The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are intended to be used in general laparoscopic surgical procedures requiring the use of Monpolar electrosurgical cutting and/or coagulation.

Device Description

The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are sterile packaged single use stainless-steel electrodes coated with a non-stick material (PTFE), which is used to cut and coagulate soft tissue. The PTFE Coating reduced the buildup of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup. These devices have a 5mm diameter with working lengths up to 44cm and includes various tip geometries (L-hook, Spatula, etc.). Additionally, devices are provided in either foot-activated (via a standard 4mm female monopolar connector) or hand-activated (via a standard electrosurgical pencil) versions.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the standard information related to AI/ML device studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable here.

This document describes the LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes, a device for electrosurgical cutting and coagulation in laparoscopic procedures. The acceptance criteria and study information provided in this document are focused on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative table format alongside the reported performance for each criterion, as would be common for AI/ML performance metrics. Instead, it describes various non-clinical tests conducted to demonstrate that the device meets design specifications and is substantially equivalent to the predicate device. The general acceptance criterion for all the tests described is that the subject device's performance is equivalent to, or within acceptable limits compared to, the predicate device or established standards.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Conformance to ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, EO residuals).	Conforms to ISO 10993 (ISO 10993-1, -5, -7, -10, -11, -23) standards.
Medical Electrical Equipment Safety	Conformance to IEC 60601-1 and IEC 60601-2-2 standards for basic safety and essential performance.	Conforms to ANSI AAMI ES60601-1 and IEC 60601-2-2.
Aging	Device maintains performance characteristics after aging simulations.	Testing conducted, implying positive outcome as part of design specifications. (Specific results not detailed in this summary).
Sterilization	Sterilization to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11135.	Ethylene Oxide Sterilization Validation per ISO 11135:2014 achieved an SAL of 10^-6.
Performance (Appearance, Dimensions, Corrosion Resistance, Operational Forces, Cutting Efficacy)	Equivalent to predicate device and met design specifications.	Compared to predicate device through various performance studies; implied positive results for substantial equivalence (specific metrics not detailed in this summary).
Thermal Effects on Tissue	Equivalent thermal spread compared to the predicate product under the same conditions across different tissue types and power settings.	Results showed an equivalent thermal spread under the same conditions across different tissue types and power settings. Specific "Thermal Damage Rate" values reported for the subject device: - 25W: Fatty (1.21 ±0.08 mm/s), Lean (1.34 ±0.14 mm/s), Extra Lean (1.65 ±0.24 mm/s) - 50W: Fatty (1.60 ±0.26 mm/s), Lean (2.34 ±0.30 mm/s), Extra Lean (2.40 ±0.24 mm/s) - 90W: Fatty (3.87 ±1.65 mm/s), Lean (5.15 ±4.82 mm/s), Extra Lean (5.57 ±7.59 mm/s)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for each non-clinical test beyond stating "various performance studies" and "testing on three different tissue types." The provenance is not explicitly mentioned but these are typically laboratory tests conducted by the manufacturer or contract research organizations. These are not human data, so terms like "retrospective/prospective" or "country of origin of data" are not directly applicable in the same way they would be for clinical trials or imaging datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. Ground truth, in the context of this device, refers to the established scientific and engineering principles, accepted standards (e.g., ISO, IEC), and the performance characteristics of the predicate device. Expert human review for "ground truth" as it relates to diagnostic accuracy is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically associated with resolving discrepancies in human expert interpretations, which is not part of this non-clinical device 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

Not applicable. This device is an electrosurgical probe, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a surgical instrument and does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For non-clinical testing of a surgical instrument, the "ground truth" is established by:

International and national standards: Such as ISO 10993 (biocompatibility), ISO 11135 (sterilization), IEC 60601-1 and IEC 60601-2-2 (electrical safety).
Scientific principles: Underlying the device's function (e.g., electrosurgical effects on tissue).
Comparison to predicate device: The performance characteristics of the legally marketed predicate device (Xodus Medical, Inc. PTFE Coated Electrode Tips - K081647) serve as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

December 1, 2023

Surgical Principals, Inc. Timothy Wynne President & CEO 1625 South Tacoma Way Tacoma. Washington 98409

Re: K230621

Trade/Device Name: LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 24, 2023 Received: October 24, 2023

Dear Timothy Wynne:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.12.01 15:03:26 -05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes

Indications for Use (Describe)

X 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/1 description: The image shows the logo for Surgical Principals, Inc. The logo is written in a blue sans-serif font. The "S" in Surgical and the "P" in Principals are stylized to look like surgical equipment.

510(k) K230621 510(k) Summary

1. SUBMITTER'S CONTACT INFORMATION

Company: Surgical Principals, Inc. Address: 1625 South Tacoma Way Tacoma, WA 98409 Contact Person: Timothy Wynne Phone: 253-709-2984

2. DEVICE NAME

Trade Name – LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes Common Name - Monopolar Laparoscopic Instruments Regulation Number - 21 CFR 878.4400 Classification Name - Electrosurgical, Cutting & Coaqulation Device and Accessories Product Code - GEI Device Classification - Class II Classification Panel - General and Plastic Surgery

3. PREDICATE DEVICE

The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes claim Substantial Equivalence to Xodus Medical, Inc. PTFE Coated Electrode Tips cleared under 510(k) K081647. Additionally, these devices claim the Unimax Medical Systems Laparoscopic Instruments cleared under 510(k) K103508 as a Secondary Predicate or Reference Device, specifically related to the Indication for Use.

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.

