The Laparoscopic Electrodes are electrosurgical devices, used for a variety of laparoscopic procedures through a port, for coaqulation and transection of soft tissue and vessels by use of high frequency electric current. The Monopolar cable provides the electrical connection between the Electrode and a suitable electrosurgical generator. Both the Laparoscopic Electrodes and Monopolar cables are single patient use and supplied sterile to healthcare professionals only.

The Laparoscopic Electrodes each consist of a fully insulated, stainless steel shaft. 33cm in length. incorporating three different available types of thermally conductive, insulated metal tip electrodes for conveyance of HF electric current and operated via an ergonomic plastic handle for tactile feedback during surgery procedures. The device should be used through a surgical cannula that has an internal diameter of greater than 5mm.

The Monopolar cable is an insulated copper cord for conveyance of high frequency electrosurgical energy that connects between the HF diathermy connector situated at the end of the handle of the Laparoscopic Electrode and the specified output terminal of a suitable electrosurgical generator (not supplied), with a neutral electrode (not supplied) required to complete the electrosurgery circuit. They are intended for use at a maximum rated voltage of 5.5KVpeak. Coagulation and cutting is achieved using electrosurqical energy supplied via various types of electrosurgical generator.

The associated accessories required to complete the electrosurgical circuit include: Electrosurgical generator. Neutral Electrode.

AI/ML Overview

The provided submission describes a 510(k) premarket notification for "Laparoscopic Electrodes & Monopolar cables" by Purple Surgical International Limited. The submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to meet specific, pre-defined acceptance criteria for a new AI/medical device. Therefore, a direct table of "acceptance criteria" and "reported device performance" in the typical sense of AI model evaluation (e.g., sensitivity, specificity, AUC) is not applicable here.

However, based on the document, we can infer the "acceptance criteria" in the context of a 510(k) submission as demonstrating safety and effectiveness relative to a legally marketed predicate device. The "study that proves the device meets the acceptance criteria" refers to the performance data provided to support substantial equivalence.

Here's an interpretation of your request based on the provided document:

1. Table of Acceptance Criteria (in the context of 510(k) substantial equivalence) and Reported Device Performance:

Acceptance Criteria (Inferred from 510(k) requirements for substantial equivalence)	Reported Device Performance / Evidence Presented
Biocompatibility: Device materials are not harmful when in contact with tissue (for tissue-contacting parts).	Satisfied: Biocompatibility testing conducted in accordance with ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation for Laparoscopic Electrodes. Monopolar cables (non-patient contacting) deemed not to require this testing.
Electrical Safety: Device meets electrical safety standards.	Satisfied: Electrical safety conducted on Laparoscopic Electrodes & Monopolar cables in accordance with IEC60601-2-2 and IEC60601-1 standards.
Electromagnetic Compatibility (EMC): Device does not produce unacceptable electromagnetic interference and is immune to such interference.	Not Carried Out / Justified Exclusion: EMC to IEC60601-1-2 standard was not carried out on the basis that High Frequency Surgical equipment are intentional emitters of EMC. (This is typically an accepted justification for this type of device.)
Functionality: Device performs its intended functions (cutting and coagulation).	Satisfied: Functionality testing conducted in a simulated surgical procedure, using chicken breast as the test model, to verify coagulation and transection capabilities. Results observed were as expected.
Sterility: Device is sterile and maintains sterility over its shelf life.	Satisfied: Sterility testing conducted in accordance with ISO11137 for Gamma Irradiation. Shelf life testing also conducted to ensure maintenance of sterility.
Shelf Life & Packaging Stability: Device maintains functionality and sterility over its stated shelf life, and packaging is stable.	Satisfied: Shelf life testing conducted through natural aging and accelerated aging (ASTM F1980 methodology) and ISO11607 for sterile packaging requirements.
Overall Safety and Effectiveness compared to Predicate: Demonstrates that the candidate device is as safe and effective as the predicate device and raises no new issues of safety or effectiveness.	Satisfied: Performance data demonstrates the device is fit for purpose. Stated conclusion: "Laparoscopic Electrodes & Monopolar cables are considered as safe and effective as the predicate device" and "do not raise any new issues of safety or effectiveness."

Details Regarding the "Study" (Performance Data):

As this is a 510(k) submission for a conventional medical device (electrosurgical accessories), not an AI/software device, the questions related to AI-specific evaluation methodologies are largely not applicable. The "studies" here are standard engineering and biological performance tests.

