(58 days)
Not Found
No
The device description and performance studies focus on the physical design and functionality of smoke evacuation accessories for electrosurgical units, with no mention of AI or ML technologies.
No.
The device's primary functions are to remove surgical smoke and to remotely conduct an electrosurgical current for cutting and coagulation, which are procedural tools rather than direct therapeutic interventions for a disease or condition.
No
The device is an accessory to an electrosurgical unit used for cutting, cauterizing, and removing surgical smoke, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly outlines physical components like aspiration sheaths, electrosurgical pencil bodies, and integrated smoke evacuation channels. The performance studies focus on bench testing of these physical devices, electrical safety, biocompatibility, and sterilization validation, all related to hardware. There is no mention of software as a component or its function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used to remove surgical smoke during procedures that use an electrosurgical unit for cutting and cauterizing, and to conduct electrosurgical current. This is a surgical function, not a diagnostic one.
- Device Description: The description reinforces that the devices function as part of a system to remove smoke particles from the surgical site and/or conduct electrosurgical current.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on functionality (smoke capture), electrical safety, biocompatibility, and sterilization, which are relevant to a surgical device, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely related to the surgical procedure itself.
N/A
Intended Use / Indications for Use
The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.
The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing 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. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.
Product codes (comma separated list FDA assigned to the subject device)
GEI, FYD
Device Description
The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing.
PlumePen Smoke Evacuation Pencils: The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures.
PenAdapt and SnapEvac Electrosurgical Pencil Adapters: PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.
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
Not Found
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)
Non-clinical bench testing demonstrated that PlumePen (Elite, Pro and Ultra), SnapEvac and PenAdapt are safe and effective for their intended use and are substantially equivalent in design. intended use, principals of operation, and technical characteristics to the predicates, PlumePen integrated smoke evacuation pencil cleared under K103375 the PenAdapt 10 cleared under K000904. The following testing was performed:
- Functionality verification testing, including 90% smoke capture per ISO16571
- Electrical Safety (PlumePen) per IEC 60601-1 and IEC 60601-2-2
- Biocompatibility per ISO 10993-1
- Ethylene Oxide Sterilization Validation (PlumePen and SnapEvac) per ISO 11135
- E-beam Sterilization validation (PenAdapt) per ISO 11137-1
- Packaging Validation per ISO 11607-1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 27, 2023
ConMed Corporation Ali Abusaleh Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K230547
Trade/Device Name: PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, FYD Dated: February 27, 2023 Received: February 28, 2023
Dear Ali Abusaleh:
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. 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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
| Mark | Digitally signed by |
|---|---|
| Trumbore -S | Mark Trumbore -S |
| Date: 2023.04.27 | |
| 12:40:56 -04'00' |
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
SnapEvac Electrosurgical Pencil Adapter and PenAdapt Electrosurgical Pencil Adapter
Indications for Use (Describe)
The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.
Contraindications: This device should not be used for microsurgery.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Indications for Use
510(k) Number (if known)
Device Name
PlumePen (Elite, Pro and Ultra) Surgical Smoke Evacuation Pencil
Indications for Use (Describe)
The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The perator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 6 - 510(k) Summary of Safety and Effectiveness
CONMED Smoke Evacuation Devices: PlumePen, PenAdapt and SnapEvac
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
B. Company Contact
Ali AbuSaleh Requlatory Affairs Specialist (708) 407-4324 Aliabusaleh(@conmed.com Date prepared: 4/26/2023
C. Device Name
Proprietary Name:
Common Name: Model Numbers: Classification Name: Regulation Number: Product Code: Regulatory Class: Panel:
Proprietary Name:
Common Name: Model Numbers: Classification Name: Requlation Number: Product Code: Regulatory Class: Panel:
D. Predicate Device
Primary Predicate Device Name: Company Name: 510(k):
Additional Predicate Device Name: Company Name: 510(k):
PlumePen Surqical Smoke Evacuation Pencils (Elite, Pro and Ultra) Electrosurgical Smoke Evacuation Pencil Refer to Tables 6-1 and 6-2 in Section G Electrosurgical, Cutting & Coagulation & Accessories 878.4400 GEI = General and Plastic Surgery
PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter Electrosurqical Pencil Adapter Refer to Tables 6-1 and 6-2 in Section G Electrosurgical, Cutting & Coagulation & Accessories 878.5070 FYD ll General Hospital
PLUMEPEN Integrated Smoke Evacuation Pencil CONMED Corporation K103375
PenAdapt10 CONMED Corporation K000904
5
E. Device Description
The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing.
