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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Spetzler™ Malis® Dual Illuminating Bipolar Forceps and details non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about an AI/ML device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study. Therefore, several requested sections cannot be filled from the given text.

Here's the information extracted and organized based on your request, with "N/A" for unavailable data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and the reference device, aiming for "equivalent" performance.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance (Subject Device)
Non-Stick Coagulation Events (Primary Function)	≥ 500+ events (equivalent to predicate)	500+
Illumination Output (Non-Stick Coagulation Testing)	N/A (Predicate did not have illumination)	200-204 mW
Beef Liver Steady State Temperature Rise over Ambient (after 30 min. exposure)	< 110% of Reference Scope AND < 10 degrees F (equivalent to reference)	4 degrees F
Device Output [mW] MAX (Illumination Transmission Levels)	< Reference Scope (Telescope)	220 mW
Device Output [mW] AVG (Illumination Transmission Levels)	< Reference Scope (Telescope)	207 mW
Tip Temperature [°F] MAX	< 110% of Reference Scope (Telescope)	186 °F
Tip Temperature [°F] AVG	< 110% of Reference Scope (Telescope)	164.5 °F
Electrical Safety	Conformity to IEC 60601-1, -1-2, -2-2	Performed and presumed compliant

2. Sample Sizes Used for the Test Set and Data Provenance

Non-Stick Coagulation: Not explicitly stated, but "500+" events recorded for both subject and predicate devices, implying a significant number of trials.
Beef Liver Temperature Rise: Not explicitly stated, but "6pc sample" is mentioned for Average Device Output and Average Tip Temperature, suggesting at least 6 samples were tested for these specific metrics related to illumination.
Data Provenance: The devices were tested in a "bench test" setting by internal and independent laboratories. The document does not specify the country of origin of the data or if it was retrospective or prospective, as it's a bench study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A. This was a non-clinical bench testing study, not a study involving human interpretation or ground truth established by experts.

4. Adjudication Method for the Test Set

N/A. Not applicable for non-clinical bench testing.

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

N/A. No MRMC study was conducted, as this is not an AI/ML device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. Not applicable, as this is not an AI/ML device. The testing described is for the physical device's performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on direct physical measurements and observations during bench testing, compared against the performance of a legally marketed predicate device and a reference device, and against established safety standards (IEC standards).

Non-Stick Coagulation: Performance compared to the predicate device (Spetzler™ Malis® Standard Bipolar Forceps K121426) under specific COAG settings.
Illumination Output/Temperature: Performance compared to a reference device (Karl Storz Xenon Light Source and Telescope K962595) and specific temperature increase thresholds.
Electrical Safety: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).

8. The Sample Size for the Training Set

N/A. Not applicable, as this is not an AI/ML device and no training set was used.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K160103

Device Name

Spetzler™ Malis® Dual Illuminating Bipolar Forceps

Indications for Use (Describe)

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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Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

I. SUBMITTER

Applicant's Nameand Address:	Synergetics3845 Corporate Centre DriveO'Fallon, MO 63368
Contact Person:	Dan Regan, Regulatory Affairs Director
Date Prepared:	October 11, 2016
II. DEVICE
Device TradeName:	Spetzler™ Malis® Dual Illuminating Bipolar Forceps
Common Name:	Illuminating Bipolar Forceps
DeviceClassification:	21 CFR Part 878.4400, Electrosurgical Cutting and CoagulationDevices 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

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.

Element510(k) Number	Subject DeviceSpetzler™ Malis®Dual IlluminatingBipolar ForcepsK160103	Predicate DeviceSpetzler™ Malis®Standard BipolarForcepsK121426	Reference DeviceKarl Storz XenonLight source withTelescopeK962595
Indications for Use	The Spetzler™ Malis®Dual IlluminatingBipolar Forceps aresingle use devicessold sterile and areintended for use inelectrosurgery forcoagulation of tissue	The Spetzler™Malis® StandardBipolar Forcepsare single usedevices soldsterile and areintended for usein electrosurgeryfor coagulation oftissue.	This device isdesigned to supplylight forendoscopicdiagnostic andsurgicalprocedures.

VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS:

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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 IlluminatingBipolar Forceps	Spetzler™ Malis®Standard BipolarForceps	Karl Storz XenonLight source withTelescope
Element
Product Code	GEI	GEI	FFS
Forceps Design	Bayonet Style	Bayonet Style	Not applicable
Patient Contact Material	Silver Platedaluminum base withPVDF insulation	Silver Platedaluminum basewith PVDFinsulation	Not applicable
Electrical Safety Testing	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	Not Known
Size Offerings OverallLength	8 inches and 9 inches	7 inches, 8 inchesand9 inches	Not applicable
Size Offerings Distal Tip	0.5 mm1.0 mm1.5mm	0.5 mm1.0 mm1.5mm	Not applicable
Packaging Configuration	Rigid PETG Tray witha Tyvek 1073B Lid	Rigid PETG Traywith a Tyvek1073B 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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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 riseafter 30 minutes of continuous illumination		ReferenceDevice	Analysis
Parameter	SubjectDevice
Device CatalogNumber	Synergetics Forceps80-7621	Karl Storz Telescope27023ABA	Unique
Source ConnectionMeans	Synergetics Adapter80-7630	Karl Storz Fiber Cable495NE	Equivalent
Lightsource	Karl Storz 300WXenon	Karl Storz 300WXenon	Identical
Adapter/CableOutput [mW]	1230(non-standardadapter @ 75%setting)	3400100% output	Equivalent(
Device Output [mW]MAX	335-340(1.5x Typ. Max)	326	Equivalent(
Liver Steady StateTemperature Riseover Ambient [°F]after 30 min.exposure	4 degrees F	6-8 degrees F	Equivalent(<110% of Scope& < 10 degrees Fafter 30 minutes)

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Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

Illumination Transmission Levels for Subject Device and Reference Device
Parameter	Subject Device	Reference Device	Analysis
Device Catalog Number	Synergetics Forceps80-7621	Karl Storz Telescope27023ABA	Unique
Source Connection Means	Synergetics Adapter80-7630	Karl Storz FiberCable 495NE	Equivalent
Lightsource	Karl Storz 300WXenon	Karl Storz 300WXenon	Identical
Adapter/Cable Output [mW]100% output	400(Standard Adapter)	3400	Equivalent(<Cable)
Device Output [mW]MAX, 100% Setting	220	326	Equivalent(<Scopes)
Device Output [mW]AVG, 100% Setting	207	326	Equivalent(<Scopes)

Comparative Light Output Readings from Subject Forceps and Reference Device
Parameter	SubjectDevice	ReferenceDevice	Analysis
Device CatalogNumber	Synergetics Forceps80-7621	Karl Storz Telescope27023ABA	Unique
Source ConnectionMeans	Synergetics Adapter80-7630	Karl StorzFiber Cable495NE	Equivalent
Lightsource	Karl Storz 300WXenon	Karl Storz 300WXenon	Identical
Adapter/CableOutput [mW]	400	3400	Equivalent(
Device Output[mW] MAX	220	326	Equivalent(
Tip Temperature[°F] MAX	186	171	Equivalent(<110% of Scope)

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Section 5 - 510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92

Comparative Light Output Readings from Subject Forceps and Reference Device
Parameter	SubjectDevice	ReferenceDevice	Analysis
Device Output[mW] AVG	207(6pc sample)	326(1 pc sample)	Equivalent(<Scope)
Tip Temperature[°F] AVG	164.5(6pc sample)	171(1pc sample)	Equivalent(<110% of Scope)

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 Spetzler™ Malis® Dual Illuminating Bipolar Forceps.

The non-clinical testing supports a determination of substantially equivalency to the predicate device.

VIII. SUBSTANTIAL EQUIVALENCE BASIS:

The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Spetzler™ Malis® Dual Illuminating Bipolar Forceps is as safe and effective as the predicate device, the Spetzler™ Malis® Standard Bipolar Forceps.

Regulation Number and Section

§ 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.