Neurosurgery Plastic and Reconstructive Surgery General Surgery
6. Comparison to Predicate Device
FS-1000-RF Bipolar Forceps Accessory is similar in design, material and operating parameters to the Boston Surgical Products Inc. Disposable Bipolar Coaculpting Forceps, the Olsen Electrosurgical Inc. Teflon Coated Electrodes for Electrasurgical Handles and the Guenter Bissinger Medizintechnik GmbH Claris Non Stick Birgolar Forceps.
All devices utilize two electrodes made of metal material, usually stainless steel or titanium. A coating of titanium oxide is used on the Misonix FS-1000-RF focce or accessory to minimize tissue adhesion. Predicates use other coatings such as Teflon to accomplish the same effect.
The prongs of the forceps are held together at the proximal end by plastic assemblies which both provide a spring action to either hold the forceps open or closed without. operator intervention. Nylon coatings insulate the prongs so that the operator is not touching the RF energized metal, providing a measure of safety.
7 Safety and Performance Data
The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory have been designed and tested to pass the following Voluntary Standards:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
$$
\ltimes \circlearrowright \ltimes \ltimes \ltimes$$
Page 3 of (4)
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for the
safety of high frequency surgical equipment
FCC Part 18 EMC Requirements
- This device does not contain software. 7. Software Validation
-
- Sterilization Validations Validation statements are contained in Exhibit J.
- Non-Clinical Tests Performed for Determination of Substantial Equivalence の are as follows:
Note: Forceps are passive devices. Testing was done while attached to standard electrosurgical generator. Testing confirmed that forceps did not alter expected output characteristics of any generator tested.
Life Tests Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Ouput Power Tests Temperature testing with tips closed for prolonged period of time
In Vitro Tests Performed 9.
Testing of bipolar effect on animal tissue (bench top) Temperature testing of forceps during prolonged bench testing Surgeon assisted trial on animal tissue (bench top) for clinician feedback
10. Conclusions
Based upon a review of the published literature and its internal testing. Misonix Inc. can state that the use of the FS-1000-RF Bipolar Forceps Accessory for grasping, manipulating, coagulation and transecting tissue is safe and efficacious. We can also state that the FS-1000-RF Bipolar Forceps Accessory is substantially equivalent in this regard to the Boston Surgical Products Inc. Disposable Bipolar Coagulating Forceps, the Olsen Electrosurgical
3
KOS2702
Page 4 of (4)
科
Inc. Teflon Coated Electrodes for Electrosurgical Handles and the Guenter Bissinger Medizintechnik GmbH Claris Non Stick Bipolar Forceps.
Based upon the engineering and in vitro testing experiences outlined herein, the device poses no new issues of safety or efficacy for coagulating and transecting tissue.
and the controlled on the commend and commend of the comments of the comments of the comments of the comments of
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
NOV 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ronald R. Manna Vice President Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735
Re: K052702
Trade/Device Name: Misonix Inc. FS-1000-RF Bipolar Forceps Accessory Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2005 Received: September 28, 2005
Dear Mr. Manna:
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.
5
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buckins
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): _KQ52 702
Device Name: Misonix Inc. FS-1000-RF Bipolar Forceps Accessory
Indications for Use:
The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities:
Neurosurgery Plastic and Reconstructive Surgery General Surgery
Prescription Use ズ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Louare buchns
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K052702