(133 days)
Not Found
Not Found
No
The description focuses on the mechanical and electrical function of the device for creating a tunnel using radio frequency energy. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML information.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is used to place a wound drain for fluid evacuation, which is a surgical procedure to aid in healing, but the device itself does not directly treat a disease or condition. It is a surgical tool, not a therapeutic agent.
No
The device is described as a "wound drain placement device" used in "general surgical procedures to place a wound drain for evacuation of serosanguineous fluid, blood, pus, or other bodily fluids." It uses electrocautery action to create a tunnel for the drain. There is no mention of the device being used to identify, measure, or monitor a disease, condition, or physiological state.
No
The device description clearly outlines physical components (insulated wire, drain tube, cutting tip, hand grip) and a mechanism of action involving radio frequency energy and an electrosurgical generator, indicating it is a hardware device.
Based on the provided information, the Pioneer Laboratories Elec-Trocar is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to place a wound drain for the evacuation of bodily fluids during a surgical procedure. This is a surgical tool used in vivo (within the body).
- Device Description: The device description clearly outlines a surgical instrument that uses radio frequency energy to cut tissue and create a tunnel for a drain. This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Elec-Trocar does not perform any analysis or testing of bodily fluids; it simply facilitates their removal.
Therefore, the Pioneer Laboratories Elec-Trocar is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pioneer Laboratories Elec-Trocar is intended to be used in general surgical procedures to place a wound drain for evacuation of serosanguineous fluid, blood, pus, or other bodily fluids.
The device is used in general surgical procedures to place a wound drain by electrocautery action for extraction of serosanguineous fluid, blood, pus, or other bodily fluids.
Product codes (comma separated list FDA assigned to the subject device)
GBS,GEI
Device Description
The Pioneer Laboratories Elec-Trocar is a wound drain placement device. It cuts with radio frequency energy supplied by an electrosurgical generator to create a tunnel from the inside cavity of the wound through the skin. The Elec-Trocar is composed of an insulated wire, a drain tube surrounding the wire, and an exposed cutting tip, which is connected to the wire and positioned at the distal end of the tube. The proximal end of the wire connects to a conventional electrosurgical generator with an adapter. The electrosurgical current is activated with the generator's footswitch controls.
The cutting tip is positioned inside the wound area, and the Elec-Trocar is activated electrically via the footswitch. The cutting tip is advanced through the tissue, toward and through the skin. After the entire hand grip is positioned outside the skin, the wire is detached from the generator and the hand grip is cut off. The insulated wire is then pulled from the drain tube retrograde through the wound, leaving the drain tube in the tissue tunnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
K97/728
5. 510(k) SUMMARY
A. ADMINISTRATIVE INFORMATION
Manufacturer Identification and Sponsor:
SEP | 9 1991
Pioneer Laboratories 375 River Park Circle Marquette, MI 49855
Establishment Registration Number: 1833824
Official Contact: Burns Severson Senior Vice President
B. DEVICE IDENTIFICATION
Proprietary Name: Pioneer Elec-Trocar Device
Common Name:
Classification Name and Reference: Device, Electrosurgical, CFR 878.4200
Regulatory Class: II
Device Product Code: GBS
Devices on which substantial equivalence is claimed:
Snyder Hemovac Round Drain with Trocar
Valleylab Footswitching Pencil
ConMed Trogard Universal Trocar
C. DEVICE DESCRIPTION
The Pioneer Laboratories Elec-Trocar is a wound drain placement device. It cuts with radio frequency energy supplied by an electrosurgical generator to create a tunnel from the inside cavity of the wound through the skin. The Elec-Trocar is composed of an insulated wire, a drain tube surrounding the wire, and an exposed cutting tip, which is connected to the wire and positioned at the distal end of the tube. The proximal end of the wire connects to a conventional electrosurgical generator with an adapter. The electrosurgical current is activated with the generator's footswitch controls.
The cutting tip is positioned inside the wound area, and the Elec-Trocar is activated electrically via the footswitch. The cutting tip is advanced through the tissue, toward and through the skin. After the entire hand grip is positioned outside the skin, the wire is detached from the generator and the hand grip is cut off. The insulated wire is then pulled from the drain tube retrograde through the wound, leaving the drain tube in the tissue tunnel.
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5. 510(k) SUMMARY (Cont'd)
D. INTENDED USE
The Pioneer Laboratories Elec-Trocar is intended to be used in general surgical procedures to place a wound drain for evacuation of serosanguineous fluid, blood, pus, or other bodily fluids.
E. TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICES
The Elec-Trocar and the Snyder Round Drain with Trocar both place silicone or PVC wound drains. The Snyder Drain utilizes a sharp, stainless steel trocar for puncturing a hole through tissue to place the drain, while the Elec-Trocar utilizes a stainless steel blunt tip, powered by electrocautery action (radio frequency energy) from an electrosurgical generator.
The electrosurgical characteristics of the Elec-Trocar are similar to the Valleylab footswitching pencil and the ConMed TroGard. The Elec-Trocar has the same wire terminal connection to the generator as the Valleylab pencil. The Trogard has a stainless steel blunt tip like the Elec-Trocar and is used to cut a tissue tunnel with radio frequency energy.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Burns Severson .V.P. Regulatory Affairs and Quality Assurance Pioneer Laboratories 375 River Park Circle Marquette, Michigan 49855
SEP 1 9 1997
Re: K971728 Trade Name: Pioneer Elec-Trocar Device Regulatory Class: II Product Code: GEI Dated: August 25, 1997 Received: August 29, 1997
Dear Mr. Severson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Burns Severson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Scott McWhorter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Pioneer Laboratories. The logo features a stylized image of a test tube and the company name in bold, sans-serif font. The word "Pioneer" is in a larger font size than "Laboratories". The logo is black and white.
375 River Park Circle Marquette, MI 49855
phone (906) 226-9909 fax (906) 226-9932
PIONEER LABORATORIES ELEC-TROCAR DEVICE
INDICATION FOR USE
The device is used in general surgical procedures to place a wound drain by electrocautery action for extraction of serosanguineous fluid, blood, pus, or other bodily fluids.
Pioella
(Division Sign-Off) Division of General Restorative D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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