PlumePen Smoke Evacuation Pencils
The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures.
PenAdapt and SnapEvac Electrosurgical Pencil Adapters
PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.
F. Intended Use / Indications for Use
PlumePen Electrosurgical Pencils (Elite, Ultra and Pro)
The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing 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. Indicated for use to remove smoke plume from the surqical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.
SnapEvac and PenAdapt Electrosurgical Pencil Adapters
The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.
Contraindications: This device should not be used for microsurgery.
6
G. Comparison of the Technological Characteristics with the Predicate Device
The PlumePen Electrosurgical pencils (Elite, Pro and Ultra) are similar to the predicate device in that they remain an integration of two technologies, electrosurgery and smoke evacuation in a single device. Both the predicate and subject devices enable the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site while removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The subject and predicate devices have similar design features integrating a smoke capture channel into the main body of what is otherwise a standard electrosurgical handpiece. All PlumePen devices, including the predicate, comprise of the same critical parts: 1. Housing and buttons 2. Transparent/ translucent plume/smoke capture channel 3. Plastic Swivel 4. Electrosurgical blade 5. Power cord and suction hose.
The main difference between subject and predicate devices are the dimensions of the pencil body and placement of the smoke capture channel. The PlumePen line (Elite, Pro and Ultra) is safe, effective, and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.
| Features | Subject Device: PlumePen Electrosurgical
Pencil (Elite, Pro and Ultra) | Predicate Device: PlumePen Integrated Smoke
Evacuation Pencil |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model
Numbers | PLP1020-25, PLP2020-25, PLP2520-25,
PLPRO4020-25, PLPRO4520-25,
PLPUL2020-25, PLPUL2520-25, PLP1020,
PLP2020, PLP2520, PLPRO4020,
PLPRO4520, PLPUL2020 and
PLPUL2520-25 | PLP1000 and PLP2000 |
| 510(k) | K230547 | K103375 |
| Intended Use/
Indications for
Use | The PlumePen® Elite, PlumePen® Ultra, and
PlumePen® Pro is designed for general electrosurgical
applications, including cutting and coagulation, and for
removing 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. Indicated for use to
remove smoke plume from the surgical site and to
remotely conduct an electrosurgical current from the
output connector of an electrosurgical unit to the target
tissue for the desired surgical effect. | The PLUMEPEN is designed for general electrosurgical applications,
including cutting and
coagulation, and for removing 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.
Indications for use for PLUMEPEN® Integrated Smoke Evacuation
Pencil include:
a. To remove smoke plume from the surgical site.
b. To remotely conduct an electrosurgical current from the output
connector of an
electrosurgical unit to the target tissue for the desired surgical effect
c. To remove tissues and control bleeding by means of high
frequency electrical.
current |
| Polarity | Monopolar | Monopolar |
| Rated Voltage | 5 kVpk | 10kV P-P |
| Shelf-life | 3 years | 3 years |
| Sterilization
Method | Ethylene oxide, SAL of 10-6 | Ethylene oxide, SAL of 10-6 |
| Single use /
reusable | Single patient use device | Single patient use device |
| Electrical
Safety | Fulfils Electrical Safety requirements per
IEC 60601-1
Fulfils Electrical Safety requirements per
IEC 60601-2-2 | Fulfils Electrical Safety requirements per IEC 60601-1
Fulfils Electrical Safety requirements per IEC 60601-2-2 |
Table 6-1 Feature comparison between subject and predicate electrosurgical pencils
7
PenAdapt and SnapEvac electrosurgical pencil adapters are similar to the predicate device in that they remain a sheath that can accommodate a standard electrosurgical pencil and facilitate smoke evacuation at the site of electrosurgery. The subject devices and predicate device have similar design features integrating a smoke capture channel into an accommodating sheath allowing the pencil to be inserted electrode first through the sheath tip and be secured proximally before being connected to an effective smoke evacuation system through tubing. This main difference between subject and predicate is the use of ABS in the SnapEvac devices. PenAdapt and SnapEvac are safe, effective, and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.