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Image /page/4/Picture/0 description: The image shows the logo for Surgical Principals, Inc. The logo is in blue and gray. The "S" in Surgical is stylized with a surgical instrument. The "P" in Principals is also stylized with a surgical instrument.

510(k) K230621

6. SUBSTANTIAL EQUIVALENCE TABLE

Category	Subject Device	Primary Predicate	Secondary Predicate / ReferenceDevice
Device	LaproGlide™ Disposable Monopolar PTFE CoatedLaparoscopic Probes (510(k) K230621)	Xodus Medical, Inc. PTFE CoatedElectrode Tips (510(k) K081647)	Unimax Medical Systems, UnimaxLaparoscopic Instruments (510(k)K103508)
Intended Use	The LaproGlide™ Disposable Monopolar PTFE CoatedLaparoscopic Probes are intended to be used in generallaparoscopic surgical procedures requiring the use of Monopolarelectrosurgical cutting and/or coagulation.	The intended use of this device is to conductmonopolar electrosurgical energy from anelectrosurgical unit (ESU), to an electrosurgicalelectrode consequently to the intended tissue to becut and/or coagulated.	The Unimax Laparoscopic Instrument is a family ofinstruments which includes forceps, scissors, andprobes which are intended to be used in generallaparoscopic surgical procedures requiring the useof Monopolar electrosurgical cutting and/orcoagulation.
Product Picture	Image: Foot-ActivatedImage: PTFE Coated TipImage: Hand-Activated	Image: Foot-ActivatedImage: PTFE Coated TipImage: Hand-Activated	Image: Foot-ActivatedImage: Non-Coated TipImage: Hand-Activated
Design	These devices include a stainless-steel core with PTFE-coated tip.The device is insulated with a combination of both polyolefin andPVDF insulation and include a connector on the proximal end foreither foot or hand activation.	Same	These devices include a stainless-steel core andnon-coated tip. The device is insulated withpolyolefin insulation and include a connector on theproximal end for either foot or hand activation.
Tip Geometries
Tip Geometries	Image: L-Hook, L-Wire, J-Hook, J-Wire, Curved Blade, Straight Blade, Round Spatula	Same	L-HookJ-HookRound Spatula
Diameter	5 mm	Same	Same
Length	33 to 45cm	Same	26 to 45cm
MaximumPower Settings	Cutting Mode = 1600 Vp (3200 Vp-p)Coagulation Mode = 2900 Vp (5800 Vp-p)	Unknown	Unknown
Biocompatibility	Conforms to ISO 10993	Same	Same
Sterilization	Sterilized using Ethylene Oxide for single patient usein accordance with ISO 11135 to an SAL of 10^-6.	Sterilized using Gamma Irradiation	Sterilized using EO Gas
Electrical Safety	IEC 60601-1IEC 60601-2-2	Unknown	Same
PrescriptionUse	Yes	Yes	Yes
IntendedEnvironment	Professional Healthcare Facility (Surgical Room orOperating theatre)	Same	Same

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urgical crincipals, Inc.

510(k) K230621

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7. NONCLINICAL TESTS

Nonclinical testing has been conducted to verify that these devices met all design specifications and are substantially equivalent to the predicate device. Testing included the following:

. Biocompatibility Testing performed in accordance with the following:
- ISO 10993-1: 2018 Biological evaluation of medical devices -Part 1: Evaluation and O testing within a risk management process (Recognition No. 2-258)
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro o cytotoxicity (Recognition No. 2-245)
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide O sterilization residuals (Recognition No. 14-408)
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin O sensitization (Recognition No. 2-296)
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for O systemic toxicity (Recognition No. 2-255)
- ISO 10993-23:2021 Biological evaluation of medical devices Part 10: Tests for O irritation (Recognition No. 2-291)
- Medical Electrical Equipment Safety Testing performed in accordance with the following:
  - ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and o A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (Recognition No. 19-4)
  - IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements o for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Recognition No. 6-389)
. Aging Study
. Ethylene Oxide Sterilization Validation per ISO 11135:2014 - Sterilization of health-care products - Ethylene Oxide (Recognition No. 14-529)

In addition, these devices have been compared to the predicate device through various performance studies designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy and thermal effects on tissue.

Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This requires testing on three different tissue types at minimum, default, and maximum generator power in order to simulate thermal spread across different tissue types. The spread is then measured under magnification, and recorded to be compared with the predicate product. Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings. Summary results are shown below.

Power Level	Thermal Damage Rateon Fatty Tissues( $\overline{X}$ ± σ², mm/s)	Thermal Damage Rateon Lean Tissues( $\overline{X}$ ± σ², mm/s)	Thermal Damage Rateon Extra Lean Tissue( $\overline{X}$ ± σ², mm/s)
25W	1.21 ±0.08	1.34 ±0.14	1.65 ±0.24
50W	1.60 ±0.26	2.34 ±0.30	2.40 ±0.24
90W	3.87 ±1.65	5.15 ±4.82	5.57 ±7.59

Table 1 - Rate of thermal damage on various tissue types

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Image /page/7/Picture/0 description: The image shows the logo for Surgical Principals, Inc. The logo is written in a blue sans-serif font. The "S" in Surgical is stylized to look like a surgical instrument, and the "P" in Principals is stylized to look like a surgical light.

8. CLINICAL TESTS

There were no clinical trials performed on these devices.

9. CONCLUSIONS

The subject device has equivalent indications for use as the predicate device. There are no new technologies being added to this device from the predicate, in terms of finished device functions. The device has the same intended use and application as 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.