(270 days)
No
The device description and testing focus on the physical properties and electrosurgical performance of a coated electrode, with no mention of AI or ML capabilities.
Yes.
The device is used in general laparoscopic surgical procedures for electrosurgical cutting and coagulation of soft tissue, which is a therapeutic intervention.
No
The device is intended for electrosurgical cutting and coagulation of tissue during laparoscopic procedures, not for diagnostic purposes.
No
The device description clearly outlines physical hardware components (stainless-steel electrodes, PTFE coating, 5mm diameter, various tip geometries, connectors) and describes nonclinical testing related to these physical attributes and their interaction with tissue and electrical currents. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are surgical instruments used during a surgical procedure to cut and coagulate tissue within the body. They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly states "used in general laparoscopic surgical procedures requiring the use of Monpolar electrosurgical cutting and/or coagulation." This describes a surgical intervention, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are surgical devices, not IVDs.
N/A
Intended Use / 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.
Product codes
GEI
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.
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
Professional Healthcare Facility (Surgical Room or Operating theatre)
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)
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 ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, and ISO 10993-23. Medical Electrical Equipment Safety Testing performed in accordance with ANSI AAMI ES60601-1 and IEC 60601-2-2. Aging Study. Ethylene Oxide Sterilization Validation per ISO 11135:2014. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Thermal Damage Rate on Fatty Tissues: 1.21 ±0.08 mm/s at 25W, 1.60 ±0.26 mm/s at 50W, 3.87 ±1.65 mm/s at 90W.
Thermal Damage Rate on Lean Tissues: 1.34 ±0.14 mm/s at 25W, 2.34 ±0.30 mm/s at 50W, 5.15 ±4.82 mm/s at 90W.
Thermal Damage Rate on Extra Lean Tissue: 1.65 ±0.24 mm/s at 25W, 2.40 ±0.24 mm/s at 50W, 5.57 ±7.59 mm/s at 90W.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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).
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes
Indications for Use (Describe)
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.
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
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.
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 / Reference
Device |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | LaproGlide™ Disposable Monopolar PTFE Coated
Laparoscopic Probes (510(k) K230621) | Xodus Medical, Inc. PTFE Coated
Electrode Tips (510(k) K081647) | Unimax Medical Systems, Unimax
Laparoscopic Instruments (510(k)
K103508) |
| Intended 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. | The intended use of this device is to conduct
monopolar electrosurgical energy from an
electrosurgical unit (ESU), to an electrosurgical
electrode consequently to the intended tissue to be
cut and/or coagulated. | The Unimax Laparoscopic Instrument is a family of
instruments which includes forceps, scissors, and
probes which are intended to be used in general
laparoscopic surgical procedures requiring the use
of Monopolar electrosurgical cutting and/or
coagulation. |
| Product Picture | Image: Foot-Activated
Image: PTFE Coated Tip
Image: Hand-Activated | Image: Foot-Activated
Image: PTFE Coated Tip
Image: Hand-Activated | Image: Foot-Activated
Image: Non-Coated Tip
Image: Hand-Activated |
| Design | These devices include a stainless-steel core with PTFE-coated tip.
The device is insulated with a combination of both polyolefin and
PVDF insulation and include a connector on the proximal end for
either foot or hand activation. | Same | These devices include a stainless-steel core and
non-coated tip. The device is insulated with
polyolefin insulation and include a connector on the
proximal 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-Hook
J-Hook
Round Spatula |
| Diameter | 5 mm | Same | Same |
| Length | 33 to 45cm | Same | 26 to 45cm |
| Maximum
Power 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 use
in accordance with ISO 11135 to an SAL of 10^-6. | Sterilized using Gamma Irradiation | Sterilized using EO Gas |
| Electrical Safety | IEC 60601-1
IEC 60601-2-2 | Unknown | Same |
| Prescription
Use | Yes | Yes | Yes |
| Intended
Environment | Professional Healthcare Facility (Surgical Room or
Operating theatre) | Same | Same |
5
urgical crincipals, Inc.
510(k) K230621
6
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 Rate
on Fatty Tissues
( $\overline{X}$ ± σ², mm/s) | Thermal Damage Rate
on Lean Tissues
( $\overline{X}$ ± σ², mm/s) | Thermal Damage Rate
on 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.