(134 days)
Intended Use: Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.
Indications: General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation.
Sutter Bipolar Forceps - SuperGliss is an electrosurgical tool in tweezers configuration with differences in tip size and branches styles. It is constructed with medical grade stainless steel (branches), coated with Polyamid PA 11 as electrical insulator and possesses a tip made of silver alloy that is not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is designed to grasp, manipulate and coagulate selected tissue. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.
The provided text describes a 510(k) summary for the "Sutter Bipolar Forceps - SuperGliss," an electrosurgical tool. This document outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the information provided, here's a detailed breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the sense of specific thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices, implying that its performance is comparable and acceptable for its intended use. The performance testing section mentions "determination of coagulation areas for various tip sizes and statistical analysis of the results," but no specific numerical results or targets are provided in this summary.
The "Features" table below highlights the comparative performance and design aspects, showing that the Sutter SuperGliss meets the characteristics of the predicate devices.
| Feature | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Sutter SuperGliss) |
|---|---|---|
| Intended Use | Grasp, manipulate, coagulate selected tissue; connected to bipolar output of electrosurgical generator with appropriate cable; used only with parameters for bipolar coagulation. | Same as predicate devices |
| Branches Style | Straight, angled, bayonet | Straight, angled, bayonet |
| Dimensions (Length) | 110 - 250 mm (K101080) / 110 - 240 mm (K051429) | 110 - 280 mm |
| Dimensions (Tip size) | 0.25 - 2.0 mm (K101080) / 0.25 - 2.0 mm (K051429) | 0.2 - 2.5 mm |
| Material (Tips) | Silver Alloy | Silver Alloy |
| Material (Coating) | Polyamide (PA) 11 | Polyamide (PA) 11 |
| Material (Connector) | Stainless steel/PEEK | Stainless steel/PEEK |
| Material (Branches) | Stainless steel | Stainless steel |
| Bipolar Function | Yes | Yes |
| Compliance Standard | Meets IEC 60601-2-2 | Meets IEC 60601-2-2 |
| Maximum Peak Voltage | 500 Vp | 500 Vp |
| Sterility | Non-sterile, reusable | Non-sterile, reusable |
| Sterilization Method | Steam-sterilization by user | Steam-sterilization by user |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Non-clinical laboratory performance testing was done on different types of meat with determination of coagulation areas for various tip sizes and statistical analysis of the results."
- Sample Size: Not specified. The phrase "different types of meat" suggests multiple samples were used, but the exact number is not provided.
- Data Provenance: Not specified, but generally, bench testing results conducted by the manufacturer are not typically tied to a specific country of origin in the same way clinical trial data might be. This was a non-clinical laboratory performance test. It's implicitly retrospective as it was conducted by the manufacturer for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an electrosurgical instrument, and the performance testing involved physical measurements of coagulation areas on meat, not human interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing involved physical measurements, not observational assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is a surgical instrument, and its performance was assessed through non-clinical laboratory tests.
6. Standalone Performance Study
Yes, a standalone performance study was performed in the form of "Non-clinical laboratory performance testing... on different types of meat with determination of coagulation areas for various tip sizes and statistical analysis of the results. Bench testing according to standards series IEC 60601 has also been performed." This describes the device's performance in isolation from a human operator, focusing on its functional capabilities.
7. Type of Ground Truth Used
For the non-clinical laboratory performance testing, the ground truth was direct physical measurement of "coagulation areas" on "different types of meat." For compliance with IEC 60601, the ground truth rested on fulfilling the requirements of that established standard.