| Features | Subject Device: PenAdapt and SnapEvac | Predicate Device: PenAdapt10 |
|---|---|---|
| Model Numbers | PA2010-25, PA2010B-25, SNAPEVAC20-25, | |
| PA2010, PA2010B and SNAPEVAC20 | PENADAPT10 | |
| 510(k) | TBD | K000904 |
| Intended Use/ | ||
| Indications for Use | The SnapEvac and PenAdapt is an aspiration sheath that | |
| fits over an electrosurgical pencil body and leaves the tip or | ||
| blade exposed. This device is considered an accessory to | ||
| an electrosurgical unit (ESU). SnapEvac and PenAdapt | ||
| removes surgical smoke during surgical procedures that use | ||
| ESU for cutting and cauterizing. This device is used in | ||
| conjunction with a suction (vacuum) source. | This device is an aspiration sheath that fits over an | |
| electrosurgical pencil body and leaves the tip or blade | ||
| exposed. This device is an accessory to an | ||
| electrosurgical unit (ESU). The device is used to | ||
| remove smoke, particles and body and other casual | ||
| fluids from the point of surgical activity during surgical | ||
| procedures that use ESU for cutting and cauterizing. | ||
| This device is used in conjunction with a suction | ||
| (vacuum) source. | ||
| Contraindications | This device should not be used for | |
| microsurgery. | This device should not be used for | |
| microsurgery. | ||
| Shelf-life | 3 years | 1 year |
| Sterilization Method | PenAdapt; Gamma | |
| SnapEvac; Ethylene oxide | Gamma | |
| Single use / reusable | Single patient use device | Single patient use device |
| Biocompatibility | Materials shall meet the requirements of ISO | |
| 10993-1 (tissue/bone/dentin externally | ||
| communicating device of limited duration) | Materials shall meet the requirements of | |
| ISO 10993-1 (tissue/bone/dentin externally | ||
| communicating device of limited duration) |
| Table 6-2 Feature comparison between subject and predicate electrosurgical Pencil Adapters |
|---|
H. Non-clinical Testing
Non-clinical bench testing demonstrated that PlumePen (Elite, Pro and Ultra), SnapEvac and PenAdapt are safe and effective for their intended use and are substantially equivalent in design. intended use, principals of operation, and technical characteristics to the predicates, PlumePen integrated smoke evacuation pencil cleared under K103375 the PenAdapt 10 cleared under K000904. The following testing was performed:
- Functionality verification testing, including 90% smoke capture per ISO16571 ●
- Electrical Safety (PlumePen) per IEC 60601-1 and IEC 60601-2-2
- Biocompatibility per ISO 10993-1 ●
- Ethylene Oxide Sterilization Validation (PlumePen and SnapEvac) per ISO 11135 .
- E-beam Sterilization validation (PenAdapt) per ISO 11137-1 ●
- Packaging Validation per ISO 11607-1
8
-Conclusion
The subject PlumePen Smoke Evacuation pencils (Elite, Pro and Ultra), are substantially equivalent in design, materials, indications for use, principles of operation, performance, and technological characteristics to the predicate PlumePen integrated smoke evacuation pencil cleared under K103375. Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject PlumePen family (Elite, Pro and Ultra) is substantially equivalent to the PlumePen integrated smoke evacuation pencil (K103375).
The subject PenAdapt and SnapEvac Electrosurgical Pencil Adapters, are substantially equivalent in design, materials, indications for use, principles of operation, performance, and technological characteristics to the predicate PenAdapt 10 cleared under K000904. Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy, and the subject Electrosurgical Pencil Adapters are substantially equivalent to the PenAdapt10 (K000904).