(123 days)
The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772.
The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.
This document pertains to the 510(k) premarket notification for the Valleylab™ SM Smoke Management Pencil and accessories. It's important to note that this device is a physical electrosurgical tool and does not contain an AI component. Therefore, much of the requested information regarding acceptance criteria and studies for AI-driven devices (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training set details) is not applicable here.
However, I can extract and present the acceptance criteria and performance testing conducted for this device, which are relevant to its substantial equivalence determination.
Acceptance Criteria and Reported Device Performance
The substantial equivalence determination for the Valleylab™ SM Smoke Management Pencil and accessories is based on meeting various performance standards and demonstrating safety and efficacy comparable to its predicate device (Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772).
Here's a summary of the performance testing and their acceptance criteria, as reported in the 510(k) summary:
| Category | Acceptance Criteria (Met Standards/Requirements) | Reported Device Performance |
|---|---|---|
| Sterilization & Shelf-Life | Sterilization by ethylene oxide (EO) to sterility assurance level 10-6 in accordance with ISO 11135, ISO 11737-1, ISO 11737-2, and ISO 10993-7. Product packaging designed and validated per ISO 11607-1, ISO 11607-2, ASTM D4169. Shelf-life determination based on accelerated aging methods per ASTM F1980. | The Valleylab™ SM Smoke Management Pencil and accessories met the acceptance criteria for sterilization by ethylene oxide (EO) to sterility assurance level 10-6 in accordance with the applicable validation standards. Product packaging was designed and validated in accordance with packaging standards. The Valleylab™ SM Smoke Management Pencils are labeled for a 4-year shelf-life, and the Valleylab™ SM Smoke Management Extended Nozzles are labeled for a 5-year shelf-life in accordance with accelerated aging methods. |
| Biocompatibility | Requirements of biocompatibility standard ISO 10993-1 for the following endpoints: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. | The Valleylab™ SM Smoke Management Pencil and accessories met the requirements of biocompatibility standard ISO 10993-1 for the specified endpoints. |
| Software | N/A (The device is not a software-driven device). | The Valleylab™ SM Smoke Management Pencil does not contain software. |
| Electromagnetic Compatibility & Electrical Safety | Applicable clauses of electromagnetic compatibility standard IEC 60601-1-2 and electrical safety standards IEC 60601-1, and IEC 60601-2-2. | The Valleylab™ SM Smoke Management Pencil met the applicable clauses of electromagnetic compatibility standard IEC 60601-1-2 and electrical safety standards IEC 60601-1, and IEC 60601-2-2. |
| Performance Testing - Bench | Device requirements for mechanical, functional, reliability, and ex vivo thermal tissue effect testing. (Specific quantitative acceptance criteria are not detailed in this summary document but are implied to be met through internal validation.) | The Valleylab™ SM Smoke Management Pencil and accessories met the device requirements for mechanical, functional, reliability, and ex vivo thermal tissue effect testing. |
| Usability/Human Factors | Demonstration of safe and effective use for the intended users, intended use, and use environments according to methods in IEC 60601-1-6 and IEC 62366-1. | The Valleylab™ SM Smoke Management Pencil and accessories demonstrated safe and effective use for the intended users, intended use, and use environments according to methods in IEC 60601-1-6 and IEC 62366-1. |
Study Details Regarding Acceptance Criteria (as applicable to a non-AI medical device)
Given that this is a 510(k) submission for an electrosurgical pencil and accessories, and not an AI-driven device, the detailed questions regarding AI study methodology are largely not applicable. However, I will address what is known from the provided text for each point:
- A table of acceptance criteria and the reported device performance: See the table above.
- Sample sizes 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 test (e.g., number of units tested for sterilization, biocompatibility, electrical safety, or bench performance).
- The data provenance is not explicitly stated in terms of country of origin but is from Covidien LLC, a Medtronic company. The tests would be prospective in nature, as they involve testing the actual device prototypes or production samples against established standards.
- 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): Not applicable for this type of device testing. Ground truth (e.g., sterility, electrical safety, mechanical integrity) is established by adherence to recognized international and national standards, not expert consensus in the diagnostic sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device performance against technical standards is typically assessed through objective measurements, not human adjudication.
- 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, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, "ground truth" refers to the objective, measurable parameters defined by recognized international and national standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety and EMC, ASTM for packaging and shelf-life).
- The sample size for the training set: Not applicable, as this is not an AI device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device.
