(267 days)
No
The device description and performance studies focus on the electrosurgical and illumination functions of the forceps, with no mention of AI or ML.
Yes
The device is described as "intended for use in electrosurgery for coagulation of tissue," which is a therapeutic medical action.
No
The device is described as an electrosurgical tool for tissue coagulation and illumination during surgical procedures, not for diagnostic purposes.
No
The device description clearly outlines physical components like forceps, a twin pin cord, a fiberoptic cable, and connectors, indicating it is a hardware device with electrosurgical and illumination functions, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgery for coagulation of tissue and to supply light for surgical procedures." This describes a surgical tool used directly on the patient's tissue, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details a surgical instrument with features for electrosurgery and illumination, designed for direct application during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Spetzler™-Malis® Dual Illuminating Bipolar Forceps is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
Product codes
GEI
Device Description
The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.
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
A series of bench tests were performed to assess the non-stick and illumination features of the forceps.
- Substantial Equivalence Testing, Primary Function, Non Stick Coagulation:
- Parameters: COAG Setting (25 Malis Units), Illumination Output (200-204 mW for Subject Device, N/A for Predicate), Accessory Cord (80-1184 (Single Use)), Non-Stick COAG Events (500+ for both).
- Results: Pass/Equivalent for both Subject and Predicate Device.
- Comparison of Beef Liver surface temperature rise after 30 minutes of continuous illumination:
- Devices: Synergetics Forceps 80-7621 (Subject), Karl Storz Telescope 27023ABA (Reference).
- Source Connection Means: Synergetics Adapter 80-7630 (Subject), Karl Storz Fiber Cable 495NE (Reference). Analysis: Equivalent.
- Lightsource: Karl Storz 300W Xenon (Identical for both).
- Adapter/Cable Output [mW]: 1230 (non-standard adapter @ 75% setting) for Subject, 3400 (100% output) for Reference. Analysis: Equivalent.
- Device Output [mW] MAX: 335-340 (1.5x Typ. Max) for Subject, 326 for Reference. Analysis: Equivalent.
- Liver Steady State Temperature Rise over Ambient [°F] after 30 min. exposure: 4 degrees F for Subject, 6-8 degrees F for Reference. Analysis: Equivalent (
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2016
Synergetics Mr. Dan Regan Regulatory Affairs Director 3845 Corporate Centre Drive O' Fallon, Missouri 63368
Re: K160103
Trade/Device Name: Spetzler Malis Dual Illuminating Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 7, 2016 Received: September 9, 2016
Dear Mr. Regan:
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 of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Sincerely yours,
Jennifer R. Stevenson -A
For 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) K160103
Device Name
Spetzler™ Malis® Dual Illuminating Bipolar Forceps
Indications for Use (Describe)
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design composed of several squares and lines, creating a diamond shape. To the right of the word "Synergetics" is the trademark symbol, "TM", in a smaller font size.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
I. SUBMITTER
| Applicant's Name
and Address: | Synergetics
3845 Corporate Centre Drive
O'Fallon, MO 63368 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dan Regan, Regulatory Affairs Director |
| Date Prepared: | October 11, 2016 |
| II. DEVICE | |
| Device Trade
Name: | Spetzler™ Malis® Dual Illuminating Bipolar Forceps |
| Common Name: | Illuminating Bipolar Forceps |
| Device
Classification: | 21 CFR Part 878.4400, Electrosurgical Cutting and Coagulation
Devices and Accessories are Class II devices. |
| Class Name: | Electrosurgical, Cutting and Coagulation and Accessories |
| Product Code: | GEI |
| FDA Panel: | General and Plastic Surgery |
| III. PREDICATE DEVICE | |
Predicate Devices: Spetzler™ Malis® Standard Bipolar Forceps, K121426 (primary predicate)
Karl Storz Xenon Light Source and Telescope, K962595 (reference device)
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Image /page/4/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric shape made up of smaller squares and triangles. The letters are black, and the geometric shape is outlined in black. The trademark symbol is located to the right of the word.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
IV. DEVICE DESCRIPTION
The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.
