(57 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties for smoke evacuation, with no mention of AI or ML technologies.
No.
The device's intended use is to capture smoke and odors at the surgical site for improved visibility, not to treat a disease or condition directly. It functions as an accessory to an electrosurgical pencil and a smoke evacuator.
No
The device is described as an accessory to an electrosurgical pencil that improves visibility and captures smoke and odors during surgery. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components (pencil holding clamp, wire holder, tubing pathway, connector) and describes it as a single-use hardware accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to improve visibility and capture smoke and odors directly at the surgical site during electrosurgery. This is a function performed in vivo (on a living organism) during a surgical procedure.
- Device Description: The description details a physical accessory that attaches to an electrosurgical pencil to manage surgical smoke. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed for use during a surgical procedure to manage a byproduct of that procedure (smoke), not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The New Deantronics Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Smoke Evacuation Adapter is a single-use device provided to healthcare professionals. This device is an accessory to an electrosurgical pencil. The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator. The device components include a pencil holding clamp, an electrosurgical pencil wire holder, smoke evacuator tubing pathway to the smoke evacuator, and a connector to the smoke evacuator. The clamp secures the smoke evacuation pencil adapter to the bottom of the pencil handle. Suction to remove smoke and odors is created by a smoke evacuator device furnished by the user organization. The smoke evacuator maintains a low pressure condition by a suction pump.
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
healthcare professionals / hospital, clinic
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 tests were successfully performed on the Smoke Evacuation Adapter to demonstrate that the device is as safe, as effective, and performs as well or better than the predicate device.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting hair or clothing. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top half of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2015
New Deantronics Taiwan, LTD. % Mr. Lewis Ward L. W. Ward and Associated Incorporated 4655 Kirkwood Court Boulder, Colorado 80301
Re: K152031
Trade/Device Name: Smoke Evacuation Adapter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 20, 2015 Received: July 22, 2015
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152031
Device Name Smoke Evacuation Adapter
The New Deantronics Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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.
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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."
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Image /page/3/Picture/0 description: The image shows the logo for New Deantronics Group. The logo features the word "NEW" in a light gray outlined font, followed by a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in a bold, blue font. Below the logo, the words "New Deantronics Group" are written in a smaller, blue font.
Section 5 510(k) Summary
Submitter:
New Deantronics Taiwan Ltd. 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist. New Taipei City 23675, Taiwan R.O.C. (886) 2-2268-1726 Phone (886) 2-2268-3800 Fax
大稳企業股份有限公司 New Deantronics Taiwan, Ltd 土城市中央路4段51號12 12F .. No.51. St a Yang Rd., Tu Ch Tel: 886 2 2268-1726 Fax: 886 2 2268-3800
Taiwan
Contact Person: Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 USA 303-530-3279 lwward@gwest.net
Date Prepared: July 20, 2015
Trade Name: Smoke Evacuation Adapter I.
New Deantronics Ltd 1990 North California Blvg
U.S.
II. Common Name: Electrosurgical accessory, Smoke Evacuation Adapter
III. Classification: 21 CFR 878.4400, electrosurgical cutting and coagulation device and accessories. Class 2, General and Plastic Surgery Panel 79
IV. Product Code: GEI
V. Indications for Use:
The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.
VI. Predicate Device 510(k) 945260, Valleylab Inc., Smoke Evacuation Attachment for Electrosurgical Pencils
VII. Device Description and Technological Characteristics
The Smoke Evacuation Adapter is a single-use device provided to healthcare professionals.
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Image /page/4/Picture/0 description: The image shows the logo for New Deantronics. The logo features the word "NEW" in a light blue, outlined font, followed by a blue circle with a red dot in the center. To the right of the circle, the word "DEANTRONICS" is written in a bold, blue font. Below the word "DEANTRONICS", the words "New Deantronics Group" are written in a smaller, light blue font.
This device is an accessory to an electrosurgical pencil. The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator. The device components include a pencil holding clamp, an electrosurgical pencil wire holder, smoke evacuator tubing pathway to the smoke evacuator, and a connector to the smoke evacuator. The clamp secures the smoke evacuation pencil adapter to the bottom of the pencil handle. Suction to remove smoke and odors is created by a smoke evacuator device furnished by the user organization. The smoke evacuator maintains a low pressure condition by a suction pump.
Taiwan
球企業股份有限公司 Fax: 886 2 2268-38
U.S
New Deantronics Ltd.