In conclusion, the Valleylab™ SM Smoke Management Pencil and accessories have undergone rigorous non-clinical performance evaluations against established medical device standards to demonstrate substantial equivalence to a predicate device. The nature of this product as a physical electrosurgical tool means that many of the AI-specific questions are not relevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 1, 2024
Covidien LLC Miranda Miles Sr. Regulatory Affairs Specialist 200 Medtronic Dr. Lafayette, Colorado 80026
Re: K240572
Trade/Device Name: Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10' (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15' (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10' (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4" (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5" (165mm) electrode) (VSMEN6) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 28, 2024 Received: February 29, 2024
Dear Miranda Miles:
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/cdrb/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
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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).
Your device is also subject to, among other requirements, the Quality System (OS) 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 (OS) 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-devices/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, vou 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).
Sincerelv.
Long H. Chen =S Digitally signed by Long H.Chen-S
Date: 2024.07.01 14:47:58 -04'00'
Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
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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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K240572
Device Name
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10' (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15' (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10' (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4" (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5" (165mm) electrode) (VSMEN6) Indications for Use (Describe) The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output
connector of an electrosurgical unit to the operative site for the desired surgical effect.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Medtronic
510(k) Summarv
Date: February 28, 2024
510(k) Submitter/Holder
Covidien llc 200 Medtronic Dr Lafayette, CO 80026
Contact
Miranda Miles, Sr Regulatory Affairs Specialist 800-255-6774 Telephone: Email: Miranda.r.miles@medtronic.com
Proposed Device
| Trade Name: | The Valleylab™ SM Smoke Management Pencil and accessories |
|---|---|
| Classification Name: | Electrosurgical cutting & coagulation device and accessories(21 CFR 878.4400, Class II, GEI) |
Predicate Device
| Trade Name: | The Valleylab™ Smoke Evacuation Rocker Switch Pencil and accessories |
|---|---|
| Classification Name: | Electrosurgical cutting & coagulation device and accessories(21 CFR 878.4400, Class II, GEI) |
| 510(k) Number: | K182772 (cleared 11/19/2018) |
| Manufacturer: | Covidien llc |
| Recalls: | None |
Device Description
The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772.
The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.
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Medtronic
Indications for Use
The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurgical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Comparison of Technological Characteristics with the Predicate Device
The proposed Valleylab™ SM Smoke Management Pencil and accessories have the same indications for use with different technological characteristics compared to the proposed slimmer pencil body and a swivel connection to a more flexible tubing. The proposed device has different button shapes, lower maximum rated accessory voltage, and expanded electrode compatibility.
| Proposed Device(s): | Predicate Device(s): | ||
|---|---|---|---|
| Characteristic | Valleylab™ SM SmokeManagement Pencils | Valleylab™ Smoke EvacuationRocker Switch Pencils | Comparison |
| VSMP10, VSMP15,VSMP10NSB,VSMEN4, VSMEN6 | SEP5000, SEP5015,SEP5000NSB, SEP5015NSB,SEA50595 | ||
| Classification Regulation | 878.4400 | 878.4400 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Indications | The Valleylab™ SM SmokeManagement Pencil andaccessories are designed forgeneral electrosurgicalapplications, including cutting andcoagulation, and for removingsurgical smoke generated byelectrosurgery when used inconjunction with an effectivesmoke evacuation system. Thepencil enables the operator toremotely conduct anelectrosurgical current from theoutput connector of anelectrosurgical unit to the operativesite for the desired surgical effect. | The smoke evacuation rockerswitch pencil is designed forgeneral electrosurgicalapplications, including cutting andcoagulation, and for removingsmoke generated by electrosurgerywhen used in conjunction with aneffective smoke evacuation system.The pencil enables the operator toremotely conduct anelectrosurgical current from theoutput connector of anelectrosurgical unit to the operativesite for the desired surgical effect. | Same |
