(153 days)
Not Found
No
The device description and the absence of mentions of AI, DNN, or ML, along with the lack of information on training/test sets or performance metrics typically associated with AI/ML, indicate that this is a standard electrosurgical tool without AI/ML capabilities.
No.
The device is an electrosurgical tool intended to remove tissue and control bleeding, which are surgical functions, not therapeutic ones in the context of treating a disease or condition with a medical substance or procedure.
No
The device is described as an electrosurgical tool intended to remove tissue and control bleeding, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is an electrosurgical tool constructed with physical materials (stainless steel, polyamide) and has physical components (handle, tips, cable connection). It is a hardware device used in conjunction with an electrosurgical generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to remove tissue and control bleeding." This describes a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details an electrosurgical tool used for cutting and coagulating tissue during surgery. This is consistent with a surgical instrument, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely therapeutic/surgical.
N/A
Intended Use / Indications for Use
Intended Use: Sutter Bipolar Forceps- Calvian are intended to remove tissue and control bleeding.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Sutter Bipolar Forceps - Calvian is an electrosurgical tool available in different handle styles and tip sizes. It is constructed with medical grade stainless steel, coated with Polyamide PA 11 as electrical insulator and possesses tips made of stainless steel that are partly 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 intended to remove tissue and control bleeding. 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.
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, suggesting a sense of community and care. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Sutter Medizintechnik GmbH Ulrike Zeissler Manager, Regulatory Affairs Tullastrasse 87 79108 Freiburg Germany
Re: K150959
Trade/Device Name: Sutter Bipolar Forceps - Calvian Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 1, 2015 Received: April 1, 2015
Dear Zeissler:
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
1
807); labeling (21 CFR Part 801); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150959
Device Name Sutter Bipolar Forceps - Calvian
| Indications for Use (Describe) |
|---|
| -------------------------------- |
| Intended Use: | Sutter Bipolar Forceps- Calvian are intended to remove tissue and control bleeding. |
|---|---|
| --------------- | ------------------------------------------------------------------------------------- |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER BIPOLAR FORCEPS - Calvian
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Section 807.92(c)
| Date:
| 807.92(a)(1) | March 31, 2015 | ||
|---|---|---|---|
| Submitter: | |||
| 807.92(a)(1) | Name: | SUTTER MEDIZINTECHNIK GmbH | |
| Address: | Tullastrasse 87 | ||
| 79108 Freiburg | |||
| Germany | |||
| Managing Director: | Bert Sutter | ||
| Telephone: | +49 (0) 761 51551-0 | ||
| Fax: | +49 (0) 761 51551-30 | ||
| Contact person: | Ulrike Zeissler | ||
| Telephone: | +49 (0) 761 51551-14 | ||
| E-mail: | zeissler@sutter-med.de | ||
| Product: | |||
| 807.92(a)(2) | Trade Name: | Sutter Bipolar Forceps - Calvian | |
| Classification: | Class II; CFR 21 § 878.4400 | ||
| Common Name: | Electrosurgical Instruments and Accessories | ||
| Product Code and | |||
| Classification Name: | GEI - Electrosurgical Cutting & Coagulation | ||
| Device & Accessories | |||
| Predicate | |||
| Device: | |||
| 807.92(a)(3) | Predicate device to which Sutter Bipolar Forceps - Calvian are claimed | ||
| to be substantially equivalent is manufactured by | |||
| • Xomed Surgical Products, Microfrance Electrosurgical Instruments, | |||
| various, (K993655) | |||
| Device | |||
| Description: | |||
| 807.92(a)(4) | Sutter Bipolar Forceps - Calvian is an electrosurgical tool available in | ||
| different handle styles and tip sizes. It is constructed with medical grade | |||
| stainless steel, coated with Polyamide PA 11 as electrical insulator and | |||
| possesses tips made of stainless steel that are partly 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 intended to remove tissue and control bleeding. 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. | |||
| Intended | |||
| Use: | |||
| 807.92(a)(5) | Intended Use: Sutter Bipolar Forceps - Calvian are intended to remove | ||
| tissue and control bleeding. | |||
| Substantial | |||
| Equivalence: | Sutter Bipolar Forceps - Calvian are substantial equivalent to the | ||
| predicate devices since the basic features, design and intended uses | |||
| are the same. | |||
| Feature | Sutter Calvian | Predicate device | |
| K993655 | |||
| Intended Use | As shown above under | ||
| Intended Use | Same | ||
| Branches Style | Angled | Straight, angled | |
| Dimensions | |||
| Tip size [mm]: | 0.7-2.5 | 1.3 - 2.5 | |
| Material | |||
| Tips: | |||
| Coating: | |||
| Connector: | |||
| Base material: | Stainless steel | ||
| Polyamide (PA) 11 | |||
| Stainless steel/Plastic material | |||
| Stainless steel | Same | ||
| Bipolar | yes | Same | |
| Meets IEC 60601-2-2 | yes | Same | |
| Maximum peak voltage | 500 Vp | 833 Vp | |
| Sterility | Non-sterile, reusable | Same | |
| Sterilization method | Steam-sterilisation by user | Same |
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510(k) Summary for K150959
APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER BIPOLAR FORCEPS - Calvian