8. Sample Size for the Training Set
Not applicable. This is a medical device (surgical instrument), not an AI/ML algorithm that requires a training set. The performance testing aims to demonstrate the device's functional integrity and equivalence, not to train a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH AFTERS: SUTTER BIPOLAR FORCEPS - SUPERGLISS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Section 807.92(c)
| Date:807.92(a)(1) | August 20, 2013 | ||
|---|---|---|---|
| Submitter:807.92(a)(1) | Name:Address: | SUTTER MEDIZINTECHNIK GmbHTullastrasse 8779108 FreiburgGermany | |
| Managing Director:Telephone:Fax:Contact person:Telephone:E-mail: | Bert Sutter+49 (0) 761 51551-0+49 (0) 761 51551-30Dr. Sabine Klugbauer+49 (0) 761 51551-14klugbauer@sutter-med.de | AUG 2 3 2013 | |
| Product:807.92(a)(2) | Trade Name:Classification:Common Name:Product Code andClassification Name: | Sutter Bipolar Forceps - SuperGlissClass II; CFR 21 § 878.4400Electrosurgical Instruments and AccessoriesGEI - Electrosurgical Cutting & CoagulationDevice & Accessories | |
| PredicateDevice:807.92(a)(3) | Predicate devices to which Sutter Bipolar Forceps SuperGliss areclaimed to be substantially equivalent are manufactured by• Egon Faulhaber Surgical Instruments Pinzetten, Bipolar, Nonstickbipolar forceps (K101080)• Guenter Bissinger, Claris Non-Stick Bipolar Forceps (K051429) | ||
| DeviceDescription:807.92(a)(4) | Sutter Bipolar Forceps - SuperGliss is an electrosurgical tool intweezers configuration with differences in tip size and branches styles.It is constructed with medical grade stainless steel (branches), coatedwith Polyamid PA 11 as electrical insulator and possesses a tip made ofsilver alloy that is not insulated. The forceps can be connected throughan appropriate bipolar cable with the bipolar output of an electrosurgicalgenerator. As an electrosurgical accessory it is designed to grasp,manipulate and coagulate selected tissue. The maximum peak voltageto use the forceps is 500 Vp. The forceps are provided non-sterile, arereusable and must be sterilized prior initial and subsequent use. | ||
| IntendedUse:807.92(a)(5) | Intended Use: Sutter Bipolar Forceps SuperGliss are designed tograsp, manipulate and coagulate selected tissue. They are to beconnected to the bipolar output of an electrosurgical generator with anappropriate bipolar cable and must only be used with parameters forbipolar coagulation.Indications: General surgery, Orthopaedic coagulation, Thoraciccoagulation, Neurosurgical coagulation, Gynaecological coagulation(except for use in female sterilisation), Urological coagulation, Ear- | ||
| Nose- and Throat coagulation.Contraindications: Sutter Bipolar Forceps SuperGliss have not beenshown to be effective for tubal sterilisation or tubal coagulation forsterilisation procedures and should not be used for this purpose. | |||
| PerformanceTesting:807.92(b)(1) | Non-clinical laboratory performance testing was done on different typesof meat with determination of coagulation areas for various tip sizes andstatistical analysis of the results. Bench testing according to standardsseries IEC 60601 has also been performed. | ||
| SubstantialEquivalence:807.92(b)(3) | Comparison of Basic Features, design, testing results and intendeduses show that Sutter Bipolar Forceps SuperGliss are substantialequivalent to the predicate devices. | ||
| Feature | Sutter SuperGliss | Predicate devicesK101080/K051429 | |
| Intended Use | As shown above underIntended Use | Same/Same | |
| Branches Style | Straight, angled, bayonet | Same/Same | |
| DimensionsLength [mm]:Tip size [mm]: | 110 - 2800.2 - 2.5 | 110 - 250 / 110 - 2400.25 - 2.0 / 0.25 - 2.0 | |
| MaterialTips:Coating:Connector:Branches: | Silver AlloyPolyamide (PA) 11Stainless steel/PEEKStainless steel | Same/Same | |
| Bipolar | yes | Same/Same | |
| Meets IEC 60601-2-2 | yes | Same/Same | |
| Maximum peak voltage | 500 Vp | Same/Same | |
| Sterility | Non-sterile, reusable | Same/Same | |
| Sterilization method | Steam-sterilisation by user | Same/Same |
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH SUTTER BIPOLAR FORCEPS - SUPERGLISS DEVICES:
必,
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is facing right and is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2013
Sutter Medizintechnik GmbH % Dr. Sabine Klugbauer Manager, Regulatory Affairs Tullastrasse 87 79108 Freiburg, Germany
Re: K131012
Trade/Device Name: Sutter Bipolar Forceps - SuperGliss Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagnlation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2013 Received: July 12, 2013
Dear Dr. Klugbauer:
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 docs 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Dr. Sabine Klugbauer
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES:
Indications for Use Form
Indications for Use
K131012 510(k) Number (if known):
Device Name:
Sutter Bipolar Forceps - SuperGliss
Indications for Use:
Intended Use:
Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.
Indications:
General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation.
Contraindications:
Sutter Bipolar Forceps SuperGliss have not been shown to be effective for tubal sterilisation or tubal coagulation for sterilisation procedures and should not be used for this purpose.
× 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| DSD-DIVISION SIGN-OFF | Joshua C. Nipper |
|---|---|
| Division of Surgical Devices | -S |
| 510(k) Number: K131012 |
§ 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.