| Contraindications | None | None | Same |
| Prescription Use Only | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Pencil(s) - VSMP10, VSMP15Nozzle(s) - VSMEN4, VSMEN6 | Pencil(s) - SEP5000, SEP5015Nozzle - SEA50595 | Same |
| Non-sterile | Pencil - VSMP10NSB | Pencil(s)- SEP5000NSB,SEP5015NSB | Same |
| Sterilization Method | Ethylene Oxide (EO) | Radiation (R) | Different - Differences inEstablished Category Asterilization methods. |
| Removable Extended Nozzle | Yes - VSMEN4, VSMEN6 | Yes - SEA50595 | Same |
| Instrument Design | Pencil | Pencil | Same |
| Instrument Dimensions (in) | 0.58 x 0.53 x 7.47 in | 0.8495 x 0.6430 x 7.50 in | Different - The proposed device isslimmer compared to the predicatedevice. |
| Instrument Weight (lbs) | 0.280 lbs | 0.334 lbs | Different - The proposed device islighter compared to the predicatedevice. |
| Smoke Nozzle Diameter at tip(in) | 0.320 in | 0.430 in | Different - The proposed nozzlesare narrower compared to thepredicate device. |
| Cord Length | 10 ft and 15 ft | 10 ft and 15 ft | Same |
| Energy Activation Type | Handswitching - Button | Handswitching - Rocker Switch | Different - Differences inhandswitching energy button type. |
| Energy Type | Monopolar Electrosurgery | Monopolar Electrosurgery | Same |
| ESU Compatibility / RatedAccessory Voltage (Vpk) | $4500 V_{pk}$ | $5550 V_{pk}$ | Different - Differences inmaximum Vpk compatibility. |
| ESU Connector | 3-prong plug | 3-prong plug | Same |
| Electrode Length (in) | 2.5 in | 2.5 in | Same |
| Characteristic | Proposed Device(s):Valleylab™ SM SmokeManagement PencilsVSMP10, VSMP15,VSMP10NSB,VSMEN4, VSMEN6 | Predicate Device(s):Valleylab™ Smoke EvacuationRocker Switch PencilsSEP5000, SEP5015,SEP5000NSB, SEP5015NSB,SEA50595 | Comparison |
| Electrode Diameter (in) | Standard 3/32 in. | Standard 3/32 in | Same |
| Electrode Interface | Non-hex and hex locking | Non-hex locking | Different - The proposed devicecan also accept hex lockinginterface electrodes. |
| Electrode and NozzleConfiguration | Fixed | Fixed | Same |
| Pencil to Tubing Joint | Swivel | Ball | Different - Differences in jointtype. |
| Patient Contacting MaterialsCompatible per ISO 10993-1 | Yes | Yes | Same |
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Medtronic
All differences have been evaluated using the substantial equivalence decision tree in the FDA guidance, "The 510/k) Program: Evaluating Substantial Equivalence in Premarket Notification (2014)." The evaluation and test results support a conclusion of substantial equivalence.
Performance Testing
The following test performance data were provided in support of the substantial equivalence determination of the ValleylabTM SM Smoke Management Pencil and accessories.
Sterilization and Shelf-Life
The Valleylab™ SM Smoke Management Pencil and accessories met the acceptance criteria for sterilization by ethylene oxide (EO) to sterility assurance level 10th in accordance with the applicable validation standards ISO 11135, ISO 11737-1, ISO 11737-2 and ISO 10993-7. Product packaging was designed and validated in accordance with packaging standards ISO 11607-1, ISO 11607-2, ASTM D4169. In addition, the Valleylab™ SM Smoke Management Pencils are labeled for a 4-year shelf-life, whereas the Valleylab™ SM Smoke Management Extended Nozzles are labeled for a 5-year shelf-life in accordance with accelerated aging methods per ASTM F1980.
Biocompatibilitv
The Valleylab™ SM Smoke Management Pencil and accessories met the requirements of biocompatibility standard ISO 10993-1 for the following endpoints: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.
Software
The Valleylab™ SM Smoke Management Pencil does not contain software.
Electromagnetic Compatibility and Electrical Safetv
The Valleylab™ SM Smoke Management Pencil met the applicable clauses of electromagnetic compatibility standard IEC 60601-1-2 and electrical safety standards IEC 60601-1, and IEC 60601-2-2.
Performance Testing - Bench
The Valleylab™ SM Smoke Management Pencil and accessories met the device requirements for mechanical, functional, reliability and ex vivo thermal tissue effect testing.
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Medtronic
Performance Testing - Animal
The Valleylab™ SM Smoke Management Pencil did not undergo animal testing.
Performance Testing - Clinical
The Valleylab™ SM Smoke Management Pencil did not undergo clinical studies.
Usability/Human Factors
The Valleylab™ SM Smoke Management Pencil and accessories demonstrated safe and effective use for the intended users, intended use, and use environments according to methods in IEC 60601-1-6 and IEC 62366-1.
Conclusion
The differences between the Valleylab™ SM Smoke Management Pencil and accessories relative to the predicate device did not raise different questions of safety or efficacy. The results of comparative testing to the predicate device and standards-based testing support the conclusion that the proposed device is substantially equivalent to the predicate device.
§ 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.