V. INDICATIONS FOR USE
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual llluminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
| Element
510(k) Number | Subject Device
Spetzler™ Malis®
Dual Illuminating
Bipolar Forceps
K160103 | Predicate Device
Spetzler™ Malis®
Standard Bipolar
Forceps
K121426 | Reference Device
Karl Storz Xenon
Light source with
Telescope
K962595 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Spetzler™ Malis®
Dual Illuminating
Bipolar Forceps are
single use devices
sold sterile and are
intended for use in
electrosurgery for
coagulation of tissue | The Spetzler™
Malis® Standard
Bipolar Forceps
are single use
devices sold
sterile and are
intended for use
in electrosurgery
for coagulation of
tissue. | This device is
designed to supply
light for
endoscopic
diagnostic and
surgical
procedures. |
VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS:
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Image /page/5/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo consisting of several squares arranged to form a larger diamond shape. To the right of the word "Synergetics" is the trademark symbol, "™".
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS:
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Spetzler™ Malis® | |||
| Dual Illuminating | |||
| Bipolar Forceps | Spetzler™ Malis® | ||
| Standard Bipolar | |||
| Forceps | Karl Storz Xenon | ||
| Light source with | |||
| Telescope | |||
| Element | |||
| Product Code | GEI | GEI | FFS |
| Forceps Design | Bayonet Style | Bayonet Style | Not applicable |
| Patient Contact Material | Silver Plated | ||
| aluminum base with | |||
| PVDF insulation | Silver Plated | ||
| aluminum base | |||
| with PVDF | |||
| insulation | Not applicable | ||
| Electrical Safety Testing | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-2-2 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-2-2 | Not Known | ||
| Size Offerings Overall | |||
| Length | 8 inches and 9 inches | 7 inches, 8 inches | |
| and | |||
| 9 inches | Not applicable | ||
| Size Offerings Distal Tip | 0.5 mm | ||
| 1.0 mm | |||
| 1.5mm | 0.5 mm | ||
| 1.0 mm | |||
| 1.5mm | Not applicable | ||
| Packaging Configuration | Rigid PETG Tray with | ||
| a Tyvek 1073B Lid | Rigid PETG Tray | ||
| with a Tyvek | |||
| 1073B Lid | Not applicable | ||
| Method of sterilization | ETO | ETO | Not applicable |
| Sterility Assurance Level | 10-6 | 10-6 | Not applicable |
VII. SUMMARY OF NON-CLINICAL TESTS:
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Image /page/6/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design made up of squares and lines. The letters are black, and there is a trademark symbol to the right of the word.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
A series of bench tests were performed to assess the non-stick and illumination features of the forceps. The results are summarized below.
| Substantial Equivalence Testing, Primary Function, Non Stick Coagulation | ||
|---|---|---|
| Parameter | Subject Device | Predicate Device |
| 80-7621 | 80-7621 | 80-1273 |
| COAG Setting | 25 Malis Units | 25 Malis Units |
| Illumination Output | 200-204 mW | N/A |
| Accessory Cord | 80-1184 (Single Use) | 80-1184 (Single Use) |
| Non-Stick COAG Events | 500+ | 500+ |
| Results | Pass/Equivalent | Pass/Equivalent |
| Comparison of Beef Liver surface temperature rise
after 30 minutes of continuous illumination | | Reference
Device | Analysis |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------|------------------------------------------------------------------------|
| Parameter | Subject
Device | | |
| Device Catalog
Number | Synergetics Forceps
80-7621 | Karl Storz Telescope
27023ABA | Unique |
| Source Connection
Means | Synergetics Adapter
80-7630 | Karl Storz Fiber Cable
495NE | Equivalent |
| Lightsource | Karl Storz 300W
Xenon | Karl Storz 300W
Xenon | Identical |
| Adapter/Cable
Output [mW] | 1230
(non-standard
adapter @ 75%
setting) | 3400
100% output | Equivalent
( |
| Device Output [mW]
MAX | 335-340
(1.5x Typ. Max) | 326 | Equivalent
( |
| Liver Steady State
Temperature Rise
over Ambient [°F]
after 30 min.
exposure | 4 degrees F | 6-8 degrees F | Equivalent
(