(247 days)
Not Found
No
The 510(k) summary describes a simple electrosurgical forceps with irrigation capabilities. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on electrical safety and comparative performance to a predicate device, not on algorithmic performance.
No
The device is described as being used for "electrosurgery for coagulation and irrigation of tissue," which is a surgical tool function, not a therapeutic treatment.
No
The device is primarily described for "electrosurgery for coagulation and irrigation of tissue," which are treatment functions, not diagnostic ones.
No
The device description clearly indicates it is a physical, sterile, single-use forceps with irrigating pathways, which is a 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 is "for use in electrosurgery for coagulation and irrigation of tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a surgical instrument used for electrosurgery and irrigation during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests outside of the body, or providing diagnostic information based on sample analysis.
Therefore, the Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
Product codes
GEI
Device Description
The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consists of dual inlet irrigating pathways that run along side of the forceps from the proximal end the distal end. This allows the surgeon to view the surgical field without obstruction allowing the fluid to irrigate through the irrigation module through the forceps.
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)
Bench testing, comparative performance testing to the predicate device, and relevant electrical safety testing to IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility, and IEC 60601-2-2, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment was performed on the Synergetics Disposable Spetzler Malis Dual Irigating Bipolar Forceps. The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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DEC - 7 2011
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510 (k) Summary of Safety and Effectiveness Synergetics Single Use Irrigating Bipolar Forceps Submitted in accordance with the requirements of 21 CFR 807.92
| Applicant's Name and Address: | Synergetics, Inc.
3845 Corporate Centre Drive
O'Fallon, MO 63368 | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Gary Oliveros
Synergetics, Inc.
Regulatory Affairs/ Compliance Manager
Telephone Number: (636) 794-5107
Fax Number: (636) 794-5120
Email: goliveros@synergeticsusa.com) | |
| Date Prepared: | March 31, 2011 | |
| Device Trade Name: | Synergetics™ Disposable Spetzler™ Malis® Dual Irrigating
Bipolar Forceps | |
| Common Name: | Single Use Irrigating Bipolar Forceps | |
| Device Classification: | 21 CFR Part 878.4400, Electrosurgical Cutting and Coagulation
Devices and Accessories are Class II devices | |
| Classification Name: | Electrosurgical, Cutting and Coagulation and Accessories | |
| Product Code: | GEI | |
| FDA Panel: | General and Plastic Surgery | |
| Predicate Device: | Olsen Medical Single Use Bayonet Bipolar Irrigating Bipolar
Forceps, K080187 | |
Device Description:
The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consists of dual inlet irrigating pathways that run along side of the forceps from the proximal end the distal end. This allows the surgeon to view the surgical field without obstruction allowing the fluid to irrigate through the irrigation module through the forceps.
Intended Use:
The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
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Comparison of Technical Characteristics:
| Criteria | Predicate Device - Olsen Medical
Single Use Bayonet Irrigating
Bipolar Forceps, K080187 | Synergetics Dual Irrigating
Bipolar Forceps |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Sterile single use, for use in
electrosurgery for coagulation and
irrigation of tissue. | Sterile single use, for use in
electrosurgery for coagulation
and irrigation of tissue. |
| For Use With | Electrosurgical generators,
irrigation modules and irrigation
tubing | Electrosurgical generators,
irrigation modules and irrigation
tubing |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Stainless Steel base, with Nylon
insulation | Biocompatible Silver plated
Aluminum base with PVDF
insulation |
| Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 |
| Latex Free | Yes | Yes |
| Luer connector for connection
to irrigation tubing | Yes | Yes |
| Delivery line for fluid to distal
end of forceps | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Packaging | Tyvek Pouch | Rigid PETG Tray, Tyvek lid |
| Note 1: Synergetics packaging configuration has been validated in accordance with ISO 11607-1:2006, Packaging
for Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile Barrier Systems and
Packaging Systems | | |
Risk Management:
Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices.
Sterilization Method:
Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps are sterilized in accordance with AAMINSO 11135 Medical Devices - Validation and routine control of ethylene oxide sterilization (EtO), Overkill Method.
Summary of Non-clinical Testing:
Bench testing, comparative performance testing to the predicate device, and relevant electrical safety testing to IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility, and IEC 60601-2-2, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment was performed on the Synergetics Disposable Spetzler Malis Dual Irigating Bipolar Forceps. The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synergetics, Inc. % Mr. Gary Oliveros 3845 Corporate Centre Drive O'Fallon, MO 63368
DEC - 7 2011
Re: K110924
Trade/Device Name: Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 3, 2011 Received: November 7, 2011
Dear Mr. Oliveros:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Gary Oliveros
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Synergetics™ 510 (k) Submission Synergetics Disposable Spetzler ™ Malis ® Dual-Irrigating Bipolar Forceps Section 4 - Indications for Use
510(k) Number (if known):
Device Name:
Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps
Indications for Use:
The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
X Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-On)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K110924
Section 4 - Page 1 of 1