(247 days)
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.
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.
This document is a 510(k) summary for the Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps and details its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and non-clinical testing.
Here's an analysis based on your requested information, acknowledging that this type of regulatory submission often doesn't contain detailed study breakdowns in the same way a clinical trial publication would:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable table format for various performance metrics with corresponding numerical results. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technical characteristics and non-clinical testing.
The implicit acceptance criteria are that the new device performs comparably to the predicate device and meets relevant safety standards.
| Criteria (from "Comparison of Technical Characteristics") | Predicate Device Performance (K080187) | Synergetics Device Performance |
|---|---|---|
| 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. (Note: This is a difference, but the summary implies it raises no new issues.) |
| 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: This is a difference, but validated to ISO 11607-1:2006). |
| Summary of Non-clinical Testing | Performance comparable to predicate device in bench testing and comparative performance testing. Meets IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
The "study" to prove the device meets these (mostly implicit) acceptance criteria is a sum of:
- Bench testing: Performed to compare the new device's performance to the predicate device.
- Comparative performance testing: Against the predicate device.
- Electrical safety testing: Conducted according to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Risk Management: Implemented in compliance with ISO 14971.
- Sterilization Validation: In accordance with AAMI/ISO 11135.
- Packaging Validation: In accordance with ISO 11607-1:2006.
The conclusion from these tests is that "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. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative sample size (e.g., number of units tested) for the bench or comparative performance testing. Typically, regulatory submissions for devices like this demonstrate equivalence through a sufficient number of tests to establish reliability and consistent performance rather than large clinical trial-style sample sizes for a 'test set.'
- Data Provenance: The studies are non-clinical (bench testing) and were conducted by Synergetics, Inc. (the applicant). The country of origin for the data is implicitly the United States, where the company is based. The data is prospective in the sense that the tests were specifically performed to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is a non-clinical device summary. "Ground truth" in the context of expert consensus or pathology is typically associated with diagnostic or prognostic devices, not electrosurgical tools where performance is assessed through engineering and safety standards. The "truth" here is established by adherence to technical specifications and validated performance against a known device.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is non-clinical testing against technical standards and a predicate device, not involving human interpretation or adjudication in the sense of a clinical or image-based study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is entirely outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware electrosurgical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's performance is based on:
- Engineering specifications and design attributes: For technical characteristics like design, materials, and connectors.
- International Standards: Compliance with IEC 60601 series for electrical safety and ISO standards for packaging and sterilization.
- Predicate Device Performance: The functional performance of the new device is considered "true" or acceptable if it is comparable to the legally marketed predicate device (K080187) during bench and comparative testing.
8. The Sample Size for the Training Set
Not applicable. There is no AI component or machine learning model for which a "training set" would be used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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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 DriveO'Fallon, MO 63368 | |
|---|---|---|
| Contact Person: | Gary OliverosSynergetics, Inc.Regulatory Affairs/ Compliance ManagerTelephone Number: (636) 794-5107Fax Number: (636) 794-5120Email: goliveros@synergeticsusa.com) | |
| Date Prepared: | March 31, 2011 | |
| Device Trade Name: | Synergetics™ Disposable Spetzler™ Malis® Dual IrrigatingBipolar Forceps | |
| Common Name: | Single Use Irrigating Bipolar Forceps | |
| Device Classification: | 21 CFR Part 878.4400, Electrosurgical Cutting and CoagulationDevices 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 BipolarForceps, 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 MedicalSingle Use Bayonet IrrigatingBipolar Forceps, K080187 | Synergetics Dual IrrigatingBipolar Forceps |
|---|---|---|
| Intended Use | Sterile single use, for use inelectrosurgery for coagulation andirrigation of tissue. | Sterile single use, for use inelectrosurgery for coagulationand irrigation of tissue. |
| For Use With | Electrosurgical generators,irrigation modules and irrigationtubing | Electrosurgical generators,irrigation modules and irrigationtubing |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Stainless Steel base, with Nyloninsulation | Biocompatible Silver platedAluminum base with PVDFinsulation |
| Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 |
| Latex Free | Yes | Yes |
| Luer connector for connectionto irrigation tubing | Yes | Yes |
| Delivery line for fluid to distalend 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, Packagingfor Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile Barrier Systems andPackaging 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.
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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.
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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
§ 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.