2. Sample Size Used for the Test Set and the Data Provenance:

Biocompatibility: The document does not specify the number of samples used for cytotoxicity, sensitization, or irritation testing. These tests typically involve in vitro cell cultures and in vivo animal models (e.g., guinea pigs for sensitization), but specific sample sizes are not provided.
Electrical Safety & EMC: No specific sample size is mentioned. These tests are usually performed on a representative number of devices according to the standards.
Functionality Testing: A "simulated surgical procedure, using chicken breast as the test model" was used. The number of devices tested or the amount of chicken breast material is not specified.
Sterility Testing: No specific sample size is mentioned. Sterility assurance level (SAL) validation typically involves a statistically significant number of samples.
Shelf Life & Packaging Stability: No specific sample size is mentioned. This usually involves multiple samples tested at various time points (e.g., initial, accelerated aged, and real-time aged).

Data Provenance: The document does not explicitly state the country of origin for the data collection for these performance tests. It's safe to assume they were conducted in certified laboratories, potentially local to the manufacturer or independent testing houses. All tests are inherently prospective as they are conducted specifically to evaluate the new device.

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

Not Applicable: For these types of physical performance and biocompatibility tests, "ground truth" is established by adherence to recognized international standards and objective measurement, not by expert consensus in the diagnostic sense. The results are typically quantitative measurements or qualitative assessments against defined criteria (e.g., passing/failing a cytotoxicity assay, achieving coagulation effects). No human "experts" are establishing diagnostic ground truth in this context.

4. Adjudication Method for the Test Set:

Not Applicable: As there are no human-interpreted diagnostic findings to adjudicate, this concept does not apply. Performance is measured against physical and biological standards.

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 is not an AI device or an imaging device requiring human reader interpretation. Therefore, an MRMC study was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: This is a physical electrosurgical device, not an algorithm.

7. The Type of Ground Truth Used:

Objective Measurements and Standard-Defined Criteria: For example:
- Biocompatibility: Cell viability, skin irritation scores, etc., evaluated against criteria defined in ISO 10993.
- Electrical Safety: Resistance, leakage current, dielectric strength, etc., measured against limits in IEC 60601 series.
- Functionality: Observable coagulation and transection effects on tissue, assessed against expectations for electrosurgical devices.
- Sterility: Absence of microbial growth, assessed against methods in ISO 11137.
- Shelf Life: Retention of physical properties, sterility, and functionality over time.

8. The Sample Size for the Training Set:

Not Applicable: There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not Applicable: See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of a stylized caduceus, which is a staff entwined by two snakes. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the seal. The caduceus symbol is composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2014

Purple Surgical International Limited Mr. Alan Schwartz MDI Consultants Incorporated 55 Northern Boulevard, Suite 200, Great Neck New York, New York 11021

Re: K142868

Trade/Device Name: Laparoscopic Electrodes & Monopolar cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 14, 2014 Received: October 23, 2014

Dear Mr. Alan Schwartz:

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

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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.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

K142868 510(k) Number (if known):

Device Name: Laparoscopic Electrodes & Monopolar cables

Indications for Use:

The devices are indicated for:

use in general laparoscopic surgery requiring the use of monopolar electrosurgical cutting and/or coagulation.

Prescription Use X (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)

Page __ of ____

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510(k) SUMMARY

Purple Surgical - Laparoscopic Electrodes & Monopolar cables

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Purple Surgical International Limited. 2 Chestnut House, Farm Close, Shenley, Hertfordshire, WD7 9AD UK

Phone:	+44(0) 1923 839333
Facsimile:	+44(0) 1923 839444

Contact Person:	Jason Howes
Date Prepared:	September 2014

Candidate Device details

Proprietary/Trade name:	Laparoscopic Electrode with J hook
	Laparoscopic Electrode with L hook
	Laparoscopic Electrode with Spatula
	Monopolar cable with 4mm pin
	Monopolar cable with 8mm pin

Common or Usual Name: Laparoscopic Electrode & Monopolar cable

Classification Name: Electrosurgical cutting and coagulation device and accessories, 21 C.F.R. § 878.4400

Device classification: Il

Product code: GEI

Classification Panel: General & Plastic surgery

Predicate Device details

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Device name / 510k: Monopolar J hook probe 5mm/33cm with cable (K103508) Monopolar L hook probe 5mm/33cm with cable (K103508) Monopolar Spatula probe 5mm/33cm with cable (K103508)

Manufacturer: Unimax Medical Systems Inc., Taiwan,

Further to a review of the MAUDE database – The predicate devices listed have not been subject a design related recall.

Device Description

The associated accessories required to complete the electrosurgical circuit include:

Electrosurgical generator. Neutral Electrode.

Intended Use / Indications for Use

The Laparoscopic Electrodes & Monopolar cables are used for a variety of laparoscopic procedures through a port, for coagulation and transection of soft tissue and vessels by use of high frequency electric current.

The devices are indicated for:

use in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and or coagulation.