1990 North Califomia Blvd.
Suite 1040
Walnut Creek, CA. 94596
Tel: (925) 280 8388
Fax: (925) 280 1788
Table 1: New Deantronics Smoke Evacuation Adapters
Four models are available, branded as "E Surgical".
| Item | Catalog No. | ND P/N | Description |
|---|---|---|---|
| 1 | SA01 | AE710SE1 | Smoke Evacuation Adapter, with 10mm (3/8") |
| x 20.35cm (0.70 ft) tubing with a connector to | |||
| 10mm (3/8") hose, Single Use, Sterile | |||
| 2 | SA02 | AE711SE1 | Smoke Evacuation Adapter, with 10mm (3/8") |
| x 163cm (5.5ft) tubing with a connector to 22 | |||
| mm (7/8") x 145cm (5 ft) hose, Single Use, | |||
| Sterile |
Table 2: New Deantronics Electrosurgical Pencil with Smoke Evacuation Adapter
| Item | Catalog No. | ND P/N | Description |
|---|---|---|---|
| 1 | PEN11SA01 | PB314SE1 | Button Switch Electrosurgical Pencil, Smoke |
| Evacuation Adapter, with 10mm (3/8") x | |||
| 20.35cm (0.70 ft) tubing with a connector to | |||
| 10 mm (3/8") hose, Single Use, Sterile | |||
| 2 | PEN11SA02 | PB314SE2 | Button Switch Electrosurgical Pencil, Smoke |
| Evacuation Adapter, with 10mm (3/8") x | |||
| 163cm (5.5ft) tubing with a connector to 22 | |||
| mm (7/8") x 145cm (5 ft) hose, Single Use, | |||
| Sterile |
VIII. Non-Clinical Testing
IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-2-2: 2009 (Fifth Edition) + C1:2014, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
ISO 14971:2007, Medical Device- Application of Risk Management to Medical Devices
ISO 10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.
ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.
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Image /page/5/Picture/0 description: The image is a logo for New Deantronics. The logo features the word "NEW" in a light blue, outlined font, followed by a blue circle with a red dot in the center. To the right of the circle, the word "DEANTRONICS" is written in a bold, blue font. Below the word "DEANTRONICS", the words "New Deantronics Group" are written in a smaller, blue font.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-12: 2012, Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials.
ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose.
Taiwan
U.S.
New Deantronics Ltd
1990 North California Blvd
Valnut Creek, CA 9459
大蕴企業股份有限公司 New Deantronics Taiwan, Ltd 縣土城市中央路4段51號12: 12F No.51.9 hong Yang Rd., Tu Ch Fax: 886 2 2268-38
ISO 11607:2006. Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]; Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)].
ISTA 2A Packaged-Products 150 lb (68 kg) or Less
IEC 62366:2007 Medical Devices - Application of Usability Engineering to Medical Devices
Non-clinical testing conclusion:
The non-clinical tests were successfully performed on the Smoke Evacuation Adapter to demonstrate that the device is as safe, as effective, and performs as well or better than the predicate device.
IX. Substantial Equivalence
The Smoke Evacuation Adapter is substantially equivalent to the Valleylab (Covidien) Smoke Evacuation Attachment for Electrosurgical Pencils (K945260) based on design, intended use, technology, materials, comparison testing, and performance. Both devices require a user-furnished smoke evacuator to remove the smoke and odor.
| X. Key Features Comparison to Predicate | ||
|---|---|---|
| FEATURE | New Deantronics Smoke Evacuation Adapter | Valleylab (Covidien) Smoke Evacuation Attachment for Electrosurgical Pencils (K945260) |
| Use Environment | Single Use, hospital, clinic | Single Use, hospital, clinic |
| Sterilization Method | Gamma radiation | Gamma radiation |
| Construction Design | Pencil holder, suction tube, wire holders, swivel connector, and connector to smoke evacuator | Pencil holder, suction tube, wire holders, swivel connector, and connector to smoke evacuator |
| Inlet Diameter | Approx. 10 mm | Approx. 10 mm |
| Material of suction tube | EVA | EVA |
| Connector Tube | 10 mm and 22 mm | ~10 mm |
| Materials of pencil adapter | ABS + PC | Polystyrene (PS) |
| Requires smoke evacuator suction device with a 10 mm or 22 mm port | 10 mm and 22 mm | 10 mm |