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Comparison of Technological Characteristics with the Predicate Device Substantial Equivalence Determination

Monopolar electrosurgical cutting and coagulation of soft tissue during Laparoscopic surgical procedures is the technological principle for both the candidate and predicate devices.

The candidate and predicate devices are based on the same technological elements:

. Laparoscopic Electrodes 33cm in length & 5mm diameter designed for use through the appropriate surgical trocar ports.
Three different available electrode tips : L hook, J hook & Spatula ●
Stainless steel, insulated shaft assembly. .
Plastic ergonomic handle .
HF diathermy male connector .
Monopolar cable, insulated, copper cored featuring 4mm female connector (for . connection to the electrode) and at the opposite end fitted with either a 4mm or 8mm, industry standard, male pin (for connection to the ESU).
Single use application
Provided Sterile .

The following technological differences exist between the candidate and predicate devices:

Sterilization method (Gamma Irradiation v Ethylene Oxide) .
The Laparoscopic Electrodes & Monopolar cables are as safe and effective as the predicate device and are manufactured by the same company to the same basic specification as the predicate device.

The Purple Surgical Laparoscopic Electrodes & Monopolar cables are substantially equivalent to the in terms of intended use, technological characteristics, principles of operation, materials and performance to cleared Unimax Laparoscopic instrument covered under K103508. Any minor differences in this section do not raise any new issues with respect to safety and effectiveness.

Item	Candidate device - PurpleSurgical - LaparoscopicElectrodes & Monopolar cables			Predicate device – Unimax MedicalSystems - Laparoscopic Instrument
Intended use	intended to be used for use ingeneral laparoscopic surgeryrequiring the use of monopolarelectrosurgical cutting and/orcoagulation.			use in general laparoscopic surgeryrequiring the use of monopolarelectrosurgical cutting and/or coagulation.
Models / Type /(part code)	5mm Laparoscopic electrode			Monopolar probe
	J hook	L hook	Spatula	J hook	L hook	Spatula
	(PS3880)	(PS3881)	(PS3882)	(FPJ533050)	(FPL533050)	(FPS533050)
Accessories /(part code)	Monopolar cable			Monopolar cable
	4mm pin(PS3551C4)	8mm pin(PS3551C8)		4mm pin(FDC232080)	8mm pin(FDC132080)
Energy type	Monopolar			Monopolar
Dimensions	Shaft Diameter = 5mm			Shaft Diameter = 5mm

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Sterilization	Radiation	Ethylene oxide
---------------	-----------	----------------

Performance Data

The following performance data was provided in support of the substantial equivalence determination:-

Biocompatibility testing

The biocompatibility evaluation for the Laparoscopic Electrodes was conducted in accordance with International Standard ISO 10993-1 - Biological Evaluation of the Medical Devices, Part 1 -Evaluation and testing in the risk management process as recognized by FDA. The testing included the following testing for

Cytotoxicity Sensitization Irritation

The Laparoscopic Electrodes are considered tissue contacting for a duration of less than 24 hours. The Monopolar cables are considered non-patient contacting, therefore testing was deemed unnecessary.

Electrical safety and Electromagnetic compatibility

Electrical safety was conducted on the Laparoscopic Electrodes & Monopolar cables in accordance with IEC60601-2-2 and IEC60601-1 standards. EMC to IEC60601-1-2 standard was not carried out on the basis that High Frequency Surgical equipment are intentional emitters of EMC.

Functionality testing

Functionality testing on the Laparoscopic Electrodes & Monopolar cables was conducted to verify the device's coagulation and transection capabilities in a simulated surgical procedure, using chicken breast as the test model.

Sterility testing

Sterility testing was conducted on the Laparoscopic Electrodes & Monopolar cables in accordance with ISO11137 standard for Gamma Irradiation.

Shelf Life Testing and Packaging Stability

Shelf life testing was conducted to natural aging and accelerated aging in line with ASTMF1980 methodology and ISO11607 for Sterile Packaging requirements, to ensure maintenance of sterility and retained product functionality over time.

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Conclusion

The Laparoscopic Electrodes & Monopolar cables are considered as safe and effective as the predicate device and is manufactured to the same basic specification as the predicate device. The Performance data demonstrates that the device is fit for purpose and the results observed were as expected and in accordance with recognized standards.

The Laparoscopic Electrodes & Monopolar cables have the same intended use, indications for use, principles of operation and virtually identical technological characteristics as the predicate device. Due to the similarities, it's considered that the minor differences between the Laparoscopic Electrodes & Monopolar cables and its predicate device do not raise any new issues of safety or effectiveness.

Thus, the Laparoscopic Electrodes & Monopolar cables are considered substantially equivalent to the predicate device.

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.